head and neck cancer

Expert Asserts Pembrolizumab to Play Important Role in Head and Neck Cancer Treatment

Source: www.targetedonc.com
Author: Laura Panjwani


The FDA approval of pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in August 2016 was extremely significant for this patient population, which previously had limited options following progression on a platinum-based chemotherapy.

The approval was based on the phase Ib KEYNOTE-012 study, which demonstrated that pembrolizumab had an overall response rate (ORR) of 18% and a stable disease rate of 17% in patients with recurrent/metastatic HNSCC.

Several other studies are further evaluating the immunotherapy agent in HNSCC.Preliminary results of the phase II KEYNOTE-055 study—which included 92 evaluable patients who received pembrolizumab after failing platinum and cetuximab therapies—were presented at the 2016 ASCO Annual Meeting.

In an interview with Targeted Oncology, lead study author Joshua M. Bauml, MD, an assistant professor of Medicine, Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center, discusses the impact of pembrolizumab’s success in HNSCC, the results of the KEYNOTE-055 study, and what he sees on the horizon for the PD-1 inhibitor in this field.

TARGETED ONCOLOGY: What role do you envision pembrolizumab having in this patient population?

Baumi: It is going to play a critical role in head and neck cancer. The other agents that are available have limited efficacy, and are associated with significant toxicities. This is a clear improvement for our patient population with limited options.

TARGETED ONCOLOGY: What were the key takeaways from KEYNOTE-055? Baumi: Patients with recurrent/metastatic head and neck cancer that is refractory to both platinum-based therapy and cetuximab (Erbitux) really have very few options. The historical reference population we usually use is patients treated with methotrexate, which has a response rate of 5% and an overall survival (OS) of only about 6 months. There is a really great need for this. For pembrolizumab, which is an anti–PD-L1 agent, there is biologic rationale to think that it would be active in this patient population. PD-L1 and PD-L2 are unregulated in head and neck cancer.

What KEYNOTE-055 did is really try and create a homogenous patient population. Rather than a large phase I study, here are patients all who have failed both platinum-based therapy and cetuximab. We have really identified the sickest patient population.

What we are able to show in this study was that the drug was well tolerated and it has a response rate of 17% to 18%, which compares favorably for the 5% seen with the prior data with methotrexate. The OS rate was 8 months, which again compares very favorably to the 6 months seen with methotrexate. This was true, even though 85% of patients had received at least 2 prior treatments for head and neck cancer.

TARGETED ONCOLOGY: What did this study tell us about the safety of pembrolizumab in head and neck cancer?

Baumi: The rate of grade 3 through 5 treatment-related adverse events was 12% in our study. Nearly all of the side effects are what you would expect with pembrolizumab; those have been reported in multiple other studies. There was 1 treatment-related death due to pneumonitis, which is a rare side effect of this class of drugs.

Outside of that, it was a really well-tolerated agent. The fact that if you compared grade 3 through 5 toxicities of 12% with cytotoxic chemotherapy, this is a very well-tolerated agent.

TARGETED ONCOLOGY: How common is it for patients to fail both platinum-based therapy and cetuximab?

Baumi: Any patient who has recurrent or metastatic head and neck cancer is going to go through these agents if they survive long enough to get them. Basically, we know that these are the limited tools in our toolbox. We have platinum, we have cetuximab, and then we are really out of options. Many patients have received cetuximab in the locally advanced setting and so we have already lost one of our active treatments. This affects a lot of people.

TARGETED ONCOLOGY: What is next for pembrolizumab in head and neck cancer?

Baumi: There are currently phase III studies evaluating pembrolizumab in head and neck cancer both in combination with and versus traditional cytotoxic chemotherapy to see if we can move up the treatment earlier for patients. The key difference between pembrolizumab and cytotoxics is beyond the improved safety profile. However, we have durable responses; 75% of those patients who responded are still responding to this day. That is really not something that we see.

TARGETED ONCOLOGY: What are the biggest questions that remain regarding the treatment of patients with metastatic head and neck cancer?

Baumi: One of the key questions that relates to immunotherapy—and this covers all tumors—is trying to identify who the 20% of patients are that will respond. Eighty percent of our patients are not responding to our therapies.

Identifying a biomarker to enrich this patient population is very critical. Right now, I would not select patients for pembrolizumab by virtue of PD-L1 status because there were responses in the PD-L1–negative cohorts.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

September, 2016|Oral Cancer News|

Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com
Author: Laura Panjwani


Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD.

“Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.”

The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator’s choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN.

The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator’s choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act.

Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN.

OncLive: What were the updated findings from CheckMate-141 presented at ASCO?

Ferris: The data that were presented at the 2016 ASCO Annual Meeting were further evaluations and follow-up on some preliminary data—originally presented at the 2016 AACR Annual Meeting—that listed the OS results.

At ASCO, we recapped the primary endpoint of OS as an important endpoint for immunotherapies because response rate and progression-free survival may not be as accurate. Ultimately, the FDA and people at large want OS. In this study, OS was 36% at 1 year in the nivolumab-treated arm and 16.6% in the comparator arm, which was investigator’s choice of single-agent chemotherapy, consisting of methotrexate, docetaxel, or cetuximab. In this phase III randomized trial, nivolumab was given in a 2:1 randomization: 240 patients received nivolumab and 120 received investigator’s choice.

Also at ASCO, we presented further evaluations consisting of what the regimens are in the comparator arm. There was about 20% each of docetaxel and methotrexate and 12% of cetuximab. Approximately 60% of the patients had prior cetuximab exposure and we stratified by cetuximab as a prior therapy. We also demonstrated the ORR, which was 13.3% in the nivolumab-treated arm versus 5.8% in the investigator’s choice arm.

Therefore, there was an improvement in overall response, but the difference seemed more modest than the OS benefit—which was a doubling—with 20% more patients alive at 1 year. This reinforces the concept that perhaps response rate may not be the best endpoint. Progression-free survival (PFS) was double at 6 months, with about 20% in the nivolumab arm versus about 9.9% in the investigator’s choice arm. The median PFS was not different, but the 6-month PFS was twice as high. The time to response was about 2 months in each arm at the first assessment.

Your analysis also looked at biomarkers. Can you discuss these findings and their significance?

The p16 or HPV-positive group had a better hazard ratio for OS than the overall study population. The hazard ratio was .73 for the overall population, using a preplanned interim analysis. With the HPV-positive group, we had a hazard ratio of .55 and the HPV-negative group had a hazard ratio of .99. It is still favoring the nivolumab-treated patients but, with the curves separated earlier in the HPV-positive group, one could see the improvement with nivolumab at about 1 to 2 months. It took 7 or 8 months with the HPV-negative group to show a separation of the curves in favor of nivolumab.

We looked at PD-L1 levels, and PD-L1—using a 1% or above level—had an improvement in the PD-L1–positive patients in favor of nivolumab in terms of OS and ORR. When we looked at 5% and 10% thresholds of PD-L1, the OS did not seem to improve. Therefore, in all levels above 1%, the OS was similarly beneficial over the PD-L1 less-than-1% group. However, essentially all levels of PD-L1–positivity and PD-L1–negativity still favored nivolumab, but the benefit was more when its levels were greater than 1%.

We could combine HPV status with PD-L1 status and look at subsets; however, essentially every subset benefited, whether it was PD-L1–negative or positive. This indicates that, in this group of patients, who progress within 6 months of platinum-based therapy, that no current systemic therapeutic options benefit patients as well as nivolumab.

With regard to these findings, what are you most excited about?

Head and neck cancer is a difficult disease. Until recently, we didn’t know the impact of this enrichment for HPV-positive virus-induced subsets and we didn’t know if this was an immune responsive cancer. Clearly, it is. We have all of the hallmarks that we have seen for a bright future—based on the melanoma data—and a series of other cancers indicating response rates in the 15% to 20% range, suggesting that we now have a platform of the PD-1 pathway to combine with other checkpoints and to integrate earlier in disease with radiation and chemotherapy.

We have a demonstration of head and neck cancer as an immune-responsive cancer. We are beginning to get an idea of the biomarkers and starting to be able to segment patients who will benefit. Now, we have a large comparative trial with an OS endpoint and tissue to look at biomarkers to try and understand what the best future combinations will be.

What are some questions that you still hope to answer regarding nivolumab in head and neck cancer?

We have to get down deeper into the nonresponders. We should acknowledge that the majority of patients neither had a response nor benefited. Understanding who is more likely to benefit is useful, but we also need to understand the levels of alternative checkpoint receptors or other biomarkers of resistance.

We have sequential lymphocyte specimens from the peripheral blood, tissues, and serum so those are intensively under evaluation. There are interferon gamma signatures that have risen from the melanoma checkpoint field that will certainty be applied, as well.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

August, 2016|Oral Cancer News|

FDA Spends $36 Million on Anti-Chewing Tobacco Ad Campaign

Source: www.freebeacon.com
Author: Elizabeth Harrington
Cans of smokeless tobacco sit in the Tampa Bay Rays dugout before a baseball game between the Rays and the Baltimore Orioles, Wednesday, April 14, 2010, in Baltimore. After hounding Major League Baseball and its players union over steroids, Congress now wants the sport to ban smokeless tobacco. (AP Photo/Rob Carr)

Cans of smokeless tobacco sit in the Tampa Bay Rays dugout before a baseball game between the Rays and the Baltimore Orioles, Wednesday, April 14, 2010, in Baltimore. After hounding Major League Baseball and its players union over steroids, Congress now wants the sport to ban smokeless tobacco. (AP Photo/Rob Carr)

The Food and Drug Administration is spending $36 million on an anti-chewing tobacco advertising campaign targeted at white male teenagers in the midwest.

The federal agency announced Tuesday it is expanding its “Real Cost” anti-tobacco campaign to “educate rural, white male teenagers” and convince them to stop dipping.

“Smokeless tobacco use is culturally ingrained in many rural communities,” the FDA said. “For many, it has become a rite of passage, with these teenagers seeing smokeless tobacco used by role models, such as fathers, grandfathers, older brothers, and community leaders.”

The campaign will run television, radio, and print advertisements, as well as put up public signs and billboards and post on social media.

An FDA spokesperson told the Washington Free Beacon that the total cost for the campaign is $36 million, which will be financed through taxes on tobacco manufacturers. Paid ads will cost $20 million, and the remaining budget will cover “research, strategic planning, creative development, and contract management.”

The agency is also partnering with two dozen minor league baseball teams in the midwest that will host anti-chewing tobacco events and feature advertisements from the campaign.

“Amplification of messaging from the campaign will take place at 25 Minor League Baseball stadiums throughout this summer using a variety of efforts, including sponsoring in-stadium events, the placement of print ads, running of television ad spots, and opportunities for fans to engage with players who support the FDA’s efforts on smokeless tobacco,” said Tara Goodin, an FDA spokesperson.

The list of minor league clubs participating in the campaign includes the Albuquerque Isotopes, the Fargo-Moorhead Redhawks, the Traverse City Beach Bums in Michigan, the Sioux Falls Canaries, and the Burlington Bees, an Iowa farm team for the Los Angeles Angels.

Chewing tobacco has been banned at ballparks in Los Angeles, San Francisco, and Boston, including Fenway Park, and major leaguers can face $250 fines and “are subject to discipline” from Major League Baseball’s Commissioner Rob Manfred if they dip during games.

ESPN reported that signs are now posted in Fenway with a phone number so individuals can call to report on other fans they see chewing tobacco to “alert security.”

The FDA provided an example of one of its new campaign ads, which features a man at a bowling alley with a can of chewing tobacco in his back pocket.


“This can can cause mouth cancer, tooth loss, brown teeth, jaw pain, white patches, gum disease,” text on the ad reads.

The campaign is targeted at white males aged 12 to 17 who are using smokeless tobacco, which the FDA estimates to be 629,000 nationwide, or 0.19 percent of the U.S. population of 318.9 million.

“Not only is the target audience using smokeless tobacco at a high rate, but many do not fully understand the negative health consequences of their actions,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “In communities where smokeless tobacco use is part of the culture, reaching at-risk teens with compelling messaging is critical to help change their understanding of the risks and harms associated with smokeless tobacco use.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Minimizing Imaging for Recurrence of HPV-Associated Head & Neck Cancer

Source: www.journals.lww.com/oncologytimes
Author: Robert H. Carlson


SCOTTSDALE, ARIZ.—Most recurrences of HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) can be found through imaging and physical exams within six months after treatment, according to a study from the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla.

“For most patients with HPV-associated oropharyngeal cancer who have had a negative three-month PET scan, physical exams with history and direct visualization are sufficient to find recurrences,” said Jessica M. Frakes, MD, Assistant Member of the Department of Radiation Oncology at the institute and lead author on the study, in a presentation at the 2016 Multidisciplinary Head & Neck Cancer Symposium.

“Minimizing the number of exams that do not compromise outcomes not only helps decrease anxiety and stress for our patients, but also eases the financial burden of cancer care,” she said.



The study also supports the effectiveness of specialist teams in treating HPV-positive OPSCC with definitive radiation therapy. Frakes said local control at three years was 97.8; regional control 95.3 percent; locoregional control 94 percent; and freedom from distant metastases 91.4 percent.

Three-year overall survival was 91 percent.

“The number of OPSCC patients and survivors is growing, so there is a great need to determine the general time to recurrence and the most effective modes of recurrence detection in order to guide optimal follow-up care,” Frakes said.

But National Comprehensive Cancer Network (NCCN) guidelines for treatment of OPSCC are “one size fits all,” she said, with the same follow-up recommendations whether the disease is HPV-associated or not.

To identify patterns in recurrence detection, the researchers examined 246 cases of HPV- or p16-positive non-metastatic OPSCC patients treated with definitive radiation therapy at Moffitt between 2006 and 2014. Of those, 84.6 percent received radiation therapy and a concurrent systemic therapy, and 15.4 percent received definitive radiation therapy alone.

Patients then underwent a PET/CT scan three months after completing treatment. They also had physical exams every three months in the first year following treatment, every four months in the second year, and every six months in years three through five.

Median follow-up care length for all patients was 36 months. Recurrence and survival rates were calculated from the end of radiation therapy.

“Our local control was excellent,” Frakes said, reporting 98 percent of local failures were detected by physical exam, with either direct visualization (two cases) or flexible laryngoscopy (four cases); 89 percent of regional failures were found due to symptoms—primarily a neck mass—or by three-month post-treatment imaging; and 71 percent of distant metastases were found due to symptoms or three-month post-treatment imaging.

Frakes described some disease characteristics that increased the likelihood of recurrence: patients with five or more nodes or with level IV low-neck nodes present were more likely to suffer regional failure; and there was increased risk of distant metastases with involved lymph nodes greater than 6 cm (N3 disease), bilateral lymph node involvement, five or more involved lymph nodes, or level IV lymph nodes.

Toxicity rates were low, she said, with only 9 percent of patients experiencing severe late side effects.

“And the majority of those patients had resolution of the side effects at the time of last follow-up, meaning the feeding tube was taken out or they were treated with hyperbaric oxygen for necrosis,” she said.

Sixty-four percent of toxicities and/or recurrences occurred within the first six months following treatment, and only four events occurred more than two years following treatment.

“We were pleasantly surprised by the high cure rates and the low permanent side effect rates for these patients,” Frakes said.

These findings show individuals with HPV-associated oropharyngeal cancer treated with definitive radiation therapy and cared for by multidisciplinary specialists have excellent outcomes, Frakes concluded.

Surveillance: Too Much or Too Little?

There is much debate as to whether whether the surveillance done for the HPV-positive subset of OPSCC is too much or too little, said Bhishamjit S. Chera, MD, Associate Professor and Director of Patient Safety and Quality in the Department of Radiation Oncology, University of North Carolina Hospitals, Chapel Hill, who was asked to comment on this study for OT.

“This study’s primary objective was to evaluate whether the standard cancer survivorship program that we have used for oropharyngeal cancer is appropriate, and this abstract shows that the standard cancer survivorship program adequately detected the majority of cancer recurrences.”

Chera said repeated imaging, such as with PET/CT every 3-6 months, is not likely to detect recurrences faster in these patients, and it would clearly be more costly.

“I conclude from this study that more frequent surveillance with imaging or visits is not necessary for HPV-positive OPSCC,” Chera said. “Their cancer control is so good that we may be following them too closely or too often.”

He said future studies should evaluate following these favorable prognosis HPV-positive OPSCC less often.

Imaging After Three Months Not Routine

Christine G. Gourin, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, and moderator of an online/audio preview of this meeting for the press, said she appreciated the Moffitt study’s findings.

“I think we probably do too much post-treatment surveillance imaging,” she said, “and the NCCN guidelines are fairly vague about when to perform imaging.”

Gourin said her institution has stopped routinely imaging patients after three months if a PET scan is negative.

“And it’s true we pick up recurrences more clinically than radiologically, and, of course, a false-positive causes much more morbidity.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Head & Neck Cancer Patients Face Social Isolation, Financial Burdens

Source: www.journals.lww.com/oncologytimes
Author: Robert H. Carlson

SCOTTSDALE, Ariz.—Locally advanced head and neck cancer (LAHNC) has high morbidity and is expensive to treat. The cost of the disease, not only in financial burden but also degradation of the patient’s quality of life, was highlighted in a recent study from University of Chicago Pritzker School of Medicine.

The study, using data from 73 treatment-naïve LAHNC patients, showed that 69 percent relied on one or more lifestyle-altering cost-coping strategies while managing their cancer, including spending savings (62 percent), borrowing money (42 percent), selling possessions (25 percent), and having family members work more hours (23 percent).

A more subtle disruption of patients’ lives was also identified, that of perceived social isolation— defined as a lack of social support coupled with increased loneliness—as a risk factor for less than optimal medication adherence and use of health care resources during treatment. That meant more days of missed medication, more missed appointments, and longer inpatient hospital stays.

The study was presented at the 2016 Multidisciplinary Head & Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

“Physical side effects are not the only ones our head and neck cancer patients endure,” said Sunny Kung, a second-year medical student and lead author on the study. “It is important for physicians to screen for social isolation just as we screen for depression and identify patients with high social isolation so we can intervene earlier on before they experience these negative financial side effects of their care.”

Senior study author is Jonas de Souza, MD, Assistant Professor of Medicine at The University of Chicago Medicine and frequent author on healthcare economics as well as head and neck malignancies.

Research Findings

The researchers examined factors associated with social side effects by following patients diagnosed with head and neck cancer over six months to assess how they coped with the cost of their cancer treatment, as well as whether perceived social isolation or the lack of social support was a barrier to their care.

“It was surprising that patients who had a high degree of perceived social isolation had a greater likelihood of using more lifestyle coping strategies,” Kung said, during an online press conference held in advance of the symposium.

The prospective longitudinal study collected six monthly lifestyle surveys from patients diagnosed between May 2013 and November 2014.

Most patients in the study were male (78 percent), Caucasian (74 percent), and covered by private health insurance (54.8 percent). Multivariable regression modeling was used to assess the influence of patient characteristics on the use of cost-coping strategies and perceived social isolation.

The survey assessed the use of lifestyle-altering financial burdens including extra out-of-pocket costs, loss of productivity, low compliance with their medication regimen, and added health care utilization, specifically, longer inpatient length of hospital stays and more missed appointments.

The researchers also measured patients’ demographics, health insurance status, wealth, household income, and type of tumor. Perceived social isolation was evaluated prior to treatment for each patient.

During the online preview of the symposium, Kung elaborated on the concept of social isolation as measured in two components: loneliness and lack of social support.

The first was measured using the validated UCLA Loneliness Scale, and the second by the 19-item Medical Outcomes Social Support Survey. The two scores were combined in a formula to determine low, intermediate, or high social isolation.

Kung said that, compared to LAHNC patients with adequate social support, those with a high level of perceived social isolation reported:

* more days missing the prescribed dose of medication, 21.4 days for those with high perceived social isolation versus 5.45 days for those with low/moderate perceived social isolation;

* more missed appointments, seven for those with high perceived social isolation versus three for those with low/moderate perceived social isolation; and

* longer inpatient hospital stays, 32.7 versus 27.6 days.

“Many of the patients we treat for advanced head and neck cancers need support beyond their medical care,” Kung concluded. “Social interventions can be introduced for patients who feel isolated in order to minimize financial burden while maximizing effective health care utilization.”

For example, she said, providers can work with patient navigators to improve adherence to medical care among vulnerable populations.

Need for Support

The moderator of the press preview, Randall Kimple, MD, Assistant Professor in the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, said this study’s findings would have to be replicated in other institutions.

“Even so, these are important lessons for us to learn about what our patients go through, and potential areas of research into how to lessen social isolation and all the other hardships while still doing everything we can cure as many patients as possible,” Kimple said.

This study’s findings on social isolation may apply to other cancers, he said, but he noted that head and neck cancer is unique in the intensity of therapy and the side effects that come with therapy and that affect quality of life.

“Losing the ability speak, to eat, to work, and the social isolation that can result, these can be devastating, but we as physicians can help to address many of these issues with teaching and support, and have a real impact on the lives of our patients,” Kimple said.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Source: www.medscape.com
Author: Zosia Chustecka

Human papillomavirus (HPV) vaccines have now been available for 10 years, but despite many medical professional bodies strongly recommending the vaccine, uptake in the United States remains low.

Data from a national survey show that about 36% of girls and 14% of boys have received the full schedule of HPV vaccines needed to provide protection (Vaccine. 2013;31:1673-1679).

Now the American Society of Clinical Oncology (ASCO) has become involved, and in a position statement issued today the organization calls for aggressive efforts to increase uptake of the HPV vaccines to “protect young people from life-threatening cancers.”

“With safe and effective vaccines readily available, no young person today should have to face the devastating diagnosis of a preventable cancer like cervical cancer. But unless we rapidly increase vaccination rates for boys and girls, many of them will,” ASCO President Julie M. Vose, MD, said in a statement.

“As oncologists, we see the terrible effects of these cancers first hand, and we have to contribute to improving today’s alarmingly low vaccination rates,” she added.

The new policy statement is published online April 11 in the Journal of Clinical Oncology.

The statement notes that HPV vaccination has been previously recommended by many US medical societies, including the American Cancer Society, the American College of Obstetrics and Gynecology Committee, the American Dental Association, the American Head and Neck Society, the American Nurses Association, the American Pharmacists Association, the Association of Immunization Managers, the Society for Adolescent Medicine, and the Society of Gynecologic Oncology.

In addition, a joint letter was sent out to all physicians urging them to give a strong recommendation from the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, the Centers for Disease Control and Prevention, and the Immunization Action Coalition.

Now oncologists are specifically being asked by their professional body, ASCO, to join in with the push toward greater uptake of the HPV vaccines.

“ASCO believes oncologists can play a vital role in increasing the uptake of HPV vaccines,” the new policy statement says. “Although most oncologists will not be direct providers of these preventive measures, this does not abrogate us from contributing to this process. Our unassailable role in the mission to lessen the burden of cancer…places us in a position of influence. We should use interactions with our patients, primary care colleagues, and health care systems to raise awareness of HPV-related cancers and the role of vaccination in preventing them.”

Oncology providers have a responsibility to serve as community educators.

“Oncology providers have a responsibility to serve as community educators, disseminating evidence-based information to combat misconceptions concerning the safety and effectiveness of the HPV vaccine,” it continues.

“ASCO encourages oncologists to advocate for and actively promote policy change to increase vaccination uptake,” the statement concludes.

Issues With the Statement

However, there are a few issues with the statement, says a prominent researcher in the field of HPV and cervical cancer, Diane Harper MD, professor and chair of the department of Family and Geriatric Medicine, University of Louisville, Kentucky. Dr Harper, who was approached for comment, was involved in early clinical trials with both HPV vaccines (Gardasil, Merck & Co, and Cervarix, GlaxoSmithKline), and has emphasized the need for ongoing screening with Pap tests to prevent cervical cancer.

This is also one of the issues she raises about the ASCO statement, which does not mention screening. “All messages about HPV vaccination must be couched in terms of continued lifetime screening for cervical cancer,” Dr Harper told Medscape Medical News.

The ASCO statement highlights the potential that HPV vaccination has for preventing cancer. (Both vaccines protect against HPV types 16 and 18, and Gardasil offers additional protection against several other types). The statement notes that HPV is the cause of nearly all cervical cancer cases and that HPV genotypes 16 and 18 are responsible for 70% of cervical cancers. In the United States, HPV is responsible for 60% of oropharyngeal cancers, 90% of which are caused by HPV 16. HPV is also the cause of 91% of anal cancers, 75% of vaginal cancers, 69% of vulvar cancers, and 63% of penile cancers, again with HPV 16 as the predominant oncogenic genotype.

However, the statement also notes that “because of the long latency and the prolonged preinvasive phase after infection with HPV, many years of follow-up are needed for the ongoing trials to demonstrate a significant reduction in HPV-related cancers.”

Therefore, intermediate outcomes are being used as surrogate endpoints, it continues. HPV vaccines have been shown to prevent new cancer-causing HPV genotype-specific infections and resultant diseases, such as grades 2 and 3 cervical intraepithelial neoplasias (CIN), vaginal, vulvar, and anal intraepithelial neoplasias (as precursor lesions to cancer).

There is “almost certainty that cancers caused by oncogenic HPV genotypes will be dramatically reduced,” according to the statement.

Dr Harper told Medscape Medical News that the studies conducted to date have shown that “Cervarix has a 93% efficacy against CIN 3 regardless of HPV type; Gardasil has a 47% efficacy against CIN 3 regardless of HPV type, and Gardasil 9 is equivalent to Gardasil in the prevention of CIN 3 disease regardless of HPV type. None of these vaccines can prevent all CIN 3 or potentially all cancers.”

“Hence, the most important take home point is that screening is absolutely necessary as a prevention tool for preventing cancer by early detection of disease that when found, is curable,” Dr Harper emphasized.

Also, Dr Harper noted that the studies ended at prevention of CIN 2/3 disease as a clinical outcome. CIN 3 on average progresses to cancer in 20% of women within 5 years, and to 40% of women in 30 years. But, she points out, “there are no long-term follow-up studies that show that cancers will be averted.”

“The modeling exercises indicate that we have to wait at least 40 years before we will have a detectable decrease in cervical cancers from vaccination, assuming that at least 70% of the population being surveyed is vaccinated,” she added.

In its statement, ASCO cites the success of widespread vaccination against hepatitis B virus in reducing the incidence of liver cirrhosis and liver cancer as “an exemplary health model that supports more widespread HPV vaccination.”

But Dr Harper argues that “the prevention of liver cancer was an unexpected highlight of HBV vaccination. The primary purpose was to relieve the symptoms of chronic HBV sufferers. The continual re-infection with HBV seems to allow a natural infection to act as a booster in this population, which may not be the same for HPV.”

There also remains a question of how long the protection offered by HPV vaccination will last.

The ASCO statement says, “Both vaccines have a known duration of protection of at least 5 years, with ongoing study of the full duration of their effect,” and it notes that “additional research is needed to evaluate duration of protection to determine if booster doses are required.”

Dr Harper said, “Estimates of long-term effectiveness are based on antibody titers, yet there is no surrogate of protection defined by antibody titers.”

She added: “I agree that observational studies will inform the public health authorities about when a booster will be needed and whether it is needed sooner if only 2 doses are received vs later if 3 doses​ are received.”

Last, but not least, there is the issue of safety.

The ASCO statement notes that both Gardasil and Cervarix “reported excellent short- and long-term safety results in clinical trials. The most common adverse effects were mild and included injection site pain (approximately nine in 10 people) and swelling (approximately one in three), fever (approximately one in eight), headache, and fatigue (approximately one in two). These symptoms were transient and resolved spontaneously. The incidence of serious adverse effects was low and was similar to those who received placebo (aluminum-containing placebo or hepatitis A vaccine).”

However, worldwide there continue to be reports of adolescents who report chronic side effects and pain syndromes after being vaccinated against HPV. Some of these have been documented in the medical literature, with physicians reporting instances of previously healthy athletic girls becoming incapacitated with pain, fatigue, and autonomic dysfunction, and some remaining permanently disabled.

The US Food and Drug Administration and the Centers for Disease Control and Prevention have repeatedly said that HPV vaccines have an excellent safety record and that no causal associations have been found with atypical or unusual pain syndromes or autonomic dysfunction. The European authorities have investigated two chronic syndromes reported with HPV vaccination, and have said that there is no evidence to show causation.

However, Danish researchers who were among the first to report these syndromes criticized the investigation and are conducting their own study. There have also been lawsuits filed in several countries, and a class action lawsuit is now planned in Japan against the government and the vaccine manufacturers.

In an interview with Medscape Medical News, lead author on the ASCO statement, Howard H. Bailey, MD, from the University of Wisconsin Carbone Cancer Center, Madison, said that the concerns over safety should not be dismissed and should be studied further.

These issues need to be studied further, even if the authorities say that the vaccines are safe, he emphasized. These reports of girls becoming very ill, having pain syndrome and weakness, should not be diminished, he said, adding: “We can’t just ignore these reports…if there is risk involved, then that needs to be sorted out better.”

However, there is always a possibility that the syndromes and side effects that have been reported “have nothing to do with the vaccine,” Dr Bailey commented, citing the case of now-discredited theory linking autism to the pediatric vaccine for measles, mumps, and rubella.

There may be other explanations for the symptoms that are reported, or it could be that the symptoms/syndrome would have developed in the individual, anyway, but the vaccination precipitated it sooner, he suggested.

Dr Bailey noted that across the United States physicians are very sensitive to the fact that rates of pediatric vaccination have gone down because of the link that had been made to autism, subsequently shown to be false. Even though science eventually showed no link between the vaccine and autism, public confidence in the vaccine was damaged.

“When a person’s life has been devastated by an illness, that is very important, but if it turns out that the illness is not related to the vaccine, and in the meantime, the concerns over safety have stopped thousands of young people from being vaccinated….”well, eventually this will mean that there are more people who die from cancer, he said.

“I would be very reluctant right now to shut down the goals of vaccination over what has been reported, because the bottom line is that we have a tremendous problem with the rising incidence of HPV related cancers including in men as well as women when it comes to oropharyngeal cancers here in the States,” he added.

“The data, at least in my opinion, are so strong that HPV vaccination if it’s done in a [systematic] way will reduce the incidence of these cancers…I don’t want to stop whatever progress we are making when there is at best disagreement over whether these things are associated,” he said, although he also added that “maybe if it was my daughter, I would feel differently.”

Dr Bailey also addressed some of the other issues that had been raised about the ASCO statement, and said he agreed about the importance of screening.

“Even if vaccination does all the things we expect it to do, there is no doubt that cervical cancer screening needs to continue, and that’s a pretty standard recommendation across all of the groups,” he said. “We do not mean to diminish the importance of continued screening,” he said, but he added that screening lies in the domain of other physicians, such as primary care and gynecology, whereas this statement was targeted specifically at oncologists. “To take a step back, we are taking the view of cancer physicians, who take care of women, who are unfortunately too often dying of cervical cancer, and…we wanted to remind people that HPV vaccination can prevent this…as well as other associated cancers,” he said.

“The audience in North America has not been paying attention to this vaccination issue very much,” he continued, and “we wanted to remind oncologists and the public that at the heart of the issue is cancer prevention.

“We have this relatively easy way of preventing cancers over and above the ways that we already use,” he added.

“We wanted to remind people, especially in the oncology community, that there is this intervention out there that we think is highly, highly likely — if applied and used in a population format — will significantly reduce the number of women dying of cervical cancer, the number of men and women dying from oropharyngeal cancer, which is increasing in the US…and that was the main focus of the article,” Dr Bailey commented.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Merck Says FDA Accepts Its SBLA For Keytruda For Treatment Of Head & Neck Cancer

Source: www.finchannel.com
Author: Fin Channel News Editorial Staff

The FINANCIAL — Merck, known as MSD outside the United States and Canada, on April 13 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of Aug. 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program, according to Merck.

“Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making KEYTRUDA available to these patients.”

Merck currently has the largest immuno-oncology clinical development program in head and neck cancer and is advancing multiple registration-enabling studies with KEYTRUDA as a single agent and in combination with chemotherapy.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Suicide: A Major Threat to Head and Neck Cancer Survivorship

Source: www.jco.ascopubs.com
Authors: Nosayaba Osazuwa-Peters, Eric Adjei Boakye, and Ronald J. Walker
, Mark A. Varvares

TO THE EDITOR: The article by Ringash that was recently published in Journal of Clinical Oncology provided a compelling narrative of both the improvements made in head and neck cancer survivorship, as well as the challenges created by longer-term treatment and associated toxicities. There are currently at least 280,000 head and neck cancer survivors in the United States. As the article by Ringash stated, the upturn in head and neck cancer survivorship in the last three decades has coincided with the emergence of human papilloma virus-positive oropharyngeal cancer, as well as a decrease in tobacco use in the general population. These make it a challenge to isolate survival gains as a function of improved therapy from the natural prognostic value of a diagnosis of human papilloma virus-positive oropharyngeal cancer. Whatever the case, the fact that more than one-quarter million Americans are currently alive after a diagnosis of head and neck cancer means there needs to be a more deliberate effort in longer-term management of treatment-related toxicities, some of which are lifelong.

We agree with Ringash’s conclusion that new models of care need to be developed in response to the significant quality-of-life issues faced by patients with head and neck cancer. The Institute of Medicine publication From Cancer Patient to Cancer Survivor: Lost in Transition, also cited by Ringash, called for a clear individualized survivorship plan for cancer patients. There is a serious need for this model to be implemented universally in head and neck cancer management. Although we agree with Ringash that patients with head and neck cancer face competing mortality risks from second primary cancers and other noncancers, what we found lacking was recognition of an important competing cause of mortality in head and neck cancer survivors: suicide.

Suicide associated with head and neck cancer is not just a competing cause of death; it is also a quality-of-life issue. Many authors agree that head and neck cancer is among the top cancer sites associated with suicide. One national study of 1.3 million cancer patients even found that head and neck cancer carried the highest risk of suicide among cancer survivors. As a quality-of-life issue as well as a competing cause of death, the elevated risk of head and neck cancer-related suicide, although it peaks during the first few years after diagnosis, remains virtually throughout the course of the cancer survivor’s life. Additionally, some other well-known quality-of-life issues associated with head and neck cancer (eg, pain, disability, esthetic compromise and body image issues, psychosocial function, anxiety, emotional distress, and depression) are all associated with suicide. Therefore, it is difficult to have a discussion of quality-of-life interventions in head and neck cancer without addressing the issue of suicide.

Thus, we believe that suicide in patients with head and neck cancer should be addressed as a major threat to cancer survivorship. Cardiovascular disease, for example, is a known competing cause of death among patients with head and neck cancer, and is listed in Figure 4 of Ringash’s article. Cardiovascular disease may be managed for a long time; however, when a cancer patient decides that he/she is “better off dead,” a finality, or terminality, is invoked. This is quite unique to suicide compared with other competing causes of death.

Thus, in the urgent call for “new strategies and models of care to better address quality-of-life issues and meet the needs of survivors of head and neck cancer,” we believe it is pertinent that suicide is recognized as an important threat to head and neck cancer survivorship.

DOI: 10.1200/JCO.2015.65.4673; published online ahead of print at www.jco.org on January 19, 2016

To read or download the full article, please visit: http://jco.ascopubs.org/content/34/10/1151.full.pdf+html

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
March, 2016|Oral Cancer News|

The Oral Cancer Foundation’s Founder, Brian R. Hill, honored by the Global Oral Cancer Forum – International oral cancer community honor his accomplishments in the field.

Source: www.prnewswire.com
Author: The Oral Cancer Foundation

Bryan R. Hill receiving the award at the Global Oral Cancer Forum. (PRNewsFoto/Oral Cancer Foundation)

NEWPORT BEACH, Calif., March 10, 2016 /PRNewswire-USNewswire/ — At the recent Global Oral Cancer Forum (GOCF), Brian R. Hill, Executive Director and Founder of the Oral Cancer Foundation (OCF), was honored for his work as an advocate and innovative thinker in the oral cancer arena. The GOCF organizers and community awarded Hill the 2016 Global Oral Cancer Forum Commitment, Courage and Innovation Leadership Award for his dedication and contributions to the field of oral cancer over the last 18 years. Upon accepting the award, Hill received a standing ovation from those in attendance, which included global oral cancer thought leaders, researchers, treatment physicians, other non-profit organizations and representatives from various government agencies, including the National Institutes of Health / National Cancer Institute, and the World Health Organization (WHO).

When asked about being honored Hill said, “In the beginning and for many years I was alone at OCF and it was just the seed of an idea. Those grassroots efforts matured into a robust network of important relationships with a common goal. Today OCF is so much more than just me and my singular efforts. Through the benevolence of the many OCF supporters, particularly in the RDH, dental/medical professional communities and survivor groups, OCF has grown into a powerful national force for proactive change of the late discovery paradigm, access to quality information, disease and patient advocacy, funding of research, and patient support.” Hill acknowledges that he had the mentorship of some of the brightest minds of the non-profit world to build his understanding of appropriate governorship of an entity such as OCF, as well as support from core researchers and treatment professionals in the oral cancer arena. “To paraphrase someone far more famous, if I was able to see farther than others had going before me, it was because I stood on the shoulders of many highly accomplished others who helped me achieve my goals,” says Hill.

Hill, a stage four oral cancer survivor, became a student of the disease after his own diagnosis left him looking for answers. Since founding OCF and overseeing the path and initiatives of the foundation for more than a decade and a half, Hill often finds the advocacy role suits him well. He has championed anti-tobacco legislation within the political system, and is an advocate at various government entities such as the CDC regarding vaccination of boys against the virus known to be the primary cause of most oropharyngeal cancers.  He also sits on two National Institutes of Health (NIH) oversight committees—one at the National Cancer Institute (NCI), which oversees clinical trials in immunotherapies in head and neck cancers, the other at the National Institute of Dental and Craniofacial Research (NIDCR) reviewing trials looking at long-term outcomes and complications of treatment in head and neck cancers. In addition, Hill still one-on-one counsels patients, participates in OCF’s online Patient Support Forum, and is often the voice for a community that has lost its own, through many diverse media interviews and lectures.

While OCF has received many awards for its advocacy work and contributions to the battle against oral cancer, including recognition from the NIH/NIDCR, WHO, Great Non-Profits, various universities and professional medical and dental societies, and even Internet guru Mashable.com for innovations in applying technology to serve its health oriented goals, receiving recognition from this forums organizers and some of the  leading authorities on oral cancer in the international community is particularly meaningful. Those in attendance are recognized as experts in the field and understand the challenges and importance of the work OCF has undertaken. Sponsored by the Henry Schein Cares Foundation, the benevolent arm of the powerful Henry Schein Inc., known for its long-term commitment to improve issues related to oral care, The Global Oral Cancer Forum’s vision is to build partnerships that will promote the changes required for a substantial impact on the incidence, morbidity, and mortality of oral cancer worldwide. The importance of the Schein organization’s leadership in creating this venue cannot be overstated.

Top oral cancer experts and advocates from around the world, representing countries as far away as Japan, China, and India as well as from the Americas, convened over the weekend to attend the inaugural forum. Attendees included clinicians, scientists, epidemiologists, activists, public health experts, as well as OCF Directors and other NPO organization heads who are working hard to find impactful avenues to reduce the global oral cancer burden. Attendees met to exchange ideas and learn from one another about what is and isn’t working in the global realm of this disease. Delegates from thirty-three countries presented new research findings and discussed their unique challenges and approaches to understanding and addressing one of the leading burdens of the cancer world.

Globally, the incidence rate for oral cancer is growing and has reached what many experts are calling epidemic proportions. This year approximately half a million patients will be newly diagnosed with an oral or oropharyngeal cancer. Among the topics discussed by GOCF panelists were the rise in disease incidence and the regional disparities and factors affecting global populations. Communities throughout much of South East Asia report a high percentage of the population chewing betel and areca nut, a significant risk factor for the development of oral cancer. Meanwhile in the U.S. and other developed countries the prevalence of the HPV virus is the leading contributor to the rising rates of oropharyngeal cancers. Identifying these differences is vital to the development of effective prevention, public policy, and treatment strategies. Advancement of a universal understanding of what the problems are and what initiatives are working around the globe, reveals commonalities, and within them the group will find its beginning joint efforts to effect change.

Looking forward there is clearly much work to be done. The good news is that there are significant strides being made in research and treatment; but balancing those positives, there are also significant shortcomings in current governmental policies, prevention, and public awareness and understanding. Hill said, “While I and OCF are very proud to have been chosen by the organizers, and the global oral cancer community to receive this award, it only serves to motivate us to strive to accomplish more. We have built relationships here that will translate into new avenues of endeavor for OCF in the future.” Jamie O’Day, OCF’s Director of Operations, also attended the conference and spent her time networking with her counterparts from around the world. Many new ideas were garnered from these discussions that will be applied in future OCF initiatives and support OCF’s mission to reduce the suffering caused by this disease both nationally and globally.

About the Oral Cancer Foundation:
The Oral Cancer Foundation, founded by oral cancer survivor Brian R. Hill, is an IRS registered non-profit 501(c)(3) public service charity that provides vetted information, patient support, sponsorship of research, as well as disease and risk factor reduction advocacy related to oral cancer. Oral cancer is the largest group of those cancers that fall into the head and neck cancer category. Common names for it include such things as mouth cancer, tongue cancer, tonsil cancer, head and neck cancer, and throat cancer. The Oral Cancer Foundation maintains the websites: www.oralcancer.org , www.oralcancernews.org , www.oralcancersupport.org , which receive millions of hits per month. Supporting the foundation’s goals is a scientific advisory board composed of leading cancer authorities from varied medical and dental specialties, and from prominent educational, treatment, and research institutions in the United States. The foundation also manages the Bruce Paltrow Oral Cancer Fund, a collaboration between the Paltrow family represented by Ms. Blythe Danner (Paltrow), Gwyneth Paltrow, Jake Paltrow and the Oral Cancer Foundation.

Media Contact: Jamie O’Day / The Oral Cancer Foundation (949) 723-4400 jamie@oralcancerfoundation.org

Immunotherapy Continues to Advance in Head and Neck Cancer

Source: www.onclive.com
Author: Megan Garlapow, PhD

Concomitant administration of motolimod with cetuximab (Erbitux) increases the innate and adaptive immune response in the blood and the tumor microenvironment in head and neck squamous cell carcinoma (HNSCC), overcoming negative prognostic biomarkers of cetuximab therapy alone, according to the biomarker data from a recent phase Ib clinical trial that was presented at the 2016 Head and Neck Cancer Symposium. The trial was recently amended to add nivolumab to the combination of cetuximab and motolimod.

Robert-FerrisDr. Robert Ferris, MD PhD


“We know that PD-1 and PD-L1 are overexpressed in head and neck cancer, and so it was somewhat irresistible to combine our baseline treatment of cetuximab and motolimod with the PD-L1 inhibition pathway. EGFR itself drives PD-L1, so combining cetuximab with anti-PD-1 inhibitor makes sense. So, we’ve amended this trial. We’re now accruing to treatment with cetuximab, motolimod, and the anti–PD-L1 nivolumab in this trial,” said lead author Robert Ferris, MD, PhD, professor, Departments of Otolaryngology, Radiation Oncology, and Immunology, Cancer Immunology Program, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.

According to the authors of the phase Ib data presented at the symposium, the rationale for combining cetuximab with motolimod (VTX2337) as neoadjuvant therapy was that cetuximab induces cellular immunity that correlates with neoadjuvant clinical response. The phase I dose-escalation and safety of the combination had been established (NCT 01334177).

This study of neoadjuvant cetuximab and motolimod had accrued 14 patients with HNSCC that was stage II-IV, resectable, and located in the oropharynx, oral cavity, hypopharynx, or larynx. These patients were biopsied, treated with cetuximab and motolimod for 4 weeks, and then underwent surgery. The endpoints of the trial were the modulation of immune biomarkers.

Interferon-inducible cytokine IP-10 increased after the patients were administered neoadjuvant cetuximab and motolimod (P = .0001). After the neoadjuvant treatment, the peripheral blood lymphocytes had an increased frequency of EGFR-specific CD8 T cells. After the neoadjuvant treatment, regulatory T cells had decreased suppressive receptors and transforming growth factor-β, which induces Foxp3. Also, after the neoadjuvant treatment, circulating MDSCs had decreased PD-L1 (P <.07) and macrophages had increased CD16 expression (P <.07).

After the neoadjuvant treatment with cetuximab and motolimod, genotyping of T-cell receptors showed increased clonality in peripheral blood lymphocytes (P = .003 by Wilcox signed rank test) and tumor-infiltrating lymphocytes (P = .081 by Wilcox signed rank test). Most patients are more oligoclonal than healthy individuals, and some are very clonal with highly prominent expanded clones. Genotyping of T-cell receptors found that clonality was increased by the combination of cetuximab and motolimod compared with treatment with cetuximab alone.

Recent studies have indicated that the PD-1/PD-L1 pathway is upregulated in the HNSCC microenvironment, and that EGFR blockade prevents interferon-γ-mediated upregulation of PD-L1. Thus, this study has been amended to add nivolumab to the adjuvant treatment with cetuximab and motolimod. The endpoints are still the modulation of immune biomarkers.

The aim is to target the tumor microenvironment, such that tumor immune escape is reversed and T cells eliminate HNSCC. Antitumor T cells are reprogrammed to reverse inhibitory signals. Combining the toll-like receptor agonist, motolimod, with cetuximab and with PD-1 pathway inhibitors, such as nivolumab, may enhance the priming and activity of T cells.

“Targeting the tumor microenvironment requires understanding as well as reversal of immune escape mechanisms in the cellular compartment. Reprogramming antitumor T cells to reverse inhibitory signals can be done by directly disrupting those inhibitory signals, the so-called checkpoint receptor field, and can be done potentially by combining proinflammatory signals, such as toll-like receptor agonists, to chemo-attract cells into the microenvironment and to create good inflammation to overcome suppressive factors,” said Ferris.

Recent findings have shown tremendous promise for nivolumab in head and neck cancer. Bristol-Myers Squibb (BMS) announced in January 2016 that nivolumab improved overall survival versus investigator’s choice of therapy for patients with platinum-refractory squamous cell carcinoma of the head and neck in the phase III CheckMate-141 trial. Findings from the study are being discussed with the FDA and other health authorities, according to BMS.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
February, 2016|Oral Cancer News|