chemotherapy

Checkpoint inhibitors seen to show potential of immunotherapy in several cancer studies

Source: immuno-oncologynews.com
Author: Magdalena Kegel

Several new checkpoint inhibitors — a class of immunotherapy drugs used in cancer — continue to show beneficial effects in numerous cancer types, according to data presented at the recent American Association for Cancer Research Annual Meeting in New Orleans.

Investigated checkpoint inhibitors confirmed earlier results showing evidence of efficacy in melanoma, and also suggested that this class of immunotherapies, which trigger a person’s immune system to attack cancer, might work in patients suffering from certain head and neck cancers.

One of the studies, CheckMate-141, exploring the checkpoint blocker nivolumab (Opdivo) in patients with squamous cell carcinoma of the head and neck, was stopped early after 36 percent of the 361 patients survived for one year — an increase of more than 100 percent compared to patients receiving other treatments.

Squamous cell carcinoma is usually treated with platinum-based chemotherapy, but the effects are often temporary as the cancer tends to return. Moreover, patients who fail to fully recover after chemotherapy are generally resistant to further treatment.

Maura Gillison from Ohio State University, who presented the CheckMate-141 data, said that no effective treatments have been approved for patients with this kind of cancer in over a decade. “I’ve treated head and neck cancers for more than twenty years, and this is the first time I’ve had a drug to go to for patients that have become resistant to first-line treatment,” she said in a press release.

Dr. Emma King, a Cancer Research UK-funded head and neck cancer expert, added that the findings are likely to have a “significant impact” for these cancer patients. “They also reinforce the important shift that we are seeing towards using immunotherapies for cancer treatment.”

“Before nivolumab can be used routinely to treat head and neck cancer in the UK, it will need to approved by the National Institute for Health and Clinical Excellence (NICE),” she added.

Nivolumab was investigated in the CheckMate-069 trial, where its efficiency in advanced melanoma was tested in combination with another checkpoint inhibitor, ipilimumab (Yervoy).

Data presented showed that 60 percent of patients on the combination therapy survived for two years. But the benefit can come with a high price, as severe side effects forced one-third of patients to stop the treatment.

“Both nivolumab and ipilimumab have changed survival expectations in advanced melanoma over the last few years, and these latest data show us that combining these two immunotherapies is an effective two-pronged attack against the cancer,” said Dr. James Larkin, a medical oncologist at the Royal Marsden Hospital.

Yet another study found nivolumab to increase five-year survival in advanced melanoma patients to one-third — again, a doubling compared to what can be achieved by conventional treatment.

Merkel cell carcinoma, a rare skin cancer linked to exposure to a common virus, was also among the cancer types showing benefits from checkpoint inhibitor treatment. Once the cancer spreads, no treatments are effective in holding it back. The checkpoint blocker pembrolizumab (Keytruda) caused tumors to shrink in about half of the 26 patients in the trial.

“The trial also suggests that patients whose Merkel cell carcinoma is linked to a virus may be more likely to benefit from this treatment, which fits with the idea that the more danger signals there are in a cancer, the easier it is for the immune system to recognise it,” said Peter Johnson, Cancer Research UK’s chief clinician.

Early data of checkpoint inhibition in liver and advanced bowel cancer, used in combination with radiofrequency ablation treatment, also showed promising results.

Drug Target in Rare, Lethal Glandular Cancer Discovered

Source: www.dddmag.com
Author: Yale University

 

Using a novel cell culture approach, Yale Cancer Center researchers have discovered critical vulnerabilities in adenoid cystic carcinoma (ACC), a rare and lethal glandular cancer with a high recurrence rate and few treatment options. The findings, published April 15th in the journal

Clinical Cancer Research, offer data that ACC and similar cancers could be treated with already available drugs.

ddd1604_yale_cancer

ACC most often occurs in the salivary glands but can originate in the breast, trachea, skin, or other sites. Survival rates at five years are close to 90percent but drop significantly after that with just 40percent surviving at 15 years after diagnosis. It is a slow-growing cancer that affects about 1,200 people each year, with few symptoms in early stages.

Aside from surgery, there are few treatments for ACC, which until now has proven largely resistant to radiation therapy. It is this resistance that prompted Yale researchers to develop a novel cell culture technique to isolate and study ACC cancer stem cells, known to be the root of tumor growth, aggressiveness, and resistance to chemotherapy and radiation, said co-senior author Sergey Ivanov, research scientist in surgery (otolaryngology).

“Within ACC cells, we found the especially aggressive cancer stem cells. As important, we found the Achilles heel of these cells, which is their addiction to NOTCH1, a signaling molecule that helps these cells to survive therapy and multiply,” Ivanov said. “Fortunately, cancer stem cells can be killed by blocking NOTCH1 production.”

The similarities between the ACC stem cells and cancer stem cells derived from other cancers such as melanoma, neuroblastoma, and glioma surprised the researchers, according to co-senior author Wendell Yarbrough, M.D., professor and chief of otolaryngology.

“Our study suggests that drugs, which are now used in clinical trials to block NOTCH signaling in a variety of cancers, could be effective against ACC,” Yarbrough said. “Also, our study highlights that there are good targets for therapeutic development in ACC. These findings should form the basis for clinical trials.”

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

April, 2016|Oral Cancer News|

Study supports immunotherapy/radiation combo in head and neck cancer

Source: www.onclive.com
Author: Laura Panjwani

There may be potential synergy between radiation therapy, given with or without chemotherapy, and immune checkpoint inhibitors in patients with squamous cell carcinoma of the head and neck (SCCHN), according to results of a prospective study.

The study, which was presented at the the 2016 Multidisciplinary Head and Neck Cancer Symposium in February 2016, examined blood samples from 16 consecutive patients with SCCHN undergoing curative-intent radiation therapies.

Samples were obtained at week 1 and week 6 to 7. Patients received a median of 70 Gy for disease in the oropharynx (n = 12, 75%), nasopharynx (n = 2, 12%), larynx (n = 1, 6%), or oral cavity (n = 1, 6%). The majority of patients had stage IV disease that was metastatic to regional lymph nodes and received concurrent platinum-based chemotherapy.

The analysis found that, during radiation treatment, circulating CD8-positive T-effector cells increased (P = .01), as did CD4-positive PD-1–positive cells (P = .02), CD8-positive LAG3-positive cells (P = .02), and regulatory T cells (P = .04). sPD-L1 levels also increased, mirroring increases in CD8-positive T cells over the course of therapy (P = .047).

While the extent to which these systemic changes reflect changes in the tumor microenvironment is unknown, the study authors noted that these findings support the “complex immunologic effects of fractionated chemoradiation therapy and mechanisms for potential synergy between chemotherapy, radiation treatment, and immunotherapy in SCCHN.”

To learn more about the impact of the research, OncLive spoke to one of the study’s authors, Jonathan D. Schoenfeld, MD, physician, assistant professor of Radiation Oncology, Harvard Medical School, Dana-Farber Cancer Institute, who presented the findings at the meeting.

OncLive: What were the goals of this study?

Schoenfeld: Immunotherapy, particularly immune checkpoint blockade, is demonstrating some exciting results in head and neck cancer. Largely, that work has been done in metastatic head and neck cancer. Our goal was to look at the immunologic effects of a treatment that is commonly given to patients with early-stage head and neck cancer: chemotherapy and radiation.

We found that the combination of chemotherapy and radiation—and in some cases, just radiation alone—led to immune effects that we could see not just in the site where we were radiating, but also if we looked at markers in the peripheral blood.

One of the interesting things that we found was that radiation, with or without chemotherapy, has the potential to increase the number of tumor antigens that were targeted by the host immune response. One of the ways that we hope to use radiation in the future is to stimulate an initial immune response.

Based on the data that is emerging with PD-1 inhibitors, we know that the majority of patients will not respond to these agents. We need to determine if we can use radiation and chemotherapy to increase the number of responders initially that can then be stimulated even further with immune checkpoint blockade.

What immune effects were investigated?
We looked at a variety of effects. We looked at chemokines, which are cytokines that could mediate effects outside of the radiation treatment field. We looked at circulating T cells, including CD8-positive T cells, CD4-positve T cells, and markers of activated T cells.

We also looked at potentially inhibitory T cells as well, including T-regulatory cells, T cells that were expressing checkpoint receptors, and myeloid-derived suppressor cells. We also looked, in more detail, at the types of T-cell receptors that were expressed on the surface of these T cells, and it looked like the combination of radiation and chemotherapy could change the clonality of the receptor on these T cells, suggesting that radiation or targeted tumor death could stimulate a more targeted immune response.

What can a community oncologist take away from these findings?

Chemotherapy and radiation have long been appreciated for their immunosuppressive effects. We all know that when you treat someone with radiation or chemotherapy, you can see a decrease in cytopenia and lymphocytes.

We are now learning that certain types of chemotherapy and radiation, given in the proper circumstance, can cause immunogenic cell death. That can possibly synergize with the newer types of immune checkpoint blockade that are being developed.

One of our study’s findings was that we saw an increase in T cells expressed in the PD-1 receptor. Those could potentially be targeted with new checkpoint inhibitors that target the PD-1 receptor. As we develop these therapies even further, there are exciting new combinations between immunotherapies and some of the traditional therapies that have long been used for head and neck cancer with potential.

In melanoma, there are case reports of patients who have progressed on immune checkpoint blockade and are then treated with high-dose palliative radiation that then began to experience a response outside of the radiation treatment field. That is a very exciting avenue of research for head and neck cancer, as well. Can we take patients who don’t respond to the current checkpoint inhibitors that we have and use radiation in a targeted way to stimulate a broader immune response?

Radiation and chemotherapy are a backbone of some of the definitive treatments currently used for head and neck cancer. There is a lot of interest with the success of PD-1/PD-L1 inhibitors to integrate these into the definitive management, and combine them the proper way with chemotherapy and radiation to better maximize our results.

Chemotherapy and radiation are still very important for patients with curative head and neck cancer, but perhaps we should be giving these treatments in a different way—different types of radiation and chemotherapy and different targets for radiation. All of these things need to be explored, as new therapies, such as immune checkpoint inhibitors, are developed in this disease.

What impact will immunotherapy will have in head and neck cancer?
It will have a huge impact. Exciting data are emerging in metastatic head and neck cancer that show that PD-1 inhibitors offer real benefit to patients. Many of these patients had very few other treatment options and could obtain a survival benefit after treatment with PD-1 inhibitors. That opens up a whole new realm of opportunities to study immunotherapy in different settings, in different groups of patients, and in combination with other agents.

Source:
Sridharan V, Margalit D, Curreri S, et al. Systemic immunologic effects of definitive radiation in head and neck cancer. Presented at: 2016 Multidisciplinary Head and Neck Cancer Symposium; February 18-20, 2016; Scottsdale, AZ. Abstract 2.

April, 2016|Oral Cancer News|

Patient survives stage IV, inoperable throat cancer in clinical trial

Source: medicalxpress.com
Author: staff

It took a white lie to get David Polisini, 79, to a doctor in 2004, after months of being unable to swallow.

“Two of my daughters, Toni and Susie, showed up on my back porch and told me to put my jacket on,” he says. “They told me we were just going for a ride, but the next thing I knew, we were pulling into the Clermont Mercy Hospital.”

Polisini says tests ordered in the emergency room uncovered a tumor in his throat.

“It was the size of a golf ball,” he says, adding that he then scheduled an appointment with his primary care physician, Francis Dumont, MD. “I was then referred to an ear, nose and throat physician within his group who said I needed to see someone at the University of Cincinnati (UC) Cancer Institute.”

A biopsy was performed, and a diagnosis was confirmed—it was Stage IV cancer.

“I began seeing Dr. (Bill) Barrett who explained that I would need to go through very aggressive radiation along with chemotherapy five days a week for three months,” he says. “I’d drive myself every day to every visit in my little Miata. The therapy really zapped my strength, but I’m here because of it.

“I really don’t think I realized how much trouble I was in with Stage IV inoperable cancer, but I knew I had to do what I had to do to get through it.”

The radiation and chemo regimen was a Phase III clinical trial at UC, studying the effects of the use of both radiation and chemotherapy for advanced head and neck cancers.

Besides his family, Polisini credits Barrett, chair and professor of the UC Department of Radiation Oncology and director of the UC Cancer Institute, as well as the staff and care providers at the Barrett Center, where he received treatment, with being a tremendous support.

“Dr. Barrett was there with me every step of the way,” he says. “He was so dedicated to helping me, as were the other nurses and staff at UC. I’m just so impressed with everyone who works there. They stood by me the whole time, and more than 10 years later, I’m doing fine, and the cancer hasn’t come back. To me, Dr. Barrett is an angel come to Earth.”
The clinical trial seems to have worked, and Polisini, who lives in Clermont County, says that while he has a primarily liquid diet, he doesn’t regret a thing.

“By golly, I’ll trade the ability to eat with the ability to get up every morning,” he says. “I have the energy to do the things I want and have to do. I go to the ‘Y’ every other day to exercise. I do my own house and lawn work. I just put a new floor on my front porch. I can only do these things because of the outstanding treatment I received at the UC Cancer Institute and the Barrett Center.”

And he warns others to not ignore symptoms, like he did.

“If you have something wrong, see a doctor right away, unlike I did,” he says. “I’m just thankful for my daughters and Dr. Barrett for helping me.”

March, 2016|Oral Cancer News|

Depressed Head and Neck Cancer Patients Have Lower Survival and Higher Recurrence Risk

Source: www.OncologyNurseAdvisor.com
Author: Kathy Boltz, PhD
 

Depression is a significant predictor of 5-year survival and recurrence in patients with head and neck cancer, according to a new study published in Pyschosomatic Medicine (doi: 10.1097/PSY.0000000000000256). These findings represent one of the largest studies to report on the impact of depression on cancer survival.

Although depression can have obvious detrimental effects on a person’s quality of life, its impact on cancer patients is more apparent, explained lead author Eileen Shinn, PhD, assistant professor of Behavioral Science at The University of Texas MD Anderson Cancer Center, in Houston. Increasing evidence shows modest associations between elevated symptoms of depression and greater risk for mortality among patients with lung, breast, ovarian, and kidney cancers.

The research team sought to clarify the influence of depression on survival, focusing their analysis on a single cancer type. By limiting the sample set and adjusting for factors known to affect outcome, such as age, tumor size, and previous chemotherapy, they were able to uncover a more profound impact of depression.

The researchers followed 130 patients at MD Anderson with newly diagnosed oropharyngeal squamous cell carcinoma (OSCC), a type of cancer in which the tumor originates at the back of the throat and base of the tongue.

At the beginning of their radiation therapy, Patients completed a validated questionnaire at the beginning of their radiation therapy to identify symptoms of clinical depression. Researchers monitored the participants, all of whom completed treatment, until their last clinic visit or death, a median period of 5 years.

“The results of this study were quite intriguing, showing depression was a significant factor predicting survival at 5 years, even after controlling for commonly accepted prognostic factors,” said senior author Adam Garden, MD, professor, Radiation Oncology. Furthermore, depression was the only factor shown to have a significant impact on survival.

Patients who scored as depressed on the questionnaire were 3.5 times less likely to have survived to the 5-year interval compared with those who did not score as depressed. The degree of depression was also found to be significant, as every unit increase on this scale indicated a 10% higher risk for reduced survival.

The results were replicated with a different psychological health survey and were not influenced by how soon following diagnosis the depression assessment was done.

OSCC is diagnosed in 10 000 to 15 000 Americans each year. Major risk factors known to be associated with OSCC include smoking and tobacco use, alcohol consumption, and human papillomavirus (HPV) infection. Incidence of OSCC has doubled in the last 20 years due to increasing HPV infection rates, noted Shinn.

Neither alcohol nor tobacco use, also surveyed in this group, had a significant impact on survival. HPV infection status, when available, also did not appear correlated.

Despite a high cure rate, normally 60% to 80%, recurrence rate of disease is unusually high in these patients (approximately 30%). The researchers also investigated a potential link between depression and disease recurrence.

“When we controlled for all variables, depression was linked with a nearly 4 times higher risk of recurrence,” said Shinn. In addition, never smokers had a 73% lower chance of recurrence, compared with current smokers. Those were the only two factors associated with cancer recurrence.

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

December, 2015|Oral Cancer News|

Poison’s Rikki Rockett Reveals He Is Battling Oral Cancer

Source: www.loudwire.com
Author: Chad Childers
 

Poison drummer Rikki Rockett revealed during an appearance on the Eddie Trunk Live radio show that he’s completed nine rounds of chemotherapy and seven weeks of radiation treatments after being diagnosed with oral cancer this past summer and that he’ll find out in February if the treatments were successful.

Rockett told Trunk (as transcribed by Blabbermouth), “[In] June, I kind of got sick. I had this horrible cold, sore-throat thing, and they were scoping me and they were doing biopsies, and nothing was coming up. And finally a doctor at USC did a biopsy and took a look and he said, ‘I believe you have oral cancer.’ And what it was is a tumor at the base of my tongue … This is very similar to Bruce Dickinson, very similar to Michael Douglas, similar to Tom Hamilton, as far as I know; I don’t know the details of his. And two adjacent lymph nodes that it kind of … Normally, it does spread to the lymph nodes; that’s typical. That’s how you find out you have it ninety percent of the time.”

According to the Rockett, his doctor told him that it was a very treatable cancer, but was “a son of a bitch to treat.” He was then told that he would either have to undergo radiation and chemotherapy at the same time or undergo surgery, but even if he chose the latter, he might still have to do radiation and chemotherapy.

Rockett revealed that it was tough, explaining, “I did thirty-five rounds of radiation; it was five days a week for seven weeks, and that kicks your dick into the dirt. But I went, ‘Okay, this is what I’m gonna do. I wanna beat it, so I’m just gonna go head first into this. I’m gonna set myself up where every single day, I do something positive for my health. I’m gonna work out one day, I’m gonna go to therapy one day.’”

He continued, “At the end of the day, it was really the worst thing that you can go through, for me. I’ve had a decent life, you know what I mean? I mean, we all go through our stuff. I’m not saying my life is a bed of roses, but I’m not a war veteran who got this too. I didn’t get my leg blown off and get cancer. Those guys are the guys that are really the heroes and paying for it. So for me, it was just a battle that I had to get through, and I got to the point where I couldn’t really talk. I had, I think, sixteen canker sores in my mouth at one time. And it’s, like, if you could take your throat and turn it inside out and sunburn it… I had to use this stuff called Magic Mouthwash just to drink the water. It hurt so bad, I couldn’t… And I’m still on a liquid diet.”

As for his decision to keep his cancer treatment quiet, the rocker revealed, “I wanted to see how I would do with [the treatment]. And I didn’t want people to maybe come down to USC and [take] spy photos, like TMZ guys or something like that. And I didn’t want anybody talking to my family about it or anything like that. It’s, like, you wanna forget about it when you can. So when I first start to talk about it, [I didn’t want it to be a situation where] I’d be at the mall, and I’m playing with my little girl or something, and somebody would go, like, ‘Hey, man, how’s the throat doing?’ It’s, like, ‘I just forgot about it for the last forty-five minutes and now you had to remind me.’ And everybody has a horror story. ‘Oh, you have cancer? My mom had cancer. She died from it.’ I don’t wanna hear anybody’s horror stories.”

Rockett revealed that all signs are that he’s responded well to the treatment and that he’s hoping to get good news when he goes for his PET scan in February. “I’m just gonna try to put that out of my mind for now and just continue to get better and feel better,” says Rockett. “There’s nothing that looks like it’s there anymore. They’ve gone down, they’ve looked at my throat… But it’s swelled up and it’s hard to tell, but it looks like it’s in remission.”

During the chat, Rockett revealed that his tongue cancer was caused by HPV, which is currently the number one cause of oral cancer.

While Poison were out of action during 2015, Rockett kept busy with the self-titled debut album from his band Devil City Angels.

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

December, 2015|Oral Cancer News|

SA Developed Melanoma Drug Now Seen Effective in Fighting Lung Cancer

Source: www.woai.com
Author: News Radio 1200 WOAI Staff

 

1229_1264794779Keytruda, a cancer drug developed largely at San Antonio’s START Center, has already proven to be effective in treating advanced melanoma to the point that it is the major part of former President Jimmy Carter’s treatment.  Now, News Radio 1200 WOAI reports Keytruda has been given ‘fast track’ approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States.

Dr. Amita Patnaik, a researcher and oncologist at START who helped develop the drug, says the impact of Keytruda on lung cancer patients has been amazing.

“Close to 40% of those patients will receive a response,” she said.  “And of those patients who receive a response, about 80% of those patients will have a long term response.”

The life saving potential of Keytruda in fighting non small cell lung tumors is obvious.  An estimated 221,000 Americans are diagnosed with lung cancer each year, and 158,000 die of the disease annually.

Dr. Patnaik says Keytruda is becoming the most successful of what are known as ‘targeted therapies,’ drugs which trigger the body to take action to fight the cancer.  She says both melanoma and lung cancer work essentially the same way to undermine the body’s defenses.

“The commonality between melanoma and lung cancer is there is a supressive effect of the cancer on the immune system.”

She says Keytruda essentially overrides that supressive effect, prompting the body to restart its natural immune defenses and fight the cancer.

That means the treatment takes place without chemotherapy.

“Thus avoiding some of the toxicities associated with chemotherapy including hair loss, fatigue, a drop in counts, nausea and vomiting, and the spectrum of negative side effects you get with chemo.”

Dr. Patnaik says several other types of cancers work the same way, ‘turning off’ the body’s natural immune systems, and she says there are indications that Keytruda will work for those cancers as well.

“Keytruda is showing activity in about ten or more other cancers, including liver cancer, head and neck cancer, and in a rare form of breast cancer.”

The FDA granted Keytruda ‘breakthrough therapy designation’ because of demonstrated preliminary clinical evidence that the drug may ‘offer a substantial improvement over available therapies.’

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

October, 2015|Oral Cancer News|

Imaging method has potential to stratify head and neck cancer patients

Source: www.eurekalert.org
Author: press release

Manchester researchers have identified a potential new way to predict which patients with head and neck cancer may benefit most from chemotherapy.

These patients commonly receive pre-treatment induction chemotherapy, before either surgery or radiotherapy, to reduce the risk of disease spread. However the effectiveness of such treatment is reduced in tumours with poor blood flow.

Previous studies have shown that CT scans can be used to assess tumour blood flow. Now researchers at The University of Manchester and The Christie NHS Foundation Trust – both part of the Manchester Cancer Research Centre – have explored the use of MRI scans in predicting which patients would benefit from induction chemotherapy.

Professor Catharine West, who led the study, said: “It’s also important to identify those patients who are unlikely to respond to induction therapy so that we can skip ahead in the treatment pathway and offer them potentially more effective treatments and hopefully improve their outcome.”

The team used an imaging technique known as dynamic contrast-enhanced MRI (DCE-MRI), where a contrast agent tracer is injected into a patient’s vein whilst they have a series of MRI scans taken. This allows scientists and doctors to investigate the blood flow and vessel structure of a patient’s tumour.

They found that the blood flow of a patient’s tumour before they received induction therapy could predict response to treatment. In a paper recently published in the journal Oral Oncology, the group report that those with high tumour blood flow were more likely to respond.

Jonathan Bernstein, a co-author on the paper, said: “Delivery and effectiveness of chemotherapy appears to be better in tumours with higher blood flow. However, amongst those patients with lower measured tumour blood flow, more work is needed to determine those who will and won’t respond.”

Source: ‘Tumor plasma flow determined by dynamic contrast-enhanced MRI predicts response to induction chemotherapy in head and neck cancer’, Bernstein et al. (2015) Oral Oncology

September, 2015|Oral Cancer News|

AstraZeneca joins the world of immunotherapy against cancer

Source: www.youthhealthmag.com
Author: staff

Cancer drug companies have been fighting lately in a completely different and interesting arena: immunotherapy. The competition is indeed heating up that firms such as AstraZeneca are willing to pay millions of dollars for promising treatments. AstraZeneca, through its research company called MedImmune, has just recently announced its decision to purchase a novel drug INO-3112 from Inovio, based in Pennsylvania, for a staggering price tag of $727 million.

INO-3112 is a drug for immunotherapy, a new way of combating cancer by boosting the body’s immune system. This then allows the antibodies and specific cells to fight off the tumor. The treatment may also provide synthetic proteins to boost the body’s fighting chance.

MedImmune believes that with the proper immunotherapy protocol for the patient, conventional methods such as chemotherapy and radiotherapy, which have plenty of serious risks, can now be significantly reduced, if not eliminated. In fact, patients may no longer have to go through surgery, which is a common first-line treatment.

While AstraZeneca already has immunotherapy products in the market, the acquisition of INO-3112 will make it an instrument for combination therapies.

As for Inovio, the drug, which is still not approved, is currently in the advanced stages of the clinical trials. It will be intended for treating head and neck cancers, as well as cervical cancer. While there are already cervical cancer vaccines, they cite the rather poor record of them. Their drug, on the other hand, will work on modifying DNA sequencing that will trigger the manufacture of certain T-cells, which will then curb tumor growth.

So far, MedImmune has already paid its down payment of $27.5 million. The remaining amount will be given as the research and drug reach certain milestones. The company will also pay for the research.

The partnership is also set to increase the revenues of Inovio as it receives a share in the drug’s sale. Both will also be working on cancer vaccines.

August, 2015|Oral Cancer News|

The Cost of Cancer Drugs

Source: www.cbsnew.com
Author: Lesley Stahl
 

The following is a script of “The Cost of Cancer Drugs” which aired on October 5, 2014, and was rebroadcast on June 21, 2015. Lesley Stahl is the correspondent. Richard Bonin, producer.

Cancer is so pervasive that it touches virtually every family in this country. More than one out of three Americans will be diagnosed with some form of it in their lifetime. And as anyone who’s been through it knows, the shock and anxiety of the diagnosis is followed by a second jolt: the high price of cancer drugs.

They are so astronomical that a growing number of patients can’t afford their co-pay, the percentage of their drug bill they have to pay out-of-pocket. As we first reported in October, this has led to a revolt against the drug companies led by some of the most prominent cancer doctors in the country.

Dr. Leonard Saltz: We’re in a situation where a cancer diagnosis is one of the leading causes of personal bankruptcy.

Dr. Leonard Saltz is chief of gastrointestinal oncology at Memorial Sloan Kettering, one of the nation’s premier cancer centers, and he’s a leading expert on colon cancer.

Lesley Stahl: So, are you saying in effect, that we have to start treating the cost of these drugs almost like a side effect from cancer?

Dr. Leonard Saltz: I think that’s a fair way of looking at it. We’re starting to see the term “financial toxicity” being used in the literature. Individual patients are going into bankruptcy trying to deal with these prices.

Lesley Stahl: The general price for a new drug is what?

Dr. Leonard Saltz: They’re priced at well over $100,000 a year.

Lesley Stahl: Wow.

Dr. Leonard Saltz: And remember that many of these drugs, most of them, don’t replace everything else. They get added to it. And if you figure one drug costs $120,000 and the next drug’s not going to cost less, you’re at a quarter-million dollars in drug costs just to get started.

Lesley Stahl: I mean, you’re dealing with people who are desperate.

Dr. Leonard Saltz: I do worry that people’s fear and anxiety are being taken advantage of. And yes, it costs money to develop these drugs, but I do think the price is too high.

The drug companies say it costs over a billion dollars to bring a new drug to market, so the prices reflect the cost of innovation.

The companies do provide financial assistance to some patients, but most people aren’t eligible. So many in the middle class struggle to meet the cost of their co-payments. Sometimes they take half-doses of the drug to save money. Or delay getting their prescriptions refilled.

Dr. Saltz’s battle against the cost of cancer drugs started in 2012 when the FDA approved Zaltrap for treating advanced colon cancer. Saltz compared the clinical trial results of Zaltrap to those of another drug already on the market, Avastin. He says both target the same patient population, work essentially in the same way. And, when given as part of chemotherapy, deliver the identical result: extending median survival by 1.4 months, or 42 days.

Dr. Leonard Saltz: They looked to be about the same. To me, it looked like a Coke and Pepsi sort of thing.

Then Saltz, as head of the hospital’s pharmacy committee, discovered how much it would cost: roughly $11,000 per month, more than twice that of Avastin.

Lesley Stahl: So $5,000 versus $11,000. That’s quite a jump. Did it have fewer side effects? Was it less toxic? Did it have…

Dr. Leonard Saltz: No…

Lesley Stahl: …Something that would have explained this double price?

Dr. Leonard Saltz: If anything, it looked like there might be a little more toxicity in the Zaltrap study.

He contacted Dr. Peter Bach, Sloan Kettering’s in-house expert on cancer drug prices.

Lesley Stahl: So Zaltrap. One day your phone rings and it’s Dr. Saltz. Do you remember what he said?

Dr. Peter Bach: He said, “Peter, I think we’re not going to include a new cancer drug because it costs too much.”

Lesley Stahl: Had you ever heard a line like that before?

Dr. Peter Bach: No. My response was, “I’ll be right down.”

Lesley Stahl: You ran down.

Dr. Peter Bach: I think I took the elevator. But yes, exactly.

Bach determined that since patients would have to take Zaltrap for several months, the price tag for 42 days of extra life would run to nearly $60,000. What they then decided to do was unprecedented: reject a drug just because of its price.

Dr. Peter Bach: We did it for one reason. Because we need to take into account the financial consequences of the decisions that we make for our patients. Patients in Medicare would pay more than $2,000 a month themselves, out-of-pocket, for Zaltrap. And that that was the same as the typical income every month for a patient in Medicare.

Lesley Stahl: The co-pay.

Dr. Peter Bach: Right. 20 percent. Taking money from their children’s inheritance, from the money they’ve saved. We couldn’t in good conscience say, “We’re going to prescribe this more expensive drug.”

And then they trumpeted their decision in the New York Times. Blasting what they called “runaway cancer drug prices,” it was a shot across the bow of the pharmaceutical industry and Congress for passing laws that Bach says allow the drug companies to charge whatever they want for cancer medications.

Dr. Peter Bach: Medicare has to pay exactly what the drug company charges. Whatever that number is.

Lesley Stahl: Wait a minute, this is a law?

Dr. Peter Bach: Yes.

Lesley Stahl: And there’s no negotiating whatsoever with Medicare?

Dr. Peter Bach: No.

Another reason drug prices are so expensive is that according to an independent study, the single biggest source of income for private practice oncologists is the commission they make from cancer drugs. They’re the ones who buy them wholesale from the pharmaceutical companies, and sell them retail to their patients. The mark-up for Medicare patients is guaranteed by law: the average in the case of Zaltrap was six percent.

Dr. Leonard Saltz: What that does is create a very substantial incentive to use a more expensive drug, because if you’re getting six percent of $10, that’s nothing. If you’re getting six percent of $10,000 that starts to add up. So now you have a real conflict of interest.

But it all starts with the drug companies setting the price.

Dr. Peter Bach: We have a pricing system for drugs which is completely dictated by the people who are making the drugs.

Lesley Stahl: How do you think they’re deciding the price?

Dr. Peter Bach: It’s corporate chutzpah.

Lesley Stahl: We’ll just raise the price, period.

Dr. Peter Bach: Just a question of how brave they are and how little they want to end up in the New York Times or on 60 Minutes.

That’s because media exposure, he says, works. Right after their editorial was published, the drug’s manufacturer, Sanofi, cut the price of Zaltrap by more than half.

Dr. Peter Bach: It was a shocking event. Because it was irrefutable evidence that the price was a fiction. All of those arguments that we’ve heard for decades, “We have to charge the price we charge. We have to recoup our money. We’re good for society. Trust us. We’ll set the right price.” One op-ed in the New York Times from one hospital and they said, “Oh, okay, we’ll charge a different price.” It was like we were in a Turkish bazaar.

Lesley Stahl: What do you mean?

Dr. Peter Bach: They said, “This carpet is $500” and you say, “I’ll give you $100.” And the guy says, “Okay.” They set it up to make it highly profitable for doctors to go for Zaltrap instead of Avastin. It was crazy!

But he says it got even crazier when Sanofi explained the way they were changing the price.

Dr. Peter Bach: They lowered it in a way that doctors could get the drug for less. But patients were still paying as if it was high-priced.

Lesley Stahl: Oh, come on.

Dr. Peter Bach: They said to the doctor, “Buy Zaltrap from us for $11,000 and we’ll send you a check for $6,000.” Then you give it to your patient and you get to bill the patient’s insurance company as if it cost $11,000. So it made it extremely profitable for the doctors. They could basically double their money if they use Zaltrap.

“High cancer drug prices are harming patients because either you come up with the money, or you die.”

All this is accepted industry practice. After about six months, once Medicare and private insurers became aware of the doctor’s discount, the price was cut in half for everyone.

John Castellani: The drug companies have to put a price on a medicine that reflects the cost of developing them, which is very expensive and takes a long period of time, and the value that it can provide.

John Castellani is president and CEO of PhRMA, the drug industry’s trade and lobbying group in Washington.

Lesley Stahl: If you are taking a drug that’s no better than another drug already on the market and charging twice as much, and everybody thought the original drug was too much…

John Castellani: We don’t set the prices on what the patient pays. What a patient pays is determined by his or her insurance.

Lesley Stahl: Are you saying that the pharmaceutical company’s not to blame for how much the patient is paying? You’re saying it’s the insurance company?

John Castellani: I’m saying the insurance model makes the medicine seem artificially expensive for the patient.

He’s talking about the high co-pay for cancer drugs. If you’re on Medicare, you pay 20 percent.

Lesley Stahl: Twenty percent of $11,000 a month is a heck of a lot more than 20 percent of $5,000 a month.

John Castellani: But why should it be 20 percent instead of five percent?

Lesley Stahl: Why should it be $11,000 a month?

John Castellani: Because the cost of developing these therapies is so expensive.

Lesley Stahl: Then why did Sanofi cut it in half when they got some bad publicity?

John Castellani: I can’t respond to a specific company.

Sanofi declined our request for an interview, but said in this email that they lowered the price of Zaltrap after listening “to early feedback from the oncology community and … To ensure affordable choices for patients…”

Dr. Hagop Kantarjian: High cancer drug prices are harming patients because either you come up with the money, or you die.

Hagop Kantarjian chairs the department of leukemia at MD Anderson in Houston. Inspired by the doctors at Sloan Kettering, he enlisted 119 of the world’s leading leukemia specialists to co-sign this article about the high price of drugs that don’t just add a few weeks of life, but actually add years, like Gleevec.

It treats CML, one of the most common types of blood cancer that used to be a death sentence, but with Gleevec most patients survive for 10 years or more.

Dr. Hagop Kantarjian: This is probably the best drug we ever developed in cancer.

Lesley Stahl: In all cancers?

Dr. Hagop Kantarjian: So far. And that shows the dilemma, because here you have a drug that makes people live their normal life. But in order to live normally, they are enslaved by the cost of the drug. They have to pay every year.

Lesley Stahl: You have to stay on it. You have to keep taking it.

Dr. Hagop Kantarjian: You have to stay on it indefinitely.

Gleevec is the top selling drug for industry giant Novartis, bringing in more than $4 billion a year in sales. $35 billion since the drug came to market. There are now several other drugs like it. So, you’d think with the competition, the price of Gleevec would have come down.

Dr. Hagop Kantarjian: And yet, the price of the drug tripled from $28,000 a year in 2001 to $92,000 a year in 2012.

Lesley Stahl: Are you saying that the drug companies are raising the prices on their older drugs.

Dr. Hagop Kantarjian: That’s correct.

Lesley Stahl: Not just the new ones. So you have a new drug that might come out at a $100,000, but they are also saying the old drugs have to come up to that price, too?

Dr. Hagop Kantarjian: Exactly. They are making prices unreasonable, unsustainable and, in my opinion, immoral.

When we asked Novartis why they tripled the price of Gleevec, they told us, “Gleevec has been a life-changing medicine … When setting the prices of our medicines we consider … the benefits they bring to patients … The price of existing treatments and the investments needed to continue to innovate…”

[Dr. Hagop Kantarjian: This is quite an expensive medication.]

Dr. Kantarjian says one thing that has to change is the law that prevents Medicare from negotiating for lower prices.

Dr. Hagop Kantarjian: This is unique to the United States. If you look anywhere in the world, there are negotiations. Either by the government or by different regulatory bodies to regulate the price of the drug. And this is why the prices are 50 percent to 80 percent lower anywhere in the world compared to the United States.

Lesley Stahl: Fifty percent to 80 percent?

Dr. Hagop Kantarjian: Fifty percent to 80 percent.

Lesley Stahl: The same drug?

Dr. Hagop Kantarjian: Same drug. American patients end up paying two to three times more for the same drug compared to Canadians or Europeans or Australians and others.

Lesley Stahl: Now, Novartis, which makes Gleevec, says that the price is fair because this is a miracle drug. It really works.

Dr. Hagop Kantarjian: The only drug that works is a drug that a patient can afford.

The challenge, Dr. Saltz at Sloan Kettering says, is knowing where to draw the line between how long a drug extends life and how much it costs.

Lesley Stahl: Where is that line?

Dr. Leonard Saltz: I don’t know where that line is, but we as a society have been unwilling to discuss this topic and, as a result, the only people that are setting the line are the people that are selling the drugs.

Since we first broadcast our story, President Obama asked Congress to change the law and allow Medicare to negotiate prices with drug manufacturers. Few believe, however, that Congress will let that happen anytime soon.

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