cetuximab

Immunotherapy Continues to Advance in Head and Neck Cancer

Source: www.onclive.comAuthor: 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. Dr. 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, [...]

Charlotte Parker2016-02-29T10:49:56-07:00February, 2016|Oral Cancer News|

Immunotherapies gaining traction in head and neck cancers

Source: www.targetedonc.com Author: Greg Kennelty An explosion of immunotherapies is on the horizon for patients with metastatic head and neck cancer, specifically as phase III trials begin to report findings for PD-1 inhibitors. This upcoming wave of new therapies places importance on understanding optimal treatment settings and adverse events associated with these therapies. In late January, the phase III CheckMate-141 trial investigating the anti–PD-1 agent nivolumab was stopped early, due to a substantial improvement in the primary endpoint of overall survival (OS). The drug was put up against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel following progression on a platinum-based therapy. At this time, data from the study have not yet been released but are being prepared for future presentation. Findings from the study are being discussed with the FDA and other health authorities. In addition to nivolumab, the PD-1 inhibitor pembrolizumab (Keytruda) demonstrated encouraging activity in patients with with advanced PD-L1–positive esophageal carcinoma during the phase Ib KEYNOTE-028 study. Additionally, the agent was effective for patients with squamous cell carcinoma of the head and neck in the phase I KEYNOTE-012 study. In the head and neck cancer population, the objective response rate with pembrolizumab was 24.8% in 117 evaluable patients. Tumor shrinkage was experienced by 56% of patients and another 25% had stable disease. The response rate seen with pembrolizumab was similar, regardless of HPV infection status. In those with HPV-positive disease, the ORR was 20.6% compared with 27.2% in the negative group. To gain further insight, [...]

Oral Cancer Foundation News Team - A2016-02-18T14:35:44-07:00February, 2016|Oral Cancer News|

Nivolumab Could Change Head and Neck Cancer Treatment Paradigm

Source: www.Targetedonc.comAuthor: Laura Panjwani "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer." - Robert Ferris, MD, PhD With the phase III CheckMate-141 trial being stopped early due to the anti–PD-1 agent nivolumab having met its primary endpoint of overall survival improvement in head and neck cancer, Robert Ferris, MD, PhD, couldn't be more elated. "This is what I've devoted my career to, and it is gratifying to see that really come to pass," said Ferris, professor and chief, Division of Head and Neck Surgery, vice chair for Clinical Operations, associate director for Translational Research, and coleader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, in an exclusive interview with Targeted Oncology. "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer. There is now hope for a lot of patients and physicians who have been frustrated by this difficult-to-treat disease. This opens up a whole new class of therapies for this population." Ferris, who acted as cochair/coprimary investigator for the trial alongside Maura Gillison, MD, PhD, Ohio State University, said the trial pitted nivolumab against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in patients with platinum-refractory squamous cell carcinoma [...]

Charlotte Parker2016-02-16T09:24:23-07:00February, 2016|Oral Cancer News|

Cetuximab plus RT linked with high toxicity in head and neck cancer

Source: www.cancernetwork.com Author: Anna Azvolinsky, PhD The combination of radiation therapy plus the EGFR inhibitor cetuximab had higher rates of acute toxicity among patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) compared with radiation therapy plus the chemotherapy cisplatin, according to results of a phase II trial based in Italy. Efficacy was similar with both combination therapies. According to Stefano Maria Magrini, MD, professor of radiotherapy at the Università degli Studi di Brescia in Italy, and colleagues, this is the first clinical trial to directly compare radiation therapy plus cetuximab to a chemoradiation regimen for SCCHN. The results of the randomized trial are published in the Journal of Clinical Oncology. Cetuximab was approved in combination with radiation therapy by the US Food and Drug Administration in 2006 for the treatment of unresectable SCCHN. Despite a goal of recruiting 130 patients, only 70 patients were recruited between 2011 and 2014. The 1- and 2-year overall survival rates were 75% and 68% in the cetuximab arm compared with 78% in the cisplatin arm. The 1- and 2-year local control rates were 64% and 53% in the cetuximab arm and 84% and 80% in the cisplatin arm, yet the differences between arms were not statistically significant (P = .073), reflecting the inadequate statistical power of the relatively small trial. Compliance in both treatment arms was relatively low. Only 28% of patients in the cetuximab arm and 20% of patients in the cisplatin arm received at least 7 cycles [...]

Oral Cancer Foundation News Team - A2015-12-13T09:06:40-07:00December, 2015|Oral Cancer News|

Follow-up by advance practice nurses improves care for patients with head, neck cancer

Source: www.healio.com Author: Anthony SanFilippo The launch of an advance practice nurse outpatient follow-up clinic improved symptom management for high-risk patients with head and neck cancer following radiation therapy, according to findings from a study conducted at Cleveland Clinic. This initiative led to fewer ED visits and hospital admissions, results showed. “These results are significant as they suggest more intensive follow up in high-risk head and neck patients can improve patient outcomes,” Bridgett Harr, CNP, of the department of radiation oncology at Cleveland Clinic, told HemOnc Today. “This intensive symptom management is an important role [advance practice nurses (APNs)] can fill in this and other patient groups by providing consistent, proactive management of symptoms during recovery from treatment. Our study suggests this will lead to improved patient experience, in addition to a reduction in cost to both the patient and health care system as a whole.” Patients with head and neck cancer often undergo radiotherapy or chemoradiotherapy, and many experience debilitating side effects that require ED management or admission to the hospital. In 2014, an APN-led clinic was launched to focus on the acute rehabilitation of patients with head and neck cancer undergoing these therapies. Harr and colleagues sought to evaluate the outcomes and incidence of adverse events among patients treated at an APN clinic compared with historical outcomes. The analysis included data from 25 high-risk patients with head and neck cancer who received care post-treatment at an APN clinic and 24 patients who received standard follow-up care identified using [...]

Oral Cancer Foundation News Team - A2015-11-03T10:14:55-07:00November, 2015|Oral Cancer News|

Keytruda doubles efficacy of only targeted therapy for head and neck cancer

Source: www.curetoday.com Author: Lauren M. Green The immunotherapy Keytruda (pembrolizumab), in a recent study, proved twice as effective for the treatment of head and neck cancer as Erbitux (cetuximab), the only targeted therapy indicated as a therapy for the disease. The multisite study offers the largest experience to date of how immunotherapy can be deployed in patients with head and neck cancer, and could change the way the disease is treated. The findings were announced May 29 during the annual meeting of the American Society of Clinical Oncology, a gathering of nearly 30,000 oncology professionals taking place in Chicago. Keytruda is an antibody designed to disable the protein PD-1 so it cannot do its job of keeping the immune system in check; this allows T cells to become more active in recognizing and fighting cancer cells. In the study, investigators found that the drug produced broad and durable responses in patients with advanced head and neck cancer. Fifty-six percent of patients in the study experienced some tumor shrinkage with Keytruda, and 86 percent of those patients continued to respond to treatment at data cutoff on March 23, 2015. Keytruda produced an overall response rate (ORR) of 25 percent, and it proved active in both HPV (human papillomavirus)-positive and HPV-negative patients. “The efficacy was remarkable — pembrolizumab seems to be roughly twice as effective, when measured by response, as our only targeted therapy, cetuximab,” said Tanguy Seiwart, an assistant professor of medicine and associate leader of the head and neck cancer [...]

Oral Cancer Foundation News Team - A2015-06-11T09:08:47-07:00June, 2015|Oral Cancer News|

Merck immunotherapy appears effective in head and neck cancer – study | Reuters

Source: www.firstpress.comAuthor: Bill Berkrot A Merck & Co drug that helps the immune system fight cancer was about twice as effective as the current standard therapy for patients with recurrent or advanced head and neck cancers, according to study data released on Friday. A quarter of the 132 patients who received the drug, Keytruda (pembrolizumab), saw their tumors shrink by at least 30 percent. Fifty-six percent of patients experienced at least some tumor shrinkage in the ongoing single drug Phase I study dubbed Keynote-012, researchers reported. "This is remarkable because we don't usually see this level of activity with new agents. We have a track record of failure," said Dr. Tanguy Seiwert, lead investigator of the study from the University of Chicago. Advanced head and neck cancer is currently treated with Eli Lilly's Erbitux, known chemically as cetuximab, which typically has a response rate of 10 percent to 13 percent. "The only thing that works is cetuximab and this looks at least twice as good," said Seiwert, who was presenting the Keytruda data at the American Society of Clinical Oncology meeting in Chicago. ADVERTISING Merck shares rose more than 1 percent to $60.43 on the New York Stock Exchange. Keytruda and Opdivo from Bristol-Myers Squibb Co are at the forefront of a promising new class of drugs called PD-1 inhibitors that block a mechanism tumors use to evade the immune system. Keytruda is approved to treat advanced melanoma and awaits a decision for use in lung cancer. It is being [...]

Oral Cancer Foundation News Team - A2015-06-02T11:56:50-07:00June, 2015|Oral Cancer News|

AACR says that new drug may assist therapy for Head and Neck Cancer

Source: hcplive.comAuthor: THURSDAY, Sept. 18, 2014 (HealthDay News) -- The investigational drug alpelisib (previously known as BYL719) appears to inhibit activation of the pathway that leads to resistance to cetuximab, an anti-epidermal growth factor receptor agent used in the treatment of head and neck cancer. These findings were presented at the American Association for Cancer Research's special conference "Targeting the PI3K-mTOR Network in Cancer," held from Sept. 14 to 17 in Philadelphia. Pamela Munster, MD, of the University of California in San Francisco, and colleagues tested the combination of BYL719 and cetuximab in vivo in a cetuximab-sensitive and a cetuximab-resistant xenograft model of esophageal squamous cell carcinoma. In a phase Ib study, BYL719 was administered in combination with cetuximab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck that was resistant or intolerant to platinum-based chemotherapy; prior cetuximab therapy was allowed. The researchers found that the addition of BYL719 to cetuximab showed an additive effect in the cetuximab-sensitive model. BYL719 restored sensitivity to cetuximab in the cetuximab-resistant model. In the phase Ib study, as of March 10, 2014, 37 patients have received BYL719 and cetuximab, and the overall response rate is 11%. Based on the data from preclinical studies and the phase Ib study, the combination of alpelisib and cetuximab for squamous cell carcinoma of the head and neck is being explored in a phase II study. "Treatment resistance is often conveyed through activation of the PI3K/AKT/mTOR pathway, and alpelisib is an inhibitor of this pathway," [...]

Charlotte Parker2014-09-22T12:45:41-07:00September, 2014|Oral Cancer News|

Targeted radiation, drug therapy combo less toxic for recurrent head, neck cancers

Source: medicalxpress.com Author: University of Pittsburgh Schools of the Health Sciences Patients with a recurrence of head and neck cancer who have previously received radiation treatment can be treated more quickly, safely and with fewer side effects with high doses of targeted radiation known as Stereotactic Body Radiation Therapy (SBRT) in combination with a drug that also carefully targets cancerous tumors. These findings from a UPMC CancerCenter study were presented today at the American Society of Radiation Oncology (ASTRO) annual meeting in San Francisco. SBRT uses concentrated radiation beams in high doses to destroy tumors in difficult or hard-to-reach areas. The treatment is noninvasive, which minimizes damage to surrounding healthy tissue and organs. Clinicians at UPMC CancerCenter, partner with the University of Pittsburgh Cancer Institute (UPCI), used SBRT in combination with the drug cetuximab for patients who had a recurrence of squamous cell carcinoma of the head and neck after going through radiation. "The prognosis for patients who have a recurrence of head and neck cancer that cannot be surgically removed is already poor. Traditional treatments can be associated with significant side effects so severe that patients give up on the therapy altogether," said Dwight E. Heron, M.D., vice chairman of radiation oncology at UPCI and director of Radiation Oncology Services at UPMC CancerCenter. "By taking these patients through an abbreviated course of targeted drug and SBRT, we minimize the side effects of treatment." Doctors treated 48 patients with the combination therapy between July 2007 and March 2013. All of [...]

Oral Cancer Foundation News Team - A2014-09-17T18:54:50-07:00September, 2014|Oral Cancer News|

Docetaxel regimen tops cisplatin in head and neck cancer

Source: www.cancernetwork.com Author: Anna Azvolinsky, PhD A phase II study has demonstrated that combining docetaxel-based chemoradiotherapy and the antibody cetuximab postoperatively in patients with high-risk squamous cell carcinoma of the head and neck led to improved disease-free and overall survival, with no unexpected toxicities. The results of the study were published in the Journal of Clinical Oncology. Two-hundred and thirty-eight stage III and IV patients were randomized to receive radiation therapy (60 Gy) plus cetuximab and either cisplatin (30 mg/m2) or docetaxel (15 mg/m2) once per week as part of the Radiation Therapy Oncology Group (RTOG) 0234 clinical trial. The 2-year overall survival (OS) was 69% in the cisplatin treatment arm and 79% in the docetaxel treatment arm. The 2-year disease-free survival (DFS) was 57% and 66% in the cisplatin and docetaxel arms, respectively. Previously, two large phase III trials, the RTOG 9501 and the European Organisation for Research and Treatment of Cancer (EORTC) 22931 trials, both showed a small but significant survival benefit for postoperative head and neck cancer patients who received adjuvant radiation and chemotherapy concurrently, resulting in the incorporation of cisplatin in an adjuvant regimen for high-risk patients. The drawback was that adding cisplatin to radiation therapy increased toxicity. Many of these patients are not candidates for the combination therapy due to poor performance status, older age, and renal insufficiency. The purpose of the current trial was to test whether combining a molecular therapy such as cetuximab with chemotherapy would improve survival with a better toxicity profile, [...]

Oral Cancer Foundation News Team - A2014-07-19T07:13:12-07:00July, 2014|Oral Cancer News|