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 antiPD-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 of the head and neck (SCCHN).
Eligible patients who are still enrolled in the study are now able to continue their current treatment regimen, or switch over to nivolumab. Ferris says the prospect of having a new drug available for SCCHN is exciting, especially considering the last FDA approval for the disease type came in 2006.
"It was 2006 when cetuximab was approved and that was a relatively modest advance, although it was the first targeted therapy. We have a population without any other therapeutic options and a very rapid progression," he said.
"AntiPD-1 agents have had promising data in melanoma and squamous non–small cell lung cancer (NSCLC). Squamous NSCLC genomically resembles HPV-negative head and neck cancer in its behavior regarding carcinogen exposure. Therefore, we felt it might respond well to anti–PD-1 agents, too. We designed the study to hopefully create something new and effective for an essentially hopeless palliative group of patients."
The phase III data have not yet been released from the trial, though early discontinuation has generated significant excitement in the field. The trial was scheduled to run until October 2016, has generated significant excitement in the field, says Ferris, who is a primary author on the abstract submitted for presentation at the ASCO Annual Meeting.
Ferris says the study was designed reflect the idea that there are different standards of care for SCCHN throughout the world, which is why cetuximab, methotrexate, or docetaxel were chosen for the control arms.
"We still don’t have public data for what all of the standard of care selections were, but we do know that cetuximab tends to be used more in North America. Meanwhile, the other 2 agents are more likely to be used in Europe and other countries because cetuximab is not approved there," he said.
"The benefits are really very modest with those single-agent treatments and they are toxic. There is very much a need for a new treatment. We are very interested in the toxicity profile of nivolumab, as it has proven to be well tolerated in other cancers."
Ferris adds that the excitement generated in the field stems from the revelation of efficacy for pembrolizumab (Keytruda) at the 2015 ASCO Annual Meeting, saying the data from both pembrolizumab and nivolumab "appear to be very similar."
"There was a suspicion that nivolumab would be promising in head and neck cancer, as well. There is a great deal of buzz from medical oncology leaders all over the country regarding this. People have really been waiting with bated breath for something for our patients. This is a real win for the community and for a population of patients with a devastating disease in a very important area of the body," he said.