When compared to chemotherapy, the immunotherapy agent had better outcomes both in quality of life and survival.
Treatment with Opdivo (nivolumab) showed a 32 percent reduction in the risk of death for patients with metastatic or recurrent squamous cell carcinoma of the head and neck compared to chemotherapy, according to findings from the phase 3 CheckMate-141 trial.
The two-year overall survival (OS) rate with Opdivo was 16.9 percent compared to only 6 percent in the control arm, said the study’s lead investigator, Robert L. Ferris, M.D., Ph.D., who presented the results at the 2018 American Association of Cancer Research (AACR) Annual Meeting. Median OS rates were 7.7 months with the immunotherapy agent, compared to 5.1 months in the control arm.
“For a group of patients who have very poor prognosis, it was the first study to demonstrate that immunotherapy was clinically effective and better than the standard of care at the primary analysis,” Ferris, director of the University of Pittsburgh Medical Center Hillman Cancer Center, said in an interview with OncLive, a sister publication of CURE.
Opdivo targets and inhibits a protein called PD-1, and by doing so, helps the immune system to identify the cancer cells as something foreign that needs to be attacked. While the patients with higher levels of PD-1 had better OS results than those with low levels, benefit was seen in both patient populations.
“This is pretty impressive, and it justifies not using PD-L1 as a selection biomarker for nivolumab therapy in patients with head and neck cancer,” Ferris said.
The researchers also saw that there were far fewer high-grade side effects in those treated with Opdivo, leading to a stabilization or improvement of quality of life.
These findings, while promising, bring up some more about who should receive Opdivo treatment. Since about half of the patient population with head and neck cancer also has HPV, Ferris said that might be a factor in prescribing an immunotherapy treatment plan.
“We wanted to ask whether you could select patients by HPV status, because HPV causes approximately half of head and neck cancers,” Ferris said. “At two years, the benefit appears to be the same for HPV-positive patients and HPV-negative patients, which both had about a 40 percent reduction in the risk of death.”
Ferris noted these results show that head and neck cancer is truly an immune-response disease, as it is now being used for patients who progressed on other treatments, such as surgery, radiation and chemotherapy, shifting the treatment paradigm — and outcomes – for this group of patients.
“It is very exciting, and we can use this to build on with combinations and hopefully get some biomarkers to figure out who would benefit more, and who needs a combination upfront,” he added.
In addition to CheckMate-141, there are plenty of other clinical trials that are investigating immunotherapy in the head and neck cancer space, be it through combinations in the recurrent disease setting or the locally advanced disease state in patients who are also undergoing chemotherapy and radiation.
“We are now adding immunotherapy agents such as nivolumab and other anti-PD-1 therapies to try and improve survival in the previously untreated population,” Ferris said. “Therefore, moving it into earlier stages of disease and in the recurrent metastatic setting, plus the concept of combinations is all very exciting for patients.”