Important IMvoke010 trial could shape future research in immunotherapy in locally advanced head & neck cancer after results of 1st phase III study in adjuvant therapy don't meet event-free survival endpoint. Dana-Farber's Robert Haddad, MD, explains more in this video.
At a ar we present the results of the in vogue 10 as a phase three double blind randomized trial of Azo Liza. After definitive treatment for patients with locally advanced head and neck cancer, the treatment of patients with locally advanced head and neck cancer being treated in the curative intent setting does involve surgery, radiation and chemotherapy. The standard of care for patients after completing definitive treatment is usually observation. The aim of the invoke 10 study was to assess the efficacy and safety of tizo compared to placebo in patients with locally advanced squamous cell carcinoma of the head and neck who have not progressed. After completing multimodality, curative definitive treatment, we elected to enroll patients with high risk head and neck cancer. The primary end point of the trial is investigator assessed event free survival and secondary endpoint is central review, event free survival and overall survival and safety. Now, in terms of how these patients were treated before randomized to ati or placebo. And this is an important 0.40% of the patients or close to 40% of patients were treated with primary surgery for the primary end point of investigator assessed event free survival. Unfortunately, the study did not reach the primary end 0.67% in the arti arm versus 63% in the placebo arm. And we saw the same numbers with the Central review efs, when we look at the overall survival, we were actually quite surprised that we saw an excellent overall survival in both of the arms. This study, albeit negative would really help us think. How do we design the next trial and had the neck cancer? And how do we incorporate immune therapy and the curative treatment of head and neck cancer patients? We know that checkpoint inhibitors help patients with recurrent and metastatic head and neck cancer. But as of now, we have not been able to clearly define the role of a checkpoint inhibitor in the curative treatment of head and neck cancer patient. The other point that really we did not pursue and describe that we can think about going forward is some biomarker selection in how we select patients to enroll in adjuvant trials in head and neck cancer. So this really study does not change the current standard of care for patients with locally advanced head and neck cancer, but hopefully will guide us on how we design future trials in the curative setting in patients with locally advanced head and neck cancer.
