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Bristol Myers Squibb, the global biopharmaceutical company, has shared new details about its ongoing Phase III trial of a potential first-line treatment for people diagnosed with recurrent or metastatic squamous cell carcinoma of the head and neck.
The randomized, multi-center study called CheckMate -651 is evaluating Opdivo 3 mg/kg every two weeks in combination with Yervoy 1 mg/kg every six weeks. It compares this with the extreme regimen of cetuximab, cisplatin/carboplatin and fluorouracil for the treatment of patients with relapsed or metastatic SCCHN. The dual primary endpoints of the study are overall survival in the fully randomized population and in patients whose tumors expressed PD-L1 with a combined positive score of ≥ 20.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s immune system to restore the antitumor immune response. Yervoy is a recombinant human monoclonal antibody that binds to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) and blocks the interaction of CTLA-4 with its ligands CD80/CD86. In 2011, the US FDA approved the use of Yervoy in patients with unresectable or metastatic melanoma, and it has also been approved in more than 50 countries.
The results show that although Opdivo plus Yervoy showed a clear, positive trend toward overall survival in such patients, the study failed to meet its primary endpoints. In addition, the safety profile of the said combination remained consistent with the result of previous solid tumor studies.
The secondary endpoints included overall survival in patients with tumors expressing PD-L1 at different cut-off values, objective response rate, duration of response, and progression-free survival in all participants and those with PD-L1.
In the past, particularly the CheckMate -141 trial, Opdivo monotherapy demonstrated a survival benefit in adults with relapsed or metastatic SCCHN after platinum-based therapy. This is why the US Food and Drug Administration and the European Medicines Agency Opdivo gave the green light for this in 2016.
To provide further context, significant improvements in overall survival were observed with the combination of Opdivo plus Yervoy in six Phase 3 clinical studies involving five different tumors. These are metastatic melanoma, non-small cell lung cancer, malignant pleural mesothelioma, advanced renal cell carcinoma and squamous cell carcinoma of the esophagus.
Despite the recent results on CheckMate -651, Bristol Myers Squibb researchers remain optimistic.
“In the CheckMate -651 trial, Opdivo plus Yervoy showed a positive overall survival trend over EXTREME in patients with squamous cell carcinoma of the head and neck whose tumors express PD-L1, despite the control arm performing better than expected based on historical data,” said Abderrahim Oukessou , MD, vice president for thoracic cancers and development leader at Bristol Myers Squibb.
“We are disappointed that these results have not reached statistical significance, and we remain committed to advancing research and supporting patients with this difficult-to-treat cancer,” he continued.
head and neck cancer, the sixth most common cancer worldwide, usually begins in the squamous cells that line the moist mucosal surfaces in these areas. It records approximately 930,000 newly diagnosed cases and over 467,000 related deaths each year. Risk factors for SCCHN can be viral (associated with the human papilloma virus) or behavioral, including alcohol use and smoking.