BMS’ Opdivo and Yervoy Combination Treatment Snags Two Approvals in Lung Cancer this Month


Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.

Earlier this month, the U.S. Food and Drug Administration (FDA) approved the combination of its anti-PD-1 drug Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. Then, on Tuesday, the FDA greenlit the combination therapy along with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression. These two approvals mark the fifth and sixth regulatory wins for the combination therapy.

The latest approval was made under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure effective treatments are available to patients as early as possible. Approval was based on data from a specified interim analysis from the Phase III CheckMate -9LA trial that showed the combination treatment and two cycles of platinum-doublet chemotherapy demonstrated superior overall survival versus chemotherapy alone. Median overall survival was 14.1 months for the combination treatment versus 10.7 months for chemotherapy alone. In a follow-up analysis at 12.7 months, the median overall survival was 15.6 months and 10.9 months. At one year, 63% of patients treated with Opdivo and Yervoy with limited chemotherapy and 47% of those treated with chemotherapy were still alive, BMS said.

In the trial, the overall response rate for patients treated with the combination treatment was 38% and 25% for patients treated with chemotherapy.

Adam Lenkowsky, general manager and head of U.S., Oncology, Immunology, Cardiovascular at Bristol Myers Squibb, noted that non-small cell lung cancer is a complex disease to treat and typically required multiple options to address the needs of the different patient populations within this type of cancer

“This second approval of an Opdivo and Yervoy-based combination for the first-line treatment of advanced NSCLC now gives more patients access to a dual immunotherapy approach that can be administered with or without limited chemotherapy, depending on the patient and their PD-L1 status, and the possibility of a chance to live longer,” Lenkowsky said in a statement.

Non-small cell lung cancer is one of the most common types of lung cancer, and accounts for approximately 84% of diagnoses.

David P. Carbone, lead investigator in the CheckMate -9LA study and director of the James Thoracic Oncology Center at The Ohio State University, said researchers have come a long way in understanding the role of dual immunotherapy-based approaches in cancer.

“The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With today’s approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life,” he said in a statement.


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