Bristol Myers Squibb Submits sBLA for Opdivo Plus Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer

Bristol-Myers Squibb (BMS) today announced that the U.S. FDA has accepted a supplemental Biologics License Application (sBLA) for the blockbuster PD-1 inhibitor Opdivo (nivolumab) in combination with chemotherapy as a neoadjuvant therapy for the treatment of patients with resectable non-small cell lung cancer (NSCLC). The FDA also granted Priority Review to this application. The press release noted that, if approved, the Opdivo combination would become the first immunotherapy regimen for the treatment of patients with resectable NSCLC.

Lung cancer is the leading cause of cancer death worldwide. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, accounting for 84% of all diagnosed cases. The majority of NSCLC patients at initial diagnosis have non-metastatic disease (approximately 60%). Although many non-metastatic NSCLC patients can be cured through surgery, 30%-55% of patients experience recurrence and die from the disease after surgical resection, necessitating treatment options before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option for various types of cancer.

This application is based on the results of the pivotal Phase 3 clinical trial CheckMate-816. In the trial, when Opdivo was administered in combination with chemotherapy before surgery, it demonstrated a statistically significant and clinically meaningful improvement in pathological complete response (meaning no signs of cancer in surgically removed tissue or biopsy samples, pCR) and event-free survival (EFS) compared to chemotherapy alone. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC. Results published last April at the AACR conference showed that Bristol-Myers Squibb's Opdivo, when combined with chemotherapy as a pre-surgical treatment for resectable non-small cell lung cancer, increased the pathological complete response rate to 24%, compared to only 2.2% in the chemotherapy group. Bristol-Myers Squibb is collaborating with investigators to present the EFS results from this trial at an upcoming medical conference.

References:

[1] U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer. Retrieved February 28, 2022, from https://www.businesswire.com/news/home/20220225005538/en

(Original text has been abridged)

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