Bristol Myers’ Opdivo Delivers Increased Survival in NSCLC

Bristol Myers_Jeremy Moeller/Getty Images

Jeremy Moeller/Getty Images

Bristol Myers Squibb's Phase III CheckMate -816 trial hit the primary endpoint in an interim analysis. The study was evaluating the company’s checkpoint inhibitor Opdivo (nivolumab) and chemotherapy in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), a neoadjuvant setting—as a first step to shrink a tumor before the primary treatment, typically surgery. 

The combination demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to chemotherapy alone when dosed before surgery.

Nicolas Girad, professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris, said, “While the intent of surgery is curative in resectable non-small cell lung cancer, between 30% and 55% of patients experience recurrence after surgery and ultimately succumb to the disease, presenting a strong need for additional options that can disrupt this cycle.”

He went on to say, “The positive event-free survival data seen with neoadjuvant nivolumab plus chemotherapy is groundbreaking and can have important implications for how we treat resectable non-small cell lung cancer.”

The data was from a prespecified interim analysis. Bristol Myers Squibb indicates it plans to complete a full analysis of the available CheckMate -816 data, which it will share with regulators and at a medical conference. Previous data from the trial had been presented at the 2021 American Association for Cancer Research and 2021 American Society of Clinical Oncology Annual Meetings.

The theory for the use of immunotherapy in the neoadjuvant setting is that the presence of tumor cells during immunotherapy treatment might create a stronger immune response, making treatment more effective against a primary tumor. However, it would still allow for targeting of covert micro-metastasis. 

Bristol Myers Squibb and its collaborators are studying the use of immunotherapy in this setting, as well as adjuvant and peri-operative settings, and in combination with chemoradiation.

In other studies, Opdivo has shown efficacy in the neoadjuvant or adjuvant setting for lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

“CheckMate -816 is the first Phase III trial with an immunotherapy-based combination to demonstrate a statistically significant and clinically meaningful benefit as a neoadjuvant treatment for patients with non-metastatic non-small cell lung cancer,” stated Abderrahim Oukessou, vice president, thoracic cancers development lead, BMS. “The combination of Opdivo plus chemotherapy first showed a statistically significant improvement in pathologic complete response rate without impacting surgical outcomes and has now extended the time patients live free of disease progression, recurrent or death. The event-free survival data from CheckMate -816 strengthen the evidence for the potential of Opdivo-based therapies to improve long-term clinical outcomes when used in the earlier stages of non-metastatic cancers.”

The two types of lung cancers are non-small cell and small cell. NSCLC is the most common form, making up 84% of diagnosed lung cancer cases. Non-metastatic cases make up the majority of NSCLC diagnoses, about 60%. Many non-metastatic NSCLC patients are cured by surgery, but 30% to 55% have a recurrence and die despite surgery.

There have been rumors that BMS is considering acquiring Aurinia Pharmaceuticals. Other companies apparently in the running include GlaxoSmithKline, Roche and Otsuka Pharmaceuticals

Aurinia focuses on autoimmune diseases. On November 1, Aurinia announced updated interim data from the AURORA 2 continuation study of Lupkynis (voclosporin) for lupus nephritis (LN) in patients with systemic lupus erythematosus (SLE). They plan to present the data on November 8 during Plenary Session III at the upcoming The American College of Rheumatology (ACR) Convergence 2021.

GSK has denied the rumors, but if there is a deal, BMS appears to be the leader, and analysts speculate the company might offer about $5 billion, or five times peak sales, for the company. Aurinia, however, might be holding out for a significantly higher bid. Assuming the rumors are true, the negotiations appear to be stalled.

With BMS facing key patent expiration in the next decade and Opdivo sales plateauing, many analysts expect the company to make two or more bolt-on acquisitions to stimulate their stock prices and fill up their portfolio and pipeline.

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