Opdivo Plus Chemotherapy Helps Non-Small Cell Lung Cancer Patients

Bristol Myers Squibb recently announced that Opdivo plus chemotherapy significantly improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC). 

The Phase 3 CheckMate -816 trial enrolled 358 patients to receive either Opdivo 360 milligrams plus histology-based platinum doublet chemotherapy every three weeks or platinum doublet chemotherapy every three weeks followed by surgery. 

This combination treatment previously showed notable improvement in pathologic complete response (pCR), the other primary endpoint of the trial. In addition, the safety profile of Opdivo plus chemotherapy was consistent with prior NSCLC studies.

Between 30 to 55 percent of NSCLC experience recurrence after surgery and ultimately die from the disease, explained Nicolas Girard, MD, PhD, professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris. 

Therefore, the positive data from the combination treatment is “groundbreaking” and can have important implications for how NSCLC is treated in the future, Girard said. 

A September multinational survey commissioned by Bristol Myers Squibb found that many experts expect immunotherapy to positively impact the treatment landscape for patients with earlier-stage cancers in the neoadjuvant, adjuvant, and perioperative settings.

The scientific reasoning for leveraging immunotherapy in the neoadjuvant setting is twofold. 

For example, the presence of a tumor during immunotherapy may strengthen immune response, making the treatment more effective against a primary tumor, a Bristol Myers Squibb spokesperson explained. And there is also an opportunity to target covert micro-metastasis.

So far, Opdivo has improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma.

In April 2021, FDA approved Opdivo as the first immunotherapy for patients with advanced or metastatic gastric cancer, gastroesophageal cancer, and esophageal adenocarcinoma, based on Phase 3 clinical trial results. 

In the trial, 789 patients who received Opdivo combined with chemotherapy lived longer than the 792 patients who received chemotherapy alone. 

Specifically, the median survival was 13.8 months for patients who received the combination treatment versus 11.6 months for chemotherapy alone. 

“This is the first Phase 3 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,” said Abderrahim Oukessou, MD, vice president of thoracic cancers development lead at Bristol Myers Squibb.