Bristol Myers' Opdivo clears signs of lung cancer in first-in-class pre-surgery win

opdivo
Adding Opdivo to chemotherapy before surgery improved pathologic complete response in patients with resectable non-small cell lung cancer, Bristol Myers Squibb said. (Bristol Myers Squibb )

Bristol Myers Squibb’s Opdivo may not be the most popular immunotherapy for treating metastatic non-small cell lung cancer, but it’s now the first to report positive late-stage clinical results in resectable cases before surgery.

Adding Opdivo to standard chemotherapy before surgery helped significantly more non-small cell lung cancer patients show no evidence of cancer cells in their resected tissue compared with chemo alone, BMS said Wednesday.

Although detailed data from the ongoing CheckMate-816 trial remain under wraps, BMS was quick to point out that Opdivo was the first immunotherapy to demonstrate an improvement in pathologic complete response for this patient population in a phase 3 trial.

But by Evercore ISI analyst Umer Raffat’s estimate, the neoajudvant lung opportunity isn't huge, given that patients would receive only three cycles of Opdivo and that a sizable number of patients do not get any neoadjuvant therapy at all.

Still, Opdivo’s PD-1/L1 competitors are eyeing the same field. Roche is testing its Tecentriq alongside chemo in the IMpower030 trial. AstraZeneca has the Aegean study that will evaluate the potential of Imfinzi with platinum-based chemo in both the pre-surgery and post-surgery settings. And it’s not a party without Merck & Co., which is running the Keynote-671 trial, testing its NSCLC immunotherapy king Keytruda in tandem with chemo in both pre- and post-surgery.

Pathologic complete response is a widely used marker for clinical trials of neoadjuvant therapy, but skeptics have raised concern over whether it can indeed predict a drug’s life-saving ability across different tumor types.  

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For BMS, it’s continuing the CheckMate-816 trial to assess whether the Opdivo-chemo cocktail can extend the time before patients' cancer comes back or gets worse, which is the study’s co-primary endpoint. Raffat said that event-free survival data won’t be available for another two to thee years. Merck’s trial, meanwhile, is even more ambitious: Alongside event-free survival, it has set overall survival as Keynote-671’s co-primary endpoint.

As the competitive landscape in the metastatic cancer market has largely settled for immunotherapies in several key tumor types, drugmakers are increasingly looking to move earlier into treatment, and BMS is considered a potential leader in the neoadjuvant and adjuvant fields.

A few days ago, the New York pharma reported that post-surgery use of Opdivo extended the time muscle-invasive bladder cancer patients could remain cancer-free, regardless of their PD-L1 status. Data unveiled at September's European Society of Medical Oncology virtual meeting showed that, in post-surgery patients with esophageal cancer, Opdivo staved off disease recurrence by almost two years more than placebo did. And the PD-1 inhibitor already boasts an FDA approval for the adjuvant treatment of patients with high-risk, fully resected melanoma.