Bristol Myers' Opdivo steps in FDA fast lane for potential first-in-class nod in pre-surgery lung cancer

As immuno-oncology agents gradually move in to treat earlier stages of diseases, Bristol Myers Squibb has earned a regulatory boost that could potentially make it the first company to enter a key lung cancer setting.

The FDA granted priority review for an approval application that covers Opdivo in combination with chemotherapy as a treatment prior to surgery in resectable non-small cell lung cancer (NSCLC), BMS said Monday.

Thanks to that VIP status, BMS is looking at a shortened review timeline, with a decision expected by July 13. If approved, Opdivo and chemo would be the first immunotherapy-based regimen for NSCLC in the neoadvjuant setting.

Opdivo proved its mettle in a phase 3 trial dubbed CheckMate 816. Among patients with stages 1b to 3a NSCLC, those who took Opdivo-chemo combo before surgery were nearly 14 times more likely to have no residual signs of cancer in their resected tissue compared to those who had chemo alone.

Adding Opdivo to chemo also reduced the risk of tumor recurrence, disease progression or death. BMS will disclose detailed data on that measure, known as event-free survival, at an upcoming medical conference.

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While Opdivo is angling to be first in the neoadjuvant, or pre-surgery, setting for NSCLC, Roche’s Tecentriq recently became the first FDA-approved NSCLC adjuvant treatment, meaning for use after surgery, though it’s limited to stages 2 to 3a disease bearing PD-L1 expression.

Merck’s market-leading PD-1 inhibitor, Keytruda, recently also turned up a postsurgery adjuvant win and in a broader population of patients with stages 1b to 3a NSCLC regardless of PD-L1 status.

Some doctors remain on the fence about whether PD-1/L1 inhibitors should be used as adjuvant therapy before or after surgery or whether it is appropriate at all for early NSCLC. Currently, none of the immunotherapies have produced data on whether they can prolong patients’ lives when used as neoadjuvant or adjuvant therapies.

For neoadjuvant treatments, the goal is to clear out cancer cells that may have spread, and having a specific tumor target before surgical removal may help trigger a stronger immune response in the presence of a PD-1/L1 inhibitor., BMS has argued. For post-surgery adjuvant treatment, the goal is to keep the immune system on high alert to prevent cancer from returning. 

RELATED: Bristol Myers Squibb's Opdivo posts another win in early lung cancer, but debate over treatment approach likely remains

Detailed results from CheckMate 816 trial on the more mature event-free survival results could help doctors make a decision. What’s more, as SVB Leerink analyst Daina Graybosch, Ph.D., noted during a September note after a European Society for Medical Oncology session, experts are also holding out for data from several other clinical trials including Keytruda’s adjuvant trial. Plus, BMS is running another clinical trial coded CheckMate 77T, which is evaluating adding Opdivo both before and after surgery for early-stage NSCLC.