Bristol Myers adds to neoadjuvant win for Opdivo in lung cancer, escalating early cancer showdown with Merck
Bristol Myers Squibb and Merck are locked in a heated race to bring their blockbuster PD-(L)1 drugs into early cancer patients as part of potentially curative combinations. The approvals have been coming fast and heavy, and Bristol Myers keeps adding to its case for a big-time FDA nod in lung cancer.
A combination of Opdivo and chemo in the neoadjuvant setting before surgery cut the risk of recurrence or death in patients with stage IB to IIIA non-small cell lung cancer over pre-surgery chemo alone, acing the second primary endpoint in the Phase III CHECKMATE-816 study, Bristol Myers said Monday.
There were no hard data in Monday’s release, but the drugmaker said an interim analysis came up aces for the Opdivo combo, which Bristol Myers announced back in April hit the other primary endpoint in this study: an improvement in pathological complete response.
Bristol Myers and Merck with megablockbuster Keytruda are leading the pack in terms of bringing checkpoint inhibitors into early cancer patients before their disease ever advances into the metastatic stage. In NSCLC, Bristol Myers forecasts a big market for its drug, and it’s not hard to see why: The drugmaker estimates that between 30% and 55% of NSCLC patients relapse after surgery, underscoring the need for additional therapies to knock down that risk.
Bristol Myers said it plans to present full data at an upcoming medical meeting as well as with regulators.
Back in April, the drugmaker rolled out data for the Opdivo-chemo combo showing it posted a 24% pathological complete response (pCR) rate for patients across the PD-(L)1 expression spectrum compared with just 2.2% for chemo alone. That pCR endpoint is a controversial one and has led to some backlash — including at a heated adcomm for a Keytruda regimen in triple-negative breast cancer — but adding a positive EFS readout could go a long way to soothing regulators’ concerns.
Even with Merck neck-and-neck across a growing range of tumor types in the neo/adjuvant setting, Bristol Myers thinks it has a leadership position here and is building its own case for Opdivo, either alone or in combination with chemo, as the go-to PD-(L)1 for early cancer patients.
The drugmaker now sports FDA approvals in adjuvant urothelial cancer, adjuvant esophageal or gastroesophageal junction (GEJ) cancer and adjuvant melanoma.