BMS Lands Squamous Non-Small Cell Lung Cancer Approval For Nivolumab: 28 EU Member States

This particular mid-July Monday is chock full of good immuno-oncology news for Bristol Myers Squibb, it seems.

BMS just announced that the EU has cleared Opdivo^®, in a particularly wide array of lung cancers, opening a vast market to the franchise -- based on some other CheckMate series study results. Earlier this morning, BMS stopped the CheckMate -25 study early, due to superior efficacy over standard course, in certain renal cancers. Now -- at least inside the US -- we may safely bet that some oncologists will start writing off-label, for these other cancers -- relying on the data just cleared by the EMEA arm. But the meta-narrative here continues to be that Merck is at least a year behind BMS now, in several cancers, in the EU.

Here is a quote from the press release:

. . . ."With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care," said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. "Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal."

Approval is based on the results of CheckMate -017 and -063. In the Phase III CheckMate -017 study, nivolumab demonstrated superior clinical benefit across all endpoints versus docetaxel, the standard of care, regardless of PD-L1 (programmed death ligand-1) expression status, including a 41% reduction in the risk of death, significantly superior OS rate of 42% versus 24% for docetaxel at one-year and superior durable antitumor activity. In the Phase II CheckMate -063 study, nivolumab showed an estimated 41% one-year survival rate and a median OS of 8.2 months. The safety profile of nivolumab is consistent with previously-reported trials, and in Checkmate -017, is also favorable compared to docetaxel. . . .

Perfect. . . . and. . . I must say, just as we repeatedly predicted. Onward.