Bristol Myers Squibb (BMY)

[DewDiligence]

BMY reports (stellar) results of CHECKMATE-816 in neoadjuvant NSCLC:

https://finance.yahoo.com/news/neoadjuvant-opdivo-nivolumab-plus-chemotherapy-123000624.html

Bristol Myers Squibb today announced results from the CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC).

In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94 [!], 99% Confidence Interval [CI]: 3.49–55.75; p<0.0001), with pCR defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review.

Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease.

CheckMate -816 represents the first randomized Phase 3 study to show a significant improvement in pathological response with a neoadjuvant immunotherapy combination in patients with resectable NSCLC.

…The scientific rationale for using immunotherapy in the neoadjuvant setting is twofold: it presents the earliest opportunity to treat cancer cells that have spread in the body without detection, and the presence of a tumor during immunotherapy treatment may enable a stronger immune response, potentially making the treatment more effective.

The neoadjuvant setting is where a drug regimen is given prior to surgical resection with curative intent, provided that tumor shrinkage allows for a resection to be performed.

In Oct 2020 (#msg-158760487) BMY announced that the pCR of Opdivo/chemo was statsig superior to chemo alone, but the details were not disclosed until now. The trial remains blinded to the other primary endpoint, EFS (similar to DFS or PFS).

Opdivo combined with either chemo or Yervoy has now shown a statsig benefit in the neoadjuvant settings of four cancer types: NSCLC, esophageal, bladder, and melanoma.

Is a statsig outcome on pCR, in the absence of corroborating EFS/DFS/PFS data, enough to obtain FDA accelerated approval in the neoadjuvant setting? I don’t know.