Biotech Values

[DewDiligence]

BMY presents OS data from Opdivo+Yervoy trial in first-line melanoma (CHECKMATE-067):

http://finance.yahoo.com/news/opdivo-nivolumab-combination-yervoy-ipilimumab-123000440.html

Bristol-Myers Squibb Company (BMY) today announced the first overall survival (OS) data from the Phase 3 CheckMate -067 clinical trial. With a minimum follow-up of 28 months, the median OS had not yet been reached in either of the two Opdivo treatment groups and was 20 months for the Yervoy monotherapy group (95% CI: 17.1-24.6).

Opdivo in combination with Yervoy and as a monotherapy reduced the risk of death 45% [hazard ratio (HR) 0.55; 95% CI: 0.42-0.72; P<0.0001] and 37% (HR 0.63; 95% CI: 0.48-0.81; P<0.0001), respectively, compared with Yervoy alone.

The two-year OS rates were 64% for the Opdivo plus Yervoy combination, 59% for Opdivo alone and 45% for Yervoy alone.

…The Opdivo plus Yervoy combination and Opdivo monotherapy provided OS benefits across clinically relevant subgroups of patients versus Yervoy alone. Specifically, in patients with BRAF mutations, the combination reduced the risk of death 57% (HR 0.43; 95% CI: 0.28-0.66) and Opdivo monotherapy reduced the risk of death 40% (HR 0.60; 95% CI: 0.40-0.89) compared to Yervoy alone. In patients without BRAF mutations (Wild-type patients), the combination reduced the risk of death 38% (HR 0.62; 95% CI: 0.48-0.80) and Opdivo monotherapy reduced the risk of death 36% (HR 0.64; 95% CI: 0.49-0.83) compared to Yervoy alone.

In patients with PD-L1 expression >=5%, Opdivo in combination with Yervoy and Opdivo monotherapy resulted in a 40% (HR 0.60; 95% CI: 0.36-1.00) and 44% (HR 0.56; 95% CI: 0.34-0.90) reduction in risk of death, respectively, compared to Yervoy alone.

In patients with PD-L1 expression <5%, the combination and Opdivo monotherapy resulted in a 45% (HR 0.55; 95% CI: 0.42-0.72) and a 35% (HR 0.65; 95% CI: 0.50-0.84) reduction in risk of death, respectively, compared to Yervoy alone.

This trial (CHECKMATE-067) was the basis for FDA accelerated approval of Opdivo + Yervoy in first-line melanoma (irrespective of BRAF status) based on PFS in Jan 2016 (#msg-120042769 ). With the OS dataset from CHECKMATE-067, BMY should be able to obtain full FDA approval in this setting. Note, however, that CHECKMATE-067 was not powered to show a statsig OS benefit for Opdivo + Yervoy relative to Opdivo monotherapy—and it did not do so.