Once again undermining confidence in its all-important immuno-oncology pipeline, Bristol-Myers Squibb conceded Tuesday evening that a combination of Opdivo and Yervoy failed to hit a key co-primary endpoint in a Phase III study for frontline renal cell carcinoma.
Comparing the combo against sunitinib (Sutent) in CHECKMATE-214, researchers said that Opdivo/Yervoy failed to significantly improve progression-free survival for patients. They did note, though, that the combo hit a co-primary endpoint on the objective response rate, achieving a 41.6% ORR versus 26.5% for sunitinib. In their words: “The median PFS was 11.56 months (95% CI 8.71 – 15.51) for the Opdivo and Yervoy combination versus 8.38 months (95% CI 7.03-10.81) for sunitinib.”
Coming fast on the heels of AstraZeneca’s woeful failure on PFS for its PD-L1/CTLA4 combo in lung cancer, investors clearly didn’t like the latest setback for Bristol-Myers, driving shares $BMY down 3.5% in pre-market trading. Investigators will continue to follow patients to see how the combo works on overall survival.
Analysts offered two key opinions on the results. A few noted that the PFS numbers only narrowly missed their target on statistical significance, meaning the combo isn’t out for the count. And Michael Schmidt at Leerink noted that Exelixis $EXEL investors are likely to be relieved as one near-term threat to cabo’s franchise for Exelixis at least got delayed by the late-stage miss.
Underscoring that point, Exelixis reported this morning that it had filed a supplemental NDA for cabo in frontline RCC. Exelixis’ shares jumped 3.5% overnight.
Bristol-Myers has been working hard to overcome suspicions about the future of Opdivo and I/O in general after a major blow was leveled by a failure in frontline lung cancer. This latest flop won’t help, but it also won’t deter the company from its comeback mission.
“We are encouraged by the totality of the CHECKMATE-214 data. The overall response rate and durability of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer. This is an important study in first-line renal cancer as these patients need new options,” said Vicki Goodman, development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We look forward to presenting the full results from this study at an upcoming medical meeting.”
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