Bristol-Myers Squibb's Stock Topples as Kidney Cancer Drug Flunks Phase III Study

Published: Aug 16, 2017

Bristol-Myers Squibb's Stock Topples as Kidney Cancer Drug Flunks Phase III Study August 16, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Princeton, N.J. – Bristol-Myers Squibb released mixed topline results from its Phase III CheckMate-214 clinical trial of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in patients with advanced or metastatic renal cell carcinoma.

Investors were quick to respond, with dropping to $57.25 from $57.87, but analysts were less pessimistic, generally.

John Carroll, writing for Endpoints News, said, “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 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.”

The Opdivo-Yervoy combination met the co-primary endpoint of objective response rate (ORR) and hit a 41.6 percent ORR versus 26.5 percent for sunitinib (Sutent). It didn’t hit the median duration of response. There was improvement in progression-free survival (PFS), but its stratified two-sided did not hit statistical significance.

“We are encouraged by the totality of the CheckMate-214 data,” said Vicki Goodman, Bristol-Myers Squibb’s development lead, Melanoma and Genitourinary Cancers, in a statement. “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. We look forward to presenting the full results from this study at an upcoming medical meeting.”

At least part of the problem in term of investors is the failure of Opdivo in front-line lung cancer earlier this year. On the other hand, in early July, the company released promising interim data of Opdivo compared to Yervoy in melanoma.

Goodman, at that time, said, “These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma. There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience diseases recurrence after surgery. We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon.”

Renal cell carcinoma (RCC) is the most common form of kidney cancer in adults. It makes up more than 100,000 fatalities globally each year. Clear-cell RCC is the most common type of RCC, making up 80 percent to 90 percent of all cases. It is about twice as common in men as in women. The highest rates are in North America and Europe. The five-year survival rate for patients diagnosed with metastatic, or advanced kidney cancer, is 12.1 percent.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor. It was the first PD-1 immune checkpoint inhibitor to receive approval anywhere in the world and is currently approved in more than 60 countries. In October 2015, the Opdivo-Yervoy combo treatment was the first immuno-oncology (IO) combo to be approved for metastatic melanoma.

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