Barclays analysts said Bristol-Myers’ trial provides date with perhaps the evidence that progression-free survival might not be the best yardstick to gauge the benefit of immunology-oncology drugs.
(Reuters) – Bristol-Myers Squibb Co said on Thursday the success of its combination therapy to improve overall survival in kidney cancer patients helped it end the trial well ahead of schedule, despite earlier reporting mixed effects on other main goals.
“We believe the overall survival benefit probably confirms the durability of the sign found on progression-free survival, leading to a very large likelihood of approval,” Leerink Research analyst Seamus Fernandez wrote in a client note.
The failure led to Merck & Co Inc’s Keytruda getting a leg up at the field that was immuno-oncology that was key and Bristol-Myers’ becoming the target of activist investors.
Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide annually, Bristol-Myers estimates.
Still, Bristol-Myers’ Opdivo failed to prolong survival in patients with non-small cell lung cancer, the largest cancer market, based on test results this season.
Bristol-Myers said the combination treatment had failed to improve survival in patients, but had succeeded in reducing the size of the tumors.
Exelixis Inc, which is developing a kidney cancer treatment, tumbled 10 percent. But, Bristol-Myers’ trial results raised hopes for AstraZeneca Plc’s lung cancer therapy that, in July, failed to reveal survival.
Published at Thu, 07 Sep 2017 15:58:36 +0000
Bristol-Myers said the study was stopped early after the successful results at a planned interim analysis, sending its shares up 4.2 per cent to a 52-week high of $62.415.
That is why, Bernstein analyst Timothy Anderson said, survival is today incorporated by most trials as a primary endpoint.
The trials to track overall survival rates were to run through the second half of 2019, according to Cowen and Co..
U.S. health regulators on Wednesday put a partial grasp on three trials examining Opdivo in combination with other medicines for multiple myeloma due to risks found in similar studies on a rival drug.
The business said a mixture of Yervoy and Opdivo, its two drugs, demonstrated overall survival rates than a standard-of-care drug in patients with metastatic or advanced renal cell carcinoma.