August 5, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Shares of Bristol-Myers Squibb are down more than 16 percent this morning after its lung cancer drug Opdivo failed to meet its endpoints in a late-stage trial for lung cancer patients.
Opdivo, which has been approved for use against some cancers, was being studied in a Phase III trial as a monotherapy for a “broad patient population” in patients with previously untreated advanced non-small cell lung cancer. However, the company announced this morning that the drug failed to meet its endpoints of progression-free survival in patients expressing PD-L1 at 5%.
Although disappointing news, the company said it’s proud of the work done on Opdivo as BMS transforms cancer care. The company said the trial, dubbed CheckMate-026, was designed to treat patients in a broad category to see if Opdivo could stand on its own as a form of therapy. The company is still running a Phase III trial in combination with another BMS cancer drug, Yervoy for PDL-1 positive patients and for PDL-1 negative patients.
“We believe that combination therapy may provide an important opportunity to address the needs of every patient with first-line lung cancer,” the company said in a statement.
Giovanni Caforio, chief executive officer of Bristol-Myers Squibb, said in a statement that Opdivo has become a “foundational treatment that is transforming cancer care across multiple tumor types.”
In December 2014, Opdivo was approved by the U.S. Food and Drug Administration for patients with advanced melanoma who no longer respond to other drugs, or cannot be treated via surgery. In March 2015, it was approved for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is an immuno-therapy drug delivered via injection that harnesses the patient’s own immune system to fight cancerous cells. Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells.
Opdivo, which is being heavily advertised in the media, had sales near $1 billion in 2015, but analysts predict it could go much, much higher, hitting nearly $13 billion annually within a few years. According to Bloomberg estimates, Opdivo costs patients in the United States about $12,500 per month and $150,000 annually.
Opdivo’s failure as a monotherapy was surprising, given its successes. However, BMS is not the first to see a Phase III trial come crashing around their ears. In February, Peregrine Pharmaceuticals saw its stock fall 60 percent after the company announced it was discontinuing the company’s Phase III trial of bavituximab in patients previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The company said it discontinued the trial following an independent data monitoring committee review that showed the drug did not improve overall patient survival rates.
BMS is also not the only company to develop PD-LI inhibitors. AstraZeneca and Merck are both developing such drugs, including Merck’s Keytruda, which has shown great promise.
