August 15, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – The details are in the data, not the headlines. That’s the message a Seeking Alpha contributor has regarding Bristol-Myers Squibb ‘s recent trial failure of Opdivo.
The contributor, who writes under the pen name Pharma Doc, a self-described Ph.D. at a “major pharmaceutical company” said that despite the nearly 20 percent drop in stock price for Bristol-Myers, he continues to believe the stock is a strong buy. He said he believes investors and analysts have overreacted as far as Opdivo and maintains the drug is still a high value driver for the company.
Earlier this month, BMS announced Opdivo failed to meet its endpoints in a Phase III trial as a monotherapy for a “broad patient population” in patients with previously untreated advanced non-small cell lung cancer. The company said the drug failed to meet its endpoints of progression-free survival in patients expressing PD-L1 at 5 percent. However, Pharma Doc noted that Opdivo has a strong record of working well in patients who have higher levels of PD-L1 expression.
Following the announcement, BMS stock fell, while rival Merck jumped as investors looked to that company’s PD-L1 targeting drug, Keytruda, which recently posted its own successful trial results. However, that may have been due to better trial design, as Keytruda was being used to evaluate patients expressing 50 percent PD-1 and not 5 percent, as the Opdivo trial.
Pharma Doc noted that when BMS releases the trial data, investors will likely see the drug for its potential in treating lung cancer. In a Motley Fool podcast, analysts said it’s likely that Opdivo and Keytruda stack up well to each other when it’s an apples to apples comparison of patients with similar PD-1 expressions.
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.
Since the trial failure though, Bristol-Myers continues to study Opdivo as a cancer treatment. This morning the company entered into a developmental partnership with Bavarian Nordic to study a combination therapy of Opdivo and Bavarian Nordic’s experimental cancer therapy, CV301. Bavarian Nordic’s therapy has been shown to upregulate PD-L1, suggesting its ability to stimulate an immune attack to cancer and the potential benefit of an anti-PD-1 antibody. Under the new collaboration, BMS will supply OPDIVO for a Phase 2 clinical study in combination with CV301 to treat patients with non-small cell lung cancer.
Opdivo has an advantage over Keytruda, which requires patients pass a regulatory diagnostic before being prescribed the medication. BMS’ treatment does not have that restriction, which may make it preferable to prescribe.
