August 13, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Bristol-Myers Squibb Company announced yesterday that after delivering additional clinical trial data regarding expanded use of cancer drug Opdivo, the U.S. Food and Drug Administration (FDA) had delayed the decision date in order to evaluate the new data.
Originally the supplemental Biologics License Application (sBLA) for Opdivo was submitted on April 29, 2015 and a decision was expected on Aug. 27. Now, the date has been delayed to Nov. 27, 2015.
On July 20, Bristol-Myers Squibb announced that its Phase III trial of Opdivo (nivolumab) compared to everolimus in patients with advanced or metastatic renal cell carcinoma (RCC) was halted because it met its endpoint. The primary endpoint was overall survival and the secondary endpoints were objective response rate and progression-free survival.
Earlier, on April 17, 2015, the company announced another Phase III trial of Opdivo, this time in patients with advanced non-squamous non-small cell lung cancer (NSCLC), was halted early because the independent Data Monitoring Committee (DMC) decided the study had met its endpoint, superior overall survivor compared to the control group.
Opdivo was approved for sale in December 2014 to treat patients with a type of skin cancer, advanced melanoma. The current evaluation, which has additional data, is for patients with previously untreated advanced melanoma. Bristol-Myers Squibb indicates that it wanted to add the extra information so the FDA had “the broadest data set, irrespective of BRAF status.”
The drug has also been approved for the treatment of metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy, and in the U.S. for the treatment of unresectable or metastatic melanoma and disease progression after Yervoy (ipilimumab) treatment, and if the tumors are BRAF V600 mutation positive, a BRAF inhibitor.
Opdivo is a new class of drug that is of particular interest to the biopharma industry. It falls into the broad area of immuno-oncology drugs and is a programmed death-1 (PD-1) immune checkpoint inhibitor. Tumors often have molecules that slow down the body’s immune system. PD-1 inhibitors act by blocking those molecules, in a sense, taking the brake off the body’s immune system.
Other companies working in this area include Amgen , Roche , Merck KgaA , Pfizer Inc. , Regeneron Pharmaceuticals, Inc. , Sanofi and others.
Bristol-Myers Squibb indicates that Opdivo is being studied in various tumors types in more than 50 clinical trials. Some are standalone, monotherapy treatments and others are in combination with other therapies. Often the combination therapies involve administering Opdivo with a therapy that stimulates the immune system, roughly equivalent to releasing the brake on the immune system while simultaneously hitting the gas on specific immune cells.
According to the company, Opdivo generated about $122 million in sales in this year’s second quarter. According to some analysts if the company receive approval expansions, Opdivo sales could hit $5 billion annually. In 2014 the company reported $15.9 billion in total revenue, with projected revenue for this year of $16 billion and $16.8 billion in 2016.
has been pretty solidly on an upward trend until recently. Shares traded for $48.92 on Oct. 14, 2014, rose to $62.39 on Jan. 13, 2015, rising to $68.48 on Mar. 18. They dropped a bit on April 7 to $63, then rose to $70.06 on July 14. Shares dropped to $64.30 on July 27 and are currently trading for $62.39.
Jefferies Group analysts raised the company’s price target to $64 and gave it a “hold” rating. Leerink Swann analysts gave it a “buy” rating and Vetr analysts changed from a “sell” rating to a “hold” rating with a price target of $65.50. On Monday, Aug. 3, the company declared a quarterly dividend of $0.37 per share, or a $1.58 annualized dividend.
