The efficacy of Bristol-Myers Squibb Co’s experimental immunotherapy nivolumab for the treatment of a common form of advanced lung cancer has been established in a mid-stage clinical trial resulting in a
one-year survival rate of 41 percent. The result is in accordance with the data to be presented at a medical meeting which has sent the drug maker’s shares up 8.8 percent. Although CheckMate-063, as the study has been titled, made no comparison of nivolumab with another drug or placebo, between 5.5 percent and 18 percent patients in the trial, with progresses in the squamous non-small cell lung cancer (NSCLC) even after two or more prior therapies, have shown a historical one-year survival rate, as reported by the company on Thursday. ISI Group analyst Mark Schoenebaum confirmed that the data looked pretty good and predicts well about an ongoing Phase III trial in NSCLC patients after just one prior therapy. His estimate was a 1-year survival rate of about 20 percent as the number to beat
Nivolumab is a member of a new class of drugs known as PD-1 inhibitors which has created waves in the medical community for its property of blocking a tumor’s ability to camouflage itself. This, consequently, allows the immune system of the body to identify and attack the cancer cells. Last month, the first U.S. approval for a drug belonging to this class was granted to Merck & Co Inc for treating advanced melanoma, recognized as the most fatal form of skin cancer
Director of medical oncology at Winship Cancer Institute of Emory University, Dr. Suresh Ramalingam, said “the Phase II findings from CheckMate-063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies.” Bristol-Myers has proposed Opdivo as the brand name for nivolumab and plans to incorporate the data in their rolling submissions for U.S. and European approvals. Tim Anderson, Sanford Bernstein analyst, expects the sales of Opdivo to reach $4.6 billion in 2020.
In the 117-patient trial, the median overall survival had been recorded to be 8.2 months, however, the median duration of response had not reached yet. The prime aim of the trial was the objective response rate (ORR) which was evaluated by an independent review committee as 15 percent. ORR referred to the reduction of the target lesion of at least 30 percent without any new lesion. The revelation of the results was scheduled at a thoracic oncology meeting in Chicago on Friday.
The common adverse side effects which have been reported include diarrhea, lung tissue inflammation and fatigue. The company also reported two drug-related deaths along with 12 percent discontinuation rate owing to drug-related side effects. As per the World Health Organization, lung remains the most prominent cause of cancer deaths throughout the globe, with a statistics of 1.5 million each year. About 85 percent of lung cancer cases are associated with NSCLC. Squamous cell cancer affects the middle of the lung. The New York Stock Exchange marked that the shares of Bristol-Myers were up $4.71 at $58.87