Treatment of a common form of advanced lung cancer with Bristol-Myers Squibb Co’s experimental immunotherapy nivolumab led to a one-year survival rate of 41 percent in a midstage clinical trial, according to data to be presented at a medical meeting, sending the drugmaker’s shares up 8.8 percent.
While the study, called CheckMate-063, did not compare nivolumab with another drug or placebo, the historical one-year survival rate for patients like those in the trial, whose squamous non-small cell lung cancer (NSCLC) had progressed after treatment with two or more prior therapies, is between 5.5 percent and 18 percent, the company said on Thursday. Squamous cell cancer tends to be found in the middle of the lung.
“The data today look very, very good,” ISI Group analyst Mark Schoenebaum said, adding that it bodes well for an ongoing Phase III trial in NSCLC patients following just one prior therapy.
He had estimated a 1-year survival rate of about 20 percent as the number to beat.
Nivolumab belongs to a new class of drugs called PD-1 inhibitors that have generated great excitement in the medical community. They work by blocking a tumor’s ability to camouflage itself, allowing the body’s immune system to recognize and attack the cancer.
Merck & Co Inc last month received the first U.S. approval of a drug from the class to treat advanced melanoma – the deadliest form of skin cancer.
“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,” Dr. Suresh Ramalingam, director of medical oncology at Winship Cancer Institute of Emory University, said in a statement.
Bristol-Myers, which has proposed the brand name Opdivo for nivolumab, plans to use the data as part of its rolling submissions seeking U.S. and European approvals.
Sanford Bernstein analyst Tim Anderson sees Opdivo sales reaching $4.6 billion in 2020.
Median overall survival was 8.2 months in the 117-patient trial. The median duration of response had not yet been reached.
The objective response rate (ORR), which was the primary goal of the trial, was 15 percent as assessed by an independent review committee. That compares with historical expectations in the single digits, the company said. ORR was defined as reduction of the target lesion of at least 30 percent with no new lesions.
The results were scheduled to be reported on Friday at a thoracic oncology meeting in Chicago.
Fatigue, lung tissue inflammation and diarrhea were among the most common adverse side effects reported. The discontinuation rate due to drug-related side effects was 12 percent, and there were two drug-related deaths, the company reported.
Lung is the leading cause of cancer deaths globally, with about 1.5 million each year, according to the World Health Organization. NSCLC accounts for about 85 percent of lung cancer cases. (Reuters)