The new remedy, nivolumab (tradenamed Opdivo by developer Bristol-Myers Squibb), is the first approved treatment using the body’s immune system, rather than chemotherapy, to fight squamous cell non-small cell cancer (NSCLC), found in seven out of every eight lung cancer patients. Lung cancer causes the most cancer deaths in the U.S. (nearly 160,000 last year), and about 225,000 new lung cancer diagnoses are made each year.
A randomized clinical trial included 272 people with advanced NSCLC who had previously been treated with platinum-based chemotherapy drugs. After starting treatment, the 135 patients who received Opdivo had an average survival time 3.2 months longer than the 137 patients who received docetaxel, a leading taxane-type chemotherapy drug also marketed under the names Taxotere and Docecad.
Tumors shrank or disappeared in about 15% of patients given the new drug, and among them, 59% saw the improvement continue for more than six months. In contrast, chemotherapy typically brings such results in 10% or less of NSCLC patients, and the trial participants had already taken chemotherapy treatments without success.
The trial, planned to continue through June this year, was stopped more than three months ahead of schedule, since its results showed a clear survival advantage for patients given the new immunotherapy treatment.
The new drug works by attacking the PD-1 protein, which some cancer cells make as a shield against the immune system. By lowering that shield, the drug enables the patient’s immune system to fight the spread of cancer cells.
Dr. Rachel Sanborn, an oncologist with the Providence Cancer Center in Portland, Oregon, which participated in the SNCLC trial, hailed the FDA’s approval of the first-ever immunotherapy treatment for lung cancer an exciting development, calling it “the beginning point, not the end point.” While all participants in the clinical trial had previously received chemotherapy, future trials are planned to examine whether the drug could be a first-line treatment.
Opdivo had qualified for priority review by the FDA, a program that speeds review of drugs designed to treat serious conditions with the potential of bringing significant improvement in either or both safety or effectiveness.
The drug had won FDA approval last December for treating melanoma, responsible for almost 10,000 deaths in this country annually, making it the nation’s fifth most prevalent form of cancer. That trial involved patients who could not be treated by surgery or whose cancer had metastasized and did not respond to chemotherapy.
Like the case with the lung cancer trial, the melanoma trial finished three months early, and qualified for priority review at the FDA. The agency also designated it as a potential breakthrough therapy and accorded it special orphan-drug procedures.
That clinical trial found almost a third of 120 participants with inoperable or metastatic melanoma experienced tumor shrinkage; the shrinkage persisted for over six months in about a third of those patients.
Encouraged by the drug’s performance with two forms of cancer, researchers plan to test whether it can show similar results against other forms of the disease.