Immunotherapy lung cancer drug shows promising results in trial

30 Oct 2014

As part of a clinical trial, treatment of a common form of advanced lung cancer with an experimental immunotherapy drug led to a promising 1-year survival rate of 41%. The compound is called nivolumab and the trial focused on squamous non-small cell lung cancer.

In particular, the study focused on patients whose cancer had progressed after treatment with two or more prior therapies.


Squamous non-small cell lung cancer: 1-year survival rates historically low

The historical one-year survival rate for patients like those in the trial is between 5.5% and 18%, according to Bristol-Myers Squibb (the manufacturer of this experimental drug). Squamous cell cancer tends to be found in the middle of the lung.

Nivolumab: a "PD-1 inhibitor"

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.

Study findings

The study did not compare nivolumab with another drug or placebo.

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% 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% with no new lesions.

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%, and there were two drug-related deaths, the company reported.

The study is still incomplete.

"Encouraging findings" for the experimental drug

"The Phase 2 findings from [the trial] 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.

The pharmaceutical company behind the compound, 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.


Source: Reuters
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