A First in Lung Cancer: Immunotherapy Improves Survival

Zosia Chustecka

January 12, 2015

The immune checkpoint inhibitor nivolumab (Opvido, Bristol-Myers Squibb), which was recently approved for use in melanoma, has shown a survival advantage over chemotherapy in a pivotal trial in lung cancer. The trial (known as CheckMate 017) was stopped early due to benefit.

This is the first time that a survival advantage has been demonstrated in lung cancer with an immunomodulator drug, the company notes. It announced the top-line result of a superior overall survival in a press release, and says that clinical data will be presented at a forthcoming meeting.

The trial was conducted in 272 patients with advanced or metastatic squamous cell non-small cell lung cancer, and was open-label, randomizing patients to treatment with either nivolumab 3 mg/kg intravenously every 2 weeks or docetaxel 75 mg/m² intravenously every 3 weeks.

Pharmaceutical analysts reacting to the news speculate that the drug could be approved for use in lung cancer before the end of the year. The company has already filed for this indication in both the United States and Europe, and now says that it will "share" the new data with regulatory authorities.

Another check-point inhibitor is also making progress in lung cancer — pembrolizumab (Keytruda, Merck & Co). The company has announced that it is accelerating its development of the drug for use in lung cancer, and hopes to file for approval of this new indication by mid-year. Pembrolizumab is already marketed for use in melanoma. In fact, it beat nivolumab to the market to be the first program death inhibitor to become available in the United States, to the surprise of many analysts.

Early results with these immunomodulator drugs in lung cancer have been causing excitement at recent meetings, as previously reported by Medscape Medical News, leading one researcher to predict that "immunotherapy is heralding a new era of lung cancer treatment."

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