Imunotherapy approved for Squamous NSCLC

On March 4 the FDA approved Opdivo (Nivolumab) by Bristol-Myers for the treatment of Squamous NSCLC who have previously been treated by at least one chemotherapy. Patients do not have to have PD-L1 expression in order to get the drug.

The Checkmate 017 phase III trial was stopped early (1-11-15) because there was a 3 month (41%) survival improvement from 6 months to 9.2 months. Given that this drug appears to work on 15-20% of patients, that suggests that the benefit was much longer for some patients. The WSJ reported a case of a patient having a response for four years and two months. Of the patients responding 59% had responses longer than 6 months. The trial involved 272 patients.

There is another trial for those NSCLC patients with adenocarcinoma (checkmate 057) that has completed enrollment. Some results are likly to be released this year.

The drug costs $12,500 a month and $150,000 a year. It is delivered intravenously every two weeks.

FDA Opdivo press release

Bristol-Myers Opdivo press release

WSJ article on Opdivo approval.

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