FDA dubs new drug a ‘breakthrough therapy’ for advanced cancers

FDA dubs new drug a ‘breakthrough therapy’ for advanced cancers

A lengthy follow-up study to Bristol-Myers Squibb’s cancer medication nivolumab (Opdivo) has shown a 28 percent reduced risk of death in patients with advanced lung cancer.

A lengthy follow-up study to Bristol-Myers Squibb’s cancer medication nivolumab (Opdivo) has shown a 28 percent reduced risk of death in patients with advanced lung cancer.

The phase III CheckMate-057 study was presented at the 2015 European Cancer Congress and also published in The New England Journal of Medicine.

After 17.2 months, 582 patients with advanced nonsquamous non–small cell lung cancer (NSCLC) were given randomized treatments- half nivolumab, half docetaxel. The median age of the participants was 62.

The overall survival rates for patients given nivolumab was 39 percent, compared with the 23 percent rates for patients taking docetaxel, a leading competitor. Moreover, adverse events were far less common with nivolumab (10 percent) than with docetaxel (54 percent).

“These longer term survival results for nivolumab in advanced, nonsquamous non–small cell lung cancer support the potential for this immuno-oncology agent in treating lung cancer patients,” said lead investigator Leora Horn, MD, of the Vanderbilt-Ingram Cancer Center. “CheckMate-057 builds upon its critical findings and now, data show a sustained survival benefit for nivolumab in this hard-to-treat disease that is incredibly encouraging for oncologists, and most importantly, for our patients.”

“Importantly, data from this analysis show that a greater proportion of patients had tumors that shrank in response to nivolumab than to everolimus; the objective response rate was 25% for nivolumab versus 5.4% for everolimus, the partial response rate was 24.1% versus 4.9%, the complete response rate was 1% versus 0.5% respectively, and many other patients experienced stable disease when the tumors did not grow – 34.4% for nivolumab-treated patients versus 55.2% for everolimus-treated patients.”

Based on the phase III CheckMate-057 trial, on September 2, the FDA granted nivolumab the designation of breakthrough therapy and a priority review for patients with previously treated nonsquamous NSCLC.

“It is exciting to see the outcome of this study, as the results are significant and clinically meaningful to patients and healthcare professionals alike. They are likely to change the treatment of patients with advanced kidney cancer, whose disease has progressed on prior treatment. Although we cannot speculate at this time on when nivolumab might enter the clinic, we hope that this study will quickly lead to approval of nivolumab as a standard of care therapy for these patients.”

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