Bristol-Myers Squibb's Opdivo wins expanded US approval for treatment of NSCLC

Bristol-Myers Squibb's shares gained as much as 5.7 percent on Wednesday after the FDA announced it extended the indication for the company's PD-1 inhibitor Opdivo (nivolumab) to include treatment of advanced squamous non-small-cell lung cancer (NSCLC) in patients who progressed on or after platinum-based therapy. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research, said the approval, which was granted more than three months ahead of the June 22 action date, "will provide patients and healthcare providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials."

The regulator stated that the decision was supported by data from the Phase III CheckMate-017 study of 272 patients with advanced squamous NSCLC. In January, the company halted the study early after Opdivo met the primary endpoint, extending overall survival by an average 3.2 months versus docetaxel (for related analysis, see ViewPoints: Bristol-Myers Squibb passes through key Opdivo checkpoint with Merck & Co. hot on its heels). In addition, data from the mid-stage CheckMate-063 trial revealed that treatment with Opdivo in patients with refractory squamous NSCLC resulted in an objective response rate of 15 percent, with 59 percent of these patients having response durations of at least six months.

Commenting on the news, Evercore ISI analyst Mark Schoenebaum estimated that Opdivo, which is the first immunotherapy cleared for NSCLC, could amass $1 billion to $1.5 billion in revenue for the treatment of lung cancer in the US and Europe, while an analysis by Barclays projects a worldwide commercial market for squamous cell lung cancer of over $3 billion. Leerink analysts Seamus Fernandez and Aneesh Kapur remarked that the FDA's "blisteringly fast" expanded approval of Opdivo gives Bristol-Myers Squibb "a nice marketing window" over Merck & Co. and Roche. The analysts estimated that Bristol-Myers Squibb would capture 60 percent of the squamous NSCLC market, but noted that the rapid regulatory turnaround in the Opdivo filing "bodes well for timing of all future potential label expansions for the PD1/PDL1 class."

Merck recently said it will apply around midyear to expand its PD-1 inhibitor Keytruda (pembrolizumab), currently approved in the US against melanoma, for use in patients with NSCLC whose disease progressed on or following platinum-containing chemotherapy. Meanwhile, Roche recently garnered breakthrough therapy status from the FDA for its anti-PDL1 therapy, MPDL3280A, in certain patients with NSCLC (for additional analysis, see ViewPoints: Roche turns up the heat in NCSLC immuno-oncology race).

Bristol-Myers Squibb and partner Ono Pharmaceutical launched Opdivo in Japan for melanoma last September at a cost of $143 000 annually per patient, making it the first PD-1 inhibitor to be marketed anywhere in the world. In December, the FDA granted accelerated approval to Opdivo for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs.

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