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Bristol-Myers Reports Long-term Follow-up Results From Study 003 Of Nivolumab

Bristol-Myers Squibb Co. (BMY), Friday reported long-term follow-up results from the Phase 1 dose-ranging study or 003, of an investigational PD-1 immune checkpoint inhibitor, nivolumab, showed sustained activity in heavily pre-treated patients with non-small-cell lung cancer or NSCLC, as defined by one- and two-year survival rates of 42 percent and 24 percent, respectively, across dose cohorts.

The study 003 is a Phase 1 study evaluating the safety, antitumor activity and pharmacokinetics of nivolumab in patients with NSCLC, advanced melanoma, renal cell carcinoma , castration-resistant prostate cancer and colorectal cancer. All patients had at least one therapy prior to nivolumab and 54 percent received three or more therapies before nivolumab.

The company said that the data presented at the 2013 American Society of Clinical Oncology, with all patients having greater than or equal to one year of follow up, demonstrated a spectrum, frequency and severity of treatment-related adverse events that were consistent with those initially reported in the study in 2012.

"These are encouraging Phase 1 results from the expanded cohort of patients with lung cancer, the leading cause of cancer deaths globally, and we are seeking to confirm these early data in ongoing Phase 3 trials." said Michael Giordano, senior vice president, Head of Development, Oncology & Immunology, Bristol-Myers Squibb.

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