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2015/06/03

Shark-Tank investors were shocked by this

Shark Tank
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Shark Tank Entrepreneurs Go Head-to-Head Over This Crazy Product!

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Top Product In Shark Tank's History
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CHICAGO -- An immunotherapy combination for untreated melanoma reduced the risk of death or progression by more than half as compared with a drug currently used as a standard of care, a large randomized trial showed. Patients treated with nivolumab (Opdivo) and ipilimumab (Yervoy) had a median progression-free survival (PFS) of 11.5 months compared with 2.9 months for ipilimumab alone and 6.9 months with nivolumab monotherapy. Median PFS with the combination and with nivolumab alone increased to 14 months -- more than four times greater than the PFS of patients who received only ipilimumab -- among patients whose tumors tested positive for programmed death receptor ligand 1 (PD-L1), the target of nivolumab. ADVERTISEMENT The PFS improvement came at a price of increased toxicity, as grade 3/4 adverse events occurred twice as often with the combination as with ipilimumab monotherapy, but even patients who discontinued treatment because of side effects did better with the combination, as reported here at the American Society of Clinical Oncology meeting. "The majority of adverse events were managed and resolved with established algorithms, so based upon the available evidence, the combination represents a means to improve outcomes, particularly for patients whose tumors have less than 5% PD-L1 expression," Jedd D. Wolchok, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York City, said during a press briefing. The findings were reported simultaneously online in the New England Journal of Medicine. The outcome of the phase III trial corroborates and extends results from a phase II study reported in April, also showing a significant PFS advantage for the combination over ipilimumab alone. The rationale for combining the two drugs comes from recognition that cytotoxic T-lymphocyte antigen 4 (CTLA-4) and PD-1 represent distinct but complementary pathways involved in the negative regulation of anti-tumor immunity. Ipilimumab targets CTLA-4 and nivolumab targets PD-L1. Preclinical and phase I and II clinical studies have consistently shown greater activity (including response, complete response, and survival) with the combination than with ipilimumab alone.

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