Tafinlar in Combination with Mekinist and Nivolumab Have Considerable Efficacy and Tolerability Advantages Over Currently Used Therapies for the Treatment of Unresectable Malignant Melanoma

Surveyed Oncologists Say Hematological Toxicity is the Most Important Safety and Tolerability Attribute in Their Prescribing Decisions, According to a New Report from Decision Resources

July 9, 2013—Burlington, Mass. —Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed U.S. and European oncologists indicate that overall survival is the factor that most influences their prescribing decisions for unresectable malignant melanoma, and that increased overall survival is associated with the highest level of unmet need. Interviewed thought-leaders are optimistic that Bristol-Myers Squibb/Ono Pharmaceuticals’ nivolumab and GlaxoSmithKline’s Tafinlar plus GlaxoSmithKline’s Mekinist, in particular, will show advantages over sales-leading ipilimumab (Bristol-Myers Squibb’s Yervoy) on this attribute.

The DecisionBase 2013 report entitled As Vemurafenib and Ipilimumab Gain Traction in the Market, What Key Attributes Will Differentiate Emerging Therapies According to Oncologists and Payers? finds that surveyed U.S managed care organization (MCO) pharmacy directors demand that emerging therapies provide significant improvements in overall survival over vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf) to justify their cost and secure reimbursement. Vemurafenib is the premium-priced standard-of-care in unresectable malignant melanoma patients harboring the V600 BRAF mutation. Notably, a third of surveyed payers would not reimburse a new therapy priced the same as vemurafenib or higher that offers a six-month improvement in overall survival over vemurafenib, citing insufficient overall clinical benefit as one of the key reasons for not granting reimbursement.

The report also finds that surveyed U.S. and European oncologists identified hematological toxicity as the safety and tolerability attribute that is most important when making prescribing decisions in unresectable malignant melanoma, thus indicating the persisting high level of unmet need for therapies with a more favorable hematological profile.

“Despite the improvements effected by vemurafenib and ipilimumab on patient overall survival in unresectable malignant melanoma, our survey results suggest that both physicians and MCO pharmacy directors have high expectations of the requirements of emerging therapies to further extend survival,” said Decision Resources Business Insights Analyst Samuel Mentzer, M.Sc. “Early-stage clinical data suggest that Tafinlar in combination with Mekinist and nivolumab have the potential to gain a competitive edge over ipilimumab and vemurafenib if they can replicate these promising results in their ongoing Phase III trials.”

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