Bristol Myers spells out Opdivo win in melanoma — how does it stack up against Keytruda?

2022-10-20

Bristol Myers Squibb is ready for a data showdown with Merck as they move their respective PD-1 inhibitors PD-1 inhibitors into earlier lines of melanoma treatment. Taking the stage at the annual meeting of the Society for Melanoma Research, Bristol Myers reported that in the Phase III CheckMate-76K trial, Opdivo reduced the risk of recurrence or death by 58% — translating to a hazard ratio of 0.42 on the primary endpoint of recurrence-free survival (p < 0.0001). In the trial, Opdivo was given as an adjuvant treatment to patients with stage IIB or IIC melanoma after their tumors were completely resected. “Within five years after surgery, one third of stage IIB and one half of IIC patients see their cancer return. Helping reduce that risk remains a need to be addressed when it comes to treating melanoma,” said Georgina Long, co-medical director of Melanoma Institute Australia Melanoma Institute Australia, in a prepared statement. Bristol Myers added that 12-month RFS rates by stage for patients who received Opdivo were 93% in stage IIB (versus 84% in placebo) and 84% in stage IIC (versus 72% with placebo). While trials are never directly comparable, Merck measured the efficacy of Keytruda in the same patient population by the same metric of RFS — and came up with a hazard ratio of 0.65 (p=0.0132), according to the FDA’s release about its approval late last year. At 12 months, investigators looked at distant metastasis-free survival, which was 94.7% in the Keytruda group and 90.2% in the placebo cohort. As in previous studies, side effects are still an issue, with 10% of patients in the Opdivo arm experiencing Grade 3/4 treatment-related adverse events versus 2% in the placebo arm. Among those taking Opdivo, 15% dropped out of the trial due to those events, compared to 3% on placebo. Opdivo is already approved in a range of melanoma indications, including the most serious metastatic forms. The -76K trial is part of a broader program to test Opdivo, both as monotherapy and in combination, in earlier stages of cancer across seven tumor types.

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