A randomized controlled comparison of pembrolizumab and chemotherapy in patients with ipilimumab-refractory melanoma

Abstract

2 and 10 mg/kg Q3W, respectively, over control (P<0.00001 for both comparisons). The 6-month PFS rate was 34% (95% CI 27%-41%) and 38% (95% CI 31%45%) for pembrolizumab 2 and 10 mg/kg, respectively, compared with 16% (95% CI 10%-22%) for the control arm. PFS by investigator assessment was similar to that of central review. The PFS effect was consistent in all subgroups. ORR was 21% at 2 mg/kg, 25% at 10 mg/kg, and 4% in the control arm (P<0.0001 for both comparisons). Median response duration was not reached in either pembrolizumab arm and was 37 weeks in the control arm. Forty-eight percent of patients in the control arm crossed over to pembrolizumab treatment. OS data are not mature (final OS analysis will be performed after 370 deaths have occurred). The safety profile was consistent with that previously observed for pembrolizumab. Despite a decreased therapy duration, rates of grade 3-5 drug-related AEs were numerically higher in the chemotherapy control arm (26%) than in the pembrolizumab 2-mg/kg (11%) and 10-mg/kg (14%) arms.

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Affiliated Institutions

• Sheba Medical Center IL
• The Netherlands Cancer Institute NL
• University of Duisburg-Essen DE
• Beverly Hills Cancer Center US
• University of Arizona US
• University of California, Los Angeles US
• University of Zurich CH
• Merck (Japan) JP
• Institut Gustave Roussy FR
• Duke Cancer Institute
• University of Colorado Denver US
• Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" IT
• Dana-Farber Cancer Institute US
• Vanderbilt University US
• New York University US
• University of Arizona Cancer Center
• University of California, San Francisco US
• Duke University US
• Northern California Melanoma Center US

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