Standard-Dose Pembrolizumab Plus Alternate-Dose Ipilimumab in Advanced Melanoma: KEYNOTE-029 Cohort 1C, a Phase 2 Randomized Study of Two Dosing Schedules.

Document Type

Article

Publication Date

7-1-2021

Publication Title

Clinical cancer research : an official journal of the American Association for Cancer Research

Keywords

california; santa monica; psjhc; jwci; sjci

Abstract

PURPOSE: Standard-dose pembrolizumab plus alternative-dose ipilimumab (1 mg/kg Q3W for 4 doses) was tolerable and had robust antitumor activity in advanced melanoma in cohort B of the phase 1 KEYNOTE-029 study. Cohort C evaluated standard-dose pembrolizumab with two other alternative ipilimumab regimens.

EXPERIMENTAL DESIGN: Patients with treatment-naive unresectable stage III/IV melanoma were randomly assigned 1:1 to pembrolizumab 200 mg Q3W for {less than or equal to}24 months plus ipilimumab 50 mg Q6W for 4 doses (PEM200+IPI50), or the same pembrolizumab regimen plus ipilimumab 100 mg Q12W for 4 doses (PEM200+IPI100). Primary end points were incidence of grade 3-5 treatment-related adverse events (TRAEs) and objective response rate (ORR) per RECIST v1.1 by independent central review. Per protocol-defined thresholds, grade 3-5 TRAE incidence {less than or equal to}26% indicated meaningful toxicity reduction and ORR {greater than or equal to}48% indicated no decrease in efficacy versus data reported for other PD-1 inhibitor/ipilimumab combinations.

RESULTS: Median follow-up on February 18, 2019, was 16.3 months in PEM200+IPI50 (

CONCLUSIONS: Pembrolizumab 200 mg Q3W plus ipilimumab 50 mg Q6W or 100 mg Q12W demonstrated antitumor activity above the predefined threshold; pembrolizumab plus ipilimumab 50 mg Q6W had lower incidence of grade 3-5 TRAEs than the predefined threshold, suggesting a reduction in toxicity.

Clinical Institute

Cancer

Department

Oncology

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