Clin Cancer Res: Efficacy and safety of standard doses of pembrolizumab combined with different doses of ipilimumab in the treatment of advanced melanoma

In cohort B of the phase 1 KEYNOTE-029 study, the standard dose of pembrolizumab + replacement dose of ipilimumab (1 mg/kg Q3W, 4 doses in total) was tolerable in advanced melanoma.

This article reports the results of the study in the C cohort (evaluating the efficacy and safety of standard-dose pembrolizumab + other two groups of alternative ipilimumab regimens)

Patients with unresectable initial stage 3/4 melanoma were randomly (1:1) divided into two groups and received the same dose of pembrolizumab (200 mg Q3W, ≤24 months), combined with ipilimumab 50 mg Q6W x 4 doses (PEM200+IPI50) or Ipilimumab 100 mg Q12W x 4 doses (PEM200+IPI100)

Treatment-related adverse events

Treatment-related adverse events

As of February 18, 2019, the median follow-up time for the PEM200+IPI50 group (n=51) and PEM200+IPI100 group (n=51) were 16.

PEM200 + IPI50 PEM200 + group and the incidence of grade 3-5 TRAE IPI100 group were 24% and 39% PEM200 + IPI50 PEM200 + group and the incidence of grade 3-5 TRAE IPI100 group were 24% and 39% immune PEM200 The incidence of immune-related adverse events or infusion reactions in the +IPI50 group and PEM200+IPI100 group were 42% and 55%, respectively

PFS(B) and OS(C) of PEM200+IPI50 group and PEM200+IPI100 group

PFS(B) and OS(C) of PEM200+IPI50 group and PEM200+IPI100 group

In summary, the anti-tumor activity of the combination regimen of pembrolizumab 200 mg Q3W and ipilimumab 50 mg Q6W or 100 mg Q12W exceeded the above-mentioned predetermined threshold; and pembrolizumab + ipilimumab 50 The incidence of grade 3-5 TRAE of the mg Q6W regimen is lower than the predetermined threshold, suggesting that the regimen can reduce toxicity while ensuring efficacy

The anti-tumor activity of the combination regimen of pembrolizumab 200 mg Q3W and ipilimumab 50 mg Q6W or 100 mg Q12W exceeded the above-mentioned predetermined threshold; and 3 -The incidence of grade 5 TRAE is lower than a predetermined threshold, suggesting that this program can reduce toxicity while ensuring efficacy

Original source:

Georgina V.

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

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