Baseline characteristics were well-balanced between the 2 arms. The vast majority enrolled had metastatic disease and 82.2% (nivo3 + ipi1) and 73.9% (nivo1 + ipi3) were evaluable for PD-L1 expression. Some 62.2% in the nivo3 + ipi1 arm and 67.6% in the nivo1 + ipi3 arm had PD-L1 expression ≥1%. More than 80% in each arm had received prior platinum therapy and radiation therapy. Some 42.2% in the nivo3 + ipi1 arm and 52.2% in the nivo1 + ipi3 arm had not received systemic therapy in the R/M setting.
In the nivo3 + ipi1 arm, the objective response rate was 31.6% in those patients who received no prior systemic therapy for R/M disease and 23.1% in those with prior systemic therapy for R/M. The corresponding ORR percentages in the nivo1 + ipi3 arm were 45.8% and 36.4%, respectively. A complete response was observed in 4 patients in each treatment arm. Eight patients in the nivo3 + ipi1 arm and 15 in the nivo1 + ipi3 arm had a partial response. The median duration of response had not been reached in patients treated in the first-line setting for metastatic disease in both arms.
In the nivo3 + ipi1 arm, the ORRs were 30.8% (no prior systemic treatment for R/M disease) and 40.0% (prior systemic treatment) in those with PD-L1 tumor expression ≥1%, and 33.3% and 9.1%, respectively, in those with PD-L1 expression <1%. In the nivo1 + ipi3 arm, the ORRs were 36.4% and 16.7%, respectively, in the PD-L1–positive patients, and 0% and 57.1%, respectively, in those with PD-L1 expression <1%.
There was a higher incidence of treatment-related adverse events (AEs) leading to treatment discontinuation in the nivo1 + ipi3 arm compared with nivo3 + ipi1 (32.6% vs 17.8%), as well as a higher rate of treatment-related serious AEs leading to discontinuation (21.7% vs 6.7%).
There was a higher incidence of treatment-related gastrointestinal events in the nivo1 + ipi3 arm compared with nivo3 + ipi1 (56.5% vs 35.6%) “and this could be due to the higher ipilimumab dose,” said Oaknin.
CheckMate-358 is continuing to enroll patients with R/M cervical cancer.
Naumann RW, Oaknin A, Meyer T, et al. Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358. Presented at 2019 ESMO Congress; September 27-October 2, 2019; Barcelona, Spain. Abstract LBA62.
<<< View more from the 2019 ESMO Congress