89.9%) occurred less frequently with pembrolizumab than chemotherapy. 41%) and any-grade treatment-related adverse event (62.7% vs.
Grade 3 to grade 5 treatment-related adverse events (17.8% vs. Median duration of response was 20.2 months with pembrolizumab compared with 8.3 months for chemotherapy. 32%), 20% or greater expression cohort (33.4% vs. ORR was higher in the pembrolizumab arm for the 50% or greater expression cohort (39.5% vs.
#Keynote 042 update trial
12.1 months HR = 0.81 95% CI, 0.71-0.93).ĭespite the benefit observed across expression levels, researchers noted pembrolizumab conferred greater benefit when PD-L1 expression was higher.Īn external data monitoring committee recommended continuing the trial to explore PFS as a secondary endpoint. Pembrolizumab significantly improved OS among patients with tumor proportion score of more than 50% (median OS, 20 months vs. Results indicated patients who received pembrolizumab had longer median OS - regardless of level of PD-L1 expression in the tumor - than patients who received standard chemotherapy.
#Keynote 042 update plus
Researchers randomly assigned 1,274 patients with locally advanced or metastatic NSCLC without EGFR mutations or ALK translocation to receive 200 mg pembrolizumab every 3 weeks (n = 637) or investigator’s choice of maximum six cycles of paclitaxel plus carboplatin or pemetrexed plus carboplatin (n = 637) with optional pemetrexed maintenance for nonsquamous disease.Īmong the patients, 599 had tumor PD-L1 expression score of at least 50%, 818 had at least 20% PD-L1 expression, and all 1,274 patients had at least 1% PD-L1 expression. In the KEYNOTE-042 trial, Lopes and colleagues evaluated pembrolizumab at a lower PD-L1 expression threshold, defined as a tumor proportion score of at least 1%. FDA approved pembrolizumab in this setting based on these data.
#Keynote 042 update driver
“Given the overall efficacy and safety profile, pembrolizumab monotherapy is a standard-of-care, first-line therapy for PD-L1-expressing locally advanced or metastatic squamous or nonsquamous NSCLC without sensitizing EGFR mutations or ALK translocation,” Gilberto Lopes, MD, MBA, medical director of international programs at Sylvester Comprehensive Cancer Center of University of Miami Health System, said during a press conference.Ĭhemotherapy has been the standard of care for patients with NSCLC without driver mutations.įindings from the smaller KEYNOTE-024 trial showed pembrolizumab is superior to chemotherapy as first-line therapy for advanced NSCLC with a PD-L1 tumor progression score of at least 50% and no sensitizing EGFR mutations and ALK translocations. Patients with a PD-L1 expression of 1% or greater first treated with pembrolizumab (Keytruda, Merck) lived a median of 4 to 8 months longer than patients who received chemotherapy. If you continue to have this issue please contact to HealioĬHICAGO - First-line pembrolizumab conferred longer median OS than chemotherapy among patients with non-small cell lung cancer and PD-L1 expression, according to results of the phase 3 KEYNOTE-042 clinical trial presented during the plenary session at ASCO Annual Meeting.
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