“These findings continue to support first-line pembrolizumab in patients with locally advanced/metastatic PD-L1–positive NSCLC without sensitizing EGFR/ALK alterations,” explained lead investigator, Byoung Chul Cho, MD, PhD, in a virtual presentation of the data.
A second course pembrolizumab was found to be feasible and was also associated with antitumor activity. Pembro monotherapy remains a standard of care in these pts.Patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer (NSCLC) without sensitizing EGFR/ ALK alterations were evaluated on long-term treatment with pembrolizumab (Keytruda) and continued to demonstrate improvement in overall survival (OS), overall response rate (ORR), and time to progression on next-line therapy (PFS-2) compared with chemotherapy, according to follow-up results from the KEYNOTE-042 study (NCT02220894).Īccording to a presented on the data given as part of the 2020 World Conference on Lung Cancer Singapore (WCLC) Singapore, patients who completed 35 cycles of pembrolizumab treatment saw durable responses, and many patients experienced a continued response after the completion of therapy. At data cutoff, 79 pts in each group had begun subsequent therapy 4 pts began a second course of pembro.Ĭonclusion: Similar to the global KEYNOTE-042 study, first-line pembro continues to prolong OS and provide durable response in pts in China with advanced/metastatic PD-L1-positive NSCLC without EGFR/ALK alterations after nearly 4 y of follow-up. Among 22 pts who completed 35 cycles of pembro, ORR was 81.8% (95% CI, 59.7%-94.8%) estimated OS rate 4 y after randomization was 69.1%.
19.5% and 68.8% of pts in the pembro and chemo groups experienced treatment-related grade 3-5 AEs. Median time from randomization to data cutoff (Apr 28, 2021) was 47.2 (range, 39.8-56.1) mo.
Results: 262 pts with PD-L1 TPS ≥1% were randomized in China to pembro (n = 128) or chemo (n = 134). No alpha was allocated to the China extension analysis. Eligible pts who completed 35 cycles of pembro could receive a second course of pembro. Primary endpoints were OS in pts with PD-L1 TPS ≥50%, ≥20%, and ≥1%. Methods: Pts enrolled in China in the KEYNOTE-042 global (NCT02220894) and China extension (NCT03850444) studies were randomized 1:1 to pembro 200 mg Q3W for ≤35 cycles or carboplatin+paclitaxel or pemetrexed with optional pemetrexed maintenance (nonsquamous only). We present efficacy and safety outcomes with an additional 14 calendar mo of follow-up in Chinese pts in KEYNOTE-042. Background: In the global, phase 3 KEYNOTE-042 study, pembrolizumab (pembro) significantly prolonged OS vs chemotherapy (chemo) in patients (pts) with previously untreated advanced/metastatic NSCLC with PD-L1 TPS ≥1% without EGFR/ALK alterations.
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