![]() Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Writing support was provided by Kathleen Estes, PhD, of ICON plc (Blue Bell, PA, USA), funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. These data further support pembro monotherapy as a standard of care for these pts. Similar to the global KEYNOTE-042 study, after 5 y of follow-up, pembro continued to demonstrate improved OS vs chemo with manageable safety in Chinese pts with previously untreated advanced or metastatic NSCLC without EGFR/ALK alterations with PD-L1 TPS ≥1%. At data cutoff, 80 pts in the pembro arm and 79 in the chemo arm had begun subsequent therapy 5 pts began second-course pembro.Table: 42P PD-L1 TPS ≥50% Of 22 pts who completed 35 cycles of pembro, ORR was 81.8% (95% CI, 59.7%–94.8%) and 3-y OS rate after completion of 35 cycles (∼5 y after randomization) was 56.6%. Grade 3–5 treatment-related AEs occurred in 19.5% of pts in the pembro arm and 68.8% in the chemo arm. 5-y OS rates were ∼2 fold higher with pembro vs chemo across all 3 PD-L1 TPS groups (table). ![]() Median time from randomization to database cutoff (Sep 12, 2022) was 63.7 (range, 56.3–72.6) mo. Of 262 pts enrolled in China, 128 were randomized to pembro and 134 to chemo. No alpha was assigned to this exploratory analysis of pts enrolled in China in KEYNOTE-042 global (NCT02220894) and China extension (NCT03850444) studies. Primary endpoints were OS in pts with PD-L1 TPS ≥50%, ≥20%, and ≥1%. MethodsĮligible pts were randomized 1:1 to receive pembro 200 mg Q3W for ≤35 cycles or carboplatin + paclitaxel or pemetrexed with optional pemetrexed maintenance (nonsquamous only). We report results after 16 mo of additional follow-up. 14 State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region/CNĪfter 4 y of follow-up in patients (pts) enrolled in China in the phase III KEYNOTE-042 study, pembrolizumab (pembro) improved OS vs chemotherapy (chemo) in pts with previously untreated advanced or metastatic NSCLC without EGFR/ALK alterations in the PD-L1 tumor proportion score (TPS) ≥50% (HR, 0.66 95% CI, 0.45–0.95), ≥20% (0.68, 0.49–0.93), and ≥1% (0.67, 0.51–0.89) groups.13 MSD China, Plot B-12, Electronic City West Zone, Chaoyang District, Beijing/CN. ![]()
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