389P - Updated analysis from the KEYNOTE-042 China study: 1L pembrolizumab (pembro) vs chemotherapy (chemo) in Chinese patients (pts) with advanced NSCLC with PD-L1 TPS ≥1%

Background

Pembro monotherapy significantly improved OS vs chemo in PD-L1–positive (TPS ≥1%) locally advanced/metastatic NSCLC without targetable EGFR/ALK aberrations in the KEYNOTE-042 global study (NCT02220894) and in an analysis of Chinese pts from the KEYNOTE-042 global and China extension (NCT03850444) studies. Here we present an updated analysis of Chinese pts after ∼17 mo additional follow-up.

Methods

The global and extension studies were designed identically. Pts were randomized 1:1 (stratified by ECOG PS 0/1, squamous/nonsquamous histology, TPS ≥50%/1%‒49%) to up to 35 cycles of pembro 200 mg Q3W or up to 6 cycles of paclitaxel/pemetrexed + carboplatin with optional pemetrexed maintenance (nonsquamous only). Primary endpoints were OS in pts with PD-L1 TPS ≥50%, ≥20%, and ≥1%.

Results

262 Chinese pts with PD-L1–positive NSCLC were enrolled (global, n=92; China extension, n=170) and randomized to pembro (n=128) or chemo (n=134). As of Feb 21, 2020, median time from randomization to database cutoff was 33.0 (range, 25.6‒41.9) mo. Pembro improved OS vs chemo in all populations (Table); in pts with PD-L1 TPS ≥1%, the 24-mo rate for OS was 43.8% vs 28.2%, PFS was 15.6% vs 10.6%, and PFS2 was 26.4% vs 8.6%. Grade 3-5 drug-related AEs occurred in 19.5% of pembro-treated pts vs 68.8% of chemo-treated pts. In 22 pts who completed 35 cycles of pembro, ORR was 77.3% and median DOR was 27.6 mo. Additional efficacy and safety outcomes will be presented.

Conclusions

In this longer-term follow-up (∼3 y), 1L pembro monotherapy continued to improve OS with a manageable safety profile vs platinum-based chemo in Chinese pts with locally advanced/metastatic NSCLC without sensitizing EGFR/ALK aberrations and PD-L1 TPS ≥1%. Most pts who completed 2 y of pembro had durable responses. These findings support 1L use of pembro for PD-L1–positive advanced/metastatic NSCLC in China Table: 389P

HR, hazard ratio.

Clinical trial identification

Editorial acknowledgement

Writing support was provided by Michael S. McNamara, MS, ICON plc (North Wales, PA, USA) and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Legal entity responsible for the study

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

Y-L. Wu: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Sanofi; Advisory/Consultancy: Merck; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim. L. Zhang: Research grant/Funding (self): Hengrui; Research grant/Funding (self): BMS; Research grant/Funding (self): Innovent Biologics. Q. Zhou: Honoraria (self): AstraZeneca; Honoraria (self): Roche. C. Zhou: Honoraria (self): Boehringer Ingelheim; Honoraria (self): Eli Lilly; Honoraria (self): Hengrui, MSD; Honoraria (self): Sanofi; Honoraria (self): F. Hoffmann-La Roche Ltd.; Honoraria (self): Qilu. F. Souza: Full/Part-time employment: Merck & Co., Inc., Kenilworth, NJ, USA. J. Lin: Full/Part-time employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. J. Wang, B. Li: Full/Part-time employment: MSD China. T. Mok: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): Clovis Oncology; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche/Genentech; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): SFJ Pharmaceuticals; Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (self): Taiho; Research grant/Funding (self): XCovery; Honoraria (self), Speaker Bureau/Expert testimony: Amoy Diagnostics Co. Ltd.; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Honoraria (self), Speaker Bureau/Expert testimony: InMed Medical Communication; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Serono; Honoraria (self), Speaker Bureau/Expert testimony: PRIME Oncology; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Virtus Medical Group; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda Oncology; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Biolidics Ltd.; Shareholder/Stockholder/Stock options: Hutchison ChiMed, Loxo-Oncology; Advisory/Consultancy, Shareholder/Stockholder/Stock options: OrigiMed; Shareholder/Stockholder/Stock options: Sanomics Ltd.; Advisory/Consultancy: ACEA Biosciences Inc; Advisory/Consultancy: Alpha Biopharma Co., Ltd.; Advisory/Consultancy: Bayer; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Incyte Corporation; Advisory/Consultancy: Celgene; Advisory/Consultancy: Cirina; Advisory/Consultancy: CStone Pharmaceuticals; Advisory/Consultancy: Fishawack Facilitate Ltd.; Advisory/Consultancy: geneDecode Co. Ltd.; Advisory/Consultancy: Hengrui Therapeutics; Advisory/Consultancy: Ignyta Inc.; Advisory/Consultancy: IQVIA; Advisory/Consultancy: Janssen; Advisory/Consultancy: Loxo-Oncology; Advisory/Consultancy: MoreHealth; Advisory/Consultancy: OncoGenex Technologies Inc.; Advisory/Consultancy: Sanofi-Aventis; Advisory/Consultancy: Vertex Pharmaceuticals; Advisory/Consultancy: Yuhan Corp; Leadership role: ASCO; Leadership role: CSCO; Leadership role: IASLC. All other authors have declared no conflicts of interest.