2017 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Saturday June 3, 8:00 AM to 11:30 AM
Location: Hall A
First-line carboplatin and pemetrexed (CP) with or without pembrolizumab (pembro) for advanced nonsquamous NSCLC: Updated results of KEYNOTE-021 cohort G.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2017 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #420)
J Clin Oncol 35, 2017 (suppl; abstr 9094)
Author(s): Vassiliki Papadimitrakopoulou, Shirish M. Gadgeel, Hossein Borghaei, Leena Gandhi, Amita Patnaik, Steven Francis Powell, Ryan D. Gentzler, Renato G. Martins, James Stevenson, Shadia Ibrahim Jalal, Amit W. Panwalkar, James Chih-Hsin Yang, Matthew A. Gubens, Lecia V. Sequist, Mark M. Awad, Joseph Fiore, Joy Yang Ge, Harry Raftopoulos, Corey J. Langer; The University of Texas MD Anderson Cancer Center, Houston, TX; Karmanos Cancer Institute, Detroit, MI; Fox Chase Cancer Center, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; South Texas Accelerated Research Therapeutics, San Antonio, TX; Sanford Cancer Center, University of South Dakota Sanford School of Medicine, Sioux Falls, SD; Emily Couric Clinical Cancer Center, University of Virginia School of Medicine, Charlottesville, VA; Seattle Cancer Care Alliance, Seattle, WA; Cleveland Clinic, Cleveland, OH; Indiana University School of Medicine, Indianapolis, IN; Sanford Roger Maris Cancer Center, Fargo, ND; National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan; University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA; Merck & Co., Inc., Kenilworth, NJ; Abramson Cancer Center, Philadelphia, PA
Background: Data from the randomized, phase 2 cohort G of KEYNOTE-021 (NCT02039674) showed that adding pembro to first-line CP in patients (pts) with advanced nonsquamous NSCLC significantly improved the primary end point of ORR (55% vs 29%, P = 0.0016) and the key secondary end point of PFS (HR 0.53, P= 0.0102) compared with CP alone and had a manageable safety profile (grade 3-4 treatment-related AEs, 39% vs 26%; treatment-related AEs leading to discontinuation, 10% vs 13%). We present updated efficacy for cohort G based on 5 mo additional follow-up. Methods: 123 pts with stage IIIB/IV, chemotherapy-naive, nonsquamous NSCLC and no EGFR mutation or ALK translocation were randomized to 4 cycles of carboplatin AUC 5 + pemetrexed 500 mg/m2 Q3W ± 24 mo of pembro 200 mg Q3W; maintenance pemetrexed was permitted in both arms. Eligible pts in the CP arm who had radiologic progression could crossover to pembro monotherapy. Response was assessed per RECIST v1.1 by blinded, independent central review. All Pvalues are nominal. Results: As of Dec 31, 2016, median follow-up was 14.5 mo (range, 0.8-24.0). 36 of 48 pts (75.0%) in the CP arm who discontinued CP received subsequent anti–PD-1 or PD-L1 therapy. There was 1 additional response in each arm, and ORR was 56.7% (95% CI 43.2%-69.4%) with pembro + CP vs 30.2% (95% CI 19.2%-43.0%) with CP (P = 0.0016). Median DOR was not reached for pembro + CP (range, 1.4+ to 18.6+ mo) and was 16.2 mo (range, 2.8 to 20.7+) for CP alone. PFS remained longer with pembro + CP (HR 0.49, 95% CI 0.29-0.83, P = 0.0035; median [95% CI] NR [9.7 mo-NR] vs 8.9 mo [6.2-10.3]; 12-mo estimate, 56% vs 34%). With 16 deaths in the pembro + CP arm and 23 deaths in the CP arm, HR for OS was 0.69 (95% CI 0.36-1.31, P= 0.13). Median OS was not reached in either arm; at 12 mo, estimated OS was 76% in the pembro + CP arm and 69% in the CP alone arm. Conclusions: With 5 mo additional follow-up, first-line pembro + CP continues to provide a substantial, clinically relevant improvement in efficacy over CP alone in pts with advanced nonquamous NSCLC, including an almost doubled ORR, halved risk of progression or death, and a trend toward improved OS despite a 75.0% crossover rate in the CP arm. Clinical trial information: NCT02039674
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