Reference Detail

Ref Type

Journal Article

PMID

(33446564)

Authors

Wainberg ZA, Fuchs CS, Tabernero J, Shitara K, Muro K, Van Cutsem E, Bang YJ, Chung HC, Yamaguchi K, Varga E, Chen JS, Hochhauser D, Thuss-Patience P, Al-Batran SE, Garrido M, Kher U, Shih CS, Shah S, Bhagia P, Chao J

Title

Efficacy of Pembrolizumab Monotherapy for Advanced Gastric/Gastroesophageal Junction Cancer with Programmed Death Ligand 1 Combined Positive Score ≥10.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Clinical cancer research : an official journal of the American Association for Cancer Research	27	7	2021 Apr 01	1923-1931	Clin Cancer Res

URL

Abstract Text

Pembrolizumab demonstrated efficacy in PD-L1-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and third-line setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE-059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS ≥ 10 in these trials.Included were patients with CPS ≥ 10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n = 46; post hoc), KEYNOTE-061 (pembrolizumab, n = 53; chemotherapy, n = 55; post hoc), and KEYNOTE-062 (pembrolizumab, n = 92; chemotherapy, n = 90; primary). Efficacy outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR).In KEYNOTE-059, median follow-up was 6 months, median OS was 8 months [95% confidence interval (CI), 5.8-11.1], ORR was 17%, and median (range) DOR was 21 months (3+ to 35+). In KEYNOTE-061, median follow-up was 9 months, median OS (pembrolizumab vs. chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range) DOR was not reached (4 to 26+ months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs. chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+ to 34+) versus 7 months (2+ to 30+).This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS ≥ 10 G/GEJ cancer.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 over exp	stomach cancer	predicted - sensitive	Pembrolizumab	Clinical Study - Cohort	Actionable	In a combined analysis of three clinical trials, Keytruda (pembrolizumab) treatment resulted in favorable outcome in gastric or gastroesophageal junction cancer patients with CD274 (PD-L1) combined positive score (CPS) of 10 or higher, median overall survival, objective response rate, and duration of response were 8 mo, 17% (8/46), 21 mo in KEYNOTE-059, 10 mo, 25% (13/53), not reached in KEYNOTE-061, 17 mo, 25% (23/92), 19 mo in KEYNOTE-062 (PMID: 33446564; NCT02335411, NCT02370498, NCT02494583).	33446564
CD274 over exp	gastroesophageal junction adenocarcinoma	predicted - sensitive	Pembrolizumab	Clinical Study - Cohort	Actionable	In a combined analysis of three clinical trials, Keytruda (pembrolizumab) treatment resulted in favorable outcome in gastric or gastroesophageal junction cancer patients with CD274 (PD-L1) combined positive score (CPS) of 10 or higher, median overall survival, objective response rate, and duration of response were 8 mo, 17% (8/46), 21 mo in KEYNOTE-059, 10 mo, 25% (13/53), not reached in KEYNOTE-061, 17 mo, 25% (23/92), 19 mo in KEYNOTE-062 (PMID: 33446564; NCT02335411, NCT02370498, NCT02494583).	33446564