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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients
Published date:
12/08/2021
Excerpt:
KEYNOTE-063 (NCT03019588) investigated pembrolizumab versus paclitaxel as second-line therapy in Asian patients with advanced programmed death ligand 1 (PD-L1)-positive (combined positive score ≥1) gastric/gastroesophageal junction (GEJ) cancer….Median OS was 8 months (95% confidence interval [CI], 4-10 months) with pembrolizumab versus 8 months (95% CI, 5-11 months) with paclitaxel (hazard ratio [HR], 0.99; 95% CI, 0.63-1.54).
DOI:
10.1002/cncr.34019.
Trial ID:
Source:
Title:
Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial
Published date:
09/01/2021
Excerpt:
Pembrolizumab demonstrated a trend toward improved OS vs paclitaxel in the CPS ≥ 1 population (HR, 0.81); 24-month OS rates: 19.9% vs 8.5%....In this long-term analysis, 2L pembrolizumab did not significantly improve OS but was associated with higher 24-month OS rates than paclitaxel. Pembrolizumab also increased OS benefit with PD-L1 enrichment among patients with PD-L1-positive gastric/GEJ cancer and led to fewer TRAEs than paclitaxel.
DOI:
10.1007/s10120-021-01227-z.
Trial ID:
Source:
Title:
LBA8_PR Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study
Published date:
09/01/2020
Excerpt:
...pts with ESCC PD-L1 combined positive score (CPS) ≥10 tumors...Pembro + chemo provided superior OS, PFS, and ORR vs chemo, with a manageable safety profile in pts with untreated, advanced esophageal and EGJ cancer.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.annonc.2020.08.2298
Trial ID:
Source:
Title:
Pembrolizumab versus paclitaxel for previously treated patients with PD-L1–positive advanced gastric or gastroesophageal junction cancer (GC): Update from the phase III KEYNOTE-061 trial.
Published date:
05/13/2020
Excerpt:
Pembrolizumab prolonged OS vs paclitaxel in PD-L1–positive patients (Table). No significant differences appeared between groups in PFS (Table). Objective response rate (ORR) was higher for pembrolizumab in the CPS ≥10 group, and DOR was longer with pembrolizumab using all CPS cutoffs (Table).
DOI:
10.1200/JCO.2020.38.15_suppl.4503
Trial ID:
Source:
Title:
Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial
Excerpt:
...patients with a programmed cell death ligand 1 (PD-L1)...Median overall survival was 9·1 months (95% CI 6·2-10·7) with pembrolizumab and 8·3 months (7·6-9·0) with paclitaxel (hazard ratio [HR] 0·82, 95% CI 0·66-1·03; one-sided p=0·0421)...Median progression-free survival was 1·5 months (95% CI 1·4-2·0) with pembrolizumab and 4·1 months (3·1-4·2) with paclitaxel (HR 1·27, 95% CI 1·03-1·57)...Pembrolizumab had a better safety profile than paclitaxel.
DOI:
10.1016/S0140-6736(18)31257-1
Trial ID:
Excerpt:
Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Source:
Title:
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)
Excerpt:
...As of 20 March 2016, participants must be PD-L1 positive to be enrolled....
Trial ID:
Source:
Title:
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
Excerpt:
...- Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status...
Trial ID:
More C2 evidence
Source:
Title:
A Study of Perioperative mFOLFOX6 Plus Pembrolizumab in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach
Excerpt:
...Objective Response Rate (ORR)`Disease Free Survival post surgery`Overall Survival (OS)`PET response`PD-L1 expression in tumor cells...
Trial ID:
Source:
Title:
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Excerpt:
...- Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status...
Trial ID:
Source:
Title:
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Excerpt:
...PD-L1 expression status in tissue samples collected at baseline before receiving any prior systemic anticancer therapy are of highest interest....
Trial ID:
Source:
Title:
Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma
Excerpt:
...Programmed cell death ligand 1 (PD-L1) expression in tumor cells...
Trial ID:
Source:
Title:
Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)
Excerpt:
...- Has PD-L1 positive tumor (based on analysis of sample provided to core lab)....
Trial ID:
Source:
Title:
A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)
Excerpt:
...Note: All participants in Cohort 3 had a PD-L1-positive tumor status.`...
Trial ID:
Source:
Title:
Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659)
Excerpt:
...- Has a PD-L1 positive tumor as determined by immunohistochemistry (IHC) at a central laboratory...
Trial ID:
Less C2 evidence
Source:
Title:
A phase II study of perioperative pembrolizumab plus mFOLFOX in patients with potentially resectable esophagus, gastroesophageal junction (GEJ), and stomach adenocarcinoma
Published date:
06/16/2023
Excerpt:
6/29 (21%; 95% CI: 0.08-0.40) achieved ypCR with TRS 0 in resected patients. 26/29 (90%; 95% CI: 0.73-0.98) had ypRR with TRS ≤2. Twenty-six patients finished adjuvant therapy with a median 36.3-month follow-up...Preoperative ICI + chemotherapy enhanced immune responses significantly with increasing expression of PD-L1 (CPS ≥10, p = 0.0078) and CD8 (>5%, p = 0.0059)...The perioperative pembrolizumab and mFOLFOX combination in resectable esophageal/gastric/GEJ adenocarcinoma is very effective with 90% ypRR, 21% ypCR, and impressive long-time survival benefits.
Secondary therapy:
mFOLFOX6
DOI:
10.1002/cam4.6263
Trial ID:
Source:
Title:
Pembrolizumab or pembrolizumab plus chemotherapy versus standard of care chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062
Published date:
03/07/2023
Excerpt:
Eligible patients were randomly assigned 1:1:1 to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin + 5-fluorouracil or capecitabine)...In the programmed death ligand 1 combined positive score ≥10 population, median overall survival was also numerically longer with pembrolizumab versus chemotherapy (28.5 vs 14.8 months; hazard ratio, 0.43; 95% confidence interval, 0.21-0.89)...pembrolizumab monotherapy was associated with numerically improved overall survival and a favourable tolerability profile versus chemotherapy in Asians with programmed death ligand 1-positive advanced gastric cancer/gastrooesophageal junction cancer.
Secondary therapy:
capecitabine; cisplatin + 5-fluorouracil
DOI:
10.1093/jjco/hyac188
Trial ID:
Source:
Title:
O-12 KEYNOTE-061: Response to subsequent therapy following second-line pembrolizumab or paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma
Published date:
07/08/2020
Excerpt:
Among patients with PD-L1–positive advanced gastric/GEJ cancer, OS on subsequent therapy was better in the pembrolizumab group than the paclitaxel group, with a possibly greater effect when an anti-VEGF plus taxane was given as subsequent therapy.
DOI:
10.1016/j.annonc.2020.04.065
Trial ID:
Source:
Title:
O-12 KEYNOTE-061: Response to subsequent therapy following second-line pembrolizumab or paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma
Published date:
07/01/2020
Excerpt:
Among patients with PD-L1–positive advanced gastric/GEJ cancer, OS on subsequent therapy was better in the pembrolizumab group than the paclitaxel group, with a possibly greater effect when an anti-VEGF plus taxane was given as subsequent therapy.
DOI:
10.1016/j.annonc.2020.04.065
Trial ID:
