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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) + Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
05/05/2021
Excerpt:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Secondary therapy:
Chemotherapy
Source:
Published date:
01/05/2023
Excerpt:
For patients with HER2-positive gastric or GEJ previously untreated, unresectable or metastatic AC, trastuzumab plus pembrolizumab is recommended, in combination with CT.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.22.02331
Source:
Title:
The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer
Published date:
12/15/2021
Excerpt:
...placebo-controlled phase III KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for unresectable or metastatic, HER2-positive gastric or gastro-oesophageal junction adenocarcinoma...adding pembrolizumab to trastuzumab and chemotherapy markedly reduces tumour size, induces complete responses in some participants, and significantly improves objective response rate.
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.1038/s41586-021-04161-3
Trial ID:
Source:
Title:
LBA-4 Initial data from the phase 3 KEYNOTE-811 study of trastuzumab and chemotherapy with or without pembrolizumab for HER2-positive metastatic gastric or gastroesophageal junction (G/GEJ) cancer
Published date:
07/04/2021
Excerpt:
...receive pembrolizumab 200 mg IV Q3W or placebo IV Q3W for up to 2 years or until intolerable toxicity or PD; all participants also receive trastuzumab...CAPOX was chosen for 87.1%...The combination of pembrolizumab, trastuzumab, and chemotherapy provides a substantial, statistically significant improvement in ORR compared with placebo, trastuzumab, and chemotherapy as first-line therapy for HER2-positive, metastatic G/GEJ cancer.
Secondary therapy:
CAPOX
DOI:
https://doi.org/10.1016/j.annonc.2021.06.011
Trial ID:
Source:
Title:
Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (G/GEJ) cancer: Initial findings of the global phase 3 KEYNOTE-811 study.
Published date:
05/19/2021
Excerpt:
Confirmed ORR (95% CI) was 74.4% (66.2-81.6) for pembro + SOC vs 51.9% (43.0-60.7) for placebo + SOC (difference, 22.7 percentage points [95% CI, 11.2-33.7], P = 0.00006); CR rate was 11.3% vs 3.1% and DCR (95% CI) was 96.2% (91.4-98.8) vs 89.3 (82.7-94.0)....Adding pembro to tras and chemo resulted in a substantial, statistically significant increase in ORR versus trastuzumab and chemo alone as 1L therapy for HER2+ metastatic G/GEJ cancer...
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2021.39.15_suppl.4013
Trial ID:
Source:
Title:
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Published date:
05/05/2021
Excerpt:
KEYNOTE-811 (ClinicalTrials.gov, NCT03615326), a multicenter, randomized, double-blind, placebo-controlled trial that was designed to enroll 692 patients with HER2-positive advanced gastric or GEJ adenocarcinoma....At the time of the interim analysis, ORR and DOR were assessed in the first 264 patients randomized….A statistically significant improvement in ORR was demonstrated in patients randomized to KEYTRUDA in combination with trastuzumab and chemotherapy compared with placebo in combination with trastuzumab and chemotherapy.
Secondary therapy:
CAPOX; CF
Trial ID:
Source:
Title:
Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
Excerpt:
...Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH), as assessed by central review on primary or metastatic tumor....
Trial ID:
Source:
Title:
First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial
Published date:
05/18/2020
Excerpt:
pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer...Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer.
DOI:
10.1016/S1470-2045(20)30169-8
Trial ID:
Source:
Title:
First-line pembrolizumab (P), trastuzumab (T), capecitabine (C) and oxaliplatin (O) in HER2-positive metastatic esophagogastric adenocarcinoma (mEGA).
Excerpt:
...pembrolizumab with chemotherapy/trastuzumab...The RECIST 1.1 ORR was 83% [95%CI: 63%-95%] (17 PR , 3 CRs), median PFS 11.4 [95%CI: 6-15] months.
Secondary therapy:
capecitabine + oxaliplatin
DOI:
10.1200/JCO.2019.37.4_suppl.62
Trial ID:
