Title:
DCGI approves MSD’s Keytruda for additional indications of cervical and esophageal cancers
Excerpt:US-based pharma major MSD (tradename of Merck & Co., Inc) announced that the Drugs Controller General of India (DCGI) has approved its anti cancer drug Keytruda (pembrolizumab), for additional indications of cervical cancer and esophageal cancer. The company said that the anti-programmed death receptor-1 (PD-1), has received approval for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS =1, and for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS = 10.
Title:
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma
Excerpt:Merck...today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
Secondary therapy:cisplatin + 5-fluorouracil
Evidence Level:Sensitive: B - Late Trials
Title:
Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) in Combination With Chemotherapy as First-Line Treatment for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma
Excerpt:Merck...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus...The positive CHMP opinion is based on results from the pivotal Phase 3 KEYNOTE-590 trial...
Evidence Level:Sensitive: B - Late Trials
Title:
First-line pembrolizumab plus chemotherapy versus chemotherapy in patients with advanced esophageal cancer: Chinese subgroup analysis of KEYNOTE-590.
Excerpt:Of 749 patients enrolled...88.7% were male and 49.1% had PD-L1 CPS ≥10...Additionally, in Chinese patients (pembrolizumab + chemotherapy vs chemotherapy), median OS was 10.5 months versus 8.0 months (HR, 0.51; 95% CI, 0.32-0.81), median PFS was 6.2 months versus 4.6 months (HR, 0.60; 95% CI, 0.39-0.92), ORR was 37.3% versus 20.0%, and median DOR (range) was 6.4 months (2.2+ to 18.9+) versus 4.0 months (1.5+ to 16.6+).
DOI:10.1200/JCO.2021.39.15_suppl.4049
Evidence Level:Sensitive: B - Late Trials
Title:
Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer
Excerpt:In this open-label, phase III study, we randomly assigned (1:1) 628 patients with advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, that progressed after one prior therapy, to pembrolizumab...OS was prolonged with pembrolizumab versus chemotherapy for patients with CPS ≥ 10 (median, 9.3 v 6.7 months; hazard ratio [HR], 0.69 [95% CI, 0.52 to 0.93]; P = .0074)....Pembrolizumab prolonged OS versus chemotherapy as second-line therapy for advanced esophageal cancer in patients with PD-L1 CPS ≥ 10...
Evidence Level:Sensitive: B - Late Trials
Title:
LBA8_PR Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study
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.
DOI:10.1016/j.annonc.2020.08.2298
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma
Excerpt:...Programmed cell death ligand 1 (PD-L1) expression in tumor cells...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas
Excerpt:...- Patients must have analysis of PD-L1 expression in cancer cells quantitated by immunohistochemistry analysis....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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.`...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma
Excerpt:...Improved 1 Year Survival`Induction of PD-L1 Expression or Induction of an Inflammatory Signature in Tumors.`...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pembrolizumab Plus Chemo in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (Eastern Cooperative Thoracic Oncology Projects 2004, ECTOP-2004)
Excerpt:...PD-L1 expression is measured by 22C3 clone PD-L1 IHC assay followed by combined positive score (CPS) scoring methods.`...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
Q-TWiST analysis for pembrolizumab plus chemotherapy versus chemotherapy as first-line treatment for patients with advanced esophageal cancer in the KEYNOTE-590 study
Excerpt:In all patients at month 33, patients receiving pembrolizumab + chemotherapy had a 1.51 month (95% CI, 0.10-2.95) longer restricted mean time in TWiST...In patients with PD-L1 CPS 10, those receiving pembrolizumab + chemotherapy had a 2.24 month (95% CI, 0.08-4.44) longer restricted mean time in TWiST (6.35 vs 4.11 months)...Pembrolizumab + chemotherapy demonstrated clinically meaningful
improvement in quality-adjusted survival based on Q-TWIST analyses compared with chemotherapy in patients with advanced esophageal cancer.
DOI:https://doi.org/10.1016/j.annonc.2022.04.374
Evidence Level:Sensitive: C3 – Early Trials
Title:
261 Association of T-cell–inflamed gene expression profile and PD-L1 status with efficacy of pembrolizumab in patients with esophageal cancer from KEYNOTE-180
Excerpt:The KEYNOTE-180 trial (NCT02559687) was a single-arm phase 2 study of pembrolizumab as third-line or greater therapy in advanced/metastatic esophageal/gastroesophageal junction adenocarcinoma or squamous cell carcinoma (SCC). Median OS was slightly higher among patients with SCC in the GEPnon-low subgroup and the CPS ≥10 subgroup versus GEPlow and CPS <10 subgroups, respectively (tables 1, 2); this trend was reversed among patients with adenocarcinoma (tables 1, 2). Median PFS ranged from 1.9 to 2.1 across histology/biomarker subgroups. Median DOR was NR regardless of GEP or CPS status (tables 1, 2).
DOI:10.1136/jitc-2020-SITC2020.0261
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Safety and Antitumor Activity of the Anti–Programmed Death-1 Antibody Pembrolizumab in Patients With Advanced Esophageal Carcinoma
Excerpt:Overall response rate was 30% (95% CI, 13% to 53%); median duration of response was 15 months (range, 6 to 26 months)....Pembrolizumab demonstrated manageable toxicity and durable antitumor activity in patients with heavily pretreated, PD-L1–positive advanced esophageal carcinoma.
DOI:10.1200/JCO.2017.74.9846