March 13th 2024
Findings from the phase 3 CheckMate 649 trial support nivolumab plus chemotherapy as a standard frontline therapy for patients with gastric, gastroesophageal junction, and esophageal adenocarcinoma.
February 27th 2024
February 18th 2024
FDA Issues CRL for Zolbetuximab in Advanced CLDN18.2+ Gastric Cancer
January 9th 2024The FDA cannot approve the application for zolbetuximab in advanced or metastatic gastric or gastroesophageal junction adenocarcinoma due to unresolved issues following a pre-license inspection of a third-party manufacturing site.
Pembrolizumab/Chemo Receives European Approval in First-Line GI Cancers
December 18th 2023In Europe, pembrolizumab is now available as a treatment in combination with fluoropyrimidine-/platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, as well as in combination with gemcitabine/cisplatin for locally advanced biliary tract carcinoma.
FDA Updates Indication for Pembrolizumab in HER2+ Gastric/GEJ Adenocarcinoma
November 9th 2023Only patients with PD-L1–positive tumors may receive treatment with pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastroesophageal junction adenocarcinoma following the FDA’s amendment.
Frontline Pembrolizumab Combo Obtains EU Approval for HER2+ Gastric Cancer
August 30th 2023Data from the phase 3 KEYNOTE-811 trial highlight a trend towards improved overall survival among patients with HER2-positive, PD-L1–positive advanced gastric or gastroesophageal junction adenocarcinoma receiving pembrolizumab, trastuzumab, and chemotherapy.
FDA Gives Priority Review to Zolbetuximab in Advanced Gastric Cancer
July 6th 2023The FDA sets a Prescription Drug User Fee Act date of January 12, 2024 for the biologics license application for zolbetuximab in the management of Claudin 18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
Pembrolizumab/Chemo Improves Responses But Not EFS in Gastric/GEJ Cancer
June 26th 2023Topline data from the phase 3 KEYNOTE-585 trial, evaluating pembrolizumab in gastric and gastroesophageal junction adenocarcinoma, show a better rate of complete response following the experimental regimen vs chemotherapy alone.
Expanding Medicaid May Mitigate Disparities in Pancreatic/Gastric Cancers
May 26th 2023Medicaid expansion may help overcome inequities in access to care for pancreatic and gastric cancers, with notable benefit in Black patients, according to an expert from The University of Texas MD Anderson Cancer Center.
Daniel V. T. Catenacci, MD, and colleagues present findings from a study of circulating tumor DNA as a predictive biomarker for gastric and gastroesophageal cancer.
Zolbetuximab Combo Should be Considered New SOC in Gastric Cancer Subtype
March 23rd 2023Efficacy and safety findings from the phase 3 GLOW trial assessing zolbetuximab and CAPOX in CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma were consistent with the phase 3 SPOTLIGHT trial, according to an expert from Weill Cornell Medical College
Zolbetuximab/Chemo Up Front Yields Benefit in CLDN18.2+ Advanced Gastric/GEJ Cancer
January 20th 2023Investigators report benefit in patients with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma treated with first-line zolbetuximab and mFOLFOX6.