Gastric Cancer

Higher response rates with T-DXd occurred in patients with gastric cancer and plasma HER2 amplification in circulating tumor DNA in the DESTINY-Gatric01 trial.

The primary end point of overall survival was met in the KEYNOTE-811 trial assessing pembrolizumab in HER2-positive gastrointestinal cancer.

Using FOLFIRI as a doublet with durvalumab or a triplet with durvalumab and tremelimumab yielded positive safety in gastric/GEJ cancers.

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.

Data from the phase 3 RATIONALE 305 trial support the biologics license application for tislelizumab plus chemotherapy in advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Over half of the patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma achieve a major pathological complete response following treatment with sintilimab plus FLOT in a phase 2 trial.

Findings from the FRUTIGA study support fruquintinib plus paclitaxel as a promising second-line treatment for those with advanced gastric or gastroesophageal junction adenocarcinoma following prior chemotherapy.

Risk-reducing total gastrectomy is associated with short-term and long-term physical and emotional AEs in patients with pathogenic or likely pathogenic germline CDH1 P/LP variants.

Investigators observe a benefit with durvalumab plus neoadjuvant chemotherapy among subgroups of patients regardless of microsatellite instability status in the phase 3 MATTERHORN trial.

Combining ASKB589 with capecitabine, capecitabine, and sintilimab leads to no treatment discontinuation due to adverse effects among patients with gastric or gastroesophageal junction cancer in a phase 1/2 trial.

The 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.

In 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.

Approval of PD-L1 IHC 22C3 pharmDx may also identify patients with non–small cell lung cancer and other malignancies who may benefit from treatment with pembrolizumab.

Only 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.

CHM 2101 will be assessed as part of a phase 1A/B clinical study in a population of patients diagnosed with advanced colorectal cancer, gastric cancer, and neuroendocrine cancer.

CMG901 demonstrated a well-tolerated safety profile in patients with CLDN18.2-positive, advanced gastric/gastroesophageal junction cancer.

Pembrolizumab appears to improve overall survival vs placebo when added to trastuzumab and chemotherapy among patients with metastatic HER2-positive gastric or gastroesophageal junction cancer.

Adding durvalumab to standard-of-care chemotherapy appears to improve downstaging in patients with resectable gastric cancer and gastroesophageal junction cancer in the phase 3 MATTERHORN study.

Two phase 2 studies are assessing the efficacy of BDC-1001 in several disease states, including colorectal, gastroesophageal, endometrial, and breast cancer.

Combining regorafenib with nivolumab and chemotherapy appears to improve progression free survival at 6 months among those with advanced esophagogastric adenocarcinoma.

Data 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.

Phase 2 data support administering trastuzumab in combination with ramucirumab and paclitaxel for patients with HER2-positive gastric or gastroesophageal junction cancer.

Findings from the phase 3 KEYNOTE-811 trial support the CHMP’s recommendation to approve pembrolizumab plus trastuzumab in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

The marketing authorization application for this first-in-class agent is based on data from the phase 3 SPOTLIGHT and GLOW trials; a recommendation is expected in 2024.

The 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.