GI CANCERS

The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in first-line advanced gastric cancer with PD-L1 expression less than 1.

A phase 3 clinical trial studying favezelimab in combination with pembrolizumab for the treatment of patients with previously treated PD–L1-positive metastatic colorectal cancer failed to meet its primary end point of overall survival.

A new drug application has been resubmitted to the FDA for the combination of camrelizumab and rivoceranib as a first-line treatment for unresectable hepatocellular carcinoma, following a complete response letter in May 2024.

The FDA granted fast track designation to EO-3021 for the treatment of advanced or metastatic gastric and gastroesophageal junction cancers expressing Claudin 18.2, which have progressed after prior therapy.

CF33-hNIS has gained FDA orphan drug designation for the treatment of cholangiocarcinoma and is currently being evaluated in the phase 1 MAST trial.

Non-operative management showed promising results for patients with mismatch repair proficient locally advanced rectal cancer, preserving organs without compromising survival.

The combination of encorafenib, cetuximab, and FOLFIRI showed promising antitumor activity in patients with BRAF V600E-mutant metastatic colorectal cancer.

A combination of lenvatinib, pembrolizumab, and TACE significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma compared to dual placebo and TACE.

Adding retifanlimab to carboplatin and paclitaxel improved progression-free survival in patients with recurrent or metastatic squamous cell carcinoma of the anal canal.

Zanidatamab combined with chemotherapy demonstrated promising antitumor activity and safety in the first-line treatment of HER2-positive mCRC, with a high response rate and manageable adverse effects.

Findings from the DESTINY-Gastric03 study support the further exploration of the antibody-drug conjugate trastuzumab deruxtecan for the first-line treatment of patients with advanced HER2+ gastric, esophageal, and GEJ cancers.

The investigational agent certepetide has been granted FDA orphan drug designation for the treatment of patients with cholangiocarcinoma.

The FDA’s Oncologic Drug Advisory Committee will meet on September 26, 2024, to discuss PD-L1 cutoffs for immune checkpoint inhibitors in gastric, gastroesophageal, and esophageal cancers.

The application is supported by the phase 3 CheckMate -9DW study, and the FDA has set a target action date of April 21, 2025.

A number of studies are challenging the current gastrointestinal cancer treatment landscape.

A phase 1b study will investigate PTM-101, a directed administration of paclitaxel, in patients with nonmetastatic pancreatic cancer.

The blood-based ctDNA test delivered high rates of sensitivity and specificity with long lead times in detecting minimal residual disease in patients with colorectal cancer.

The FDA has set a target action date of April 3, 2025, for the supplemental new drug application of cabozantinib for the treatment of neuroendocrine tumors.

The Precision Promise and LAPIS studies failed to meet their primary end points of overall survival among patients with pancreatic cancer treated with the investigational agent pamrevlumab.

The ASPEN-06 trial found that adding evorpacept to trastuzumab, ramucirumab, and paclitaxel significantly improved overall response rates and duration of response in patients with previously treated HER2-positive advanced gastric or gastroesophageal junction cancer.

Avutometinib plus defactinib shows promising early results in pancreatic cancer, earning an orphan drug designation from the FDA.

The FDA approval of Guardant Shield marks the second blood-based diagnostic test for colorectal cancer in those age 45 and older at average risk of the disease.

A new dendritic cell vaccine has shown promising results in extending survival for pancreatic cancer patients by stimulating the immune system to fight tumor cells.

Patrick Boland, MD, discussed the practice-changing implications of the phase 3 ESOPEC study comparing FLOT vs CROSS regimens for the treatment of esophageal adenocarcinoma.

A dendritic cell vaccine called DOC1021 shows early promise in treating pancreatic cancer and has received a fast track designation from the FDA.

The ESOGUARD BE-1 trial demonstrated that the EsoGuard test, combined with EsoCheck, effectively detects esophageal precancer and supports its use as a screening tool to prevent esophageal cancer.

The FDA has received a 505(b)(2) new drug application seeking approval for a lutetium Lu 177 dotatate injection as a potential treatment for SSTR-positive gastroenteropancreatic neuroendocrine tumors.

MRG004A, a novel antibody-drug conjugate, elicited antitumor activity and had manageable toxicities when used in heavily pretreated patients with multiple tumor types with high tissue factor.

Final analysis from KEYNOTE-585 revealed that event-free survival (EFS) was not significantly improved.

Modified FOLFIRINOX with nivolumab in the neoadjuvant setting was associated with favorable rates of R0 resection in patients with borderline resectable pancreatic cancer.