Gastrointestinal Cancer

Co-editor-in-Chief Howard S. Hochster, MD, writes about the past and present of the phase 2/3 PROSPECT trial.

“We’re starting to see a lot of benefits with targeted therapies [and] immunotherapies. Unfortunately, these [benefits] remain limited to a small subset of patients across GI [gastrointestinal] [malignant tumors]. One of the biggest challenges is how to expand those benefits to the majority of patients.”

The regulatory agency has set a Prescription Drug User Fee Act date of February 7, 2024 for pembrolizumab plus chemotherapy as a treatment for patients with advanced or metastatic biliary tract cancer.

Results from the phase 2b HERIZON-BTC-01 trial show positive efficacy and safety responses in patients with locally advanced, unresectable or metastatic biliary tract cancer.

Investigators say that they do not have any safety concerns regarding GEN-001 and avelumab in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Investigators report that patients with advanced or metastatic esophageal squamous cell carcinoma may have superior overall survival benefit following treatment with tislelizumab/chemotherapy vs placebo/chemotherapy.

Patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma may experience significant survival benefit following treatment with zolbetuximab.

Investigators say that liposomal irinotecan plus fluorouracil and leucovorin should be considered as a treatment option for second-line, previously treated metastatic biliary tract cancer.

Co-editor-in-Chief Howard S. Hochster, MD, highlights the most exciting developments from the 2023 Gastrointestinal Cancer Symposium hosted by the American Society of Clinical Oncology (ASCO).

National Comprehensive Cancer Network guidelines will now include ripretinib as the ideal second-line treatment for patients with unresectable/metastatic gastrointestinal stromal tumors who are intolerant to sunitinib.

In a meeting with the FDA’s Oncologic Drugs Advisory Committee experts discussed findings that have read out with regard to dostarlimab for patients with mismatch repair deficiency/microsatellite instability–high locally advanced rectal cancer.

Data from the final analysis of the phase 3 KEYNOTE-966 trial indicate that pembrolizumab plus chemotherapy yields improvements in overall survival compared with chemotherapy alone in patients with advanced biliary tract cancer.

An expert from the Smilow Cancer Hospital and Yale Cancer Center indicates that findings from the ctDNA analysis of the phase 3 INTRIGUE study were “provocative” and that the subsequent phase 3 INSIGHT study has the potential to be practice changing should data be positive.

Findings from a phase 2 trial indicate that CTX-009 plus paclitaxel may produce an encouraging responses in patients with advanced biliary tract cancer, according to investigators.

Patients with advanced biliary tract cancer experience modest clinical benefit following treatment with atezolizumab and cisplatin/gemcitabine with or without bevacizumab.

Patients with newly diagnosed, advanced biliary tract cancers do not have a statistically significant survival benefit following treatment with nab-paclitaxel plus gemcitabine and cisplatin.

Patients with previously untreated advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma continue to benefit from treatment with nivolumab and chemotherapy.

Long-term survival benefit is seen in patients with treatment-naïve advanced esophageal squamous cell carcinoma who were treated with nivolumab plus chemotherapy or ipilimumab.

Investigators 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.

HER-Vaxx with standard-of-care chemotherapy yielded benefit in patients with HER2-overexpressing metastatic or advanced gastric/gastroesophaeal junction adenocarcinoma.

Findings from the phase 3 INTRIGUE trial highlighted improved median progression-free survival in patients with KIT exon–mutated gastrointestinal stromal tumors compared with sunitinib.

Positive topline data from the phase 2b HERIZON-BTC-01 trial indicate zanidatamab may improve outcomes for patients with HER2-amplified and expressing biliary tract cancers.

Patients with gastroenteropancreatic neuroendocrine tumors may benefit from treatment with radionucleotide therapeutic 177Lu-edotreotide, which received fast track designation from the FDA.

Results from a randomized controlled trial highlighted that the TissueCypher Barrett’s Esophagus Test heightened accuracy for assessing progression risk in high-grade dysplasia and esophageal adenocarcinoma among patients with Barrett’s esophagus.

Results from the phase 2 IMMUCHEC trial indicated that tremelimumab with or without durvalumab did not meet the primary end point of improved objective response rate vs chemotherapy in patients with treatment-naïve biliary tract cancer.

The FDA has granted orphan drug designation to second-line GNS561 following the completion of a phase 1/2a trial evaluating the novel PPT1 inhibitor in liver cancer and cholangiocarcinoma.

Findings from the phase 1/2 ReFocus study highlighted that RLY-4008 is a potentially transformative agent for the treatment of FGFR inhibitor–naïve, FGFR-mutant cholangiocarcinoma.

Long-term follow-up of the phase 2 DESTINY-Gastric02 study revealed fam-trastuzumab deruxtecan-nxki continues to show promise in locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Patients with locally advanced or metastatic biliary tract cancer can now receive treatment with durvalumab plus gemcitabine following the combination’s approval by the FDA.

“...we don’t focus on survivorship enough. It’s important to understand the other factors involved in surviving besides just a treatment.”