GI CANCERS

In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee supported the proposed clinical trial for dostarlimab as treatment of locally advanced, treatment-naïve mismatch-repair deficient or microsatellite-instability-high rectal cancer.

In an interview with Targeted Oncology, Tara Seery, MD, discussed the rationale and findings from cohort 3 of the QUILT 88 study in metastatic pancreatic cancer.

Samuel Klempner, MD, discusses zolbetuximab for patients with claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer.

In an interview with Targeted Oncology, Samuel Klempner, MD, discussed the significance of the phase 3 SPOTLIGHT study and the future impact of claudin 18.2 as a biomarker to treat cancers of the stomach and esophagus.

During a Targeted Oncology case-based roundtable event, Nilofer S. Azad, MD, discussed the data supporting the previous standard of care and the new frontline regimen of gemcitabine, cisplatin, and durvalumab for patients with biliary tract cancers.

Adding CTX-009 to paclitaxel generated promising responses for patients with advanced biliary tract cancer when given in the second- and third-line settings.

Rachna T. Shroff, MD, MS, FASCO discussed the findings from SWOG 1815 and next steps for improving upon treatment with gemcitabine and cisplatin in biliary tract cancer.

According to topline findings of the phase 3 KEYNOTE-966 trial, pembrolizumab in combination with gemcitabine and cisplatin led to an improvement in overall survival for patients with biliary tract cancer.

Phase 2 FOENIX-CCA2 study results further confirm the safety and efficacy of futibatinib for the treatment of previously treated patients with advanced/metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

Findings from the phase 3 NAPOLI 3 trial support the NALIRIFOX regimen as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.

The combination use of encorafenib plus cetuximab and chemotherapy appeared to be safe and effective in treating patients with BRAF V600E-mutant metastatic colorectal cancer.

NRG-GI002 helps to provide further total neoadjuvant therapy outcome data from multi-institutional national clinical trials that can benchmark and be used for future locally advanced rectal cancer outcomes, according to Thomas J. George, MD, FACP.

The SUNLIGHT study is the first phase 3 study in the setting of refractory metastatic colorectal cancer to demonstrate an improvement in overall survival vs an active control, according to Josep Tabernero, MD, PhD.

SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab, showed early evidence of efficacy in patients with metastatic pancreatic ductal adenocarcinoma.

Modest clinical benefit elicited with or without bevacizumab added to atezolizumab (Tecentriq) plus cisplatin/gemcitabine in biliary tract cancer.

SWOG 1815, which was investigating nab-paclitaxel plus gemcitabine and cisplatin, has missed its primary end point.

Findings from the phase 1/2 HERIZON trial showed HER-Vaxx plus standard-of-care chemotherapy to improve survival in patients with advanced gastric/gastroesophageal junction adenocarcinoma.

Nivolumab with chemotherapy or ipilimumab continued to have a clinically meaningful survival benefit vs with chemotherapy alone in patients with treatment-naïve advanced esophageal squamous cell carcinoma.

CheckMate-649 study findings continue to support frontline nivolumab and chemotherapy for patients with advanced gastric, gastroesophageal junction cancer, and esophageal adenocarcinoma.

New findings from the phase 2 INFINITY trial shows promise for tremelimumab and durvalumab in patients with gastric/GEJ adenocarinoma.

MOUNTAINEER study results have wowed the FDA, leading to an accelerated FDA approval of tucatinib plus trastuzumab as RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer treatment.

A substudy of the TIGeR-PaC trial showed that treatment with RenovoTAMP may increase local gemcitabine delivery and decrease the debilitating adverse events associated with intravenous administration in pancreatic cancer.

The COVALENT-102 study has started BMF-219 treatment in patients with KRAS-mutated, advanced solid tumors.

In IMbrave050, the risk of disease recurrence or death was decreased with adjuvant atezolizumab and bevacizumab compared with active surveillance in patients with early-stage hepatocellular carcinoma.

Months after the FDA granted accelerated approval to dostarlimab for this rectal cancer indication, phase 2 data have confirmed its efficacy and safety.

Following clearance by the FDA and AEMPS, the phase 2b VIRAGE trial of VCN-01 plus gemcitabine and nab-paclitaxel dosed its first patient with pancreatic ductal adenocarcinoma.

INTRIGUE study results show that patients with gastrointestinal stromal tumor who harbor certain KIT mutations have significantly improved responses and survival with ripretinib treatment.

New results from the advanced pancreatic cancer cohort of the CodeBreaK 100 trial show positive efficacy and safety.

Circulating tumor DNA has improved risk stratification, increased minimal residual disease in patients with early-stage gastrointestinal cancers.

The CSP-targeting antibody, ZB131, is being investigated in a phase 1/2 study of patients with pancreatic cancer and other solid tumors.