GI CANCERS

The FDA has granted orphan drug designation to AB001 for the treatment of patients with pancreatic cancer and acute myeloid leukemia.

The FDA has granted breakthrough device designation to Precision-GI, a tool that assists with performing a tumor biopsy.

The first patient has been dosed in the phase 1 KN-4802 trial examining the safety, tolerability, and preliminary efficacy of KIN-3248 in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

The phase 2 HERIZON-BTC-01 of zanidatamab in patients with HER2-amplified biliary tract cancer has met its patient enrollment goal.

In RATIONALE 306, tislelizumab plus chemotherapy extended overall survival in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

CMG90 is the only drug in its class to have received fast-track status to date. Prior to its fast track status, the drug was granted orphan drug designation by the FDA.

In an interview with Targeted Oncology, Luv Hajirawala, MD, discussed the relevance of high-risk features in patients with stage III colon cancer, and how a recent real-world analysis may change risk stratification in the future.

Samuel J. Klempner, MD, discusses the mechanism of action of the investigational agent DKN-01 in patients with gastroesophageal adenocarcinoma.

Nitika Sharma, MD, explores developments in the esophageal cancer landscape for Esophageal Cancer Awareness Month.

The recent, significant advances for immunotherapy in esophageal and gastroesophageal junction cancer are promising, and oncologists hope it is just the beginning of further improvements in patient outcomes.

Treatment with nivolumab plus chemotherapy was more effective compared with chemotherapy alone in patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in the CheckMate 649 study.

According to 5-year survival data from the BILCAP study, capecitabine stands up to observation as a treatment strategy for patient with biliary tract cancer.

Several notable trials in colorectal cancer suggest a shift in treatment management, especially in the length of treatment with immunotherapies.

Samuel J. Klempner, MD, discusses unmet needs in patients with gastroesophageal adenocarcinoma when it comes to biomarker-targeted agents.

Using combination treatments in the concurrent setting with chemotherapy, radiation therapy, or small molecule oncogene and pathway inhibitors may yield positive data in one setting but not another.

Andreana Holowatyj discusses the key takeaway for community oncologists about early-onset appendiceal cancer.

The FDA has accepted for priority review a new drug application for futibatinib seeking approval for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma who harbor FGFR2 gene rearrangement, including gene fusions.

During a debate at the Gastrointestinal Cancers Symposium, Florian Lordick, MD, argued that knowledge of PD-L1 expression level was needed before starting immune checkpoint inhibitor therapy. He was challenged by Aaron James Scott, MD, who argued that knowledge of PD-L1 is not necessary before initiating immune checkpoint inhibitor therapy.

Michael Chuong, MD, discusses the unmet needs for the treatment of inoperable pancreatic cancer.

Targeted therapy with tyrosine kinase inhibitors is necessary after surgery for patients with metastatic gastrointestinal stromal tumors with residual disease requiring resection to prevent disease recurrence.

There remains a need for biomarkers of primary gastrointestinal stromal tumor subclones to characterize invasion or metastasis, according to Jonathan A. Fletcher, MD.

Ryan Sugarman, MD, discusses the design and purpose of the CheckMate 649 trial for gastroesophageal cancers, gastric cancer, and esophageal adenocarcinoma.

Tanios S. Bekaii-Saab, MD, FACP, discusses the phase 1/1b and 2 KRYSTAL-1 trial and his presentation from the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

The developer has announced that half of the patients are now enrolled in the BESPOKE CRC clinical trial.