Gastrointestinal Cancer

China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.

The development of etrumadenant as a potential treatment option for patients with metastatic castration-resistant prostate cancer will be discontinued after data from the phase 1/2 ARC-6 trial did not demonstrate a sufficient clinical benefit for etrumadenant plus zimberelimab and docetaxel compared with docetaxel alone.

Michael Cecchini, MD, discusses the phase 3 PROSPECT trial of neoadjuvant chemoradiation vs neoadjuvant fluorouracil, leucovorin, and oxaliplatin chemotherapy with selective use of chemoradiation, followed by total mesorectal excision in patients with locally advanced rectal cancer, and how this regimen may fit into the current treatment landscape for rectal cancer.

In this first episode of OncChats: Mapping Progress Made in Pancreatic Cancer Surgery, Horacio J. Asbun, MD, and Domenech Asbun, MD, discuss recent advances made in the surgical field and beyond for pancreatic cancer, including the benefits of minimally invasive approaches.

The FDA has granted orphan drug designation to LSTA1 for use as a potential therapeutic option in patients with malignant glioma, according to an announcement from Lisata Therapeutics, Inc.

The FDA has approved the therascreen PDGFRA RGQ PCR kit for use as a companion diagnostic, co-developed by Qiagen and Blueprint Medicines, to assist in the identification of patients with gastrointestinal stromal tumors who may be candidates to receive avapritinib.

Pamela Kunz, MD, details key clinical trial updates across the gastrointestinal cancer arena presented during the 2023 ASCO Annual Meeting, including the phase 3 PROSPECT trial in locally advanced rectal cancer and the phase 3 IMbrave050 trial in patients with resected in hepatocellular carcinoma at high risk of recurrence.

Lionel Kankeu Fonkoua, MD, discusses the need for diverse representation across cancer clinical trials and research, emphasizes some of the disparities in enrollment criteria for these research efforts, and details some of the planned and ongoing initiatives at the Mayo Clinic that seek to facilitate change in the field.

Trastuzumab plus ramucirumab and paclitaxel yielded promising efficacy and a manageable safety profile among patients with previously treated HER2-positive advanced gastric/gastroesophageal junction cancer.

George Lau, MD, FRCP, FAASLD, discusses clinical implications for the use of dual checkpoint inhibition in HCC based on an analysis of immune-related adverse effects seen with the STRIDE regimen in the phase 3 HIMALAYA trial.

Delays in time to treatment initiation may be associated with demographic and socioeconomic disparities, with care coordination, clinical, and socioeconomic factors representing potential predictors of TTI, according to findings from a retrospective cohort study published in JCO Oncology Practice.

The FDA has granted orphan drug designation to the GSK-3β inhibitor, elraglusib, for the treatment of patients with pancreatic cancer.

An independent data monitoring committee has recommended the continuation of the phase 3 PANOVA-3 trial evaluating tumor treating fields in combination with nab-paclitaxel and gemcitabine for the treatment of patients with unresectable, locally advanced pancreatic cancer.

Treatment with the combination of rivoceranib and camrelizumab led to a statistically significant and clinically meaningful benefit in progression-free survival and overall survival compared with sorafenib in previously untreated patients with unresectable hepatocellular carcinoma.

Sanjay Goel, MD, MS, expands on the findings from the phase 1b/2 trial, noting the potential benefit this approach may have for patients with cholangiocarcinoma, and detailed next steps for investigating tinengotinib.

Mark Lewis, MD, discusses the contested designs of the NorPACT-1 trial and NAPOLI 3 trial; where trastuzumab deruxtecan falls in the HER2-positive metastatic colorectal cancer treatment paradigm; and how the PROSPECT trial results can improve quality of life for patients with rectal cancer.

Sherise Rogers, MD, MPH, discusses the rationale for investigating irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin in the preoperative treatment of patients with pancreatic adenocarcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors have a PD-L1 combined positive score of at least 1.

Eileen M. O’Reilly, MD, expands on the updated survival data from NAPOLI-3, explains how NALIRIFOX could fit into the current pancreatic ductal adenocarcinoma treatment paradigm, and shares potential opportunities to build upon this research moving forward.

Treatment with the combination of ENB-003 and pembrolizumab was well tolerated and produced preliminary signs of clinical activity in patients with platinum-refractory or -resistant, microsatellite stable ovarian cancer, and those with other advanced refractory solid tumors.

Theseus Pharmaceuticals has announced that the development of THE-630 as a potential therapeutic option for patients with gastrointestinal stromal tumor has been terminated, and enrollment to the ongoing phase 1/2 trial evaluating the agent’s safety and efficacy in this population has been discontinued.

The European Medicines Agency has accepted a marketing authorization application seeking the approval of zolbetuximab for first-line treatment of patients with Claudin18.2-positive, HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA has accepted for review a new drug application seeking the approval of rivoceranib in combination with camrelizumab as a first-line treatment option for patients with unresectable hepatocellular carcinoma.

As more is understood about the biology of PDAC tumors, targeting common KRAS variants in these tumors following exhaustion of all curative intent surgery, chemotherapy, and radiation ushers in a novel postadjuvant setting for investigators.

Treatment with trastuzumab deruxtecan resulted in clinically meaningful efficacy in patients with HER2-positive gastric or gastroesophageal junction cancer following disease progression on or after a trastuzumab-containing regimen.