Gastroenterology Month in Review: July 2024

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The July 2024 gastroenterology month in review highlights FDA news, GI pipeline updates, and a new clinical practice update from the American Gastroenterological Assocation.

HCPLive Gastroenterology Month in Review: July 2024

Coming off of a busy first half of 2024 in the field of gastroenterology, July saw equal excitement and was a promising sign of good things to come in the latter half of the year. From US Food and Drug Administration (FDA) approvals to new clinical trial data and clinical practice updates, July was a busy couple of weeks for the gastroenterology community. This month in review spotlights HCPLive’s coverage of some of the top GI news and research.

GI Pipeline News

Vonoprazan (Voquezna) Receives FDA Approval for Heartburn Associated with Non-Erosive GERD

On July 18, 2024, the US Food and Drug Administration (FDA) approved Phathom Pharmaceuticals’ vonoprazan (Voquezna) as a daily treatment for heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adult patients, less than a year after it earned approval for the healing of and the maintenance of healing of all grades of erosive GERD as well as the relief of heartburn associated with erosive GERD. The decision was supported by positive phase 3 data from the PHALCON-NERD-301 study demonstrating control of heartburn symptoms with vonoprazan 10 mg and 20 mg through the entire 6 months of the study and with a safety profile consistent with prior vonoprazan studies.

“Millions of patients with Non-Erosive GERD continue to suffer from heartburn despite current treatment options,” said Colin W. Howden, MD, professor emeritus at the University of Tennessee College of Medicine. “The pivotal study that led to this approval showed that VOQUEZNA significantly reduced heartburn episodes in patients with Non-Erosive GERD along with an established safety profile. Today’s approval of VOQUEZNA provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients.”

FDA Approves First Blood Test for Primary Colorectal Cancer Screening

In a strong final push to end the month on a high note, the FDA approved Guardant Health’s Shield blood test for CRC screening in adults 45 years of age and older at average risk for the disease, making it the first FDA-approved blood test for primary colorectal cancer screening. The decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024 and is based on results from a registrational study, ECLIPSE, which enrolled more than 20,000 average-risk patients.

“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” Daniel Chung, MD, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a press release. “The FDA's approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”

CVS Clinical Practice Update

Cyclic Vomiting Syndrome Clinical Practice Update Guides Diagnosis, Management

A new American Gastroenterological Association clinical practice update was published on July 16, 2024, in Gastroenterology, providing clinicians with a review of the available evidence and expert advice regarding the diagnosis and management of CVS, a highly prevalent yet poorly recognized condition that is often underdiagnosed and subsequently undertreated.

Mixed Results from Clinical Trials

Mirna Chehade, MD, MPH: “Exciting” Phase 3 Data for Dupilumab in Pediatric Eosinophilic Esophagitis

Phase 3 data from the EoE KIDS trial showed treatment with weight-tiered higher dose dupilumab led to significant and sustained improvements in key histologic, endoscopic, and cellular measures of eosinophilic esophagitis (EoE) in children 1-11 years of age. Results suggest dupilumab’s potential to change the standard of care for young children with EoE, a population for whom there were no US Food and Drug Administration-approved medications prior to dupilumab’s expanded approval for children 1-11 years of age with EoE on January 25, 2024.

In this Q&A with HCPLive, Mirna Chehade, MD, MPH, professor of pediatrics and medicine at the Icahn School of Medicine and founding director of the Mount Sinai Center for Eosinophilic Disorders, offered additional insight into the key findings from EoE KIDS and explained how they inform dupilumab’s use in pediatric patients with EoE.

Risankizumab Induction, Maintenance Therapy Improves Clinical Remission Rates in UC

Findings from a pair of phase 3 randomized clinical trials describe the impact of treatment with risankizumab on rates of clinical remission in patients with moderately to severely active ulcerative colitis (UC), showing improved clinical remission rates with risankizumab compared to placebo. Data from the induction trial, INSPIRE, and the maintenance trial, COMMAND, were the basis for the FDA’s approval of risankizumab for UC on June 18, 2024.

VTX958 Misses Primary Endpoint for CDAI Change in Phase 2 Crohn’s Disease Trial

Contrary to other positive GI clinical trial data published in July, Ventyx Biosciences announced the primary endpoint of a phase 2 trial of VTX958 in patients with moderately to severely active Crohn’s disease (CD) was not met in either dosing group. Although both dose groups achieved nominal statistical significance on the key secondary endpoint of endoscopic response as measured by simple endoscopic score for Crohn’s disease (SES-CD), neither group met the primary endpoint for mean CDAI score change at week 12 due to a higher-than-anticipated placebo response.