Genome&Company's 'GEN-001' Combination Phase 2 Clinical Trial, IDMC Recommends "Continuation of Trial"

Genome & Company, a specialized company in microbiome therapeutics, announced on the 18th that it has successfully achieved the interim analysis goal of the Phase 2 clinical trial for gastric cancer of ‘GEN-001,’ an immune-oncology microbiome therapeutic under development, and has decided to proceed with the second phase of the trial.

Genome&Company CI [Photo by Genome&Company]

This Phase 2 clinical trial is being conducted in combination with Merck and Pfizer’s immune-oncology drug Bavencio (generic name: avelumab). It targets 42 patients with programmed cell death protein (PD)-L1 positive advanced gastric cancer or gastroesophageal junction adenocarcinoma who have failed two or more prior standard treatments, regardless of previous immune-oncology drug administration. The trial is designed as an adaptive clinical trial, where interim data is analyzed after the first phase involving 21 patients to decide whether to proceed to the second phase.

The independent data monitoring committee (IDMC)’s interim data analysis was conducted by comparing it with the existing monotherapy clinical data that led to Bavencio’s approval for gastric cancer indications. As a result, the IDMC recommended continuing the trial according to the original clinical trial protocol.

The company expects that since the interim analysis showed an objective response rate (ORR) exceeding the target, the final analysis data will also be secured smoothly. Detailed data from the interim results of the Phase 2 clinical trial will be presented at an international conference scheduled for the second half of this year. The top-line data from the Phase 2 clinical trial is expected to be available around the second half of next year. Through this, if the trial is successful, the combination therapy of Bavencio and GEN-001 is anticipated to establish itself as a new third-line standard treatment for gastric cancer.

Professor Ji-Yeon Lee, head researcher of this combination clinical trial and a hematology-oncology specialist at Samsung Seoul Hospital, stated, “It is very important to develop new treatment options for gastric cancer patients who have failed two or more prior standard treatments. The interim analysis results of this Phase 2 trial are quite promising, raising high expectations for the final analysis, and we will continue to cooperate to ensure the clinical trial proceeds smoothly.”

Jisoo Bae, CEO of Genome & Company, also said, “The IDMC’s recommendation to continue the trial means that the interim clinical results have met the targeted goals,” adding, “We plan to secure the Phase 2 clinical data of ‘GEN-001’ for gastric cancer next year and discuss technology transfer with partners or global big pharma.”