Genome & Company announced that this phase II trial (NCT05419362) will continue without modifications to move on to the second stage, based on the positive result of the interim analysis. Using a single-strain bacteria in combination with avelumab (Bavencio®?) from Merck KGaA, Darmstadt, Germany and Pfizer Inc., it is the first time to show positive antitumor activity per ORR in Phase II trial. On the basis of these results and in accordance with the predetermined hypothesis of the interim analysis, Genome & Company highly expect that the evidence for treatment with GEN-001 plus avelumab as a 3rd line of therapy for GC/GEJ will be strongly established.

This is a Phase II study to evaluate the safety and efficacy of GEN-001 plus Avelumab as a =3rd line treatment for PD-L1 positive GC/GEJ patients regardless of prior immune-oncology treatment. Following enrollment of the 21st patient, a pre-planned interim analysis was conducted and results were reviewed by an independent data monitoring committee. As the observed ORR met the pre-determined criteria together with no safety concerns, the IDMC recommended to continue with the second stage without modifications and enroll additional 21 patients.

The detailed results will be presented at an Oncology conference in the second half of 2023. The top-line data of the final analysis from Phase II are expected in the second half of next year.