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SEOUL, South Korea, Jan. 24, 2024 /PRNewswire/ -- Genome & Company (KOSDAQ: 314130), a clinical stage biotech leading in microbiome therapeutic development announced on January 18th (local time) that a poster was presented on the positive topline results from the phase 2 clinical trial (NCT05419362) in gastric cancer of its microbiome immunotherapy, GEN-001 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2024).
GEN-001 is an oral therapeutic candidate consisting of a single strain of Lactococcus lactis, and the phase 2 clinical trial for gastric cancer was conducted in combination with avelumab (Bavencio®) developed and commercialized by Merck KGaA, Darmstadt, Germany.
The clinical trial is being conducted at 6 domestic institutions in South Korea on 42 patients with PD-L1-positive advanced gastric cancer or gastroesophageal junction adenoma cancer who has failed second-line or later standard of care treatment regardless of prior immunotherapy. The positive headline results of the interim analysis of the Phase 2 clinical trial were made public in May of last year, and detailed topline results of the Phase 2 clinical trial conducted to date were disclosed for the first time at this ASCO GI 2024.
As a result of the efficacy evaluation of 42 patients participating in the phase 2 clinical trial, partial responses (PRs) were observed in 7 out of 42 patients. Furthermore, 3 out of 8 patients among 42 patients who were previously treated by immunotherapy experienced PRs (overall response rate, ORR 37.5%).
In addition, the topline results revealed the median progression free survival (PFS) at 1.7 months and the median overall survival (OS) at 7.9 months.
Under the current frontline immunotherapy landscape in gastric cancer, GEN-001 and Bavencio® combination may become an attractive therapeutic option in the salvage setting of gastric cancer. Treatment-related adverse events (TRAEs) were observed in 14 patients out of 42 patients, and only 2 patients experienced grade 3 TRAEs including anemia, fatigue, and pneumonitis. Overall, this combination showed manageable safety and tolerability.
Prof. Jeeyun Lee (M.D.) from the Department of Hemato Oncology at Samsung Medical Center, the coordinating investigator of the study stated, "while there are limited treatment options available for patients with metastatic gastric cancer, combination of GEN-001 and avelumab demonstrated favorable therapeutic effects leading to an extended survival. The overall response rate (ORR) of 37.5% is particularly promising among PD-L1-positive refractory patients to prior immunotherapy. We intend to further validate these results in subsequent clinical studies to establish this treatment regimen as a viable third-line treatment." Expressing enthusiasm, she added, "we are excited that this marks the first clinical study to showcase the potential of microbiome therapeutics in the treatment of gastric cancer."
Dr. Jisoo Pae, CEO of Genome & Company, said, "we are incredibly pleased by our presentation at ASCO GI 2024 on the topline data of the phase 2 clinical trial for gastric cancer with our microbiome immuno-oncology treatment, GEN-001. Based on the results, we can confirm not only the results of exceeding the primary endpoints, but also compelling clinical benefits compared to the previously published Bavencio® monotherapy data". He continued, "we plan to establish a future development strategy from obtaining further data in response duration, biomarker analysis, and overall survival."
Meanwhile, in addition to the ongoing clinical trials in combination with Bavencio®, GEN-001 is currently in another phase 2 combination clinical trial for biliary tract cancer with pembrolizumab (Keytruda®), a cancer immunotherapy drug from MSD (a tradename of Merck & Co., Inc., Kenilworth, N.J., USA). Through combination therapy clinical trials with anti-PD-1 and PD-L1 immunotherapy drugs, Genome & Company aims to develop treatments in overcoming the resistance to immunotherapy.