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TOKYO, May 22, 2025 ~ PRISM BioLab, Co. Ltd., a leading biotechnology company specializing in small molecule inhibitors of protein-protein interaction (PPI) targets, has announced that the results of a combination study involving their drug E7386 and Lenvatinib mesylate will be presented at the American Society of Clinical Oncology (ASCO) Congress in 2025. The study was conducted in collaboration with Eisai Co., Ltd.
The open-label Phase Ib study, known as NCT04008797, aimed to determine the optimal dose of E7386 when combined with Lenvatinib in patients with advanced endometrial cancer who had previously progressed after receiving platinum-based chemotherapy and anti-PD-(L)1 immunotherapy. The study enrolled 30 patients and was completed by October 2024, with nine patients still on treatment.
The data collected by the cutoff date of October 22, 2024 showed that 30% of patients (nine out of 30) had a confirmed response to the treatment, defined as a decrease in tumor size greater than 30%. This resulted in an overall response rate of 30.0%. Notably, among patients who had not received prior treatment with Lenvatinib, the overall response rate was even higher at 42.9%.
Based on these promising results, Eisai has initiated enrollment for the subsequent dose-optimization part of the study for E7386 + LEN in advanced endometrial cancer. The company plans to enroll more patients to further evaluate the efficacy and safety profile of this combination therapy.
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E7386 is an orally available small molecule inhibitor that targets CBP/β-catenin interactions and regulates Wnt signaling. It achieved clinical proof-of-concept (POC) in October 2021 and is currently being studied in various clinical trials for different types of solid tumors both as monotherapy and in combination with other drugs.
Lenvatinib, on the other hand, is a multi-kinase inhibitor that was discovered by Eisai and is being co-developed and co-commercialized with Merck & Co., Inc. It targets various receptors involved in tumor growth, including VEGFRs, FGFRs, PDGFR-alpha, KIT, and RET. Lenvatinib has already been approved for the treatment of thyroid cancer, hepatocellular carcinoma, thymic cancer, renal cell carcinoma (in combination with Everolimus or pembrolizumab), and endometrial cancer (in combination with pembrolizumab).
The ongoing Phase Ib study (NCT04008797) is being conducted in Japan, Korea, Taiwan region, US, and France to evaluate the safety and recommended phase 2 dose (RP2D) of E7386 + Lenvatinib in patients with solid tumors. The study also aims to assess the pharmacokinetics and efficacy of this combination therapy.
The results of this study are highly anticipated as they could potentially provide a new treatment option for patients with advanced endometrial cancer. PRISM BioLab and Eisai are committed to furthering their research and development efforts to bring innovative therapies to patients in need.
The open-label Phase Ib study, known as NCT04008797, aimed to determine the optimal dose of E7386 when combined with Lenvatinib in patients with advanced endometrial cancer who had previously progressed after receiving platinum-based chemotherapy and anti-PD-(L)1 immunotherapy. The study enrolled 30 patients and was completed by October 2024, with nine patients still on treatment.
The data collected by the cutoff date of October 22, 2024 showed that 30% of patients (nine out of 30) had a confirmed response to the treatment, defined as a decrease in tumor size greater than 30%. This resulted in an overall response rate of 30.0%. Notably, among patients who had not received prior treatment with Lenvatinib, the overall response rate was even higher at 42.9%.
Based on these promising results, Eisai has initiated enrollment for the subsequent dose-optimization part of the study for E7386 + LEN in advanced endometrial cancer. The company plans to enroll more patients to further evaluate the efficacy and safety profile of this combination therapy.
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E7386 is an orally available small molecule inhibitor that targets CBP/β-catenin interactions and regulates Wnt signaling. It achieved clinical proof-of-concept (POC) in October 2021 and is currently being studied in various clinical trials for different types of solid tumors both as monotherapy and in combination with other drugs.
Lenvatinib, on the other hand, is a multi-kinase inhibitor that was discovered by Eisai and is being co-developed and co-commercialized with Merck & Co., Inc. It targets various receptors involved in tumor growth, including VEGFRs, FGFRs, PDGFR-alpha, KIT, and RET. Lenvatinib has already been approved for the treatment of thyroid cancer, hepatocellular carcinoma, thymic cancer, renal cell carcinoma (in combination with Everolimus or pembrolizumab), and endometrial cancer (in combination with pembrolizumab).
The ongoing Phase Ib study (NCT04008797) is being conducted in Japan, Korea, Taiwan region, US, and France to evaluate the safety and recommended phase 2 dose (RP2D) of E7386 + Lenvatinib in patients with solid tumors. The study also aims to assess the pharmacokinetics and efficacy of this combination therapy.
The results of this study are highly anticipated as they could potentially provide a new treatment option for patients with advanced endometrial cancer. PRISM BioLab and Eisai are committed to furthering their research and development efforts to bring innovative therapies to patients in need.
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