Shanghai, China, September 25, 2024 β Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, announced that the phase II clinical trial of oral APL-1202 in combination with the PD-1 inhibitor tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC) has been completed and achieved encouraging efficacy signals.
Primary objective of the Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients with newly diagnosed MIBC for whom radical cystectomy (RC) is planned, and who are cisplatin ineligible or refuse to receive cisplatin based neoadjuvant chemotherapy. The primary efficacy endpoint is pathological complete response rate. Pathological complete response rate (pCR) is defined as the absence of residual tumor lesions in the bladder and lymph node specimens confirmed by histopathological assessment after RC.
Results from the Phase II clinical trial indicate that APL-1202 in combination with tislelizumab shows encouraging efficacy signals with acceptable safety characteristics. In the population diagnosed with MIBC by central pathology at baseline (modified evaluable analysis set, mEAS), the pCR rate was 41% (9/22) for the APL-1202 combined with tislelizumab group and 20% (4/20) for the tislelizumab monotherapy group. Detailed data from this clinical trial will be disclosed at upcoming academic conferences.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, stated, βThese findings strongly support the company’s further development of APL-1202 in combination with immune checkpoint inhibitors in the field of bladder cancer. The company is actively preparing for discussions with regulatory authorities both domestically and internationally to advance the late-stage clinical development of this therapy.β
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patientβs dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
