Shanghai, China, February 14, 2025 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a leading global biopharmaceutical company dedicated to advancing innovative therapies for genitourinary tumors and women’s health with significant unmet medical needs, announced the release of Phase II clinical study results of APL-1202 in combination with PD-1 inhibitor tislelizumab as neoadjuvant therapy for muscle-invasive bladder cancer（MIBC） at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in the form of a poster presentation (Abstract No. 793).
The primary objective of the Phase II clinical study is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to the tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The study 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 metastasis, as confirmed by histopathological assessment of bladder and lymph node specimens after RC.
The results of this Phase II clinical study demonstrate that the combination therapy group of APL-1202 and tislelizumab (combination group) showed positive efficacy signals compared to the tislelizumab monotherapy group (monotherapy group): in the ‘protocol eligible’ subset, the pCR rates were 41% and 20% for the combination group and monotherapy group, respectively. Particularly in the PD-L1 low-expression tumors, the combination group exhibited stronger positive efficacy signals compared to the monotherapy group. Additionally, the combination therapy was safe: treatment related adverse events (TRAEs) were 59% in the combination group and 44% in the monotherapy group, respectively, with 94% of TRAEs predominantly ≤ CTCAE Grade 2 in severity.
“These findings strongly support the company’s further development of APL-1202 in combination with immune checkpoint inhibitors in the field of bladder cancer,” stated Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals. “The company is actively preparing the global clinical development plan for this therapy and seeking collaboration with partners to advance its development worldwide.”
APL-1202 is currently undergoing a Phase III clinical study as a monotherapy for untreated intermediate-risk non-muscle invasive bladder cancer (NMIBC), alongside a Phase II study evaluating its efficacy in the treatment of free-living amoebae (FLA) infections.
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 patient’s 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.
