Shanghai, China – January 28, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a leader in the global biopharmaceutical industry specializing in the discovery, development, and commercialization of novel drugs for genitourinary tumors and related diseases, proudly announced the release of interim analysis data from the Phase II clinical trial of APL-1202 in combination with the PD-1 inhibitor tislelizumab. This trial focuses on the neoadjuvant treatment of muscle-invasive bladder cancer (MIBC). The announcement, featuring an oral presentation abstract (Abstract No: 632), was made at the prestigious 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The trial recently completed patient enrollment.
The primary aim of this Phase II trial is to assess the safety and efficacy of APL-1202 in combination with tislelizumab, compared to tislelizumab monotherapy, as a neoadjuvant therapy for MIBC patients. Participants include newly diagnosed MIBC patients who are planned for radical cystectomy (RC) but are either ineligible for cisplatin or choose not to receive cisplatin-based neoadjuvant chemotherapy. The primary measure of efficacy is the pathological complete response (pCR) rate, defined as the absence of residual tumor lesions in bladder and lymph node specimens, as confirmed by histopathological assessment after RC (pT0N0).
The interim analysis of the Phase II clinical trial revealed that in the group receiving the combination treatment of APL-1202 and tislelizumab, 7 out of 18 subjects (39%) achieved pCR. In comparison, the tislelizumab monotherapy group saw a pCR in 3 out of 14 subjects (21%). Notably, among 6 participants with clinical stage T3N0M0 in the combination treatment group, 2 achieved pCR, representing 33%. In the same stage group, no pCR was observed among participants in the tislelizumab monotherapy group. These interim results indicate that both treatment groups met the efficacy benchmarks set by the Simon’s two-stage trial design for the initial stage. Further evaluations are planned for the subsequent stage, focusing particularly on confirming the positive efficacy signals observed in the combination treatment group. In terms of safety, the combination treatment displayed acceptable safety characteristics.
The current standard of care for MIBC involves radical cystectomy (RC) with bilateral pelvic lymph node dissection, usually preceded by neoadjuvant chemotherapy (NAC) in patients eligible for cisplatin. However, approximately 50% of patients are ineligible for cisplatin due to pre-existing contraindications, and some opt out of chemotherapy. This underscores the ongoing challenges in MIBC treatment.
Dr. Linda Wu, Chief Development Officer at Asieris, commented, “Bladder cancer ranks as the tenth most common cancer worldwide, with around 573,000 new cases and 213,000 deaths annually. MIBC accounts for roughly 20% of these new diagnoses. The interim analysis of our clinical data shows that the combination of APL-1202 and tislelizumab holds significant promise as a neoadjuvant treatment for MIBC. This strengthens our confidence in its safety and efficacy, presenting a potential new treatment option for MIBC patients who cannot tolerate or refuse platinum-based therapy.”
APL-1202 is currently involved in two key phase III/pivotal clinical trials. One pivotal Phase II trial is examining APL-1202 in combination with intravesical chemotherapy for treating intermediate and high-risk non-muscle invasive bladder cancer (NMIBC) patients who have relapsed from chemotherapy. Additionally, a phase III clinical trial is investigating APL-1202 as a monotherapy in treatment-naive patients with intermediate-risk NMIBC.
References：
- Alfred Witjes J,et al. Eur Urol 2017; 71: 462-75.
- Galsky MD, et al. J Clin Oncol 2011; 29: 2432-8.
- Burger M, et al.Eur Urol 2012; 61: 1070-1.
About Asieris
Founded in March 2010, Asieris Pharmaceuticals (Stock Code: 688176.SH) is a global biopharmaceutical company committed to the discovery, development, and commercialization of innovative drugs for the treatment of genitourinary tumors and related diseases. Our mission is to enhance human health and uphold patient dignity. We aspire to be a global pharmaceutical leader, integrating research and development (R&D), manufacturing, and commercialization to deliver top-tier, integrated diagnostic and treatment solutions for patients both in China and around the world.
Asieris has been advancing its proprietary R&D platform and core technologies, pioneering new mechanisms of action, and conducting efficient screening and evaluation of drug candidates. With a robust in-house R&D system and a wealth of expertise in global drug development, we are dedicated to introducing first-in-class drugs and innovative products, addressing significant unmet medical needs in our areas of specialization.
In our pursuit of excellence in treating genitourinary diseases, Asieris actively enhances its pipeline through proprietary R&D endeavors and strategic partnerships. We remain at the forefront of emerging technologies and therapeutic advances. Our approach is both proactive and forward-thinking, focusing on identifying and addressing unmet clinical needs. We aim to develop an exceptional portfolio encompassing both diagnosis and treatment, striving to improve the lives of more patients in China and across the globe.