Shanghai, China – January 28,2024- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the first-time release of interim analysis data for 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). Release of the interim analysis data was made in the form of a rapid oral presentation abstract (Abstract No:632）at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). Patient enrollment of the trial was recently completed.

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 (pCR) rate. pCR is defined as the absence of residual tumor lesions in the bladder and lymph node specimens confirmed by histopathological assessment after RC (pT0N0).

The interim analysis results of the Phase II clinical trial showed that in the APL-1202 and tislelizumab combination treatment group, out of 18 subjects evaluated, 7 achieved pCR, accounting for 7/18 (39%). In the tislelizumab monotherapy group, out of 14 subjects evaluated, 3 achieved pCR, accounting for 3/14 (21%). Additionally, among 6 participants in the combination treatment group with clinical stage T3N0M0, 2 achieved pCR, accounting for 2/6 (33%). No pCR was observed in the tislelizumab monotherapy group among participants with clinical stage T3N0M0. The interim analysis results showed that both groups met the efficacy requirements of the Simon’s two-stage trial design for the first stage, and further evaluation will be conducted in the next stage, with a particular focus on confirming the favorable efficacy signals demonstrated by the combination treatment group. In terms of safety, the combination treatment group exhibited acceptable safety characteristics.

The recommended standard of care for MIBC is radical cystectomy (RC) with bilateral pelvic lymph node dissection, preceded by the administration of neoadjuvant chemotherapy (NAC) in patients who are eligible to receive cisplatin1. However, approximately 50% of the patients are cisplatin-ineligible because of pre-existing contraindications, and some refuse to receive any chemotherapy2,3. Currently, there are still many challenges that need to be addressed in the treatment of MIBC.

Dr. Linda Wu, Chief Development Officer of Asieris, said,”Bladder cancer is the tenth most common cancer globally, with approximately 573,000 new cases and 213,000 deaths reported each year. Muscle-invasive bladder cancer (MIBC) accounts for approximately 20% of newly diagnosed cases. The interim analysis of clinical data demonstrates that the combination of APL-1202 and the PD-1 inhibitor tislelizumab has promising therapeutic potential in neoadjuvant treatment for MIBC. This further strengthens our confidence in its safety and efficacy. This combination treatment regimen holds the potential to provide an effective treatment option for MIBC patients who are intolerant to or refuse platinum-based therapy.”

APL-1202 is currently conducting two concurrent phase III/pivotal clinical trials. A pivotal Phase II trial studying the use of APL-1202 in combination with intravesical chemotherapy for the treatment of intermediate and high-risk non-muscle invasive bladder cancer (NMIBC) patients who have relapsed from chemotherapy; and a phase III clinical trial investigating the use of APL-1202 as a monotherapy in treatment naive patients with intermediate-risk NMIBC.

https://asieris.com/asieris-presents-for-the-first-time-interim-analysis-data-of-oral-apl-1202-in-combination-with-pd-1-inhibitor-tislelizumab-for-neoadjuvant-treatment-of-muscle-invasive-bladder-cancer-at-2024-asco-gu/