On September 13, 2023 Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported that the clinical trial of oral APL-1202 in combination with PD-1 inhibitor Tislelizumab as neoadjuvant therapy for muscular invasive bladder cancer (MIBC) completed the phase II interim analysis with positive results. Detailed results will be released on academical meeting (Press release, Asieris Pharmaceuticals, SEP 13, 2023, View Source [SID1234635147]).

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The primary objective of 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 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 the 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).

Both the combination group and the Tislelizumab monotherapy group use Simon’s two-stage optimal design. According to the trial design, if at least 5 out of the first 18 evaluable patients in the first stage in the combination therapy group achieve pCR, this group will proceed to the next stage. For the Tislelizumab monotherapy group, if at least 3 out of the first 14 evaluable patients in the first stage achieve pCR, the group will continue to the next stage of evaluation.

According to the trial plan, efficacy interim analyses will be conducted when both groups complete the first stage. Both groups have now met the criteria for the first-stage efficacy set by Simon’s two-stage optimal design, and progressed to the second stage. After reviewing the data of interim analysis, the Safety Monitoring Committee (SMC) determined that the results met the pre-defined criteria.

"This promising outcome demonstrating the potential of APL-1202 in combination with Tislelizumab as neoadjuvant therapy for MIBC." said Dr. Linda Wu, Chief Development Officer of Asieris, "We look forward to the potential of this combination therapy for MIBC patients."

The phase I/II clinical trial obtained permission from the U.S. Food and Drug Administration (FDA) in June 2021 and received approval from the China National Medical Products Administration Center for Drug Evaluation (CDE) for the Investigational New Drug (IND) application by the end of September 2021. The first patient was enrolled in phase I in December of the same year. The trial move to Phase II stage in November 2022 after completing Phase I dose escalation. No dose-limiting toxicities (DLT) was observed in Phase I stage, and a recommended Phase II dose (RP2D) of 1125 mg daily was established.

Furthermore, two pivotal Phase II/III clinical trials of APL-1202 are ongoing, including APL-1202 combination with intravesical chemotherapy for intermediate- and high-risk chemo-relapsed NMIBC patients and APL-1202 monotherapy for naïve intermediate-risk NMIBC patients."