On May 31, 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 the phase I clinical data of ANTICIPATE Study was published for the first time at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago (e16607) (Press release, Asieris Pharmaceuticals, MAY 31, 2023, View Source [SID1234632309]). This is a study of taking oral APL-1202 in combination with BeiGene’s tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC).
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A total of 9 subjects were enrolled In the Phase I stage of the trial, and the clinical data showed oral APL-1202 in combination with tislelizumab was well tolerated. No dose-limiting toxicities were observed at either 375 mg, 750 mg, or 1125 mg daily dose of APL-1202 and the recommended phase II dose (RP2D) was identified as 1125 mg daily dose. Treatment-related adverse events (TRAE) were observed in 6 patients. All AEs were grade 1, except 1 case of CTCAE grade 2 T wave abnormality on ECG and 1 case of CTCAE grade 3 liver dysfunctions. No grade 4 or 5 related AEs were observed. None of these events resulted in treatment interruptions, dose reductions, or delays in radical cystectomy. Preliminary efficacy signals were observed and pathological downstaging to
The clinical trial of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in MIBC has completed the Phase I dose-escalation stage and entered into Phase II stage in November 2022. The trial is actively recruiting for Phase II with the first patient enrolled in December 2022. In addition, APL-1202 is currently undergoing two pivotal Phase II/III clinical trials：APL-1202 in combination with intravesical chemotherapy in chemo-relapsed intermediate-to-high risk non-muscle-invasive bladder cancer (NMIBC), and APL-1202 monotherapy for untreated intermediate-risk NMIBC.
"ASCO Annual Meeting is the largest international conference in the field of cancer treatment globally." said Dr. Linda Wu, Chief Development Officer of Asieris, "Bladder cancer is one of the focused areas of Asieris Pharmaceuticals. The successful selection of our clinical research demonstrates our research and development capabilities in this focused area and showcases the growing influence of China in the international oncology community. In the future, Asieris will continue to prioritize patient-centered innovation and research, strive to develop more new drugs and bring greater benefits to patients in China and around the world."