First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results

Autor: Rahul Raj Aggarwal, Jingsong Zhang, Xinhua Zhu, Paul Monk, Robert J. Jones, Mark David Linch, Dan Costin, Johann S. De Bono, Lawrence Ivan Karsh, Daniel P. Petrylak, Pascal Borderies, Rashmi Majali Deshpande, Amir Hafeez, Vincent J. O'Neill, Scott T. Tagawa
Rok vydání: 2023
Předmět:
Zdroj: Journal of Clinical Oncology. 41:176-176
ISSN: 1527-7755
0732-183X
0391-0660
DOI: 10.1200/jco.2023.41.6_suppl.176
Popis: 176 Background: BXCL701 (talabostat), oral small molecule inhibitor of dipeptidyl peptidases (DPP)—primarily DPP8/9 & DPP4—triggers inflammasome to alert and prime immune cells, leading to induction of IL-18 & IL-1ß, bridging innate & adaptive immunity. BXCL701 is evaluated in a Phase 2 study in combination with pembrolizumab, in mCRPC patients with SCNC phenotype. SCNC is highly proliferative and aggressive with limited duration of response to platinum-based chemotherapy. Here are reported the results of the Phase 2a after enrollment of 32 patients for the SCNC cohort. The final results will be presented at the Symposium. Methods: Phase 2a patients with any SCNC histopathological features, either de novo or treatment-emergent including mixed SCNC, required to have progression by PCWG3 on ≥1 prior line of cytotoxic chemotherapy (patients who either have refused chemotherapy or are considered unsuitable for chemotherapy also permitted entry with prior approval by sponsor). Patients receive pembrolizumab (200 mg IV q3week) + BXCL701 0.2 mg BID on days 1-7 with step-up to 0.3 mg BID on days 8-14, and 0.3 mg BID on days 1-14 of subsequent cycles. Primary endpoint is Composite Response, either objective response by RECIST 1.1 or PSA50 or CTC count conversion from ≥5/7.5 mL to
Databáze: OpenAIRE
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