Prelude Therapeutics Presents Preliminary Results of Phase 1 Dose-escalation Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib in Patients with Relapsed/Refractory Lymphoid Malignancies

Core Insights - Prelude Therapeutics announced interim clinical data for PRT2527, a selective CDK9 inhibitor, showing activity in relapsed/refractory lymphoid malignancies, including patients previously treated with CAR-T therapy [1][3] - The company plans to seek a partner for the future development of PRT2527 in hematologic malignancies [1] Clinical Trial Overview - The ongoing open-label, dose-escalation trial involved 46 patients treated and safety evaluable as of September 17, 2024 [2][5] - PRT2527 was well-tolerated across four dosing cohorts for monotherapy and three for combination therapy with zanubrutinib, demonstrating an acceptable safety profile [2][4] Efficacy Results - The overall response rate (ORR) for PRT2527 monotherapy was 17.4%, with complete responses (CRs) in 1 patient and partial responses (PRs) in 3 patients [9] - In the combination cohort, the ORR was 38.5%, with CRs in 3 patients and PRs in 2 patients [10] Safety Profile - The most common treatment-emergent adverse events (TEAEs) included neutropenia (48%) and nausea (33%), with grade ≥3 TEAEs being neutropenia (46%) and anemia (11%) [6] - Dose interruptions due to TEAEs occurred in 17 patients, primarily due to neutropenia, which was managed with growth factor support [7] Future Development Plans - The company intends to focus resources on advancing its SMARCA degrader programs while seeking a partner for the CDK9 program beyond the current Phase 1 study [12] - Prelude Therapeutics is recognized for developing innovative medicines in oncology, with a pipeline that includes novel drug candidates and targeted protein degradation technologies [13]