WILMINGTON, DE — Prelude Therapeutics Incorporated this week unveiled interim results from its Phase 1 trial of PRT3789, a pioneering therapy designed to target cancers with a SMARCA4 mutation. The data, shared at the European Society for Medical Oncology Congress in Barcelona, points to promising outcomes for patients with this aggressive cancer type.
PRT3789 is a first-in-class degrader, selectively targeting SMARCA2, and aims to offer new hope to individuals whose cancers are driven by SMARCA4 mutations. As of early August 2024, 65 patients with advanced cancers have been treated in the study, with 46 being evaluated for efficacy. Among these, 26 patients with non-small cell lung cancer (NSCLC) or esophageal cancer showed notable results, including tumor shrinkage in seven individuals and confirmed partial responses in three patients.
Dr. Robin Guo from Memorial Sloan Kettering Cancer Center remarked on the significance of these findings. “The observation of durable stable disease and tumor regressions in Phase I monotherapy dose escalation, coupled with a tolerable emerging safety profile, is encouraging,” Dr. Guo noted. This highlights the potential of PRT3789 as a therapy for patients with high unmet needs due to the aggressive nature of SMARCA4-mutated cancers.
The trial continues to explore optimal dosing, now in its ninth cohort, without reaching a maximum tolerated dose. Most adverse effects have been mild or moderate, with no serious side effects directly linked to the drug. The absence of dose-limiting toxicities bolsters confidence in the drug’s safety.
Prelude’s President and Chief Medical Officer, Dr. Jane Huang, expressed optimism about the early results, stating, “We are encouraged by the early clinical activity and emerging safety profile observed to date with PRT3789.” The trial aims to determine an effective monotherapy dose by year-end, with ongoing studies also exploring combination therapies with docetaxel.
PRT3789’s precision in targeting SMARCA2 over SMARCA4 is underscored by pharmacodynamic data, showing a dose-dependent degradation of SMARCA2. This selectivity is crucial in minimizing off-target effects and optimizing therapeutic outcomes.
As research progresses, Prelude Therapeutics is poised to advance PRT3789 as a promising new treatment option, potentially transforming outcomes for patients affected by hard-to-treat cancers. Health professionals eagerly anticipate further developments as this innovative therapy continues to undergo rigorous clinical evaluation.
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