Acrivon Therapeutics Reports 44% Response Rate for CHK1/2 Inhibitor ACR-368 in Endometrial Cancer Phase II Trial
核心洞察
Acrivon Therapeutics' CHK1 (搜索)/2 inhibitor ACR-368 demonstrated a 44% overall response rate in biomarker-positive endometrial cancer (搜索) patients, with 52% response in the serous subtype during phase II-B registration-intent trials.
The company's OncoSignature assay enables prospective responder prediction, identifying serous endometrial cancer (搜索) as highly sensitive to ACR-368 and driving rapid enrollment in new trial arms.
Disease control rate in serous endometrial cancer (搜索) approaches 75% with a clinical benefit rate of 65% at or above 16 weeks, significantly exceeding the 13% response rate of standard second-line care.
Acrivon Therapeutics has reported promising efficacy data for its lead asset ACR-368, a CHK1 (搜索)/2 inhibitor currently in phase II-B registration-intent trials for endometrial cancer (搜索). The compound demonstrated a 44% overall response rate in biomarker-positive patients and achieved a 52% response rate specifically in the serous subtype among patients with up to two prior lines of therapy.
Strong Clinical Activity in High-Risk Serous Subtype
The most compelling results emerged in serous endometrial cancer (搜索), where ACR-368 showed a disease control rate approaching 75% and a clinical benefit rate of 65% at or above 16 weeks. These outcomes represent a substantial improvement over standard of care, which yields only a 13% response rate and 10 months overall survival in second-line serous endometrial cancer.
Serous endometrial cancer (搜索), while representing only 8-10% of new endometrial cancer (搜索) cases, accounts for up to 50% of endometrial cancer mortality, highlighting a significant unmet medical need and addressable market opportunity.
Biomarker-Driven Patient Selection
Acrivon's OncoSignature assay enables prospective responder prediction, identifying serous endometrial cancer (搜索) as highly sensitive to ACR-368. This biomarker approach has led to rapid enrollment in new trial arms, driven by high key opinion leader enthusiasm and the urgent need for effective therapies in this patient population.
The rapid enrollment in serous cohorts reflects both the clinical urgency and the promising early signals from the compound.
Regulatory Path Forward
An interim analysis for arms three and four is planned for early Q4, with independent analysis designed to select the optimal arm for registrational advancement. The company has designed a confirmatory phase III trial as switch maintenance therapy, combining ACR-368 with immune checkpoint inhibitors and targeting both serous and pMMR all-comers populations.
The interim analysis may trigger initiation of the phase III trial and potential partnership discussions by year-end. Trial expansion into Europe is accelerating enrollment and broadening patient access.
Broader Pipeline Development
Beyond ACR-368, Acrivon is advancing ACR-2316, a dual WEE1 (搜索)/PKMYT1 (搜索) inhibitor entering expansion phase after demonstrating single-agent activity and favorable safety, particularly in lung cancer (搜索). The company's AP3 platform predicted and confirmed lung cancer sensitivity to ACR-2316, with durable responses and minimal adverse events, mainly transient neutropenia.
Both ACR-368 and ACR-2316 exhibit strong synergy with immune checkpoint and topoisomerase inhibitors, supporting future combination strategies. The company also has a CDK11 (搜索) inhibitor program (ACR-6840 (搜索)) showing complete regression in aggressive AML (搜索) models, with an IND planned for the first half of 2027.