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Arvinas Announces Interim Data from the ARV-766 Phase 1/2 Dose Escalation and Expansion Trial Showing Promising Signals of Efficacy in Late-line mCRPC, Including in Patients with AR L702H Mutations
– 42% of patients with AR ligand binding domain (LBD) mutations achieved PSA50; in patients with AR L702H mutations, 3 of 5 achieved PSA50 – – ARV-766 was
About this update from Arvinas, Inc.
[{"type":"text","content":"– 42% of patients with AR ligand binding domain (LBD) mutations achieved PSA50; in patients with AR L702H mutations, 3 of 5 achieved PSA50 – – ARV-766 was well-tolerated, and activity in a heavily pre-treated patient population supports its potential as a treatment in earlier line settings such as castration-sensitive prostate cancer (CSPC), with planned initiation of a pre-NHA trial in 2H 2023 – NEW HAVEN, Conn., June 08, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced promising interim data from the Company’s Phase 1/2 dose escalation and expansion trial of ARV-766 in men with metastatic castration-resistant prostate cancer (mCRPC). ARV-766 is an investigational orally bioavailable PROTAC® protein degrader designed to degrade all clinically relevant resistance-driving point mutations of the androgen receptor (AR), including L702H, a mutation associated with resistance to abiraterone and other AR-pathway novel hormonal agents (NHA). The company will provide an overview of these data during a fireside chat at the Jefferies Healthcare Conference today, June 8, 2023, at 11 a.m. ET, which will be available to view in the Investors and Media section of the Arvinas website. Data from the Phase 1/2 dose escalation and expansion trial show that ARV-766 was well-tolerated and demonstrated promising activity in a heavily pre-treated, post-NHA, all-comers patient population: 42% of patients with AR ligand binding domain (LBD) mutations achieved PSA50 In all patients with L702H mutations, 3 of 5 achieved PSA50 In patients with co-occurring T878/H875/L702 mutations, 3 of 3 achieved PSA50 RECIST (Response Evaluation Criteria in Solid Tumors) partial responses were observed: Of four RECIST-evaluable patients with AR LBD mutations, one achieved a confirmed partial response, and one achieved an unconfirmed partial response ARV-766 has been well tolerated and the majority of treatment-related adverse events (TRAEs) have been Grade 1 or 2, with no Grade ≥4 TRAEs and no dose limiting toxicitiesLow rates of discontinuation (1 of 47) and dose reductions (2 of 47) “Tumor resistance mechanisms such as AR LBD mutations are increasing with earlier use of NHAs, leaving limited treatment options for men with prostate cancer in...