Business
Arvinas Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
– Initiated multiple trials with ARV-471, including a 2L+ Phase 3 trial for patients with metastatic breast cancer – – Presented Phase 2 monotherapy expansion
About this update from Arvinas, Inc.
[{"type":"text","content":"– Initiated multiple trials with ARV-471, including a 2L+ Phase 3 trial for patients with metastatic breast cancer – – Presented Phase 2 monotherapy expansion data from the VERITAC trial for the treatment of patients with metastatic or locally advanced ER+/HER2- breast cancer in a late-line setting – – Gained alignment with FDA on an approach to the planned 1L Phase 3 trial with ARV-471 in combination with palbociclib to enable trial initiation in 2H 2023 – NEW HAVEN, Conn., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update. “2022 was an exciting year for Arvinas as we transitioned into a late-stage development organization and laid the foundation for an important year of data readouts and trial initiations in 2023,” said John Houston, Ph.D., president and chief executive officer at Arvinas. “Notably, the initiation of our Phase 3 monotherapy trial with ARV-471 in ER+/HER2- metastatic breast cancer marks our first registrational study and if successful, will lead to our first commercial product bringing an important new treatment option to patients. We are on-track to initiate our second and third Phase 3 trials – one in the first line setting with ARV-471 and one with bavdegalutamide in metastatic castrate resistant prostate cancer – in the second half of this year, further validating our novel PROTAC® discovery engine platform.” Recent Developments and 4Q Business Highlights Gained alignment with FDA on an approach to the planned 1L Phase 3 trial with ARV-471 in combination with palbociclib to enable trial initiation in 2H 2023 The approach includes a Phase 3 lead-in to evaluate the optimal dose of palbociclib (100 mg or 75 mg) in combination with 200 mg ARV-471The approach follows the recent analysis of data from the ongoing Phase 1b combination study of ARV-471 with palbociclib, in which an increase in palbociclib exposure was observed relative to historical palbociclib pharmacokinetic data Initiated the VERITAC-2 Phase 3 2L+ clinical trial of ARV-471 as a monotherapy for the treatment of patients with ER+/HER2- metastatic breast cancerPresented results from the Phase 2 cohort expa...