Potential of Arvinas’ PROTAC AR Degraders Reinforced by 11.1 months rPFS with Bavdegalutamide and Updated Positive Interim Data from Second Generation ARV-766 in mCRPC

– Data presented at the European Society for Medical Oncology from the Phase 1/2 trial with bavdegalutamide showed 11.1 months radiographic progression free survival in mCRPC patients with tumors harboring AR 878/875 mutations –

– Interim data from the Phase 1/2 trial of Arvinas’ second PROTAC AR degrader, ARV-766, showed robust efficacy in a broader mCRPC patient population with a tolerability profile well-suited to both early- and late-line settings –

– Company to prioritize the initiation of a Phase 3 trial with ARV-766 in mCRPC –

– Arvinas will host conference call to discuss results on Sunday, October 22 at 3:00 p.m. CEST / 9:00 a.m. ET –

NEW HAVEN, Conn., Oct. 22, 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 the presentation of interim data from the Company’s Phase 1/2 clinical trial for bavdegalutamide (ARV-110), a novel PROTAC protein degrader targeting the androgen receptor (AR), in a poster session at the European Society for Medical Oncology Congress being held in Madrid from October 20 – 24, 2023. The Company will host a conference call to discuss these data and present new data from an updated analysis of its ongoing Phase 1/2 clinical trial with its second-generation PROTAC AR degrader, ARV-766, showing clinical activity extending across patients harboring tumors with AR LBD mutations and a tolerability profile that is superior to bavdegalutamide.

Extended follow-up of data from the Phase 1/2 clinical trial with bavdegalutamide showed radiographic progression free survival (rPFS) of 11.1 months in a subgroup of patients with metastatic castration-resistant prostate cancer (mCRPC) and tumors harboring AR T878X/H878Y mutations (AR 878/875; T878X=T878A or T878S) in the absence of co-occurring AR L702H mutations. AR L702H is a common AR ligand-binding domain (LBD) mutation that is not potently degraded by bavdegalutamide. In patients with tumors harboring any AR LBD mutation except L702H alone, bavdegalutamide showed an rPFS of 8.2 months.

"We are incredibly pleased with the results from bavdegalutamide’s Phase 1/2 trial as they demonstrate the promise of our AR PROTAC degraders to help patients with prostate cancer,” said John Houston, Ph.D., chairperson, chief executive officer, and president of Arvinas. “While bavdegalutamide’s efficacy is very exciting, its breadth of activity could be limited to a small patient population in a late-line setting. Our second generation PROTAC AR degrader, ARV-766, has demonstrated a broader efficacy profile and even better tolerability compared to bavdegalutamide in clinical settings. Arvinas is committed to bringing forward the best PROTAC AR degrader for patients with prostate cancer. We believe ARV-766 has the potential to be a first- and best- in-class treatment for patients with castrate-sensitive and castrate-resistant prostate cancer, and we are prioritizing the initiation of a Phase 3 clinical trial in mCRPC with ARV-766.”