Business
Arvinas Reports First Quarter 2023 Financial Results and Provides Corporate Update
–Multiple vepdegestrant (ARV-471) studies enrolling globally, including Phase 1, 2, and 3 studies– – Preliminary data from the Phase 1b combination trial of
About this update from Arvinas, Inc.
[{"type":"text","content":"–Multiple vepdegestrant (ARV-471) studies enrolling globally, including Phase 1, 2, and 3 studies– – Preliminary data from the Phase 1b combination trial of vepdegestrant + palbociclib suggests potential clinical benefit in a heavily pretreated patient population – NEW HAVEN, Conn., May 05, 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 first quarter ended March 31, 2023 and provided a corporate update. “We made substantial progress throughout the first quarter across all areas of our early- and late-stage pipeline,” said John Houston, Ph.D., president and chief executive officer at Arvinas. “Preliminary data from the ongoing Phase 1b combination study of vepdegestrant with palbociclib reinforce our confidence in the potential of vepdegestrant as an important treatment option in metastatic breast cancer. Together with Pfizer, we are on-track to initiate the safety lead-in to identify the dose of palbociclib for the planned Phase 3 trial with vepdegestrant and palbociclib. For bavdegalutamide, we are also on track to initiate a phase 3 trial in the second half of 2023, and we plan to share radiographic progression free survival data from the Phase 1/2 trial in the second half of 2023 as well. We look forward to progressing our clinical programs and new clinical candidates in the coming years.” Recent Developments and 1Q Business Highlights Evaluated preliminary data (November 2022 cutoff) from Part C of the ongoing Phase 1b/2 ARV-471-mBC-101 study (ClinicalTrials.gov Identifier: NCT04072952).Preliminary results from the Part C dose escalation (the Phase 1b combination of vepdegestrant + palbociclib 125 mg) demonstrate an observed clinical benefit rate (CBR; rate of confirmed complete response, confirmed partial response, or stable disease ≥24 weeks) of 60.7% (95% CI, 40.6 – 78.5) across all dose cohorts (17 of 28 CBR-evaluable patients; patients are CBR-evaluable if they received their first dose >24 weeks prior to the cut-off). Data are expected to be presented at a medical conference in the second half of 2023. 85.7% of the 28 CBR-evaluable patients had received CDK4/6 inhibitor therapy prior to study entry.An increase in palbociclib exposure was observed relative to histor...