Arvinas, Inc. Provides Update on ARV-471 and Other Programs

Strategic Insights -

Arvinas, Inc., a biotechnology company focused on developing targeted protein degraders, has filed a FORM 8-K report with the Securities and Exchange Commission (SEC) providing an update on their programs, including the ongoing Phase 1b combination study of ARV-471 with palbociclib and the proposed amendment to the VERITAC-3 Phase 3 study protocol. According to the report, the company and Pfizer plan to present updated guidance related to the anticipated initiation of the VERITAC-3 Phase 3 study of ARV-471 in combination with IBRANCE (palbociclib) in the second half of 2023.

Key Takeaways:

  • The company has proposed a modification to the planned VERITAC-3 Phase 3 study and requested a meeting with the FDA to review the proposed update to the study protocol for ARV-471 in combination with palbociclib.
  • An approximate increase of 50% in mean palbociclib exposure was observed relative to historical palbociclib pharmacokinetic data in the fed state.
  • Grade 3/4 neutropenia was 76% for 200 mg ARV-471 with 125 mg palbociclib, which is comparable to the rates reported in the registrational Phase 3 studies of palbociclib.
  • The Company initiated the TACTIVE-U, the Phase 1b trial with ARV-471 in combination with ribociclib and abemaciclib, in two of the combination arms in the fourth quarter of 2022.
  • The Company expects to initiate a Phase 3 trial with ARV-471 in the adjuvant setting, a pivotal trial for bavdegalutamide (ARV-110), and an IND or CTA for its LRRK2 degrader.
  • The Company announced plans to present data from the Phase 1b combination trial of ARV-471 with palbociclib in the second quarter of 2023 and to report data from the Phase 1 dose escalation trial of ARV-766 in the second quarter of 2023.

Statistics:

  • 50% increase in mean palbociclib exposure in the fed state relative to historical palbociclib pharmacokinetic data in the fasted state.
  • 76% Grade 3/4 neutropenia for 200 mg ARV-471 with 125 mg palbociclib.
  • 66% Grade [?]3 decrease in neutrophil counts reported in 66% of patients receiving IBRANCE plus letrozole in Study 1 (PALOMA-2) and 66% of patients receiving IBRANCE plus fulvestrant in Study 2 (PALOMA-3).

Sources:

  • Arvinas, Inc. (2023). FORM 8-K. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________ FORM 8-K __________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2023 __________________