Arvinas, Inc. · NASDAQ:ARVN
Arvinas — San Antonio Breast Cancer Symposium 2023
23 slides from Arvinas's conference presentation, Dec 6, 2023
Slide 1: Vepdegestrant program update
Vepdegestrant program update - Phase 1b data: combination trial with palbociclib - Development plan update San Antonio Breast Cancer Symposium December 6, 2023
Slide 2: Safe harbor and forward-looking statements: Arvinas
Safe harbor and forward-looking statements: Arvinas This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential for vepdegestrant (ARV-4
Slide 3: Forward-looking Statements and Other Notices: Pfizer
Forward-looking Statements and Other Notices: Pfizer Our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. We
Slide 4: Introduction
Introduction ARVINAS
Slide 5: Vepdegestrant: Potential best-in-class PROTAC ER-targeting therapy for ER+/HER2- breast cancer
Vepdegestrant: Potential best-in-class PROTAC® ER-targeting therapy for patients with ER+/HER2- breast cancer • Vepdegestrant degrades wild-type and ESR1-mutant estrogen receptor (ER) to directly inhibit signaling pathways • More than 350 patients and healthy volunteers have been treated with vepdeg
Slide 6: Expanded clinical development program to position vepdegestrant as backbone ER-targeting therapy
Our expanded clinical development program is designed to position vepdegestrant as a backbone ER-targeting therapy in breast cancer Adjuvant (Post-Surgical) Metastatic Breast Cancer (~60K1) Breast Cancer (~190K1) First Line Second/Third Line VERITAC-2 monotherapy pivotal trial (enrolling) TACTIVE-N
Slide 7: Updated vepdeg monotherapy data in the VERITAC Phase 2 trial reinforces durable activity
Updated vepdeg monotherapy data in the VERITAC Phase 2 trial reinforces durable activity • SABCS poster (poster P03-05-08) shows continueda durable activity and favorable tolerability in heavily pre-treatedb patients enrolled in the Phase 2 VERITAC trial • 40% of patients received vepdegestrant for
Slide 8: Results from Phase 1b trial with vepdegestrant + palbociclib set the stage for multiple paths forward
Results from Phase 1b trial with vepdegestrant + palbociclib set the stage for multiple paths forward as combination regimen • Interim vepdeg plus palbociclib data showed compelling signals of efficacy • Objective Response Rate: 42% (ESR1 mutant, 47%; ESR1 wild-type, 42%) ⎻ Median duration of respon
Slide 9: Vepdegestrant Phase 1b combination with palbociclib
Vepdegestrant Phase 1b combination with palbociclib San Antonio Breast Cancer Symposium Poster Spotlight Session 9
Slide 10: Clinical program includes combination with palbociclib to inform potential of vepdegestrant
Clinical program includes combination with palbociclib to inform potential of vepdegestrant as backbone ER therapy Additional Eligibility Criteria Treatment Part A Common Eligibility Criteria for (Phase 1 Vepdegestrant Dose Escalation) • Vepdegestrant orally once First-In-Human: • ≥2 prior endocrine
Slide 11: Patients in the Phase 1b combination trial were heavily pre-treated
Patients in the Phase 1b combination trial were heavily pre-treated with multiple lines of therapy Baseline characteristics Characteristic Total (N=46) Characteristic Total (N=46) Sex, n (%) Baseline ESR1 status, n (%)a Female 45 (98) Mutant 29 (63) Median age, y (range) 62 (29–78) Wild-type 15 (33)
Slide 12: Prior combination trials to establish potential of CDK4/6i after CDK4/6i in the 2L+ setting
Prior combination trials to establish potential of CDK4/6i after CDK4/6i in the 2L+ setting Data are not from head-to-head studies. Cross-trial data interpretation should be considered with caution; limited by differences in study population and other factors Trial Combination Prior Prior Prior chem
Slide 13: Vepdegestrant plus palbociclib achieved robust antitumor activity regardless of ESR1 status
In phase 1b trial, vepdegestrant plus palbociclib achieved robust antitumor activity in patients regardless of ESR1 status Antitumor activity (best percentage change from baseline in sum of target lesions) in response-evaluable patients (n=31) 100 Objective response rate Vepdegestrant 180 mg QD + pa
Slide 14: Progression-free survival results support durability of antitumor activity
Progression-free survival results in Phase 1b trial support durability of antitumor activity in heavily pre-treated patients Preliminary analysis of PFS in all patients Total (N=46) • Robust mPFS regardless of ESR1 100 Events, n (%)a 22 (48) status 90 Median PFS, months (95% 11.1 (8.2–NR) CI) 80 • O
Slide 15: Efficacy measures in prior CDK4/6i-after-CDK4/6i trials
Efficacy measures in prior CDK4/6i-after-CDK4/6i trials Data below are not from head-to-head studies. Cross-trial data interpretation should be considered with caution as it is limited by differences in study population and many other factors. Prior CDK4/6i 100% 100% 100% 100% 87.0% Prior chemo for
Slide 16: Manageable tolerability, with TRAEs consistent with known profiles
Manageable tolerability, with TRAEs generally consistent with the known profiles of palbo and observations from other clinical trials with vepdeg TRAEs attributed to either vepdegestrant or palbociclib in ≥10% of total population • Higher rates of Gr 4 neutropenia linked to Total (N=46)a ~50% higher
Slide 17: Strong durability of vepdeg + palbo combination after palbo dose reductions
Strong durability of vepdeg + palbo combination treatment after standard dose reductions of palbo • Dose reductions occurred early (median, 38 days), well before the median time to response (109 days) Vepdegestrant 180 mg QD + palbociclib (n=2) • Patients received a dose intensity of 63% of the Vepd
Slide 18: Median duration of response of 10.2 months; ORR of 44% in dose-reduced patients
Vepdegestrant plus palbociclib: Median duration of response of 10.2 months; ORR of 44% in dose-reduced patients Maintained 125 mg palbociclib (n=10) Median time on treatment: 8.1 weeks (range: 2.0–80.1) Response-evaluable (n=6) ORR: 33.3% Dose-reduceda palbociclib (n=36) Median time on treatment: 36
Slide 19: Expanded development plans with vepdegestrant
Expanded development plans with vepdegestrant Adam Schayowitz, Vice President, Development Head Breast Cancer, Pfizer 19
Slide 20: Results from Phase 1b trial show potential for additional opportunity in ER+/HER2- mBC
Results from Phase 1b trial show potential for additional opportunity in ER+/HER2- mBC Neutropenia occurred early • Standard on-label palbo dose reductions (to 100 or 75 and was managed per mg) in 78% of patients vs. 36% in label protocol, which mirrored • At patients’ final doses, only 5 of 46 (11%
Slide 21: Expanded development plan to make vepdegestrant the potential ER therapy of choice
Expanded development plan designed to make vepdegestrant the potential ER therapy of choice in advanced metastatic breast cancer 2L Development Program Ongoing VERITAC-2 Phase 3 2L Phase 3 trial on track for topline data in pivotal trial monotherapy 2H24 Phase 3 2L combination with Health authority
Slide 22: Q&A
Q&A • John Houston, Ph.D, President and Chief Executive Officer, Arvinas • Ron Peck, M.D., Chief Medical Officer, Arvinas • Ian Taylor, Ph.D, Chief Scientific Officer, Arvinas • Adam Schayowitz, Ph.D, Vice President, Development Head, Breast Cancer, Colorectal Cancer, and Melanoma, Pfizer 22
Slide 23: Thank you
Thank you 23