Arvinas, Inc. · NASDAQ:ARVN
Arvinas — San Antonio Breast Cancer Symposium 2021
16 slides from Arvinas's conference presentation, Dec 10, 2021
Slide 1: ARV-471: Phase 1 Dose Escalation Clinical Trial Results
ARV-471: Phase 1 Dose Escalation Clinical Trial Results San Antonio Breast Cancer Symposium December 10, 2021 Exhibit 99.2
Slide 2: Safe harbor and forward-looking statements
Safe harbor and forward-looking statements 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 development and regulatory status of ARV-47
Slide 3: Agenda
Agenda Topic Participant Introduction John G. Houston, Ph.D. President and Chief Executive Officer, Arvinas ARV-471 Clinical Data Update Ron Peck, M.D. Chris Boshoff, M.D., Ph.D. Chief Medical Officer, Arvinas Chief Development Officer, Pfizer Oncology ? Q&A
Slide 4: ARV-471: Potential to be the endocrine backbone of choice for ER+/HER2- breast cancer treatment
ARV-471: Potential to be the endocrine backbone of choice for ER+/HER2- breast cancer treatment Potential Future US ER+/HER2- Breast Cancer Treatment Paradigm with ARV-471 Adjuvant (Post-Surgical) Breast Cancer (~160K) Metastatic Breast Cancer (~50K) Second/Third Line First Line Clinical Limitations
Slide 5: ARV-471: Potential best-in-class estrogen receptor-targeting therapy
ARV-471: Potential best-in-class estrogen receptor-targeting therapy December 2020: 21 patients, clinical benefit rate of 42% (5 of 12 evaluable patients) December 2021: 60 patients, clinical benefit rate of 40% (19 of 47 evaluable patients) Continued robust signals of efficacy in a patient populati
Slide 6: Design: 3+3 dose escalation with backfill
Design “3 + 3” dose escalation with backfill ARV-471 orally administered with food Starting dose: 30 mg administered orally once daily Maximum administered daily dose: 700 mg ARV-471: First-in-Human study “3+3” dose escalation study Endpoints Primary: Maximum tolerated dose and recommended Phase 2 d
Slide 7: After CDK4/6 inhibitor treatment, ~66% of breast cancers have ER-independent resistance
After CDK4/6 inhibitor treatment, ~66% of breast cancers have ER-independent mechanisms of resistance† Previously disclosed data demonstrate poor outcomes following CDK4/6 inhibitor therapy, e.g., fulvestrant: Median PFS = 1.9 months†† CBR = 13.7%†† 100% of patients in Phase 1 study were post- CDK4/
Slide 8: ARV-471 Phase 1 patients received extensive prior therapy (N=60)
ARV-471 Phase 1 patients received extensive prior therapy (N = 60) Patient Characteristics Parameter N (%) Median age (years) 65.5 (38-80) ECOG performance status* 0 1 29 30 (48) (50) Sites of metastases Bone Liver Lung Other 33 23 13 13 (55) (38) (22) (22) Median prior lines of therapy total (range
Slide 9: ARV-471 was well tolerated at all dose levels; no DLTs and MTD not reached
ARV-471 was well tolerated at all dose levels; no dose limiting toxicities and MTD not reached Discontinuation rate <2% (1 out of 60) Dose reductions <2% (1 out of 60) *Advanced breast cancer is highly associated with venous embolisms. Event was included as potentially treatment related, so treatmen
Slide 10: 40% clinical benefit rate (CBR) in evaluable patients
40% clinical benefit rate (CBR) in 47 evaluable patients* CBR = rate of confirmed CR or PR or SD ≥24 weeks 3 patients had confirmed PRs 14 patients were ongoing at the time of data cutoff, including 2 who have been on treatment for >18 months AVR-471: High CBR (40%) in heavily pretreated population
Slide 11: Antitumor activity in response-evaluable patients (n=38)
Antitumor activity in response-evaluable patients (n=38)* *Patients with measurable disease at baseline who had a baseline and ≥1 on-treatment scan †Patient had disease progression on subsequent scan and discontinued treatment PD=progressive disease; PR=confirmed partial response; SD=stable disease;
Slide 12: ARV-471 degraded ER up to 89%
ARV-471 degraded ER up to 89% through the 500 mg dose level * Data available as of September 3, 2021; median time on treatment at biopsy: 31 days (range: 16–77). ER immunoreactivity analyzed by QIF using the AQUA method, and ER positivity threshold derived by examining AQUA scores and visually inspe
Slide 13: Summary: ARV-471 has shown robust signals of efficacy in a challenging patient population
Summary: ARV-471 has shown robust signals of efficacy in a challenging patient population † Wander 2020; ††CBR defined as SD persisting ≥ 24 weeks, or a best response of confirmed CR or PR. Patients expected to have ER-independent disease† Of patients with prior fulvestrant treatment 80% Of patients
Slide 14: Arvinas and Pfizer aim to characterize the activity of ARV-471 across treatment lines
Arvinas and Pfizer aim to characterize the activity of ARV-471 across ER+/HER2- breast cancer treatment lines † SEER database; includes US patient population only, †† E.g., everolimus or as part of umbrella study with multiple combination agents CDK, cyclin-dependent kinases Pi3Ki; phosphoinositide
Slide 15: ARV-471: Evidence for best-in-class potential in a large area of unmet need
Potential for 1L/2L/3L approval as monotherapy or in combination Planned combinations with CDK inhibitors and other targeted therapies in adjuvant or early metastatic cancers LARGE UNMET NEED AND OPPORTUNITY In the US alone, ER+/HER2- breast cancer represents an addressable patient population of >20
Slide 16: Thank You
Thank You