Full Press Release Details
Arvinas Announces New Data from Completed Phase 1 Dose Escalation and Ongoing Phase 2
ARDENT Expansion Cohort with Novel PROTAC Degrader Bavdegalutamide (ARV-110) to be
Presented at 2022 ASCO GU Meeting
Bavdegalutamide demonstrated a 46% PSA50 rate in patients with metastatic
castration-resistant prostate cancer (mCRPC) and androgen receptor (AR) T878X/H875Y tumor mutations
initiate a pivotal trial by year end 2022 evaluating bavdegalutamide in patients with mCRPC who have progressed on or after novel hormonal agents (NHAs) and have tumors that harbor AR T878X/H875Y mutations
Updated data to be presented in a rapid abstract session and a poster session at ASCO GU and Arvinas to hold conference call on
Thursday, February 17 at 8:30 a.m. ET
NEW HAVEN, Conn., Feb. 14, 2022 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 new data showing that bavdegalutamide (also known as ARV-110), a novel PROTAC protein degrader targeting the androgen receptor (AR), continues to provide evidence of anti-tumor activity and patient benefit in metastatic castration-resistant prostate cancer (mCRPC). These
data show that bavdegalutamide reduced prostate-specific antigen (PSA) levels greater than or equal to 50% (PSA50) in 46% of patients with tumors harboring AR T878X/H875Y (T878X = T878A or
T878S) mutations. Updated Phase 1 and interim Phase 2 ARDENT data will be presented in both a rapid abstract session and a poster session on February 17, 2022, at the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers
These results are very encouraging and reinforce our conviction that bavdegalutamide has the potential to provide meaningful clinical
benefit to patients with mCRPC who have progressed after treatment with novel hormonal agents and for whom few treatment options exist, said John Houston, Ph.D., president and chief executive officer of Arvinas. With particularly robust
activity in a molecularly defined patient population, we believe there is a clear path forward to developing this novel treatment as a precision medicine and plan to initiate a pivotal trial by year end 2022.
Highlights from the bavdegalutamide abstract (data cut-off date August 26, 2021):
Across 140 biomarker-evaluable patients with 1 month of PSA follow-up in the completed Phase 1 dose escalation
and ongoing Phase 2 ARDENT expansion cohort:
Novel hormonal agents have become standard of care in castration-sensitive prostate cancer and there is a need for novel AR
therapies with the potential to provide benefit for patients with mCRPC and tumors that have developed resistance, said Ron Peck, M.D., chief medical officer at Arvinas. As an oncologist, I m particularly excited by a precision
medicine approach with the potential to identify patients who are most likely to respond to bavdegalutamide.
Additional data from the completed
Phase 1 and interim results from the ongoing Phase 2 ARDENT trial will be presented on Thursday, February 17, 2022. The cut-off date for data in the rapid abstract session and the poster session was
Poster presentation:
Rapid abstract session (7:45 8:45 p.m. ET):
The full abstract can be found at the official ASCO Genitourinary Cancers Symposium website.
Arvinas Webcast Investor Meeting Arvinas will host a conference call and webcast Thursday, February 17, 2022, at 8:30 a.m. ET, to discuss the
completed Phase 1 dose escalation data and interim data from the Phase 2 ARDENT trial presented at ASCO GU. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 1085203.
materials for the conference call and webcast will be available on the Arvinas website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the
About Bavdegalutamide (ARV-110)
Bavdegalutamide is an investigational orally bioavailable PROTAC protein degrader designed to
selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer. Bavdegalutamide has demonstrated activity in preclinical models of
AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.
Arvinas is a clinical-stage biotechnology
company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary
PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed
to harness the body s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of
PROTAC protein degraders against validated and undruggable targets, the company has three clinical-stage programs: bavdegalutamide and
ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic
ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
Arvinas Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential
advantages and therapeutic benefits of bavdegalutamide, the development and regulatory status of bavdegalutamide and our other product candidates, and the timing of clinical trials and data from those trials and plans for registration for our
product candidates, and the potential commercialization of any of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations,
prospects, plans and objectives of management, are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, might, plan,
predict, project, target, potential, will, would, could, should, continue, and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the
forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we and, as applicable, Pfizer will be able to successfully conduct and complete clinical development for ARV-471, bavdegalutamide, ARV-766 and our other product candidates, including whether we initiate and receive results from our clinical trials on our expected timelines or at
all, obtain marketing approval for and commercialize ARV-471, bavdegalutamide, ARV-766 and our other product candidates on our current timelines or at all, and other
important factors discussed in the Risk Factors sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our
current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any
date subsequent to the date of this release.