ARVINAS, INC. Item 7.01 Regulation FD Disclosure.
Spokespersons of
A copy of the presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K (this "Current Report") and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
By providing the information in Item 7.01 of this Current Report, including
Exhibit 99.1 hereto, the Company is not making an admission as to the
materiality of any information herein. The information contained in this Current
Report is intended to be considered in the context of more complete information
included in the Company's filings with the
Item 8.01 Other Events
On
In the most recent analysis of data from the ongoing Phase 1b combination study of ARV-471 with palbociclib, an increase in palbociclib exposure was observed relative to historical palbociclib pharmacokinetic data.
In light of the recent data analysis, the Company and Pfizer have proposed a
modification to the planned VERITAC-3 Phase 3 study and requested a meeting with
the
In the most recent analysis of data from the ongoing Phase 1b study of ARV-471 in combination with palbociclib, the following were observed: •An approximate increase of 50% in mean palbociclib exposure (i.e., pharmacokinetic area under the curve and Cmax) in the fed state was observed relative to historical palbociclib pharmacokinetic data in the fasted state. •Grade 3/4 neutropenia, a known dose-related adverse reaction associated with palbociclib, was 76% for 200 mg ARV-471 with 125 mg palbociclib (n=21). •As per theU.S. Package Insert, (USPI) the starting dose of palbociclib for patients with HR+/HER2- metastatic breast cancer is 125 mg. As per the palbociclib USPI, a Grade ?3 decrease in neutrophil counts was 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). •There was no increase in the rate of infection reported in the ARV-471 with palbociclib Phase 1b investigation relative to the rates reported in the registrational Phase 3 studies of palbociclib. •The neutropenia events in the ARV-471 Phase 1b study were manageable with standard dose reductions of palbociclib. •In the arm combining palbociclib with 200 mg ARV-471, one of 21 patients discontinued.
In addition to the above, the Company also provided the updated guidance set forth below related to its other programs. •VERITAC-2, a Phase 3 pivotal trial (First Subject First Visit) with ARV-471 as a second-line treatment in patients with ER+/HER2- metastatic breast cancer, is actively recruiting.
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•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 present data from the Phase 1b combination trial of
ARV-471 with palbociclib in the second quarter of 2023.
•The Company expects to initiate a Phase 3 trial with ARV-471 in the adjuvant
setting.
•The Company expects to initiate a pivotal trial for bavdegalutamide (ARV-110)
for the treatment of men with metastatic castration-resistant prostate cancer in
the second half of 2023.
•The Company expects to report data from the Phase 1 dose escalation trial of
ARV-766 for the treatment of men with metastatic castration-resistant prostate
cancer in the second quarter of 2023.
•The Company expects to submit an investigational new drug ("IND") application
or clinical trial application ("CTA") for its BCL6 PROTAC® degrader in the
second half of 2023.
•The Company expects to submit an IND or CTA for its PROTAC® LRRK2 degrader in
the second half of 2023.
•The Company expects to have two additional programs in IND-enabling studies by
the end of 2023.
Forward-Looking Statements
This Current Report contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the proposed amendment to the VERITAC-3 Phase 3 study protocol, the timelines related to the initiation of such study; the anticipated initiation, data read out and/or IND/CTA filing timelines associated with monotherapy and combination studies of ARV-471, the bavdegalutamide (ARV-110) pivotal trial, ARV-766 Phase 1 trial, and LRRK2 and BCL6 clinical candidates. All statements, other than statements of historical facts, contained in this Current Report, including statements regarding the Company's 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.
The Company may not actually achieve the plans, intentions or expectations
disclosed in the Company's forward-looking statements, and you should not place
undue reliance on the Company's forward-looking statements. Actual results or
events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements the Company makes as a result of
various risks and uncertainties, including but not limited to: the Company's and
Pfizer's performance of their respective obligations with respect to the
Company's collaboration with Pfizer; whether the Company and Pfizer will be able
to successfully conduct and complete clinical development for ARV-471; whether
the Company obtains marketing approval for and commercialize ARV-471 on its
current timelines or at all; whether the Company's cash and cash equivalent
resources will be sufficient to fund its foreseeable and unforeseeable operating
expenses and capital expenditure requirements; and other important factors
discussed in the "Risk Factors" section of the Company's Annual Report on Form
10-K for the year ended
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Company Presentation, datedJanuary 9, 2023 . 104 Cover Page Interactive Data File (formatted as Inline XBRL).
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