On December 8, 2022, the Company announced that in a post-hoc analysis from the Phase 2 cohort expansion portion (VERITAC) of a Phase 1/2 study with ARV-471, a patient subgroup (n=8) with no prior treatment with fulvestrant or chemotherapy in the metastatic setting, which thus approximates the expected VERITAC-2 Phase 3 trial population, achieved a clinical benefit rate (CBR: rate of confirmed complete response, confirmed partial response, or stable disease ≥ 24 weeks) of 62.5%. The post-hoc analysis is included in the updated company Presentation and was not available when the conference presentation was released prematurely by SABCS on November 21, 2022. All patients were previously treated with cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and while the subgroup in the post-hoc analysis was not actively selected by ESR1 status, all 8 patients harbored ESR1 mutations by circulating tumor DNA analysis.
Median progression free survival for patients in the post-hoc analysis had not been reached as of the November 2022 data analysis. 3 of the 8 patients discontinued as of November 2022; the 5 continuing on therapy had treatment durations of 8-14 months.
The Company expects a similar patient population in terms of prior treatment to enroll in the VERITAC-2 Phase 3 trial investigating ARV-471 as a second-line monotherapy treatment.
Forward-Looking Statements
This Current Report contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the patient population expected to enroll in the VERITAC-2 Phase 3 trial investigating ARV-471 as a second-line monotherapy treatment. 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 December 31, 2021 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this Current Report reflect the Company’s current views with respect to future events, and the Company assumes 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 the Company’s views as of any date subsequent to the date of this Current Report.