Table 2.

VERITAC-2 study end points.

End points
Primary	PFS in the ITT population and ESR1 mutation-positive subpopulation – Time interval from the date of randomization to the date of first documented tumor progression determined by BICR assessment as per RECIST v1.1 or death due to any cause, whichever comes first
Secondary	OS – Time from date of randomization until the date of death due to any cause
	ORR – Proportion of patients with confirmed complete CR or PR by BICR
	DOR – Time from first documented evidence of CR or PR until progressive disease by BICR
	CBR – Proportion of patients with confirmed CR, PR, or SD ≥24 weeks by BICR
	Incidence of AEs, SAEs, and ECG and laboratory abnormalities
	QT interval (QTc)
	Plasma concentrations of vepdegestrant and its epimer, ARV-473
	Patient disease-, health-, and treatment-related QOL, assessed by: – EQ-5D-5La – EORTC QLQ-C30b – EORTC QLQ-BR23c – BPI-SFd
	Circulating tumor DNA changes

^aThe EQ-5D-5L assesses patients' current state of self-care, usual activities, mobility, pain/discomfort, and anxiety/depression. The visual analog scale score records the respondent's self-rated health status [33].

^bThe EORTC QLQ-C30 contains 1 global QOL score and 5 multi-item functional subscales, including physical, role, emotional, cognitive, and social. Higher scores on QOL/functional domains are indicative of higher levels of functioning. Oncology-related symptoms are assessed using 9 symptom scales, where higher scores are reflective of a greater presence of symptoms [34].

^cThe female and male versions of the EORTC QLQ-BR23 contain 4 functional scales to assess body image, sexual functioning, sexual enjoyment, and future perspective and 4 symptom scales to assess systemic therapy side effects, breast symptoms, arm symptoms, and being upset by hair loss. Higher scores represent greater severity [35].

^dThe BPI-SF assesses pain levels and their effect on daily life [36].

AE: Adverse event; BICR: Blinded independent central review; BPI-SF: Brief Pain Inventory-short form; CBR: Clinical benefit rate; CR: Complete response; DOR: Duration of response; ECG: Electrocardiogram; EORTC QLQ-BR23: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module; EORTC QLQ-C30: EORTC Quality of Life Questionnaire Core; EQ-5D-5L: 5-level EQ-5D; ITT: Intention-to-treat; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival; PR: Partial response; QTc: Corrected QT interval; QOL: Quality of life; RECIST: Response Evaluation Criteria in Solid Tumors; SAE: Serious AE; SD: Stable disease.