Vepdegestrant Drug Asset Due Diligence Report 2026

This Vepdegestrant Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Approved

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Vepdegestrant can convert its Proteolysis-targeting chimeras (PROTAC) profile and ER biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Vepdegestrant (query alias: vepdegestrant)
Modality / target	Proteolysis-targeting chimeras (PROTAC); ER; ERs degraders
Highest global status	Approved
Originator	Arvinas, Inc.
Active developers	Pfizer Inc., Arvinas Estrogen Receptor, Inc., Arvinas, Inc.

The MCP disease footprint includes ER-positive/HER2-negative/ ESR1-mutated breast cancer, Advanced breast cancer, HER2-negative breast cancer. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06347861	Phase 1	Completed	52	Maximum observed concentration (Cmax) for vepdegestrant
NCT07231991	Phase 1	Recruiting	24	Maximum observed concentration (Cmax) for vepdegestrant
NCT06645938	Phase 1	Completed	12	Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Vepdegestrant, a proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader, plus abemaciclib (ABE) in ER+/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC): TACTIVE-U phase 1b/2 results.

Phase 1/2; n=37; evaluation: Positive. Reported fields: ORR = 45.0 % ( 25.8 - 65.8); ORR = 30.6 % ( 18.0 - 46.9)

Safety profile of post-CDK4/6 treatments in HR+/HER2− metastatic breast cancer (mBC): A network meta-analysis

Phase 2/3; n=16; evaluation: Positive. Reported fields: AE(Grade ≥3) = 2.76 RR ; AE(Grade ≥3) = 0.47 RR ; -

A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)

Phase 3; n=624; evaluation: not stated. Reported fields: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants(Median) = 3.6 Months (95% Confidence Interval, 2.2 - 3.8); Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants(Median): Hazard Ratio (HR) = 0.83(95% CI, 0.676 - 1.016), P-Value = 0.0358; Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants(Median): Hazard Ratio (HR) = 0.83(95% CI, 0.676 - 1.016), P-Value = 0.0358

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Vepdegestrant addresses ER-positive/HER2-negative/ ESR1-mutated breast cancer, Advanced breast cancer, HER2-negative breast cancer. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Proteolysis-targeting chimeras (PROTAC)—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 3 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2026-05-12	Arvinas and Pfizer Enter into a Transaction with Rigel Pharmaceuticals for the Exclusive Global Rights of VEPPANU (vepdegestrant)	Approved	US$70.0M upfront; US$335.0M milestones
2025-09-18	Arvinas, Pfizer to grant commercial rights of experimental breast cancer drug to third party	NDA/BLA	Financial terms not disclosed
2021-07-22	Arvinas and Pfizer Announce Global Collaboration to Develop and Commercialize PROTAC® Protein Degrader ARV-471	NDA/BLA	US$650.0M upfront; US$1,400.0M milestones

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Combinations of vepdegestrant and CDK4/6 inhibitors for treating ESR1-mutant breast cancer”. The milestone feed surfaced a patent-application signal described as “Administration of CYP3a inhibitors in the treatment of cancer”. The milestone feed surfaced a patent-application signal described as “Methods of treating estrogen receptor-positive breast cancer”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Class crowding and differentiation versus other PD-(L)1/VEGF agents
Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
Biomarker strategy, indication selection, and head-to-head endpoint execution

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO