Annuncio • May 03

Arvinas Inc. and Pfizer Inc. Receive FDA Approval for Veppanu for Treatment Of ESR1m, ER+/HER2- Advanced Breast Cancer

Arvinas, Inc., with its partner Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for VEPPANU (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. VEPPANU offers a new therapeutic option in ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, where treatment resistance remains a major clinical challenge. Breast cancer is the most common cancer among women worldwide, with many tumors driven by estrogen receptor signaling. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 40-50% of patients treated with endocrine therapy and a CDK4/6 inhibitor have ESR1 mutations, resulting in endocrine resistance and poor prognosis. These patients often experience rapid disease progression and face limited options after first-line therapy. The FDA approval of VEPPANU addresses a significant unmet need, offering a new treatment option for adults with ESR1-mutant, ER+/HER2- advanced breast cancer by targeting a key biological driver of resistance to current therapies. VEPPANU was discovered by Arvinas and jointly developed by Arvinas and Pfizer. FDA approval was granted based on data from VERITAC-2 (NCT05654623), a global, randomized, open-label, pivotal Phase 3 clinical trial evaluating vepdegestrant versus fulvestrant. In the trial, among patients with an ESR1 mutation (n=270), vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 43% compared to fulvestrant. Median PFS was 5 months (95% CI: 3.7, 7.4) in the vepdegestrant arm and 2.1 months (95% CI: 1.9, 3.5) in the fulvestrant arm (hazard ratio 0.57 [95% CI: 0.42, 0.77]; p-value 0.0001). Overall survival was immature with 16% of deaths in this population at the time of the PFS analysis. The majority of adverse events (AEs) with vepdegestrant were low grade (Grade 1-2) and the most common (=10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation. Arvinas and Pfizer intend to jointly identify and select a third-party partner with the capabilities and expertise to maximize the commercial potential of VEPPANU. The companies are on track to announce selection of a third party. VEPPANU is a prescription medicine to treat people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after at least one line of endocrine-based therapy. Your healthcare provider will perform a test to make sure that VEPPANU is right for you. VEPPANU can cause serious side effects, including heart rhythm problems (QTc interval prolongation). VEPPANU can cause changes in the electrical activity of your heart and may increase your risk of abnormal heart rhythm problems, and sudden death. Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and check your blood potassium and magnesium levels before and as needed during treatment with VEPPANU. The most common side effects of VEPPANU include decreased white blood cell counts, decreased red blood cell counts, abnormal electrocardiogram (QT prolonged), nausea, increased liver function tests, muscle and bone pain, tiredness, decreased appetite, decreased platelet counts, decreased potassium levels in your blood, and constipation. Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with VEPPANU, if you develop certain side effects. VEPPANU may affect fertility in males and in females who are able to become pregnant. The Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global, randomized, open-label trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor plus endocrine therapy. The trial enrolled 624 patients, 270 of whom had ESR1m positive disease, at 213 sites in 25 countries. Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. VEPPANU (vepdegestrant) is an orally bioavailable PROteolysis TArgeting Chimera (PROTAC), estrogen receptor degrader approved in the U.S. for use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant.

Annuncio • May 18

Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE)

Arvinas, Inc. and Pfizer Inc. announced updated clinical data from a Phase 1b combination cohort evaluating vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®). After six months of additional follow-up, these data are consistent with data presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2023, and show that vepdegestrant plus palbociclib continue to demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of prior therapy with locally advanced or metastatic ER positive (ER+)/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These updated data were presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is an investigational PROTAC ER degrader designed to harness the body’s natural protein disposal system to specifically target and degrade the estrogen receptor. Vepdegestrant is being co-developed by Arvinas and Pfizer and is being evaluated as a monotherapy in the second-line setting in the ongoing Phase 3 VERITAC-2 trial and in the first-line setting in combination with palbociclib in the ongoing study lead-in cohort of the Phase 3 VERITAC-3 trial. The Phase 1b cohort of the ARV-471-mBC-101 study (NCT04072952) is designed to assess the safety, tolerability, and anti-tumor activity of vepdegestrant in combination with palbociclib among 46 patients with heavily pre-treated locally advanced or metastatic ER+/HER2- breast cancer. Patients in the study received a median of four prior therapies (median of three in the metastatic setting); 87% were previously treated with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor; 80% were previously treated with fulvestrant; and 78% were previously treated with chemotherapy, including 48% in the metastatic setting. Patients were treated once daily with oral doses of vepdegestrant at 180 mg (n=2), the recommended Phase 3 dose (RP3D) of 200 mg (n=21), 400 mg (n=3) or 500 mg (n=20), plus 125 mg of palbociclib given orally once daily for 21 days, followed by seven days off treatment in 28-day cycles. Initial data were presented at SABCS 2023 based on a data cutoff of June 6, 2023. After six months of additional follow-up with a data cutoff of December 18, 2023, updated data from the study continue to demonstrate an encouraging clinical benefit rate, objective response rate and progression-free survival, and a consistent safety profile as previously reported at SABCS 2023. Data presented at the 2024 ESMO Breast Cancer Annual Congress: Clinical Benefit Rate (CBR): CBR, defined as the rate of confirmed complete response, partial response, or stable disease =24 weeks across all dose levels (n = 46) was 63% (95% CI: 47.5 - 76.8), with a CBR of 72% in patients with mutant ESR1 (n=29; 95% CI: 52.8 - 87.3) and a CBR of 53% in patients with wild-type ESR1 (n=15; 95% CI: 26.6 – 78.7). CBR in patients dosed at the RP3D of 200 mg (n=21) was 67% (95% CI: 43.0 - 85.4) with a CBR of 79% in patients with mutant ESR1 (n=14; 95% CI: 49.2 - 95.3) and a CBR of 43% in patients with wild-type ESR1 (n=7; 95% CI: 9.9 - 81.6). Objective Response Rate (ORR) and Duration of Response (DOR): The ORR in evaluable patients with measurable disease at baseline (n=31) was 42% (95% CI: 24.5 - 60.9) with a median DOR in 13 responders of 14.6 months (95% CI: 9.5 – not reached). At the RP3D of 200 mg (n=15), the ORR was 53% (95% CI: 25.6 – 78.7). ORR in patients with mutant ESR1 (n=17): 47% (95% CI: 23.0 - 72.2). ORR at the RP3D of 200 mg (n=10): 60% (95% CI: 26.2 - 87.8). ORR in patients with wild-type ESR1 (n=12): 42% (95% CI: 15.2 - 72.3). ORR at the RP3D of 200 mg (n=5): 40% (95% CI: 5.3 - 85.3). Progression-free Survival (PFS): Median PFS (mPFS) based on 27 (59%) events across all dose levels was 11.2 months (95% CI: 8.2 – 16.5) with a mPFS of 13.7 months (95% CI: 8.2 - NR) in patients with ESR1 mutation (n=29) and mPFS of 11.1 months (95% CI: 2.8 - 19.3) in patients with wild-type ESR1 (n=15). mPFS in patients dosed at the RP3D of 200 mg (n=21) based on 12 events (57%) was 13.9 months (95% CI: 8.1 - NR) with a mPFS of 13.9 months (95% CI: 8.1 - NR) in patients with ESR1 mutation (n=14) and mPFS of 11.2 months (95% CI: 1.8 - NR) in patients with wild-type ESR1 (n=7). Circulating Tumor DNA (ctDNA): Exploratory ctDNA analyses found marked reduction (median change, -98.9%) in tumor fraction after one treatment cycle (all dose groups) regardless of ESR1 mutant status and robust on-treatment decreases in mutant ESR1 ctDNA levels sustained through cycle 7 (evaluated in patients in 200 mg dose cohort), as presented in the poster session. Safety Profile: The safety profile of vepdegestrant plus palbociclib was consistent with what was previously reported with Grade 3/4 treatment-related adverse events (TRAEs) =10% of neutropenia (91%) and decreased white blood cell count (15%); no grade 5 TRAEs or febrile neutropenia were reported. The majority of Grade 4 neutropenia events occurred in the first cycle of treatment and occurrences of Grade 3/4 neutropenia decreased following palbociclib dose reductions as described in the prescribing label. The safety profile of vepdegestrant in combination with palbociclib was otherwise consistent with the profile of palbociclib and what has been observed in other clinical trials for vepdegestrant. Three of 46 patients discontinued palbociclib due to neutropenia including one out of 21 patients treated with the RP3D of vepdegestrant (200 mg) plus palbociclib 125 mg.

Indice di copertura degli interessi	n/a
Contanti	US$614.90m
Patrimonio netto	US$386.80m
Totale passività	US$260.70m
Totale attività	US$647.50m

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/07/07 04:37
Prezzo dell'azione a fine giornata	2026/07/07 00:00
Utili	2026/03/31
Utili annuali	2025/12/31

Pacchetto	Dati	Tempistica	Esempio Fonte USA ^*
Dati finanziari della società	10 anni	Conto economico Rendiconto finanziario Bilancio	Modulo SEC 10-K Modulo SEC 10-Q
Stime di consenso degli analisti	+3 anni	Previsioni finanziarie Obiettivi di prezzo degli analisti	Rapporti di ricerca degli analisti Blue Matrix
Prezzi di mercato	30 anni	Prezzi delle azioni Dividendi, scissioni e azioni	Dati di mercato ICE Modulo SEC S-1
Proprietà	10 anni	Top azionisti Insider trading	Modulo 4 SEC Modulo 13D SEC
Gestione	10 anni	Team di leadership Consiglio di amministrazione	Modulo SEC 10-K Modulo SEC DEF 14A
Sviluppi principali	10 anni	Annunci aziendali	Modulo 8-K SEC

Analista	Istituzione
Peter Lawson	Barclays
Etzer Darout	Barclays
Tazeen Ahmad	BofA Global Research

Arvinas Salute del bilancio

Criteri Salute finanziaria verificati 6/6

Informazioni chiave

Aggiornamenti recenti sulla salute finanziaria

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Recent updates

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Consensus revenue estimates increase by 31%

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Arvinas, Inc. to Report Q1, 2026 Results on May 12, 2026

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Arvinas, Inc., Annual General Meeting, Jun 24, 2026

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ARVN: Upcoming Neurology Data Readouts Will Challenge Current Share Price Assumptions

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ARVN: 2026 Neurology Readouts And Cash Runway Will Drive Future Upside

Arvinas Inc Presents Positive Phase 1 Data For ARV-102 Showing Greater Than 50% LRRK2 Degradation In The CSF Of Patients With Parkinson’s Disease Treated For 28 Days

Director recently sold US$466k worth of stock

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Consensus EPS estimates fall by 22%

New major risk - Revenue and earnings growth

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ARVN: New Hematology And KRAS Data Will Balance Cash Burn Risks

ARVN: Future Returns Will Balance Breast Cancer Setbacks And Cash Burn Risks

Price target decreased by 32% to US$12.44

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Arvinas, Inc. to Report Q3, 2025 Results on Nov 05, 2025

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Arvinas, Inc. Announces New Patient-Reported Outcomes (PRO) Data from the Phase 3 Veritac-2 Clinical Trial Evaluating Vepdegestrant

Arvinas, Inc. Presents Positive Phase 1 Clinical Data for ARV-102, a PROTAC LRRK2 Degrader at the 2025 International Congress of Parkinson's Disease and Movement Disorders

Precision Therapies Will Meet Demand Despite Clinical And Regulatory Risks

Arvinas, Inc. Approves Reduction in Workforce of Approximately 15% Across Roles in Functional Areas of the Company Primarily Related to Vepdegestrant Commercialization

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Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind

Arvinas, Inc. to Report Q2, 2025 Results on Aug 06, 2025

Arvinas Announces Retirement of John Houston, Ph.D., Chairperson as President

Insufficient new directors

Arvinas, Inc. Announces John Young Decides to Resign from its Board of Directors and Compensation Committee, Effective June 30, 2025

Logos Global Management LP Issues a Letter to the Board of Arvinas, Inc.

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We're Not Very Worried About Arvinas' (NASDAQ:ARVN) Cash Burn Rate

Price target decreased by 7.9% to US$34.24

First quarter 2025 earnings: EPS and revenues exceed analyst expectations

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Arvinas, Inc., Annual General Meeting, Jun 25, 2025

Arvinas, Inc. to Report Q1, 2025 Results on May 01, 2025

Arvinas Announces Results from the Veritac-2 Trial Selected as Late-Breaking Oral Presentation At the 2025 American Society of Clinical Oncology Annual Meeting

Price target decreased by 8.9% to US$39.47

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Insider recently sold US$74k worth of stock

Phase III And PROTAC Data Will Advance Pipeline Despite Hurdles

Arvinas: Veritac-2 ITT Failure Confirms Limited Prospects

Price target decreased by 18% to US$50.05

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New major risk - Share price stability

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Chairperson recently sold US$524k worth of stock

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