On May 1, 2026 The U.S. Food and Drug Administration (FDA) reported it has issued a "safe to proceed" letter to Revolution Medicines, allowing the company to initiate an expanded access treatment protocol (EAP) for daraxonrasib, an investigational RAS(ON) inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

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The EAP is intended to provide treatment access in a controlled and monitored setting, consistent with FDA regulations governing investigational medicines.

Revolution Medicines commends the FDA’s expedited review and continued commitment to providing a pathway for patients with life-threatening diseases to access investigational therapies outside of a clinical trial when no comparable or satisfactory alternative treatment options are available.

This authorization represents a critical step in the process of opening an EAP. Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States.

Per FDA regulations governing expanded access programs, Revolution Medicines is not able to accept requests directly from patients or caregivers. All requests for expanded access must be initiated by a licensed treating physician.

For additional information regarding this EAP or for other questions regarding Revolution Medicines investigational agents, physicians may contact: [email protected]

(Press release, Revolution Medicines, MAY 1, 2026, View Source [SID1234665009])

On May 1, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the publication of Phase 1 clinical data in Nature Cancer demonstrating the potential of the tumor-localized CD40 agonist, MP0317, to modulate the tumor microenvironment (TME). MP0317 is designed to activate immune cells specifically within the TME by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

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The peer-reviewed paper published by Steehgs et al., entitled "Tumor-localized CD40 agonism with MP0317, a FAPxCD40 DARPin, reprograms the tumor microenvironment – results of a Phase 1 monotherapy study", reports the positive results from the completed Phase 1 dose escalation study of MP0317 (NCT05098405). The comprehensive biomarker data confirm proof-of-mechanism for MP0317, including tumor-localized activation of the CD40 pathway and evidence of TME remodeling in patients with advanced solid tumors. MP0317 displayed a favorable safety profile up to the highest tested dose and serum pharmacokinetics confirmed suitability for dosing either weekly or every three weeks. Of the 46 patients in the study, one patient achieved an unconfirmed partial response and 14 patients stable disease in this heterogeneous population with advanced diseases. Data were presented at the 2024 Annual Meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

"The Phase 1 data published in Nature Cancer demonstrate the promising ability of MP0317 to turn cold tumors hot by locally modulating the tumor microenvironment, while avoiding systemic toxicities often seen with untargeted CD40 agonists. These data support further clinical evaluation of MP0317 in combination with other immunotherapy modalities, such as checkpoint inhibitors," said coordinating investigator Philippe Cassier, M.D., Ph.D., of the Centre Léon Bérard in Lyon, France. "We are currently enrolling patients with cholangiocarcinoma in an investigator-initiated Phase 2 study of MP0317 in combination with standard of care chemotherapy and anti-PDL1 therapy, led by Prof. Christophe Borg, and look forward to assessing its clinical benefit for patients."

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 combined with standard-of-care (SoC) for the treatment of patients with advanced cholangiocarcinoma is now open with eight sites activated (NCT07036380) and patient dosing ongoing. The multicenter study aims to recruit 75 patients in France, randomized 2-to-1 with 50 patients in the experimental arm, and 25 in the control arm. The objective of the study is to assess the clinical benefit of MP0317 combined with SoC comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to SoC alone. The TME is known to play a crucial role in cholangiocarcinoma development and treatment resistance. MP0317 is hypothesized to lead to immune-mediated reshaping of the TME, thereby improving the 12-month progression-free survival rate of patients compared to those treated with SoC alone.

The publication in Nature Cancer is available online and accessible via the following URL: View Source

(Press release, Molecular Partners, MAY 1, 2026, View Source [SID1234665008])

On May 1, 2026 EORTC reported that the choice of treatment for patients with newly diagnosed, advanced classic Hodgkin lymphoma (cHL) is often based on local availability, preference and practice, rather than on the individual’s patient’s characteristics and risk profile. However, results from EORTC-1537-LYMG COBRA study published 01 May 2026 in The Lancet Haematology* show that a very early PET scan—performed after just one cycle of chemotherapy—can help personalise therapy. This approach enables more intensive treatment to be reserved for those who truly need it, sparing others from unnecessary side effects.

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Led by EORTC Lymphoma group, the COBRA study enrolled 150 patients aged 18–60 with newly diagnosed cHL across 16 centres in seven countries. The trial completed recruitment just short of the planned two-year timeframe, highlighting its operational success. All patients received an initial cycle with a chemotherapy regimen known as A-AVD, which combines the targeted agent brentuximab vedotin (BV) with standard cytostatic drugs. Following this, each patient underwent a centrally reviewed 18FDG-PET scan to assess early treatment response.

Patients whose scans were negative—indicating a good early response—continued with five additional cycles of A-AVD. Those with positive scans were switched to a more intensive regimen, BrECADD, for six cycles. The PET scans were centrally reviewed in real time by a panel of expert nuclear medicine physicians, ensuring consistent interpretation and guiding treatment for nearly all patients. This centralised approach enabled rapid decision-making and high protocol adherence.

The primary endpoint was modified progression-free survival rate at two years (2y mPFS), where relapse, progression, death or start of new treatment for cHL when not in complete remission at the end of protocol treatment were considered failures. After a median follow-up of 30.1 months, the 2y mPFS rate was 90% overall. Those who remained on A-AVD had a 2y mPFS rate of 88%, while those who switched to BrECADD achieved a 2y mPFS rate of 91%. Overall survival was 100%. The main side effects were neutropenia (a low white blood cell count), anaemia, and neurological symptoms in the hands and feet (peripheral sensory neuropathy). Serious adverse events occurred in 30% of patients, and no deaths were reported.

In addition to its clinical findings, the COBRA trial incorporated a robust translational research component. Serum samples were collected at multiple timepoints to measure levels of serum TARC (thymus and activation-regulated chemokine), a biomarker associated with treatment response. The study successfully demonstrated that early changes in TARC levels could further refine prognosis, particularly among patients with positive PET scans. This dual-modality approach—combining imaging and biomarker data—represents a significant step forward in personalised cancer care.

Furthermore, the trial implemented central expert review of radiotherapy (RT) plans for the small subset of patients (6%) who required RT. This quality assurance process led to treatment plan modifications in one-third of these cases, ensuring optimal and standardised care across participating centres.

"By assessing response after just one treatment cycle, we can identify which patients truly need treatment intensification and spare others unnecessary toxicity. This marks an important step towards more personalised therapy for advanced Hodgkin lymphoma." said Prof Martin Hutchings, principal investigator of the COBRA study, and past chair of EORTC Lymphoma group." Scanning patients after a single treatment cycle can accurately identify which patients need more intensive treatment, and is an important step along the road to personalised treatment for advanced cHL patients who are treated with BV-based chemotherapy. Our findings underline the importance of adopting PET-adapted strategies to minimise unnecessary toxicities as and when new treatments become available."

(Press release, EORTC, MAY 1, 2026, View Source [SID1234665007])

On May 1, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA mutant locally advanced or metastatic breast cancer ("ABC"), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results will be presented in a late-breaking abstract ("LBA") oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois.

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The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the "gedatolisib triplet") demonstrated a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing gedatolisib plus fulvestrant (the "gedatolisib doublet") versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.

Celcuity intends to submit these data to the U.S. Food and Drug Administration (the "FDA") as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

"Patients with PIK3CA mutant HR+/HER2- advanced breast cancer whose disease has progressed while on or after treatment with a CDK4/6 inhibitor typically derive modest benefit from subsequent therapies that target only PI3Kα or AKT," said Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutch Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head, Division of Hematology and Oncology, University of Washington, School of Medicine and co-principal investigator for the trial. "VIKTORIA-1 represents the first Phase 3 study to demonstrate that comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component of this pathway."

HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.

"These positive topline results demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with PIK3CA mutant HR+/HER2-advanced breast cancer," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "When considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient’s tumor."

The FDA has granted Priority Review of Celcuity’s New Drug Application ("NDA") for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type ("WT") ABC and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

"We believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR pathway. Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity," commented Brian Sullivan, Chairman, CEO and co-founder of Celcuity.

Mr. Sullivan added, "The implications of these results may extend beyond HR+/HER2- advanced breast cancer patients in the second-line setting, and we are working urgently to explore the development of gedatolisib for additional groups of patients whose cancers involve the PI3K/AKT/mTOR pathway."

Presentation Details

Presenting Author: Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine

Title: A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant advanced breast cancer (VIKTORIA-1 Study 2)

Abstract: LBA1008

Session Type/Title: Oral Abstract Session – Breast Cancer—Metastatic

Date and Time: June 2, 2026, 9:45 AM-12:45 PM CDT

Late-breaking abstracts accepted for an Oral Abstract Session at the ASCO (Free ASCO Whitepaper) Annual Meeting will be published online via the ASCO (Free ASCO Whitepaper) website on the day of presentation.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6 and PI3K/AKT/mTOR ("PAM"), are primary oncogenic drivers of HR+/HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for ABC. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA WT cohort of VIKTORIA-1 have been previously reported. For the PIK3CA mutant cohort, subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1 and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, MAY 1, 2026, View Source [SID1234665006])

On May 1 2026 Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), reported 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.

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"Today’s FDA approval is a transformative moment for Arvinas as we achieve our first approved medicine and the first-ever approved PROTAC therapy based on the technology we’ve pioneered since 2013," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "This milestone demonstrates that targeted protein degradation can translate into meaningful clinical impact. It also strengthens our confidence in the breadth and versatility of our exciting clinical pipeline across oncology, neurodegenerative, and neuromuscular diseases. We are especially encouraged by receiving FDA approval ahead of the June 5 PDUFA date and together with Pfizer, we are on track to announce selection of a third party to bring this new treatment option to patients as soon as possible."

"For patients living with ESR1 mutant, ER+/HER2 advanced breast cancer, there have been minimal second-line treatment options once standard therapies are no longer effective," said Erika Hamilton, M.D., Chief Development Officer, Late Phase, and Director, Breast Cancer Research, Sarah Cannon Research Institute, as well as a principal investigator of the VERITAC-2 trial. "The introduction of a new, targeted treatment is an encouraging development for this community and highlights meaningful innovation in the way this disease is treated. The approval of vepdegestrant gives clinicians another tool in the breast cancer treatment arsenal and brings renewed hope to individuals who need additional options."

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.

"The approval of VEPPANU is an important milestone for patients, their caregivers, and physicians," said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer at Arvinas. "VEPPANU addresses an unmet need for patients with this aggressive form of breast cancer who have progressed on their initial therapy. Today’s approval provides a new oral treatment option that showed improved progression free survival when compared to the current standard of care, fulvestrant, which is administered via an intramuscular injection."

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.

Arvinas was originally founded based on pioneering research at Yale University, where Professor Craig Crews, Ph.D., co-authored the first-ever paper on PROTAC protein degraders.

Please see below for the Important Safety Information for VEPPANU. Please see full U.S. Prescribing Information for VEPPANU here.

What is VEPPANU?
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.

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking VEPPANU?

All your medical conditions, including if you:
have heart failure or heart rhythm problems, including QTc prolongation, and long QTc syndrome
have low blood levels of potassium or magnesium
are pregnant or plan to become pregnant. VEPPANU can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider may do a pregnancy test before you start treatment with VEPPANU.
Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.
Males with female partners who are able to become pregnant:

Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.
are breastfeeding or plan to breastfeed. It is not known if VEPPANU passes into your breast milk. Do not breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VEPPANU and other medicines may affect the way each other works and may cause serious side effects.

What should I avoid while taking VEPPANU?
Avoid taking St. John’s wort, eating grapefruit, or drinking grapefruit juice during with treatment with VEPPANU.

What are the possible side effects of VEPPANU?
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. Get emergency medical help right away if you get any signs and symptoms of abnormal heart rhythm, including:
feeling lightheaded or faint
dizziness
feeling that your heart is pounding or beating fast (heart palpitations)
shortness of breath
chest pain
The most common side effects of VEPPANU include:

decreased white blood cell counts
increased liver function tests
muscle and bone pain
tiredness
decreased red blood cell counts
nausea
decreased potassium levels in your blood
decreased appetite
abnormal electrocardiogram (QT prolonged)
decreased platelet counts
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. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of VEPPANU.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

About the VERITAC-2 Clinical Trial
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.

About VEPPANU
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.

(Press release, Arvinas, MAY 1, 2026, View Source [SID1234665005])