Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025

On September 25, 2025 Pfizer Inc. (NYSE: PFE) reported it will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held October 17-21 in Berlin, Germany (Press release, Pfizer, SEP 25, 2025, View Source [SID1234656250]). Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer’s core scientific modalities and key tumor areas.

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"At ESMO (Free ESMO Whitepaper), Pfizer is demonstrating how earlier interventions with our innovative medicines have the potential to deliver greater impact to even more patients," said Jeff Legos, Chief Oncology Officer, Pfizer. "The survival benefits we’re seeing across certain cancer types reinforce our commitment to accelerating innovative medicines that bring new hope to patients everywhere, while pipeline data highlight the next wave of potential breakthroughs that could transform care for even more people living with cancer."

Pfizer will share highlights from its leading Oncology portfolio at ESMO (Free ESMO Whitepaper), including:

In a Presidential Symposium, unprecedented survival results from the Phase 3 EV-303 trial (KEYNOTE-905) evaluating PADCEV (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), plus KEYTRUDA (pembrolizumab)* in patients with muscle-invasive bladder cancer who are ineligible for or declined cisplatin-based chemotherapy, showing potential to redefine standard of care in these patients (Presentation #LBA2)
Final overall survival results from the Phase 3 EMBARK trial evaluating XTANDI (enzalutamide)** in combination with leuprolide and as monotherapy in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence, highlighting the benefit of XTANDI in this earlier line of treatment (Presentation #LBA87)
Updated overall survival data from the Phase 2 PHAROS study of BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib)*** in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC), reinforcing this combination as a potential key treatment option for these patients (Presentation #1849MO)
Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here.

Presentation Title

Details

Genitourinary Cancer

Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study [Merck/MSD-led]

Vulsteke et. al

Presidential Symposium (Presentation #LBA2)

Saturday, October 18, 2025, 4:30 PM CEST

Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression [Remegen-led]

Sheng et. al

Presidential Symposium (Presentation #LBA7)

Sunday, October 19, 2025, 4:30 PM CEST

Overall survival with enzalutamide in biochemically recurrent prostate cancer

Freedland et. al

Oral Presentation (Presentation #LBA87)

Sunday, October 19, 2025, 10:55 AM CEST

Randomised phase 3 trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303)****

Nguyen et. al

Oral Presentation (Presentation #LBA86)

Sunday, October 19, 2025, 10:15 AM CEST

Thoracic Cancer

Updated overall survival analysis from the phase 2 PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC)

Johnson et. al

Mini Oral Presentation (Presentation #1849MO)

Sunday, October 19, 2025, 8:30 AM CEST

Enfortumab vedotin plus pembrolizumab (EV + P) as first-line (1L) treatment in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): results from a cohort of the EV-202 trial [Astellas led]

Swiecicki et. al

Mini Oral Presentation (Presentation #1329MO)

Sunday, October 19, 2025, 4:30 PM CEST

Breast Cancer

Health-Related Quality of Life (HRQoL) from the PATINA Trial (AFT-38): Impact of Adding Palbociclib to HER2 and Endocrine Therapy (ET) after Induction in HR+/HER2+ Metastatic Breast Cancer (MBC)

Ines Vaz-Luis et. al

Mini Oral Presentation (Presentation #485MO)

Monday, October 20, 2025, 10:15 AM CEST

Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)−advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial*****

Campone et. al

Mini Oral Presentation (Presentation #489MO)

Monday, October 20, 2025, 10:15 AM CEST

Gastrointestinal Cancer

Circulating tumor (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER******

Kopetz et. al

Mini Oral Presentation (Presentation #729O)

Monday, October 20, 2025, 08:30 AM CEST

Cancer-Related Conditions

Efficacy and safety of ponsegromab in patients with cancer-associated cachexia: Results from the open-label extension of a randomized, placebo-controlled, Phase 2 study

Oral Presentation (Presentation #LBA102)

Friday, October 17, 2025, 4:00 PM CEST

Taiho Pharmaceutical Enters Into Exploratory Collaboration with Guardant Health to Accelerate the Development of Therapies for Early-Stage, Recurrent Cancer Using Multimodal Real-World Data Including Genomic Profiling of MRD (Minimal Residual Disease)

On September 23, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical"), reported a collaboration agreement with Guardant Health, Inc. (hereinafter "Guardant Health") to discover new biomarker signatures by leveraging Guardant Health’s "GuardantINFORMTM" platform for multimodal analysis of real-world data (Press release, Taiho, SEP 24, 2025, View Source [SID1234656173]).

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This collaboration aims to discover new biomarker signatures with clinical and biological significance for addressing unmet needs in early-stage recurrent cancer, where the presence of microscopic cancer cells remaining in the body after surgery is a cause of recurrence. This collaboration leverages unique multimodal and longitudinal cohorts within GuardantINFORM, including those with minimal residual disease (MRD) testing.

This initiative is expected to support the development of treatments for patients at high risk of recurrence and lead to new and clinically relevant approaches enabling medical interventions at an early stage of cancer. The collaboration has an overarching goal of driving significant progress in overcoming cancer.

Taiho Pharmaceutical has a strong track record of developing multiple investigational and approved drugs in Japan, the US, and Europe by utilizing its proprietary "Cysteinomix drug discovery" which enables the creation of drugs that bind specifically and strongly to drug targets. By further analyzing the novel gene signatures identified through this collaboration and integrating these insights with the Cysteinomix drug discovery platform, we anticipate substantial potential to develop precise and effective treatment approaches for new drug targets that were previously difficult to discover.

Takeshi Sagara, Taiho Pharmaceutical’s Executive Director, Clinical Development and Medical Affairs, Discovery & Preclinical Research, said, "We believe that future anticancer drug discovery focusing on research and development not only for advanced cancer but also for early-stage recurrent cancer, with an eye on the patient’s journey, will lead to long-term survival and ultimately the overcoming of cancer. Through our collaboration with Guardant Health, we aim to identify and develop biomarker signatures, that arise in early-stage recurrence and contribute to the creation of next-generation treatment methods."

About Cysteinomix Drug Discovery
Cysteinomix drug discovery is Taiho Pharmaceutical’s original drug discovery technology designed to continuously generate covalent drugs targeting a variety of proteins that contain cysteine. Covalent drugs are pharmaceuticals that irreversibly control the function of target proteins by forming covalent bonds with them. These drugs consist of a ligand that binds to a protein pocket and a reactive group that forms a covalent bond with a specific amino acid. The Cysteinomix drug discovery platform is composed of a target protein database, a covalent compound library, and various compound evaluation systems, among other components. To date, this platform has successfully led to the creation of several pipelines.

Kura Oncology to Participate in Upcoming Investor Conference

On September 24, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that management is scheduled to participate in the following investor conference (Press release, Kura Oncology, SEP 24, 2025, View Source [SID1234656198]).

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UBS Virtual Oncology Day
Wednesday, October 1, 2025
2:30 p.m. ET / 11:30 a.m. PT

A live audio webcast will be available in the Investors section of Kura’s website at View Source, with an archived replay available following the event.

ITM and TerThera Sign Supply Agreement for Medical Radioisotope Terbium-161

On September 24, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and TerThera BV, a leading provider of GMP-grade Terbium-161, reported a supply agreement for non-carrier-added (n.c.a.) Terbium-161 (Tb-161), a novel medical radioisotope with distinct chemical properties and emerging potential in radiopharmaceutical therapy. Under the terms of the agreement, TerThera will supply Good Manufacturing Practice (GMP)-compliant n.c.a. Tb-161 to ITM to support the development of its Terbium-based pipeline candidates, complementing ITM’s established manufacturing capabilities in cooperation with the Paul Scherrer Institute (PSI).

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"Driving innovation across isotopes, targeting molecules and cancer indications keeps ITM at the forefront of the rapidly evolving radiopharmaceutical industry," said Dr. Andrew Cavey, CEO of ITM. "We see strong potential in Terbium-161 as a critical new isotope for targeted radiopharmaceutical therapy, and our partnership with TerThera will allow us to advance its use in our pipeline. With supply of Terbium-161, we are well-positioned to harness its radiation properties to deliver meaningful advances for people living with cancer."

Currently, Tb-161-based radiopharmaceuticals are being clinically investigated for various types of cancers. Tb-161 is gaining attention in the radiopharmaceutical field for its unique emission profile. Like Lu-177, it emits medium-range beta particles and has a similar half-life. However, Tb-161 also emits low-energy Auger and internal conversion electrons, delivering highly localized radiation that can effectively target isolated cancer cells and micro-metastases with minimal off-target effects.

"As industry interest in Terbium-161 grows, a safe and sustainable supply of this radionuclide is crucial to support the development of new treatment options and strategies and we see this as our core mission," added Philippe van Overeem, CEO of TerThera. "ITM is a true innovator in the dynamic radiopharmaceutical field and we look forward to supplying them with our GMP-grade Terbium-161 as they advance their pipeline candidates and make progress in bringing the benefit of this valuable isotope to patients."

(Press release, ITM Isotopen Technologien Munchen, SEP 24, 2025, View Source [SID1234661163])

Veracyte Announces First Prospective Validation Data for Biomarker Predicting Hormone Therapy Benefit in Men with Recurrent Prostate Cancer Will Be Presented at ASTRO 2025

On September 24, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that the first prospective validation data for a molecular signature to predict hormone therapy benefit in men with recurrent prostate cancer will be presented at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology (Press release, Veracyte, SEP 24, 2025, View Source [SID1234656199]). The findings were derived using Veracyte’s Decipher GRID (Genomic Resource for Intelligent Discovery) research tool. The study is among nine Decipher-focused abstracts—including six selected for podium presentations—in prostate cancer that will be presented at the conference, being held September 27 to October 1 at the Moscone Center in San Francisco.

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"We look forward to the presentation of important new data examining the role of adverse molecular features in predicting disease progression and treatment response for patients with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Such insights will ultimately make prostate cancer care more precise, giving greater molecular dimension to the classification and treatment of the disease. We believe that our Decipher GRID research tool, combined with our extensive database of prostate tumor whole-transcriptome-derived genomic profiles—the largest of its kind in prostate cancer research—uniquely positions Veracyte to usher in the next generation of cancer diagnostics."

The following Decipher-focused presentations examining the role of adverse molecular features in prostate cancer are among those being presented at ASTRO 2025:

Title:

A Double-Blinded Placebo-Controlled Biomarker Stratified Randomized Trial of Apalutamide (APA) and Radiotherapy for Recurrent Prostate Cancer (NRG GU006, BALANCE trial) (LBA-04)

Presenter:

Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University

Format:

Podium

Date/Time:

Sunday, Sept. 28; 1:00-1:10 p.m. PDT

Room:

San Francisco Ballroom

Title:

Discordance of Adverse Molecular Features between the 22-Gene Genomic Classifier Score, Histologic Grade, and NCCN Risk Groups: Analysis of Over 200,000 Patients​ (Abstract #1116)

Presenter:

Michael Zelefsky, M.D., FASTRO, NYU Langone Laura and Isaac Perlmutter Cancer Center

Format:

Podium

Date/Time:

Wednesday, Oct. 1, 8:15-8:20 a.m. PDT

Room:

155/157

Information about all of the Decipher-related abstracts being presented at ASTRO 2025 can be found here. Meeting attendees can also visit Veracyte’s booth (#3001).

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found.