On September 26, 2025 Novartis reported it will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin (October 17-21, 2025) (Press release, Novartis, SEP 26, 2025, View Source [SID1234656245]).

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"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, PhD, Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper) include:

Medicine Abstract title Abstract Number/
Presentation Details
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Phase 3 trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition) #LBA6
Presidential Symposium 2 (Proffered Paper session)
October 19, 2025
16:30 – 18:15 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Associations between quantitative baseline 68Ga-PSMA-11 PET parameters and 177Lu-PSMA-617 efficacy in the PSMAfore Study #2390P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Final analysis of patients treated with [177Lu]Lu-PSMA-617 in early access program in metastatic castration-resistant prostate cancer (mCRPC) in France #2389P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
[225Ac]-PSMA-617 PSMAcTION trial-in-progress: a phase 2/3 randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy #2516TiP
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes #LBA14
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST
Kisqali (ribociclib) Impact of neoadjuvant chemotherapy (NACT) response on clinical outcomes with ribociclib (RIB) in HR+/HER2− EBC: a subgroup analysis from the phase 3 NATALEE trial #366P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) A NATALEE data–based machine learning (ML) model to predict distant recurrence (DR) and treatment (tx) effect in real-world (RW) patients (pts) with HR+/HER2– early breast cancer (EBC) without CDK4/6 inhibitor (CDK4/6i) tx #372P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Real-world characteristics, treatments and outcomes of NATALEE and monarchE-eligible HR+/HER2- early breast cancer patients in the hospital district of Helsinki and Uusimaa (HUS), Finland #360P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Risk of Recurrence (ROR) After Neoadjuvant Ribociclib Plus ET in Clinically High-Risk ER+/HER2− BC: Preliminary Analysis of the SOLTI-RIBOLARIS Trial #296O
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST

On September 25, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib, an investigational, once-daily, oral menin inhibitor, in adult patients with relapsed/refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML) (Press release, Kyowa Hakko Kirin, SEP 25, 2025, View Source [SID1234656275]). Although newly diagnosed patients with NPM1-m AML have high response rates to approved standard of care, relapses are common and survival outcomes are poor. There is currently no approved therapy to specifically target NPM1-m AML. Ziftomenib is currently under priority review by the Food and Drug Administration (FDA) for treatment of R/R NPM1-m AML.

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"Relapsed or refractory NPM1-mutated AML remains very challenging to treat, particularly after venetoclax-based therapy or transplant," said Eunice Wang, M.D., Chief of Leukemia Service, Professor of Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY. "The manuscript describes deep responses, signals of clinical activity across relevant subgroups and a generally manageable tolerability profile, which is important in treatment of late line AML patients where accumulated toxicity can limit treatment options. The benefit-risk profile of ziftomenib is highly encouraging and, if replicated in additional treatment settings, has potential to be transformative for a large population of patients with menin pathway-driven AML."

"Publication in ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology is an important advancement for adult patients with NPM1-m AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "In addition to evidence of monotherapy activity, the safety and tolerability profile of ziftomenib from this trial is encouraging, marked by the absence of clinically meaningful QTc prolongation as well as low rates of both myelosuppression and treatment discontinuation. No clinically meaningful drug-drug interactions were observed, including with commonly used supportive-care medications, which may simplify co-administration in a polypharmacy setting. We continue to conduct studies in earlier line settings and in combination with multiple therapeutic agents in close collaboration with investigators, study teams and our partner Kyowa Kirin."

Summary of the published data
The publication, entitled "Ziftomenib in Relapsed or Refractory NPM1-Mutated AML", includes positive data from 92 adult patients with R/R NPM1-m AML in the phase 2 portion of the clinical trial as of the primary data cutoff date of October 28, 2024.

The KOMET-001 phase 2 trial met its primary endpoint with a complete remission with full or partial hematologic recovery (CR/CRh) rate of 22% (95% CI, 14 to 32; P=0.0058), which was significantly higher than the 12% historical standard-of-care response rate for patients with R/R NPM1-m AML. One additional response of CRh occurred after the primary analysis data cutoff resulting in a cumulative CR/CRh rate of 23% (95% CI, 15 to 33). 61% of evaluable CR/CRh responders were negative for measurable residual disease (MRD). Overall response rate (ORR) was 33% (95% CI, 23 to 43), with a median duration of overall response of 4.6 months (95% CI, 2.8 to 7.4).

Median overall survival (OS) was 6.6 months (95% CI, 3.6 to 8.6). Among ORR responders, median OS was 18.4 months (95% CI, 8.6 to not estimable) vs. 3.5 months (95% CI, 2.7 to 4.2) among non-responders. Two responders received subsequent allogeneic stem cell transplant and both resumed ziftomenib maintenance after transplant. At the time of data cutoff, nine patients (two after transplantation) remained on ziftomenib treatment. Prespecified subgroup analyses showed comparable CR/CRh rates regardless of lines of therapy, prior venetoclax exposure, or presence of co-mutations, including FLT3m or IDH1/2m.

Ziftomenib was well tolerated with a safety profile consistent with previously disclosed data. The most common grade ≥3 treatment-emergent adverse events were febrile neutropenia (26%), anemia (20%), and thrombocytopenia (20%). Differentiation syndrome occurred in 25% of patients (15% grade 3; no grade 4-5) and was manageable with protocol-defined mitigation. Three patients (3%) discontinued treatment because of ziftomenib-related adverse events.

These findings formed part of the data set used for the New Drug Application for ziftomenib as a potential treatment for patients with R/R NPM1-m AML. The FDA target action date is November 30, 2025. There is currently no FDA-approved treatment for patients with R/R NPM1-m AML.

"The publication of the investigational ziftomenib data adds important scientific context for clinicians and patients," said Takeyoshi Yamashita, Ph. D., Executive Vice President and Chief Medical Officer, Kyowa Kirin. "Together with Kura Oncology, we are committed to rigorous, globally coordinated evidence generation to support the benefit-risk profile of menin inhibition across the treatment landscape. Our shared goal is to advance development rapidly and generate the evidence needed to deliver ziftomenib to appropriate patients in need."

The publication is now available on the Journal of Clinical Oncology website and in the Scientific Manuscripts section on Kura’s website.

Ziftomenib is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.

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

On September 25, 2025 TAE Life Sciences (TLS), a global leader in advancing next-generation boron neutron capture therapy (BNCT), and the University of Wisconsin–Madison (UW) reported to have signed a memorandum of understanding (MOU) announcing the intention to launch the first accelerator-based BNCT center in the United States (Press release, TAE Life Sciences, SEP 25, 2025, View Source [SID1234656249]). As part of this collaboration, UW would install the Alphabeam compact accelerator-based BNCT system developed by TAE Life Sciences. This significant milestone has the potential to pave the way for the adoption of BNCT in the United States.

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As part of this proposal, UW and TAE Life Sciences will collaborate on research and development of Alphabeam and novel boron-10 drugs through pre-clinical and clinical studies on several cancer indications with high unmet need, including brain and head and neck cancers. Available in Japan, and currently being evaluated in clinical trials in several other countries, BNCT is a cutting-edge cancer treatment that selectively targets cancer cells while minimizing harm to healthy tissue. TAE Life Sciences, with its compact accelerator-based neutron source and novel targeted boron-10 drug development, is the only company to have a comprehensive BNCT solution that replaces earlier challenges with nuclear reactor-based BNCT and has the potential to establish accelerator-based BNCT as a mainstay cancer treatment in the United States. This announcement further builds upon the success TAE Life Sciences has had deploying its technology globally. To date, the company has installed its neutron beam system in China’s Xiamen Humanity Hospital, which is currently running human clinical trials, and its Alphabeam will soon be installed at Italy’s National Center of Oncological Hadrontherapy (CNAO).

"Our collaboration with the esteemed University of Wisconsin–Madison underscores the growing momentum and recognition of BNCT as a transformative cancer therapy," stated Robert Hill, Chief Executive Officer of TAE Life Sciences. "By working closely with UW and the University of Wisconsin Carbone Cancer Center, a leading cancer center renowned for its commitment to innovation, we aim to revolutionize the landscape for cancer treatment, and make even the most challenging cancers treatable with minimal side effects."

Alphabeam is a patented neutron source developed for clinical BNCT that offers a breakthrough approach to cancer treatment. This combinational therapy utilizes targeted boron-10 drugs and low-energy neutrons to destroy tumors with no damage to healthy tissues. With this system, patients can undergo a short, minimally invasive treatment in just one or two sessions, providing a streamlined alternative to traditional cancer therapies.

"Today marks a significant milestone in the field of oncology in the United States," said Dr. Zachary Morris, Chair and Paul Harari Professor of Human Oncology at the University of Wisconsin School of Medicine and Public Health. "Our collaboration with TAE Life Sciences brings together our expertise in clinical radiation medicine, translational research, and theranostics with the accelerator-based BNCT system, enabling us to harness the full potential of this advanced cancer treatment. Together, we aim to accelerate the development and clinical implementation of this therapy, ultimately providing patients with what we hope will be a markedly improved cancer treatment option that is currently not available anywhere else in North America."

The Alphabeam BNCT system and novel boron-10 drugs are for research purposes and not available for sale.

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On September 25, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the successful manufacture of its first clinical cell product using lentiviral vector supplied by Miltenyi Bioindustry, a dedicated CDMO division of Miltenyi Biotec (Press release, Verismo Therapeutics, SEP 25, 2025, View Source [SID1234656248]). The batch was produced for STAR-101, a Phase 1 clinical trial evaluating Verismo’s lead pipeline SynKIR-110 targeting mesothelin. This marks a major milestone in the clinical trial and lays the groundwork for later-stage development of SynKIR-110 for the treatment of solid tumors.

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This collaboration ensures a reliable supply chain and is an important step in preparation for Phase 2 and beyond, including use in commercial applications. Miltenyi Bioindustry is a leader in translating gene-edited cell therapy products into the clinic, including design, construction, and production of lentiviral vectors, from research through GMP manufacturing.

"Our collaboration with Miltenyi Bioindustry plays a key role as we scale our programs," said Dr. Bryan Kim, CEO of Verismo Therapeutics. "This partnership reflects Verismo’s commitment to ensuring manufacturing continuity and Phase 2 clinical readiness."

Stefan Miltenyi, founder and CEO at Miltenyi Biotec, added: "We’re proud to continue supporting Verismo’s efforts with our viral vector platform. Their work in next-generation CAR T therapies reflects the innovation we strive to enable."