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Flatiron Health Announces 12 Abstracts Accepted to Be Presented at ISPOR Europe 2025

On October 23, 2025 Flatiron Health reported its presence at ISPOR—The Professional Society for Health Economics and Outcomes Research Europe 2025 Conference, set to take place November 9-12 in Glasgow, Scotland, UK. Flatiron’s real-world data is featured across more than 18 pieces of research to be presented at the conference, including two Top 5% Award acceptances and ten other Flatiron-authored abstracts. Additionally, Flatiron will participate in a workshop on the opportunities and challenges of transportability analyses in the context of European Union Joint Clinical Assessments.

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"The studies we’re showcasing at ISPOR Europe represent years of methodological advancement enabled by our unique combination of data depth and scientific rigor," said Nathan Hubbard, Chief Executive Officer, Flatiron Health. "Our research teams and collaborators have demonstrated the true potential of real-world data—pioneering new approaches to real-world evidence that address the most challenging questions in oncology research. From transportability studies to bias assessment in AI-extracted data, we’re advancing the science of what real-world data can achieve."

In addition to novel multi-country analyses enabled by Flatiron’s robust multinational real-world data from the US, the UK, Germany, and Japan, the Flatiron FORUM (Fostering Oncology RWE Uses and Methods) research consortium is addressing gaps in representative, locally-available data by bringing together biopharma and academic partners to collaboratively advance a portfolio of research studies focused on the transportability of oncology data across borders.

Research highlights include:

a Top 5% Award Poster presentation assessing if survival outcomes were transportable between the US and Austria, highlighting the challenges of applying RWE across different healthcare settings, as evidenced by the significant differences in survival outcomes between the US and Austrian datasets.
a Top 5% Award Poster presentation comparing patient characteristics and first-line treatment patterns in mNSCLC using the Flatiron Health Research Database and French ESME database providing findings crucial for guiding population adjustment in transportability analyses of real-world outcomes between countries.
a Poster presentation exploring the use of electronic health records (EHRs) to monitor liver function tests in patients with breast cancer treated with CDK4/6 inhibitors across the UK, Germany, and Japan, underscoring the potential of EHRs to enhance drug safety surveillance.
Schedule a meeting with Flatiron Health at ISPOR Europe 2025 and follow Flatiron Health on X and LinkedIn for more updates from #ISPOREurope.

Abstracts and Poster Presentations

Are Real-World Survival Outcomes in Metastatic Breast Cancer Transportable Between the US and Austria?
TOP 5% FINALIST
Harlan Pittell, Uwe Siebert, Per-Olof Thuresson, Lu Chen, Carol Hawkes, Danalyn Byng, Gabriel Rinnerthaler, Simon Peter Gampenrieder, Richard Greil, Mohamed Ali, Philani Mpofu, Elsie Horne, Qianyi Zhang, Amit Samani, Blythe Adamson
Author Affiliations: Flatiron Health, UMIT TIROL, Daiichi Sankyo, Roche, AGMT, Paracelsus Medical University
Poster Session 4
Poster Code: HTA38
Poster Session Date/Time: Tuesday, 11 November, 16:00 – 19:00

Descriptive Comparison of Patient Characteristics and Treatment Patterns in Metastatic NSCLC: US and France Cohorts to Inform Transportability
TOP 5% FINALIST
Alison Antoine, Mathieu Robain, Philani Mpofu, Elsie Horne, Harlan Pittell, Qianyi Zhang, Amit Samani, Per-Olof Thuresson, Thomas Filleron, Matthieu Carton, Olga Tymejczyk, Marian Eberl, Maurice Pérol, Christos Chouaid, Nicolas Girard, Didier Debieuvre, Xavier Quantin, Hervé Léna, David Pérol, Blythe Adamson
Author Affiliations: Flatiron Health, Unicancer, Institut Claudius Régaud, PSL Research University, Daiichi Sankyo, Centre Léon Bérard, CHI Créteil, Institut Curie, Groupe hospitalier de la région de Mulhouse Sud Alsace, CHU Montpellier, CHU Rennes
Poster Session 2
Poster Code: RWD56
Poster Session Date/Time: Monday, 10 November, 16:00 – 19:00

Comparing Countries’ Time to Treatment Initiation: A Study of Metastatic Breast Cancer in Austria and the United States
Harlan Pittell, Mohamed S. Ali, Philani Mpofu, Elsie Horne, Per-Olof Thuresson, Qianyi Zhang, Amit Samani, Blythe Adamson
Author Affiliations: Roche, Flatiron Health
Poster Session 1
Poster Code: HSD26
Poster Session Date/Time: Monday, 10 November, 10:30 – 13:30

Advancing Real-World Evidence in Diffuse Large B-Cell Lymphoma: Insights from EHR-Derived Data in the UK
Elsie Horne, Christoph Buhl, Tamra Downing, Harlan Pittell, Blythe Adamson
Poster Session 1
Poster Code: HSD4
Poster Session Date/Time: Monday, 10 November, 10:30 – 13:30

Assessing Bias in LLM-Extracted Real-World Data: A Health Equity Analysis of Access to Care and Outcomes in Metastatic Breast Cancer
Olive Mbah, Gene Ho, Catherine Keane, Qianyu Yuan, Cleo Ryals
Poster Session 1
Poster Code: MSR39
Poster Session Date/Time: Monday, 10 November, 10:30 – 13:30

Fit-for-Purpose Real-World Data: Lessons from FDA QCARD and EMA Data Quality Framework
Angela Chen, Lockwood Taylor, Lou Palladino, Vanessa Maniuszko
Poster Session 2
Poster Code: HPR96
Poster Session Date/Time: Monday, 10 November, 16:00 – 19:00

Laboratory Testing Patterns in Patients with Breast Cancer Treated With CDK4/6 Inhibitors: A Multi-Country Electronic Health Record Study From the UK, Germany, and Japan
Elsie Horne, Amit Samani, Sascha van Bömmel-Wegmann, Blythe Adamson, Lockwood Taylor
Poster Session 3
Poster Code: SA59
Poster Session Date/Time: Tuesday, 11 November, 10:30 – 13:30

Incidence of Neutropenia Adverse Events Identified in Electronic Health Care Records Among Initiators of CDK4/6 Inhibitors With Advanced Breast Cancer in the UK
Lockwood Taylor, Elsie Horne, Amit Samani, Qianyu Yuan, Sascha van Bömmel-Wegmann, Blythe Adamson
Poster Session 3
Poster Code: EPH143
Poster Session Date/Time: Tuesday, 11 November, 10:30 – 13:30

Real-World Insights into Prostate Cancer Management Using EHR-Derived Data from the UK
Elsie Horne, Amit Samani, Arun Sujenthiran, Tamra Downing, Deepika Singh, Harlan Pittell, Blythe Adamson
Poster Session 4
Poster Code: RWD161
Poster Session Date/Time: Tuesday, 11 November, 16:00 – 19:00

Real-World Insights Into Breast Cancer in the UK: Findings From UK EHR-Derived Data
Amit Samani, Mohamed Ali, Arun Sujenthiran, Blythe Adamson
Poster Session 5
Poster Code: RWD159
Poster Session Date/Time: Wednesday, 12 November, 9:00 – 11:30

Real-World Study of Breast Cancer Epidemiology and Treatment Patterns: A Pilot Study to Assess EHR-Derived Data in the United Kingdom
Peter McMahon, Kevin Nolan, Natalia Sadetsky, Matthew Hodgeson, Blythe Adamson, Amit Samani
Author Affiliations: Gilead Sciences, Flatiron Health
Poster Session 5
Poster Code: RWD163
Poster Session Date/Time: Wednesday, 12 November, 9:00 – 11:30

Transportability of Overall Survival in Multiple Myeloma From the US to Germany: A Benchmarking Study
Elsie Horne, Marco DiBonaventura, Per-Olof Thuresson, Felipe Castro, Christoph Buhl, Mohamed S. Ali, PharmD, Harlan Pittell, Philani Mpofu, Blythe Adamson
Author Affiliations: Pfizer, Roche, Flatiron Health
Poster Session 5
Poster Code: HTA340
Poster Session Date/Time: Wednesday, 12 November, 9:00 – 11:30

(Press release, Flatiron Health, OCT 23, 2025, View Source [SID1234656970])

BostonGene to Highlight Omnimodal AI Innovations for Precision Oncology at the 21st Annual Precision Oncology & RadMed Symposium

On October 23, 2025 BostonGene, developer of the leading AI foundation model for cancer and the immune system, reported its participation at the 21st Annual Industry/Academia Precision Oncology & RadMed Symposium, where global leaders in life sciences will explore the latest innovations in AI and immuno-oncology, molecular imaging, targeted therapies and more. The event will be held on November 5 at The Alexandria at Torrey Pines Conference Center in San Diego, California.

During the symposium, BostonGene will present "Omnimodal AI for Precision Oncology: Integrating Data to Drive Discovery." The presentation will highlight how BostonGene’s foundation model integrates genomic, transcriptomic, immune and clinical data to generate biologically grounded insights that drive discovery, inform therapeutic development and improve patient outcomes. Through real-world applications and case studies, BostonGene will demonstrate how AI-driven integration of complex molecular and clinical datasets accelerates biomarker discovery, identifies novel therapeutic targets and supports patient stratification strategies that enhance trial design and translational success.

"The 21st Annual Industry/Academia Precision Oncology & RadMed Symposium provides a unique opportunity to highlight how omnimodal AI is reshaping the way we approach cancer research and treatment," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By integrating diverse biological and clinical data types, BostonGene’s solutions deliver the insights necessary to match patients with the right therapies, de-risk development and accelerate drug development."

To learn more or to schedule a meeting with BostonGene during the event, please contact Hannah Oman at [email protected]. For additional details, visit the 21st Annual Industry/Academia Precision Oncology & RadMed Symposium website.

(Press release, BostonGene, OCT 23, 2025, View Source [SID1234656969])

Nuvation Bio Enrolls First Patient in Global, Randomized Study of Safusidenib for Maintenance Treatment of High-Grade IDH1-Mutant Glioma

On October 23, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported enrollment of the first patient into part 2 of G203 (NCT05303519), a global, randomized study evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-grade IDH1-mutant astrocytoma following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1.

"Following surgery and standard-of-care treatment, these patients and their healthcare providers are left to watch and wait for progression or recurrence," said Dr. Katherine Peters, professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center at Duke Cancer Institute and a trial investigator. "Patients with this form of glioma need effective, well-tolerated options that can further delay this eventuality. Safusidenib has shown promising activity in a Phase 1 study of patients with recurrent or progressive high-grade IDH1-mutant gliomas, with higher response rates than other IDH inhibitors have demonstrated in this setting. We look forward to further studying its potential in this trial."

A protocol amendment is in progress to finalize G203 as a global Phase 3 study by increasing the study size to support potential regulatory approvals. Based on this amendment, which has been aligned on with the U.S. Food and Drug Administration (FDA), G203 part 2 is now enrolling approximately 300 patients with newly diagnosed IDH1-mutant astrocytoma—either grade 3 with high-risk features or grade 4—in the U.S., Australia, and China. Following resection, radiation or chemoradiation, and adjuvant chemotherapy, patients will be randomized 1:1 to receive 250 mg safusidenib or placebo twice daily. The primary endpoint is progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0; FDA agreed that the primary endpoint of PFS could support full approval in this setting. Secondary endpoints include overall survival, PFS as assessed by the investigator, objective response rate, and duration of response, among others.

"No targeted therapies have been approved to delay recurrence or progression in these patients, who are dealing with an aggressive disease that inevitably returns," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With our first patient now enrolled in the U.S., we look forward to expanding the study into additional sites to support potential registration, as we continue our commitment to bringing therapies with meaningful clinical benefits to more patients with cancers that have severe unmet treatment needs."

Nuvation Bio will provide further updates on the progress of the safusidenib program in the upcoming earnings call on November 3, 2025.

About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, prognosis worsens for those with high grade tumors.

About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. In a Phase 1 clinical study, safusidenib was well-tolerated and demonstrated anti-tumor activity and high blood-brain barrier penetration.

(Press release, Nuvation Bio, OCT 23, 2025, View Source [SID1234656968])

Immunome Presents Preclinical Data Showing Proprietary TOP1i ADC Payload HC74 Overcomes Multiple Mechanisms of ADC Resistance

On October 23, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported preclinical data showing its proprietary antibody-drug conjugate (ADC) payload HC74 overcomes multiple mechanisms of ADC resistance, including payload efflux and target heterogeneity.

HC74 is a novel topoisomerase I inhibitor that serves as the payload in IM-1021, a ROR1-targeted ADC currently in a Phase 1 trial for solid and liquid tumors, and as the payload in several preclinical candidates within the Immunome pipeline.

The data were presented on Oct. 23, 2025, in a poster entitled "HC74, a novel topoisomerase I inhibitor payload for antibody-drug conjugates that overcomes multi-drug resistance" at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston.

Highlights of the poster include:

Over-expression of drug efflux transporters such as ABCC1 and ABCB1 drives primary and acquired resistance to approved ADC payloads and standard chemotherapies but not to HC74
HC74 exhibits high membrane permeability, leading to enhanced cytotoxicity and robust bystander activity
ADCs incorporating HC74 show meaningful efficacy in multiple preclinical tumor models, including:
Colorectal cancer refractory to trastuzumab-DXd and irinotecan
Models with acquired resistance to trastuzumab-DXd
Non-small cell lung cancer with heterogenous target expression
"HC74 is designed to overcome key limitations of existing ADC payloads," said Immunome’s Chief Scientific Officer, Jack Higgins, Ph.D. "Clinical data show high levels of efflux transporters and target heterogeneity can reduce ADC efficacy. We believe HC74’s ability to overcome those resistance mechanisms supports its potential as a best-in-class payload. We look forward to advancing IM-1021 and our broader HC74 pipeline."

A copy of the poster is available in the "Events & Presentations" portion of Immunome’s website.

(Press release, Immunome, OCT 23, 2025, View Source [SID1234656967])

CDR-Life Presents Early Clinical Data Demonstrating Pharmacodynamic Activity of CDR404, a Novel Antibody-Derived T Cell Engager Targeting MAGE-A4+ Solid Tumors

On October 23, 2025 CDR-Life, Inc., a biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, reported the first clinical data showing that CDR404, the company’s lead M-gager TCE, achieved all four canonical pharmacodynamic (PD) hallmarks of TCE activity in patients with MAGE-A4+ solid tumors. The data, presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), in Boston, Massachusetts, highlights CDR404’s robust immune activation and early signals of clinical activity, including tumor stabilization and biomarker improvements in patients with ovarian cancers and synovial sarcomas.

CDR404 is an antibody-based TCE designed to target intracellular tumor antigens presented on HLA molecules. It engages MAGE-A4 peptides displayed by HLA-A*02:01 on cancer cells and redirects CD3+ T cells for targeted tumor cell killing. The ongoing Phase 1 CDR404 trial (NCT06402201) is being conducted at leading cancer centers across the United States and Europe. Unlike conventional approaches utilizing T cell receptors, the proprietary M-gager platform leverages antibody-derived binding domains that combine exceptional specificity with strong potency, excellent developability and ease of manufacturing.

At initial dose levels of 100–200 μg, CDR404 triggered the full cascade of immune activation associated with effective TCE therapy, including CD8+ T cell activation and expansion, reprogramming to a memory phenotype and recruitment of lymphocytes into tumors. Notably, repeated dosing did not induce PD-1–mediated T cell exhaustion, suggesting sustained biological activity. In one patient, a transient tumor flare followed by stabilization was observed, which is consistent with tumor infiltration by cytotoxic T cells.

"These early data demonstrate that our M-gager platform can extend the precision and power of antibody-based T cell engagers to intracellular antigens, an area long thought to be accessible only to TCR-based modalities," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "Seeing all four pharmacodynamic hallmarks of activity in patients even at low doses underscores the potential of this approach to redefine how we target solid tumors."

The study’s first-in-human dose was guided by quantitative systems pharmacology modeling, enabling detection of pharmacodynamic effects more quickly than traditional approaches. Based on these encouraging signals, the trial will begin to focus on patients with MAGE-A4–positive ovarian cancers, a population with high unmet need.

Additional analyses, including integrated pharmacokinetic-pharmacodynamic and circulating tumor DNA (ctDNA) data, are ongoing.

Presentation Details:
Title:

Hallmarks of pharmacodynamic activity of CDR404, a new antibody-derived T cell engager (TCE) targeted against MAGE-A4+ solid tumors in HLA-A02:01+ patients

Presenter:

Melissa Vrohlings, Head of Translational Science, CDR-Life

Date and Time:

October 23, 2025 | 12:30 – 4 pm ET

Location:

Poster Session A

Level 2, Exhibit Hall D

In addition to the poster presentation on CDR404, CDR-Life is also presenting a poster on CDR609, the company’s newest T cell engager clinical candidate that targets LGR5, a highly cancer-specific cell surface antigen widely expressed on common solid tumors.

Presentation Details:

Title:

CDR609: A First-in-Class LGR5-targeted T Cell Engager for treatment of Colorectal Cancer and other solid tumors