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])

On October 21, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the addition of several key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612 ), notably Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. BriaCell anticipates reporting top line data as early as H1-2026.

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The extensive national effort already includes the following noteworthy clinics: Mayo Clinic, Los Angeles Cancer Network, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center.

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice of treatment in a dvanced metastatic b reast c ancer (Bria-ABC).

"We are encouraged by the strong engagement from major academic and leading community cancer centers which underscores confidence in BriaCell’s novel technology," stated Dr. William V. Williams, BriaCell’s President & CEO. "We expect the addition of these clinical sites will further accelerate patient enrollment in BriaCell’s pivotal Phase 3 study of Bria-IMT regimen in MBC and support our mission to bring this therapy to patients with significant unmet medical needs."

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, OCT 23, 2025, View Source [SID1234656938])

On October 23, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, reported that three abstracts featuring its investigational intravenous Deciparticle everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of Deciparticle and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.

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Sapu003 is a novel Deciparticle formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor-positive (HR )/HER2 metastatic breast cancer.

Presentation Details

Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST

Abstract Number Presentation Number Title
1834 PS4-04-04 High RICTOR / Low RPTOR Gene Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First in Human Trial
1702 PS4-04-21 Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811 PS4-06-05 Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer

"These three accepted abstracts underscore the breadth and innovation of our Deciparticle nanomedicine platform," said Dr. Vuong Trieu, CEO of Sapu Nano. "Sapu003 represents the first intravenous everolimus formulation with the potential to deliver robust mTOR inhibition and direct tumor cytotoxicity. We are honored to share these findings with the global oncology community at SABCS."

The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical-translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle everolimus.

(Press release, Oncotelic, OCT 23, 2025, View Source [SID1234656955])

On October 23, 2025 Hoffmann-La Roche reported strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised (Presentation, Hoffmann-La Roche, OCT 23, 2025, View Source [SID1234661652]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On October 22, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported that it will host a live webcast presentation on Thursday, October 23, 2025 at 1:30 p.m. Pacific Time to provide topline results from the registrational ChonDRAgon study investigating ozekibart (INBRX-109) as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma. The Company will also provide an update on the ongoing expansion trials investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx Biosciences, Inc. or the conference ID 9577647 when calling in. Following the webcast, the presentation may be accessed through a link on the investors section of Inhibrx’s website at View Source The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma.

Additionally, in Phase 1/2 trials, Inhibrx is investigating ozekibart in colorectal cancer in combination with FOLFIRI and Ewing sarcoma in combination with irinotecan/temozolomide, as well as other tumor types.

(Press release, Inhibrx, OCT 22, 2025, View Source [SID1234656904])