Jeff Allen

A cross-national review of novel oncology approvals in the United States and China (2020-2025)

Grace Collins, Divita Pandita, Hillary S. Andrews, Bernat Navarro-Serer et autres

Introduction: The United States and China are among the largest hubs for oncology drug development and commercialization. We conducted a comprehensive characterization of how the 2 largest oncology drug markets are evolving relative to one another, with implications for regulators, sponsors, clinicians, …

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Early Circulating Tumor DNA Dynamics Predict Overall Survival in Solid Tumors: A Landscape Assessment

Elena Levi-D’Ancona, Hillary S. Andrews, Grace Collins, Bernat Navarro-Serer et autres

PURPOSE Circulating tumor DNA (ctDNA) is an emerging biomarker for early, minimally invasive treatment response assessment, but heterogenous sampling schedules, assay methods, and molecular response (MR) definitions have slowed progress toward regulatory acceptance of ctDNA reductions as an early end point. METHODS …

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Assessing contribution of effect in oncology combination therapies: lessons learned to inform and optimize future registrational trial designs

Hillary Andrews, Raja Agnihotram, Gideon Blumenthal, J. Bruce Bullock et autres

Combination therapies can be used to significantly improve clinical outcomes in patients undergoing treatment for cancer; however, they also present challenges when establishing the contribution of effect (COE) for each component. Although factorial trials remain the most rigorous approach for determining COE, …

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Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images

Jeff Allen, Pedro A Torres-Saavedra, Santhosh Balasubramanian, Sarah Hersey et autres

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Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images

Brittany A. McKelvey, Pedro A Torres-Saavedra, J Li, Glenn Broeckx et autres

Historically, eligibility for receiving human epidermal growth factor receptor 2 (HER2)-targeted therapies was limited to HER2-positive tumors (immunohistochemistry 3+ or in situ hybridization amplified), but recent advances in antibody-drug conjugates have expanded these criteria to include HER2-low and HER2-ultralow expression. This evolving …

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Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery

Mark Stewart, Christopher R. Cabanski, Jeff Allen, John E. Connolly et autres

Genetically modified cell-based therapies hold transformative potential, particularly for patients with rare cancers and ultra-rare diseases. However, progress toward regulatory approval, reimbursement, and broad patient access is often constrained by misaligned regulatory, manufacturing, and financial frameworks that do not reflect the realities …

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Supplementary Data DS1 from Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies

Grace Collins, Mark Stewart, Brittany A. McKelvey, Hillary Stires et autres

Supplementary Data DS1 from Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies

Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program

Grace Collins, Jeff Allen, Hillary S. Andrews, Bernat Navarro-Serer et autres

BACKGROUND: The Biomarker Qualification Program (BQP), formally established in 2016 under the 21st Century Cures Act, is a key pathway for developing novel biomarkers for regulatory use. We evaluated eight years of BQP experience to assess whether it has facilitated the qualification …

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Molecular response cutoffs and ctDNA collection timepoints influence on interpretation of associations between early changes in ctDNA and overall survival in patients treated with anti-PD(L)1 and/or chemotherapy

Hillary S. Andrews, Névine Zariffa, Katherine K. Nishimura, Yu Deng et autres

BACKGROUND: Circulating tumor DNA (ctDNA) is a promising intermediate end point for oncology drug development, potentially accelerating regulatory approvals by providing early insights into treatment response. However, challenges remain in standardizing ctDNA assessment, including optimal blood collection timing and defining molecular response …

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Abstract P2-02-18: Agreement Across 10 Artificial Intelligence Models in Assessing HER2 in Breast Cancer Whole Slide Images: Findings from the Friends of Cancer Research Digital PATH Project

Brittany A. McKelvey, Pedro A. Torres‐Saavedra, Jessica Li, Glenn Broeckx et autres

Abstract Recent successes of HER2 antibody-drug conjugates (ADCs) have expanded patient eligibility for HER2-targeted therapy; therefore, accurate and consistent identification of patients who may benefit from ADCs is more critical than ever. Previous studies of agreement between pathologists highlight areas of discordance, …

Data from ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials

Hillary S. Andrews, Névine Zariffa, Katherine K. Nishimura, Stephanie H. Choi et autres

AbstractPurpose: Circulating tumor DNA (ctDNA) holds promise as an early endpoint to predict overall survival (OS). The creation and structured interrogation of aggregated datasets inform the hypothesis that ctDNA is reasonably likely to predict treatment benefit. Friends of Cancer Research convened a …

Supplementary Table S1 from ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials

Hillary S. Andrews, Névine Zariffa, Katherine K. Nishimura, Stephanie H. Choi et autres

Supplementary Table S1. Clinical trials included in the analysis. This table summarizes the clinical trials included in the analysis, detailing the study name, sponsor, trial type, tumor type, treatment, and ctDNA assay used. References to the original trial publications are also provided.