FCS Contributing to Cutting-Edge Advancements in Hematology Science

Research Presented at Global Hematology Symposium

Fort Myers, Fla., December 11, 2023 – Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) will be among the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65^th Annual Meeting and Exposition in San Diego on Dec. 9 – 12, 2023.  Scientific abstracts submitted by FCS hematologists and medical oncologists are among the 7,000 accepted submissions selected through an extensive peer review process.

Manish Patel, MD, FCS Director of Drug Development, will present six oral and/or poster presentations reviewing the following research abstracts:

• Pirtobrutinib in Post-cBTKi CLL/SLL: ~30 Months Follow-up and Subgroup Analysis With/Without Prior BCL2i from the Phase 1/2 BRUIN Study
• Pirtobrutinib in Richter Transformation: Updated Efficacy and Safety Results with 18-Month Median Survival Follow-up from the Phase 1/2 BRUIN Study
• Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed / Refractory Marginal Zone Lymphoma: Results from Phase 1/2 BRUIN Study
• A First-in-Human Phase 1 Trial of NX-2127, a First-in-Class Bruton’s Tyrosine Kinase (BTK) Dual-Targeted Protein Degrader with Immunomodulatory Activity, in Patients with Relapsed/Refractory B Cell Malignancies
• Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed/Refractory Follicular Lymphoma: Results from the Phase 1/2 BRUIN Study;
• Fixed-Duration Pirtobrutinib Combined with Venetoclax ± Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia: Updated Results, Including MRD Data, from the BRUIN Phase 1b Study  
  

Of note, Dr. Manish Patel is co-author of multiple abstracts in recent years involving Pirtobrutinib, the first next-generation BTK inhibitor specifically approved by the FDA for adult patients with mantle cell lymphoma (MCL), a rare type of non-Hodgkin’s lymphoma (NHL) that affects about one in 200,000 people worldwide each year. Pirtobrutinib has also been approved for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). FCS was one of the first two sites participating in the first cohort of the initial Phase 1 dose trial, now considered a best-in-class targeted treatment for certain blood diseases.

“It is very exciting to be at the forefront of developing novel therapies, especially those that are proving effective for refractory blood cancers that are resistant or non-responsive to traditional treatments,” said Dr. Patel.

Additionally, the following FCS hematologists and medical oncologists will present abstracts in oral and/or poster sessions at the ASH Conference:

• FCS President & Managing Physician Lucio N. Gordan, MD, as first author, and Anjan J. Patel, MD, as co-author, – Systematic Literature Review and Meta-Analysis of Comparative Clinical Evidence Investigating Daratumumab, Lenalidomide, and Dexamethasone (DRd) versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) as First-line Treatment for Transplant-Ineligible Newly Diagnosed Multiple Myeloma
• Jennifer Cultrera, MD – Zanubrutinib in Acalabrutinib-Intolerant Patients with B-Cell Malignancies Clinically Relevant Abstract
• Judah Friedman, MD – Brentuximab Vedotin, Nivolumab, Doxorubicin and Dacarbazine for Advanced Stage Classical Hodgkin Lymphoma: Efficacy and Safety Results from the Single Arm Phase 2 Study
• Kapisthalam S. Kumar, MD, FACP – A 10 Year Analysis of Gender Distribution in National Institutes of Health Funding for Non-Malignant Hematology, and Design Characteristics and Risk of Bias of Pivotal Trials Supporting Approval of Hematological Drugs By FDA, 2008-2022: Cross Sectional Analysis
• Ke Ning, MD – Differential Host Response Contributing to Incidence of Arterial and Venous Thromboembolism at Index Hospitalization for Sars-Cov-2 Infection across Wuhan, Delta, Omicron and Omicron BA.x Variants
• Shachar Peles, MD –  Subcutaneous Mosunetuzumab Is Active and Has a Manageable Safety Profile in Patients with Previously Untreated, Low-Tumor Burden Follicular Lymphoma: Initial Results from the Phase II Morningsun Study

FCS Physician Director of Clinical Research Gustavo Fonseca, MD, FACP said, “The ASH Conference is the premier annual event that brings together top minds in the global hematology community. Once again, FCS is proud to have a strong presence, sharing the latest and most promising research and science that is moving the field forward.”

With more than 18,000 members from nearly 100 countries, ASH is the world’s largest professional society serving clinicians and scientists who are working to conquer blood diseases.

To view a comprehensive list of the abstracts and presentations at ASH, visit: https://www.hematology.org/meetings/annual-meeting.