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Florida Cancer Specialists Expands Treatment Options Through Clinical Research

• FCS research is broadening treatment options for gastrointestinal and genitourinary cancers, presenting findings at ASCO® symposia. • Studies focus on targeted immunotherapies and molecular-based treatments, revealing critical discoveries in cancer care. • FCS's early-phase drug development units contribute to next-generation therapies for hematologic conditions, including blood cancers. • Real-world evidence studies from FCS are shaping the approach to managing hematologic diseases, improving treatments, and patient outcomes.

Florida Cancer Specialists & Research Institute (FCS) is advancing cancer treatment through extensive clinical research, presenting significant findings at major oncology and hematology conferences. The research spans gastrointestinal (GI) and genitourinary (GU) cancers, as well as various blood cancers, offering new hope for patients with these challenging diseases.

Advancements in GI and GU Cancers

FCS medical oncologists and hematologists presented research at the ASCO® 2025 Gastrointestinal Cancers Symposium. Key studies included:
  • NALIRIFOX in Metastatic Pancreatic Cancer: A post hoc analysis of the NAPOLI 3 trial examined the effect of dose adjustments on overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with NALIRIFOX.
  • Muzastotug (ADG126) in MSS CRC: An update on a phase 1b/2 study of muzastotug, an anti-CTLA-4 SAFEbody, in combination with pembrolizumab in advanced/metastatic microsatellite stable colorectal cancer (MSS CRC).
  • XTX101 in Advanced Solid Tumors: Results from a Phase 1/2 study of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with advanced solid tumors and MSS CRC.
  • BBI-355 in Esophageal and Gastric Cancers: Preclinical and phase 1/2 data of the CHK1 inhibitor BBI-355 in development for esophageal and gastric cancers (EGC) with EGFR or FGFR2 amplifications.
At the ASCO® 2025 Genitourinary Cancers Symposium, research included a Phase I dose-escalation study of CRB-701 (SYS6002), a next-generation nectin-4 targeting antibody-drug conjugate, in patients with urothelial cancer and other solid tumors.

Breakthroughs in Blood Cancer Treatment

FCS also presented research at the American Society of Hematology (ASH) Annual Meeting. Studies highlighted included:
  • PRT543 in Myeloid Malignancies: A Phase Ib study of PRT543, an oral protein arginine methyltransferase 5 (PRMT5) inhibitor, in patients with relapsed or refractory, splicing factor-mutant myeloid malignancies.
  • AC676 in B-Cell Malignancies: A Phase 1 study of AC676, a novel BTK chimeric degrader, in patients with B-cell malignancies.
  • Belantamab Mafodotin in Multiple Myeloma: A subset analysis of belantamab mafodotin plus pomalidomide and dexamethasone versus pomalidomide plus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma who have received 1 prior line of therapy including lenalidomide.
  • Isatuximab in Multiple Myeloma: A Phase 2 study of subcutaneous isatuximab, administered by an on-body delivery system, in combination with weekly carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma.

Real-World Evidence

The FCS Real-World Evidence (RWE) team presented a study on frontline treatment patterns in patients with newly diagnosed multiple myeloma, utilizing data from a large community-based oncology practice network in the US.
According to FCS Chief Executive Officer Nathan H. Walcker, the research conducted across their statewide practice continues to be a driving force in the positive trends in the care and treatment of patients diagnosed with GI and GU cancers.
Manish Patel, MD, FCS Director of Drug Development, emphasized the importance of these studies in revealing critical new discoveries, particularly in targeted immunotherapies and molecular-based treatments. He also highlighted the recent FDA approval of revumenib, a drug for relapsed or refractory acute leukemia first administered to an FCS patient, showcasing the impact of their early-phase clinical research program.
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