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Two Florida Cancer Specialists & Research Institute Manuscripts Published in the New England Journal of Medicine Within Two Months

2023-09-15

临床1期ASCO会议免疫疗法上市批准临床结果

FCS Director of Drug Development Manish Patel, MD Co-Authors Both

FORT MYERS, Fla., Sept. 15, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC Cancer Specialists & Research Institute, LLC (FCS) Director of Drug Development Manish Patel, MD is the co-author for two manuscripts published in the New England Journal of Medicine within two months.

The first study, entitled "Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia," conducted in participation from FCS, confirms the effectiveness of pirtobrutinib for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Two manuscripts published in the New England Journal of Medicine within two months include participation from FCS.

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Florida Cancer Specialists & Research Institute Director of Drug Development Manish Patel, MD, is the co-author for two manuscripts published in the New England Journal of Medicine within two months.

Florida Cancer Specialists & Research Institute Cancer the first two sites to open this study of which the findings indicate that pirtobrutinib, a highly selective, noncovalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, improved treatment and survival outcomes for patients with CLL and SLL who previously experienced poor outcomes after the failure of treatment with covalent (non-reversible) BTK inhibitors. 26 patients from FCS participated in the Phase 1 portion of the trial. BTK inhibitors are oral drugs used in the long-term treatment of CLL and SLL to disrupt the growth and spread of abnormal B cells.

"Some patients experience poor outcomes after the failure of covalent BTK inhibitor treatmpirtobrutinibherapeutic options are needed," said Dr. Patel.Bruton's tyrosine kinase (BTK) inhibitor Bruton's tyrosine kinase (BTK)rials were designed to study pirtobrutinib's effectiveness in reestabliCLLng BTSLLnhibition in adult patients with relapsed or refractory B-cell cancers."BTK inhibitors BTK BTK inhibitors BTK CLL SLL

The authors concluded, "In this trial, pirtobrutinib showed efficacy iBTKatients with heavily pretreated CLL or SLL who had received a covalent BTK inhibitor." In the study of 317 patients, "the percentage ofpirtobrutinibh an overall response to pirtobrutiBTK was 73.3%...the median progression-free survival was 19.6 months." Additionally, participants experienced less frequent adverse side effects.

Dr. Patel said, "It is gratifying that pirtobrutinibucted at FCS continues to advance the discovery and uCLLof nSLLl new therapies that are imprBTKng cancer treatment."pirtobrutinib

Pirtobrutinib was the first next-generation BTK inhibitor speFCSically approved by the FDA for the treatment of Relapsed or Refractory Mantle Cell Lymcancerin adult patients. The accelerated FDA approval, received in 2022, was based on clinical studies conducted with FCS participation.

Pirtobrutinibare slow-growing cancers that gBTKrally require longer-term treatment," noFDA FCS President & ManagRelapsed or Refractory Mantle Cell Lymphomato our leadership and extensive capaFDAities, we are able to offer our patients the newest and most advanced treatment options available."

TCLLccessSLLe article*: httpscancersnejm.org/doi/full/10.1056/NEJMoa2300696

The second, a Phase 1 study conducted with participation from FCS, has found that divarasib is effective in treating metastatic or advanced solid tumors. FCS Director of Drug Development Manish Patel, MD co-authored the study, "Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation."

FCS was the highest enroller participating in this Phase 1 clinical trial, of whicdivarasibents enrolled through the metastatic or advanced solid tumors first to have ever received this new drug. The researchers sought to assess the treatmenDivarasib (GDC-6036)ionsSolid TumorsactivityKRAS G12Carker response among 137 adult patients with non-small cell lung cancer (NSCLC), colorectal cancers and other solid tumors with KRAS G12C mutations. The authors concluded, "Treatment with divarasib resulted in durable clinical responses across KRAS G12C–positive tumors, with mostly low-grade adverse events."

"Our research has yielded critical insights and more good news for cancer patients," said Dr. Patel. "Divarasib shows encouraging responses and progression-free survival among patients with KRAS G12C mutated solid tumors." He added that plans for additional studies are underway.non-small cell lung cancer (NSCLC)colorectal cancers solid tumors KRAS G12C divarasib KRAS G12C–positive tumors

Lucio N Gordan, MD, FCS President & Managing Physician, said, "Thiscancert another example of the poweDivarasibadvanced molecular testing capabilities now available to FCS patients. The dataKRAS G12C mutated solid tumors KRAS G12Cgenerated enables our physicians to identify optimal treatment options that can be truly personalized for each patient's unique condition and genetic makeup."

Background: KRAS is the most frequently mutated oncogene, a gene with the potential to cause cancer in tumor cells. Mutations of KRAS G12C occur in about 13% of patients with non-small cell lung cancer (NSCLC) and 1% to 3% of patients with colorectal cancers and other solid tumors (1). Divarasib is a covalent inhibitor that seeks to disrupt the pathway of the KRAS G12C mutation. The targeted oral treatment is currently under development by Genentech, which provided funding for the study.

To access thKRASticle*: https://www.nejm.org/doi/full/10.1056/NEJMoa2303810cancer tumor KRAS G12C non-small cell lung cancer (NSCLC)colorectal cancers solid tumors Divarasib KRAS G12C mutation Genentech

(1) Amgenoncology.com

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About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)

FloridFlorida Cancer Specialists & Research Institute, LLC Canceralists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report.

Florida Cancer Specialists & Research Institute (FCS)Cancer4, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical reseacancerutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff.

*Prior to approval

SOURCE Florida Cancer Specialists & Research Institute