Recent FDA Approval of Advanced Treatment for Patients with Metastatic Non Small-Cell Lung Cancer (NSCLC) Demonstrates Importance of Participation in Clinical Trials

Fort Myers, Fla., December 6, 2022 – A clinical study conducted with participation by Florida Cancer Specialists & Research Institute, LLC (FCS) has led to FDA approval of a new immunotherapy that improves chemotherapy treatment outcomes for patients with metastatic non small-cell lung cancer (mNSCLC). FCS medical oncologist Maen Hussein, MD, who served as a principal investigator and co-author of the study results, says this positive outcome demonstrates the vital importance of clinical trial participation by physicians and their patients.

“FCS is on the leading edge of improving cancer care and we will continue to do more, thanks to our robust clinical research capabilities,” said Dr. Hussein. “Across our statewide practice, FCS provides patients with the newest cancer therapies, some not yet available elsewhere, through convenient access to clinical trial opportunities,” said Dr. Hussein.

The National Institutes of Health estimates that less than five percent of cancer patients are currently enrolled in clinical trials. An active cancer researcher throughout his career, Dr. Hussein is committed to boosting physician and patient participation. “Clinical trials offer hope and enable our patients to live their very best quality of life,” said Dr. Hussein. “As medical oncologists, we are in the best position to educate our patients about the many benefits of participating.”

Gustavo A. Fonseca, MD, FACP, FCS Physician Director of Clinical Research, notes that the majority of new cancer drugs approved for use in the United States have been studied in clinical trials conducted by FCS, prior to approval. Dr. Fonseca and a robust team of clinical research experts based at FCS’ three early phase Drug Development Units and its regional late phase research offices coordinate Phase I – IV clinical trials at 36 FCS locations in Florida.

“Currently, across our practice, more than 160 trials are open to accrual for all forms of cancer,” Dr. Fonseca said. “FCS provides opportunities that are rarely available in a community setting. Our patients have access to the most promising treatment therapies close to home, provided by the team of medical professionals they know and trust.”

Dr. Hussein added, “Thanks to the positive outcomes achieved in our recent study, a new therapeutic option utilizing immunotherapy in the treatment of first-line non small-cell lung cancer is now available to patients across the United States. With expanded participation from our physicians and patients, FCS will continue to be part of cancer discoveries and the ongoing development of novel therapies. In turn, we are able to increasingly provide our patients with targeted and individualized treatment plans so that they achieve the best possible outcomes.”

Dr. Hussein continues, “the success of this trial, or the dozens occurring at any time at FCS, could not be possible without our patients. They, too, have a large impact on these significant advances in oncology care.”

The Phase III study, conducted between June 2017 and March 2021 and recently published in the Journal of Clinical Oncology, included adult patients receiving treatment at FCS clinic locations across Florida. The trial evaluated the efficacy and safety of the use of tremelimumab plus durvalumab and chemotherapy (T + D + CT) and durvalumab plus chemotherapy (D + CT) versus chemotherapy alone (CT) in patients with first-line metastatic non-small-cell lung cancer (mNSCLC). Tremelimumab and durvalumab are immune checkpoint inhibitor blockers, which use the body’s own immune system to find, target and fight many forms of cancer. FDA approval was announced based on the study’s positive outcomes.