FDA approves cellular therapy, offering hope to more people with cancer

The Food and Drug Administration approved an adoptive cell therapy for adult patients with melanoma that has spread to other parts of the body (metastatic). It’s the first time a cellular therapy received approval to treat solid tumors and offers the potential to be used as a treatment for other solid cancers.  

The FDA gave fast-track approval to AMTAGVI (lifileucel), an autologous adoptive cell transfer therapy, based on the safety and efficacy results of a phase II clinical trial in patients with metastatic melanoma. Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, was among the first sites to enroll patients in this global study. 

“The approval of adoptive cellular therapy in patients with advanced melanoma after progression on checkpoint immunotherapy or targeted therapy represents a significant advance,” says Brendan Curti, M.D., medical director, Melanoma Program, Cytokine and Adoptive Immunotherapy, and Robert W. Franz Endowed Chair for Clinical Research at Providence Cancer Institute.

Dr. Curti was the principal investigator at Providence on the lifileucel study, known as LN-144. “It's taken a long time to learn how to manipulate a very complex [immune] system. But we're getting better at doing that in a way that helps our patients,” he says.

In a Journal of Clinical Oncology article, Dr. Curti and other LN-144 investigators found that "lifileucel demonstrated durable responses and addresses a major unmet need in patients with metastatic melanoma with limited treatment options after approved therapy.”

The FDA approval marks another milestone for Providence researchers whose decades of scientific and clinical research has culminated in harnessing the power of a patient’s own T cells as a living drug.

“This achievement is a testament to the vision of Dr. Walter Urba who has overseen the development of a worldclass team of scientists and physicians dedicated to unleashing the power of the immune system to cure cancer," says Bernard Fox, Ph.D., Harder Family Endowed Chair for Cancer Research and leader of the Molecular and Tumor Immunology Laboratory at Providence. 

Dr. Urba was recruited from the National Cancer Institute to establish a cancer program for Providence in Oregon in 1993. He serves as chief medical officer for Providence Cancer Institute and director of cancer research for the Earle A. Chiles Research Institute.

“Under Dr. Urba’s leadership, our team began exploring cellular therapy for melanoma and other cancers in the 1990s,” says R. Bryan Bell, M.D., D.D.S., FACS, FRCS(Ed), division director of Surgical Oncology, Radiation Oncology and Clinical Programs for Providence Cancer Institute. “Because of this work, patients treated at Providence have had access to this life-saving therapy years before it became widely available.”

Dr. Urba and Dr. Curti served as lead investigators in the global clinical trial of ipilimumab, the first immunotherapy approved for metastatic melanoma in 2011. This seminal immune checkpoint inhibitor helped establish cancer immunotherapy as a standard of care for many types of cancer.

In 2022, Providence researchers led by Rom Leidner, M.D., director of Immune Cell Experimental Therapy, and Eric Tran, Ph.D., leader of the Adoptive Cell Therapy Laboratory, demonstrated the world’s first report of metastatic pancreatic cancer regression though gene-engineered, adoptively transferred T cells.

They quickly launched a phase I, investigator-initiated trial to further evaluate this therapy in patients with incurable epithelial cancers, leveraging Providence’s genomics program and in-house capabilities for developing, manufacturing and administering clinical-grade adoptive cell therapy. Dr. Leidner and Dr. Tran are also collaborating with industry partners on breakthrough cell therapy studies for solid cancers.

In another investigator-initiated trial, Dr. Curti is testing a novel tumor-infiltrating lymphocyte (TIL) therapy in patients with metastatic melanoma and other solid tumors. The first-in-human, phase I trial is co-led by Providence immunologist Andrew Weinberg, Ph.D., Judith Ann Hartmann Endowed Chair for the Basic Immunology Laboratory, in collaboration with Dr. Weinberg’s biotechnology spin-off, AgonOx, and Phio Pharmaceuticals.

"Our vision of the future is to select and engineer immune cells with enhanced abilities to attack tumors. We have a strong record of accomplishment in translating laboratory ideas into clinical practice,” says Dr. Curti. “The TIL research with Dr. Weinberg is another example of exciting first-in-human translational science from our institute and its many ongoing collaborations.”

With a robust clinical trial portfolio spanning early phase, industry-sponsored and cooperative group trials, Providence researchers are improving outcomes for patients with limited treatment options. Their expertise and capabilities in precision immuno-oncology make Providence Cancer Institute a sought-after clinical partner for adoptive cell therapy development.

As Dr. Bell notes, “the recent decision by the FDA serves as validation that our commitment to discovery and drug development, especially to that of developing next-generation, gene-engineered cell therapy, deserves the best of our energies and continued support. Philanthropy is a driving force of our research efforts. We are grateful to our generous donors whose gifts help bring hope to cancer patients and their families."

Watch the documentary Within Reach: The Fight to Finish Cancer to learn more about our expertise and commitment to adoptive cell therapy research and the impact of philanthropy in advancing cancer research and care. The film was produced in partnership with Providence Foundations of Oregon and features Providence patients and researchers in pursuit of this revolutionary cancer therapy. 

Learn more about other clinical trials at Providence Cancer Institute. New research studies are added frequently. 

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