Clinical Perspectives

The World’s First T-cell Therapy for a Solid Tumor Cancer is Poised for Approval via Moffitt Partnership

June 03, 2020

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Iovance Biotherapeutics, Inc., a biotechnology company, is developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology through a clinical collaboration with Tampa-based Moffitt Cancer Center.  

Instead of modifying T cells, as is done in CAR T therapy, with this therapy Moffitt physicians extract tumor-infiltrating lymphocytes that have the natural ability to zero in on the abnormalities that distinguish tumor cells. At Moffitt, the patient’s tumor is biopsied and then tissue is sent to Iovance's where the autologous TILs are isolated and multiplied by the billions in the lab. Due to this custom creation, the TIL therapy recognizes the complex array of antigens that are unique to the patient’s tumor cells. When re-infused into the patient, they launch a sustained attack. Melanoma patients were the first to experience dramatic remissions in TIL clinical trials.

Dr. Amod Sarnaik
Dr. Amod Sarnaik, Surgical Oncologist

“Treatment options are limited for patients with advanced melanoma whose cancers have progressed on checkpoint inhibitors such as PD-1 antibody-based treatment,” said Moffitt Cancer Center surgical oncologist Dr. Amod Sarnaik. He is the lead author of the abstract that outlined the phase 2 results of a global study of Iovance's TIL therapy Lifileucel (LN-144).

Adoptive cell therapy using TILs leverages and enhances the body’s natural defense against cancer and has shown durable responses in heavily pretreated melanoma patients. The latest trial results for Lifileucel presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting were encouraging for several reasons, which included the response rate, ease of single-treatment administration and long-lasting responses. Initial data showed that the TIL therapy had a 38% overall response (ORR) rate among patients with advanced melanoma. Of 66 melanoma patients, updated cohort 2 data presented at ASCO showed an ORR of 36.4% with median duration of response not reached at 18.7 months of median study follow up. The most common side effects included thrombocytopenia, chills, anemia, and febrile neutropenia. Overall 95% of patients experienced side effects. Clinical trial information: NCT02360579

The TIL therapy preparation is complex, yet the treatment can be safely administered to patients at a broad variety of treatment centers. “We are not just treating patients in a facility like Moffitt; we also are treating patients in sites that are not as large or may not have as much robust resources as Moffitt has,” said Sarnaik.

“It allows the treatment to penetrate patient populations in relatively remote areas, so it does not require the patient to have to travel... The trial conclusively demonstrates that treatment can be administered at a broad, regionally diverse number of medical centers.”

Moffitt researchers are leaders in advancing the field of TIL therapy. Final commercialization was done outside of Moffitt. However, in early cohorts of the trial, some of the TILs used as the Lifileucel infusions were processed at Moffitt’s cell therapy facility, which played an important role in terms of optimization, validation and advancement of this technology.

“This clinical trial could not be possible without an industry-academic partnership,” said Sarnaik.

The trial is a culmination of decades of research previously conducted and pioneered through the National Cancer Institute, with much of the advancements built upon the immunotherapy research of Dr. Steven Rosenberg, chief of the Surgery Branch at National Cancer Institute. Contributions of both the patients and their families were also essential to the success of the clinical trial to learn more about this unique cell therapy technology.

Recent advances have given promise to the idea that TIL therapy could be effective in diverse cancers beyond melanoma, such as lung cancer and cervical cancer. Through the same Moffitt-Iovance collaboration, ongoing studies in NSCLC currently underway are providing the combination of TIL and nivolumab with funding provided by Stand Up To Cancer. In May 2019, the FDA granted breakthrough therapy designation to Lifileucel (LN-145) tumor-infiltrating lymphocyte therapy technology to treat advanced cervical cancer.

Now based on expanded ongoing trials and recent results, Iovance appears to be on the cusp of winning FDA approval of TILs for advanced cervical cancer and metastatic melanoma in the second half of 2020.

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