Moffitt Research Moves New Immunotherapy Closer to FDA Approval

By Contributing Writer - June 24, 2019

Some cancer patients may be one step closer to being treated with cells from their own tumors. That’s one takeaway from a Moffitt-led study presented at the recent meeting of the American Society of Clinical Oncology (ASCO) in Chicago.  Based on the study findings, the U.S. Food and Drug Administration (FDA) will likely be asked to OK the therapy’s widespread use.

Currently in clinical trial, the treatment is called adoptive cellular therapy with tumor infiltrating lymphocytes, or TIL.  Patients whose cancer cannot be cured through surgery have part of their tumor surgically removed to gain access to cancer-fighting immune cells within it. These TIL cells are multiplied in a special processing lab so that billions of them can be infused back into the patient and zero in on the cancer. Moffitt has been working on TIL therapy for more than a decade.

Dr. Amod Sarnaik

At ASCO, Moffitt researcher and surgeon Amod Sarnaik presented preliminary results of a phase 2 clinical trial of TIL for patients whose advanced melanoma has not responded to other treatments including PD-1 antibody therapy. Among the trial participants, 38% responded to TIL.  On average, their responses have so far lasted eight months or longer. Some, said Sarnaik, actually may have been cured with a single TIL treatment. 

That includes Britta Beningfield, a patient in one of Sarnaik’s earlier TIL clinical trials. Initially diagnosed with melanoma and treated at Moffitt in 2006, Beningfield’s cancer made an unexpected return six year later. She was weak, with abdominal pain that was originally attributed to a gallbladder attack. By the time she returned to Moffitt, she required emergency surgery to stop internal bleeding from the metastasized melanoma tumor that had eroded through her stomach and into her pancreas.

Beningfield had also been through radiation therapy at Moffitt to tame an unrelated cancer in her tonsils in those intervening years. So when first told of the melanoma’s recurrence, she wasn’t sure that she had the will to continue fighting.

“I needed to plan out the rest of my life and asked how long do I have? They said think months, not years,” she remembers. That’s when she decided to learn more about a clinical trial mentioned by her Moffitt surgeon, Dr. Sarnaik.

“My only choices were to die or try this new treatment called TIL,” she says. “And thank goodness I did it because I’m still here.”

The preliminary findings Sarnaik presented at ASCO will be submitted to the FDA in hopes of gaining approval for TIL therapy use with melanoma patients nationwide.  Sarnaik predicted that TIL also may prove useful for patients with other solid tumors including cancers of the cervix, head and neck, lung and some sarcomas. Like melanomas, these types of tumors bear a high number of mutations likely linked to external factors such as sun, cigarette smoke or HPV infections.

To learn more, click here for a video interview with Dr. Amod Sarnaik at the 2019 ASCO Annual Meeting.


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