Mass General Cancer Center's Dr. Genevieve Boland on Amtagvi Approval

By Erin Harris, Editor-In-Chief, Cell & Gene
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The FDA recently approved a new TIL cell therapy from Iovance Biotherapeutics. According to the FDA, Amtagvi (lifileucel), is the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).

Regarding the approval, Genevieve Boland, M.D., Ph.D., from Mass General Cancer Center (MGCC), is quoted as stating, “The FDA’s approval of Amtagvi addresses an unmet need in melanoma patient care. Amtagvi represents not only a new treatment option for this subset of patients, but one that could be associated with long-term benefit. Importantly, effective administration of this therapy requires the collaboration and support of multidisciplinary clinical teams, which is critical to successful outcomes. We look forward to incorporating this into our care for melanoma patients, as appropriate, at Mass General Cancer Center and are confident that our integrated care model will enable us to leverage it for patients in need.”  I talked to Dr. Boland to learn more about her take on Amtagvi’s recent approval. Here’s what she had to say.

Your primary clinical focus is on cutaneous oncology, and your laboratory is currently focusing on molecular profiling of melanoma and identification of circulating biomarkers of cancer. How will the FDA approval of Iovance’s AMTAGVI impact the future of melanoma treatment?

The FDA approval opens a whole new avenue of therapies for advanced melanoma patients. This is a “first in class” therapy, offering an entirely new way of treating patients via adoptive T cell therapy. We have been (and continue to be) actively engaged with Iovance to assure rapid deployment of this new FDA approved therapy which we anticipate will offer incredible value to our patients.

What specific unmet needs in the advanced melanoma community will this personalized, one-time therapeutic option offer patients?

Patients who do not obtain benefit from initial immune checkpoint inhibitor immunotherapy may benefit from this alternative strategy to harness the body’s own immune cells to fight cancer. This therapy has shown some promising results in patient populations who do not respond to our best therapies, and this potential benefit is incredibly exciting.

What was your role in the clinical trials at MGCC for AMTAGVI?

I have been the surgeon for tumor procurement during the MGCC trials and worked closely with the multidisciplinary team throughout the entire trial process. The surgical tumor retrieval is critical for successful adoptive T cell therapy.

What were some of the most successful aspects of the clinical trial at MGCC?

This trial really is a tour-de-force of multidisciplinary care. We (surgical oncology) worked closely with melanoma medical oncology and the cellular therapy program to ease the patient’s journey and make this therapy possible.