CHICAGO — Iovance Biotherapeutics said Friday that adding its melanoma cell therapy on top of an immunotherapy — the current go-to for advanced skin cancer — resulted in cancer disappearing in seven patients. And another eight saw their tumors shrink by at least 30%.
The data are a slice of a Phase 2 study called IOV-COM-202, which has enrolled patients with a variety of solid tumor cancers, and Friday’s presentation focused on 23 patients in the advanced melanoma cohort. The data provide an early glimpse into how Iovance’s ongoing Phase 3 trial in first-line melanoma may go.
Of the 23 melanoma patients, 65% had a response to the drug, and 30% had a complete response. The effect appeared durable, as well — at 21 months, the median duration of response wasn’t yet reached and eight patients had no cancer progression for more than a year.
The results were presented Friday at the American Society of Clinical Oncology annual meeting.
In February, the company’s tumor-infiltrating lymphocyte (TIL) therapy became the first modern cell therapy approved for a solid tumor. Sold as Amtagvi, Iovance markets it as a second or third option for patients whose melanoma persists despite treatment with immunotherapies.
Lynn SchuchterIovance is hoping to use the Phase 3 trial to both expand that approval into the first line in combination with Keytruda and as a confirmatory study for the accelerated approval.
“Adding pembrolizumab to TIL is a natural thing to do,” said Lynn Schuchter, director of the University of Pennsylvania Tara Miller Melanoma Center.
The treatment, if approved as a first option in combination with Keytruda, may compete with other available combinations of checkpoint inhibitors, and analysts have noted that the T cell therapy may face an uphill climb. “We expect the debate to continue to be about access to [first-line] patients, where we think durability is likely to be viewed as a key motivator for changing referral patterns,” wrote Stifel analyst Benjamin Burnett in an investor note.
City of Hope Professor in Medicine Vijay Trisal said it would be crucial to identify which patients respond to TIL therapy — a point Schuchter agreed with but said would be challenging.
A key question Trisal had was how many patients started in the trial. “How many of those patients end up getting infusions of TILs?” he said, noting that it’s not simple to create and administer the individualized treatments. Neither Trisal nor Schuchter were involved in the study.
Friedrich Graf FinckensteinThe therapy requires a fragment of tumor to be taken from patients, from which T cells are taken. Those cells are then rejuvenated in a lab. Patients receive chemotherapy to clear space for the new immune cells, after which the TILs are infused back into the patient. During the process, patients also receive IL-2 therapy.
An important focus for an intensive therapy like Amtagvi is safety. Its side effects, which include fever, chills, low white blood cell counts and anemia, are manageable according to Trisal. “The toxicity is manageable, but very few hospitals will have the resources to be able to manage this toxicity,” he caveated.
One patient in the study died from sepsis. Iovance Chief Medical Officer Friedrich Graf Finckenstein told Endpoints News that one of the side effects of the high dose of chemotherapy is risk of infection.