FDA Approves Advanced Melanoma Drug


T-VEC is a first-in-class immunotherapy for unresectable cutaneous, subcutaneous, and nodal lesions in advanced melanoma.

T-VEC is a first-in-class immunotherapy for unresectable cutaneous, subcutaneous, and nodal lesions in advanced melanoma.

The FDA yesterday approved a first-in-class immunotherapy talimogene laherparepvec (T-VEC; Imlygic) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

The approval followed the phase 3 OPTiM study, which found that T-VEC significantly extended durable response rates (DRR) compared with GM-CSF. The results showed a 4.4-month extension of overall survival (OS) with T-VEC, but this was a statistically significant result (P = .051).

“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “This approval provides patients and healthcare providers with a novel treatment for melanoma.”

The trial randomized 436 patients with unresected stage IIIB/C and IV melanoma in a 2:1 ratio to receive intralesional T-VEC (n = 295) or subcutaneous GM-CSF (n = 141). The median age of patients was 63 years of age.

In the T-VEC cohort, 45% of patients had stage IVb/c melanoma, versus 39% in the GM-CSF cohort.

DRR was 16.3% in the T-VEC group compared with 2.1% in the GM-CSF. The objective response rate was 26.4% in the T-VEC group compared with 5.7% in the GM-CSF, while the complete response rate was 11% for T-VEC compared with 1%, for GM-CSF.

The median OS was 23.3 months in the T-VEC cohort compared with 18.9 months in the GM-CSF cohort (HR, 0.79; 95% CI, 0.62-1.00; P = .051).

In patients with previously untreated melanoma, the T-VEC group had a 50% reduction in the risk of death (HR, 0.50; 95% CI, 0.35-0.73; P <.001), while the median OS was 33.1 months in the T-VEC group (n = 138) with compared with 17 months in the GM-CSF group (n = 65).

"Advanced melanoma remains a complex disease to treat, requiring the use of several modalities over the course of a patient's therapeutic journey," said OPTiM lead investigator Howard L. Kaufman, MD, associate director for Clinical Science at the Rutgers Cancer Institute of New Jersey. "As an oncolytic viral therapy, Imlygic has a unique approach, and provides another option for treating eligible patients with unresectable disease that has recurred after initial surgery."

The primary safety analysis for the approval was based on findings from 292 patients in the T-VEC arm and 127 patients in the GM-CSF arm of the OPTiM study. The median treatment duration in the treatment versus control arms was 23 versus 10 weeks, respectively.

The most common all-grade adverse events for patients in the T-VEC group included fatigue (50.3% vs 36.2% with GM-CSF), chills (48.6% vs 8.7%), pyrexia (42.8% vs 8.7%), nausea (35.6% vs 19.7%), influenza-like illness (30.5% vs 15%), and injection site pain (27.7% vs 6.3%).

The most common serious adverse events in the treatment versus the control group were disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%).

T-VEC is also being assessed in combination with immune checkpoint inhibitors, including a phase 1/2 study of T-VEC with ipilimumab for unresected melanoma; and a phase 3 study of T-VEC with pembrolizumab for unresected melanoma.

"Imlygic is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “Not all melanoma patients currently benefit from available therapies, and Imlygic represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease."

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