2024 Breakthroughs in Skin Cancer
Source: Dermatology Times, December 2024
Discover 2024 skin cancer breakthroughs, including FDA approvals, innovative therapies, and updated clinical guidelines for melanoma and nonmelanoma care.
In 2024, significant advancements reshaped skin cancer treatment. From FDA approvals of new therapies to updated clinical guidelines, the latest breakthroughs aim to improve outcomes for patients facing melanoma and nonmelanoma cancers. With new insights into therapies such as lifileucel and IBI363, updated protocols for radiation in basal and squamous cell carcinoma, and innovative immunotherapy combinations, these developments highlight the strides made in combating skin cancer’s toughest challenges.
Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma
Iovance Biotherapeutics announced in February 2024 that the FDA approved lifileucel (Amtagvi) suspension for intravenous infusion for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Lifileucel’sindication is FDA approved under an accelerated approval based on overall response rate and duration of response. Iovance is also conducting TILVANCE-301, a phase 3 trial to confirm the clinical benefit of lifileucel. The FDA accelerated approval of lifileucel is based on safety and efficacy data from the C-144-01 clinical trial.
IBI363 Monotherapy Granted Fast Track Designation in US for Advanced Melanoma
The US FDA granted fast track designation in September 2024 to Innovent Biologics’ IBI363, a PD-1/IL-2? bispecific antibody fusion protein therapy, for patients with unresectable, locally advanced or metastatic melanoma. The treatment is intended for individuals whose disease has progressed despite intervention with at least 1 prior PD-1/L1 inhibitor and systemic therapy. It is not intended for individuals with choroidal melanoma. Of 37 patients given IBI363 at 1 mg/kg, 11 demonstrated objective responses, with 1 complete response and 10 partial responses recorded. The overall response rate was 29.7% and the disease control rate was 73.0%.