FDA to Speed Up Review of IBI363 for Advanced Melanoma

The FDA is set to speed up the review for IBI363, a novel treatment for patients with locally advanced or metastatic melanoma.

The Food and Drug Administration (FDA) granted a fast track designation to IBI363 for the treatment of patients with locally advanced or metastatic melanoma (excluding choroidal melanoma) that cannot be surgically removed. According to a press release about the designation, eligible patients must have been treated with one or more prior therapies, including a PD-1/L1 inhibitor.

IBI363 is a bispecific antibody, which is a drug that binds to two different targets at the same time. The drug blocks PD-1 (a protein that is involved in helping cancer cells hide from the immune system) and enhances IL-2, which enhances the function of certain T cells (immune cells), according to a press release from Innovent Biologics, the manufacturer of the novel drug.

Now that the FDA granted a fast track designation, the agency will work alongside Innovent Biologics to speed up the development, review and potential FDA approval of IBI363. The goal of fast track designations, according to the FDA, is to get drugs to the patients who need them in a more timely manner.

"Melanoma is the most common fatal skin cancer in Europe and the United States,” Dr. Hui Zhou, senior vice president of Innovent said in the press release. “Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy-failed melanoma around the world, and the ORR of traditional chemotherapy [with or without] anti-vascular therapy for immunotherapy-failed melanoma is only 3.8% to 6.8%, with a median (progression-free survival; time patients live without disease worsening) of less than three months, and the benefit is very limited.”

READ MORE: Researchers Urge Caution of Immunotherapy in Older Patients with Melanoma

Data from a clinical trial examining IBI363 were initially presented at the European Society of Medical Oncology Plenary meeting in June 2024. Findings showed that among 37 patients with melanoma who were previously treated with immunotherapy, IBI363 led to an objective response in 11 patients, meaning that patients’ disease shrunk from the therapy. This included one complete response (disappearance of cancer), and a disease control rate (patients whose disease is stable after therapy) of 73%.

“There is an urgent clinical need for patients who have previously (experienced disease progression or did not respond to) immunotherapy. As a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma."

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