IBI363 Monotherapy Granted Fast Track Designation in US for Advanced Melanoma

The US Food and Drug Administration (FDA) has granted Fast Track Designation to Innovent Biologics' IBI363, a PD-1/IL-2α bispecific antibody fusion protein therapy, for patients with unresectable locally advanced or metastatic melanoma.¹

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.

Image Credit: © DermNet

The first-in-class therapy, designed to enhance anti-tumor immunity by selectively stimulating PD-1+ T cells, has demonstrated promising results in treating advanced solid tumors.

"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 ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited," said Hui Zhou, PhD, senior vice president of Innovent, in a news release.¹

In June, Innovent presented early indications of IBI363's efficacy at the 2024 ESMO Virtual Plenary.² The treatment demonstrated potential effectiveness in melanoma patients who had already been treated with immunotherapy.

Out of 37 patients given IBI363 at 1mg/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%.³

In a phase 1 study involving more than 300 patients, IBI363 demonstrated good safety and tolerability with notably high response rates in squamous non-small cell lung cancer and mucosal melanoma.²

"There is an urgent clinical need for patients who have previously failed 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," Zhou said. "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."

At present, phase 1 and 2 clinical trials are underway to assess IBI363's efficacy and safety in the United States, Australia, and China.

References

1. Innovent receives Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma. News release. PR Newswire. September 3, 2024. Accessed September 4, 2024. https://www.prnewswire.com/news-releases/innovent-receives-fast-track-designation-from-the-us-fda-for-ibi363-pd-1il-2-bispecific-antibody-fusion-protein-as-monotherapy-for-advanced-melanoma-302236636.html
2. Innovent delivers oral presentation on clinical data of IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer and other solid tumors at the 2024 ESMO Virtual Plenary. News release. PR Newswire. June 14, 2024. Accessed September 3, 2024. https://en.prnasia.com/releases/apac/innovent-delivers-oral-presentation-on-clinical-data-of-ibi363-first-in-class-pd-1-il-2-bias-bispecific-antibody-fusion-protein-in-advanced-non-small-cell-lung-cancer-and-other-solid-tumors-at-the-2024-esmo-virtual-plenary-450726.shtml
3. A study evaluating the safety, tolerability, and initial efficacy of IBI110 in subjects with advanced malignant tumors. ClinicalTrials.gov. Updated September 14, 2022. NCT04085185.