Novel Bispecific Antibody Fusion Protein Earns FDA Fast Track in Melanoma
IBI363 has earned fast track designation from the FDA for the treatment of previously treated unresectable advanced melanoma.
Melanoma: © David A Litman - stock.adobe.com
- The FDA has granted a fast track designation to IBI363 for the treatment of unresectable locally advanced or metastatic melanoma that has progressed following at least 1 line of systemic therapy, including a PD-(L)1 inhibitor.
- IBI363 is an investigational PD-1/IL-2α bispecific antibody fusion protein.
- Phase 1/2 trials are evaluating the agent’s safety in advanced malignant tumors.
IBI363, a PD-1/IL-2α bispecific antibody fusion protein, has been granted fast track designation from the FDA in patients with unresectable locally advanced or metastatic melanoma who have progressed following at least 1 line of systemic therapy, including a PD-(L)1 inhibitor.1
Fast track designation is intended to facilitate the development and review of agents that treat serious medical conditions and fill unmet needs.2 With this designation, Innovent Biologics, the sponsor, is eligible for more frequent communication with the FDA as well as eligibility for priority review and accelerated approval if certain criteria are met.
“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…. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy,” said Hui Zhou, MD, senior vice president of Innovent Biologics, in a press release.1
“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,” Zhou added.
Findings to support this fast track designation were presented at a European Society of Medical Oncology Virtual Plenary in June 2024.3 In the study (NCT04085185) of IBI363 in solid tumors, 37 patients with melanoma who were previously treated with immunotherapy received 1 mg/kg of IBI363. Eleven patients responded with 1 complete response (CR) and 10 partial responses (PRs) or an objective response rate (ORR) of 29.7% and disease control rate (DCR) of 73.0%.
In 8 patients with treatment-naive mucosal melanoma, 1 patient had a CR, and 5 patients had a PR. The ORR was 75.0%, and the DCR was 100% in this cohort.
“…IBI363 has demonstrated strong antitumor effects, which could potentially be the next breakthrough in this area. Moreover, a promising efficacy signal was shown in [immuno-oncology (IO)]-naive mucosal melanoma, a relatively 'cold' tumor, which brings us great confidence in the next step to expand the IO-naive population and also indicates the broad application potential of IBI363,” Zhou said during a presentation of the data.
