ASCO 2025: Innovent Presents Phase 1/2 Data for IBI363, a First-in-Class PD-1/IL-2α Bispecific Antibody, in Immunotherapy-Refractory Advanced Melanoma

SAN FRANCISCO and SUZHOU, China, June 1, 2025 /PRNewswire/ — Innovent Biologics (HKEX: 01801), a biopharmaceutical company focused on developing high-quality medicines, today announced encouraging clinical data from Phase 1 and 2 studies of IBI363, its first-in-class PD-1/IL-2^α-bias bispecific antibody fusion protein, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The research focused on immunotherapy-pretreated melanoma, specifically the acral and mucosal subtypes, often considered “immune cold tumors” due to their resistance to conventional treatments. IBI363, according to the company, has shown “breakthrough efficacy” in patients with these typically treatment-resistant forms of melanoma. A pivotal registration trial for IBI363 is currently underway.

Innovent is conducting clinical trials in China, the United States, and Australia to assess the efficacy and safety of IBI363 across a range of tumor types. At this year’s ASCO meeting, IBI363 presented promising Phase 1/2 clinical data across three initial indications: non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma, specifically targeting immunotherapy-resistant and “cold” tumors. The data demonstrated significant clinical outcomes, from robust tumor responses to long-term survival benefits. These findings strengthen the case for the drug’s novel mechanism of action and suggest potential for broader clinical development, offering new hope in areas where immunotherapy options are limited.

A Phase 1/2 clinical study of PD-1/IL-2^α-bias bispecific antibody fusion protein (IBI363) in the treatment of advanced “cold” tumor subtypes (acral and mucosal) malignant melanoma

The data presented at ASCO originated from two multi-center Phase 1 and 2 studies (NCT05460767, NCT06081920) designed to evaluate IBI363 monotherapy in advanced melanoma. As of April 7, 2025, 31 patients with unresectable or metastatic acral and mucosal melanoma who had previously undergone immunotherapy, were enrolled and treated with 1 mg/kg Q2W. Of these patients, 64.5% had received two or more prior treatment lines.

The study revealed a breakthrough efficacy of IBI363 monotherapy in patients with “immune-cold” melanoma, accompanied by notable durable responses and extended survival benefits:

• In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type.
• Among confirmed responders treated with 1 mg/kg Q2W (n=7), a durable response was observed, with a median duration of response (DoR) of 14.0 months and events of 42.9%.
• Patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, significantly exceeding results from previous studies (PFS less than 3 months). The median follow-up time was 14.7 months, with a median overall survival (OS) of 14.8 (9.9, NC) months. The median OS of patients with the mucosal subtype was 19.3 (9.9, NC) months. The overall 12-month OS rate was 61.5%.
• In terms of safety, IBI363 was generally well-tolerated. Among patients treated with 1 mg/kg Q2W (n = 31), the treatment-related adverse events (TRAEs) occurring in > 30% of patients were arthralgia, rash, and hyperthyroidism, with most being Grade 1 or 2. The overall incidence of Grade ≥ 3 TRAEs was 29.0%, and only 3.2% of patients discontinued treatment due to TRAEs. Overall safety was manageable, with no new safety risks identified.

A pivotal Phase 2 registrational study of IBI363 in the treatment of advanced acral and mucosal malignant melanoma has been initiated

Innovent Biologics is advancing the development of IBI363 with a trial in progress (TiP). This randomized, open-label, multi-center Phase 2 study evaluates the efficacy and safety of IBI363 monotherapy compared to pembrolizumab (Keytruda®) in patients. The study focuses on unresectable or metastatic mucosal and acral melanoma who have not undergone previous systemic treatment. This trial marks the first pivotal registration study for the drug and will directly compare IBI363 monotherapy with pembrolizumab in this patient group. The study plans to enroll 180 patients, who will be divided into two groups with a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC).

The first patient was dosed in March 2025, marking a significant step in advancing IBI363. Simultaneously, the company is exploring IBI363 in combination therapies across various cancers.

Professor Guo Jun from Peking University Cancer Hospital, and the Principal Investigator of Melanoma Studies on IBI363, stated that the drug is addressing the need for more effective treatments as non-cutaneous melanoma, especially mucosal melanoma, accounts for a large proportion of melanoma cases and is considered a ‘cold tumor’ in China. “IBI363 addresses this challenge by transforming ‘cold tumors’ into ‘hot tumors’ through dual activation of the PD-1 and IL-2 pathways.” Results show the drug is delivering “significantly improved efficacy compared to previous studies in cold tumor subtypes and standard of care therapies.”

Dr. Zhou Hui, Senior Vice President of Innovent Biologics, noted that, “Approved PD-1 therapies have not substantially improved first-line outcomes in melanoma, and the clinical benefits remain limited. IBI363 is leading the evolution of next-generation immunotherapy.”

By employing a dual-mechanism of “PD-1 blockade + IL-2 directed activation,” IBI363 enhances T cell function and expands T cell populations to reshape the tumor immune microenvironment. Positive results in patients with mucosal and acral melanoma are highly anticipated, offering hope for a more effective treatment option.

About Melanoma

Melanoma, a malignant tumor, accounts for 3% of all skin cancers but is responsible for the highest mortality rate and has the greatest propensity for metastasis. Melanoma in the Chinese population differs significantly from that in Caucasian populations in Europe and the United States. For advanced cutaneous and acral melanoma with the BRAF V600 mutation, a combination of BRAF and MEK inhibitors is the preferred treatment. Though pembrolizumab was approved in September 2024 for first-line melanoma treatment, the clinical benefits of PD-1 inhibitors in this setting remain modest. Given the limited efficacy of current treatments for non-cutaneous melanomas, there is an urgent need for more effective therapies.

About IBI363 (PD-1/IL-2 ^α-bias bispecific antibody fusion protein)

IBI363, developed by Innovent Biologics, is the world’s first PD-1/IL-2^α-bias bispecific fusion protein. It integrates PD-1/PD-L1 pathway blockade with the activation of the IL-2 signaling pathway. The IL-2 arm of IBI363 is designed to maintain affinity for IL-2 Rα while reducing binding to IL-2Rβ and IL-2Rγ, thus minimizing toxicity. Its PD-1 binding arm facilitates both PD-1 blockage and targeted delivery of IL-2. In various tumor-bearing pharmacological models, IBI363 exhibited excellent anti-tumor activity.

Driven by clinical needs, Innovent Biologics is conducting clinical studies in China, the United States, and Australia to evaluate IBI363 across multiple tumor types. The first pivotal registration trial of IBI363 has been initiated for the treatment of mucosal and acral melanoma in patients who have not received prior immunotherapy.

IBI363 has received two fast track designations from the FDA. The drug has also received Two Breakthrough Therapy Designations by the National Medical Products Administration (NMPA) for advanced melanoma and squamous NSCLC treatment.

About Innovent Biologics

Innovent Biologics is a leading biopharmaceutical company founded in 2011. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Based on its motto,”Start with Integrity, Succeed through Action,” Innovent maintains the highest standards of industry practices, working to advance the biopharmaceutical industry.

For more information, visit
www.innoventbio.com.

Statement:

1. Innovent Biologics does not recommend the use of unapproved drugs/indications.

2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company

Forward-Looking Statement

The information in this press release may contain certain forward-looking statements.

REFERENCES

View original content:
https://www.prnewswire.com/news-releases/asco-2025-oral-presentation-innovent-biologics-announces-updated-data-of-ibi363-first-in-class-pd-1il-2–bias-bispecific-antibody-fusion-protein-from-phase-1-and-2-clinical-studies-on-immunotherapy-treated-advanced-malignant–302470081.html

SOURCE Innovent Biologics