The U.S. Food and Drug Administration (FDA) has granted fast track designation to IBI3003, an anti-GPRC5D/BCMA/CD3 tri-specific antibody, to expedite the development and review of a treatment for patients with relapsed or refractory multiple myeloma who have received four or more lines of previous therapy, Innovent Biologics, Inc. announced in a news release.
To qualify for this designation, patients must have previously received treatment including at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-CD38 monoclonal antibody. Fast track designation is intended to facilitate the development and speed up the review of medicines that treat serious conditions and address unmet medical needs. This status allows for more frequent interactions with the FDA to potentially accelerate clinical development and regulatory review.
Glossary
Overall Response Rate (ORR): the total percentage of patients whose cancer shrank or disappeared during treatment.
Stringent Complete Response (sCR): the cancer disappeared from standard tests and scans and highly sensitive laboratory tests (such as those looking at bone marrow or specific proteins) show no remaining signs of the disease.
Very Good Partial Response (VGPR): this indicates a significant decrease in the amount of cancer in the body.
Partial Response (PR): the treatment is working, but some cancer remains.
Cytokine Release Syndrome (CRS): this occurs when the activated immune cells release a large amount of proteins called cytokines into the blood. It often feels like a severe flu, with symptoms such as high fever, nausea, headache or low blood pressure.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): this is a side effect that affects the nervous system. It can cause temporary confusion, tremors, difficulty speaking or sleepiness.
Main data that support the findings
The designation is supported by clinical data presented at the American Society of Hematology (ASH) Annual Meeting in December 2025. These findings involved 39 patients with relapsed or refractory multiple myeloma who had failed at least two prior lines of therapy and had previously received a PI, an IMiD and an anti-CD38 monoclonal antibody.
As of the Nov. 7, 2025, data cutoff, the median follow-up duration was 3.25 months and the median treatment duration was 12.14 weeks. Among 24 patients treated at doses of 120 μg/kg or higher, the overall response rate (ORR) was 83.3%. This included:
- Four stringent complete responses (sCR)
- Seven very good partial responses (VGPR)
- Nine partial responses (PR)
The data also showed that among 10 patients with extramedullary disease (EMD), the ORR was 80%. In nine patients previously treated with BCMA- and/or GPRC5D-directed therapies, the ORR was 77.8%. For patients who achieved a complete response or better, the minimal residual disease (MRD) negativity rate was 100% (four patientd), as assessed by next-generation sequencing at a central laboratory.
Dr. Hui Zhou, Chief R&D Officer of Oncology at Innovent, stated in the news release that IBI3003 monotherapy demonstrated encouraging efficacy and a favorable safety profile. Zhou noted that meaningful clinical activity was observed even in high-risk patients with EMD or those previously treated with targeted therapies, highlighting the potential of the drug to address key unmet needs.
Trial details
IBI3003 was discovered and developed using the proprietary Sanbody platform. It is a tri-specific T-cell engager (TCE) designed to target both GPRC5D and BCMA to mitigate tumor escape associated with targeting a single antigen.
Currently, IBI3003 is undergoing a phase 1/2 clinical trial in China and Australia. In the studies presented, patients were treated at dose levels ranging from 0.1 μg/kg to 800 μg/kg. Preclinical studies showed that IBI3003 had superior antitumor activity compared with marketed benchmark T-cell engagers, even in cell lines with low BCMA and GPRC5D expression.
In December 2025, the FDA approved the investigational new drug (IND) application for IBI3003. This allows Innovent to initiate a phase 1/2 clinical trial in the United States imminently. The company aims to further evaluate its potential to provide a durable survival benefit for patients with multiple myeloma, which remains an incurable disease.
Safety
Clinical results showed that IBI3003 has a tolerable safety profile and is considered manageable. During the trial, all cases of cytokine release syndrome (CRS) were reported as grade 1 (mild) to 2 (moderate). Only two cases of grade 1 to 2 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred.
Most treatment-emergent side effects related to the targeting of GPRC5D — including effects on the oral cavity, skin and nails — were grade 1 to 2. However, two patients did experience grade 3 (severe) rash.
Reference
- “Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma,” news release; https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=577
Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.
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