#China #Suzhou #Multiple Myeloma #Innovent #IBI3003

Promising Early Results for IBI3003 in the Fight Against Multiple Myeloma

Introduction

Innovent Biologics, Inc., a prominent biopharmaceutical player known for developing and commercializing innovative therapies, recently unveiled encouraging initial data from its first-in-human clinical trial of a novel trispecific antibody, IBI3003, during an oral presentation at the 2025 American Society of Hematology (ASH) Annual Meeting. This groundbreaking treatment targets patients suffering from relapsed or refractory multiple myeloma (R/R MM), a cancer known for its resistance to conventional treatments.

About IBI3003

IBI3003 is designed to target three different pathways simultaneously: G protein-coupled receptor C5D (GPRC5D), B-cell maturation antigen (BCMA), and CD3. This multi-target approach aims to prevent cancer cells from evading treatment that often occurs with singular-target therapies. Preclinical results suggested that IBI3003 outperformed existing bispecific antibodies, exhibiting superior in vivo activity against tumors in various models, particularly those with low expressions of BCMA and GPRC5D.

Study Details

The initial trial, classified as a Phase 1/2 clinical study (NCT06083207), involved a cohort of 39 patients from China and Australia who had not responded to at least two prior treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. The trial's design mandated that participants were either relapsed or refractory to their last line of treatment, allowing those who had previously undergone BCMA or GPRC5D-targeting therapies to seek participation.

IBI3003 was administered subcutaneously on a weekly basis, with the opportunity for stabilization to a biweekly regimen for patients who showed positive response outcomes after six months.

Treatment Safety and Responses

Safety Profile

Innovent reported that the safety profile of IBI3003 was favorable and manageable.

• - Almost all participants (97.4%) experienced treatment-emergent adverse events (TEAEs), but most were common and manageable, such as cytokine release syndrome (CRS), neutropenia, and anemia.
• - Notably, only two patients faced dose-limiting toxicity (DLT), which resulted in severe platelet count reduction but was resolved with proper medical care.
• - The study took measures to reduce CRS risk, including administering initial priming doses to mitigate severe adverse reactions.

Efficacy Results

Preliminary results indicated impressive efficacy with a median follow-up duration of 3.25 months, showcasing an overall response rate (ORR) of 83.3% among patients receiving doses of 120 μg/kg or more. Among these:

• - 4 achievements of stringent complete response (sCR)
• - 7 instances of very good partial response (VGPR)
• - 9 documented partial responses (PR)

Responses were equally notable for high-risk patients with extramedullary disease or those previously treated with anti-BCMA or anti-GPRC5D therapies. The minimal residual disease (MRD) negativity rate reached 100% in patients classified as complete responders.

Conclusion

The results from Innovent Biologics' Phase 1 trial of IBI3003 highlight a significant advancement in the treatment of relapsed or refractory multiple myeloma. The favorable safety profile paired with high efficacy rates demonstrates its potential to offer hope to patients who have exhausted standard treatment options. As ongoing studies continue to evaluate this innovative therapy's long-term impact, the biopharmaceutical community remains optimistic about advancing care for multiple myeloma patients facing dire prognoses.

Professor Peng Liu from Zhongshan Hospital, affiliated with Fudan University, reaffirmed the urgency of addressing the unmet clinical needs in this patient population, emphasizing the dual-target strategy of IBI3003 as a potential game-changer in combating the evolving complexities of R/R MM. With ongoing trials and deeper analysis anticipated, the future holds promise for IBI3003 as a significant option in the treatment landscape for multiple myeloma.