**Real-World Insights into Daratumumab-Based Therapies for Multiple Myeloma in China**
In a significant real-world observational study conducted across multiple sites in China, researchers have brought new light to the treatment landscape of multiple myeloma (MM), focusing on the use of daratumumab, a human IgGκ monoclonal antibody directed against the CD38 antigen. This analysis, involving 212 patients treated with daratumumab-based regimens, offers both nuanced understanding and robust data regarding treatment patterns, efficacy, and safety in the diverse clinical settings of China, complementing existing knowledge primarily derived from randomized controlled trials.
Daratumumab has revolutionized the therapeutic approach to multiple myeloma due to its unique mechanism of targeting CD38, a glycoprotein highly expressed on myeloma cells. It exerts anti-tumor effects through multiple direct actions, including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and induction of apoptosis, in addition to modulating immune effector cells enhancing the anti-myeloma immune response. The drug’s integration into standard care, especially in Western populations, has been well documented; however, real-world data from non-Western populations, particularly the Chinese cohort, have remained sparse – a gap this study seeks to address.
The observational study enrolled adult patients with symptomatic MM who were either newly diagnosed or had relapsed/refractory disease. Importantly, patients with more than three prior lines of therapy were excluded to maintain homogeneity and reflect early-stage treatment settings. The data collection spanned prospective and retrospective methodologies, reflecting the treatment initiation dates and allowing a comprehensive capture of treatment patterns and outcomes in routine clinical practice across 13 diverse medical centers in China.
Daratumumab treatments observed in this cohort were varied, including monotherapy, combinations with dexamethasone alone, proteasome inhibitors (PIs) with or without dexamethasone, immunomodulatory drugs (IMiDs) with or without dexamethasone, and multi-agent combinations including both PIs and IMiDs. Notably, about half of the patients received daratumumab-based regimens as second-line therapy, while approximately 16.5% received it as frontline treatment. The heterogeneity of treatment combinations mirrors the personalized approach to MM management in real-world practice, influenced by disease stage, prior therapy exposure, and clinician preference.
Efficacy outcomes highlight that 71.8% of evaluable patients achieved at least a partial response (PR) or better, signifying substantial disease control in a real-world context. More impressively, over half of patients (51.4%) attained a very good partial response (VGPR) or better, indicating deep and meaningful responses comparable to clinical trial benchmarks. These response rates underline the potency of daratumumab-based regimens in controlling MM among Chinese patients, reflecting the drug’s ability to generate strong anti-myeloma effects outside controlled trial settings.
Progression-free survival (PFS) estimates further affirm the clinical benefit of daratumumab therapy. The study reports an encouraging 6-month PFS rate of 84.3% and a 12-month PFS rate of 75.0%, suggesting durable disease control over the first year of treatment. These outcomes are especially pertinent given the real-world setting, where patients often exhibit greater comorbidity and diversity than in clinical trials, implying that daratumumab maintains effectiveness across a broad patient spectrum.
Treatment regimens combining daratumumab with other agents demonstrated more favorable outcomes compared to monotherapy. This aligns with the current understanding that combining daratumumab with other agents such as PIs and IMiDs can synergistically enhance anti-tumor efficacy by targeting myeloma cells via multiple pathways and mechanisms. This multifaceted approach likely contributes to the robust response rates observed, reinforcing current clinical guidelines endorsing daratumumab-based combinations.
Safety analyses from this cohort revealed that daratumumab is well tolerated in the Chinese MM population, with 13.7% of patients experiencing serious treatment-emergent adverse events (TEAEs). The most frequent serious AE was pneumonia, noted in 4.7% of patients, potentially reflecting immune modulation and infection susceptibility intrinsic to both the disease and its treatment. Hematologic toxicities including leukopenia (6.6%), neutropenia (5.7%), and thrombocytopenia (5.7%) were the most commonly observed adverse drug reactions, consistent with known side effect profiles of daratumumab and its combinations.
This study’s longitudinal design and capture of real-world clinical data over multiple sites provide a valuable complement to randomized controlled trials, offering insights into how daratumumab is utilized and tolerated in everyday practice. Such real-world evidence is critical for validating clinical trial data, understanding patient diversity, and refining treatment protocols to optimize outcomes in different geographic and ethnic populations.
Moreover, the findings have key implications for the expanding use of novel immunotherapies in China, where multiple myeloma incidence is rising and treatment paradigms are evolving rapidly. The observational data supports the continued prioritization of daratumumab-based regimens as a standard of care not only in newly diagnosed patients but also in relapsed and refractory settings where treatment options are often limited.
Clinicians and researchers can glean from this study that expanding access to daratumumab in China, integrating it judiciously with other agents, and vigilant management of potential adverse events can collectively improve patient prognosis. The demonstrated high response rates and manageable safety profile shed light on the promising role of daratumumab in the complex therapeutic landscape of MM within China.
As this study is ongoing, further data with extended follow-up will be essential to assess long-term outcomes such as overall survival, long-term safety, and quality of life metrics. The real-world persistence of response and potential resistance patterns will also be critical to characterize, informing future therapeutic decision-making and drug development strategies.
In summary, this robust real-world observational study sheds critical light on the treatment patterns, efficacy, and safety of daratumumab-based regimes in Chinese patients living with multiple myeloma. By bridging the gap between controlled clinical trials and everyday clinical practice, it validates daratumumab as a highly effective and tolerable therapeutic cornerstone in the management of MM in this population. These findings underscore the transformative impact of immunotherapy across diverse patient cohorts, heralding improved survival prospects for patients battling this challenging hematologic malignancy.
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**Subject of Research:** Real-world treatment patterns, effectiveness, and safety of daratumumab-based regimens in multiple myeloma patients in China
**Article Title:** Real-world analysis of treatment patterns, effectiveness, and safety of daratumumab-based regimens in Chinese patients with newly diagnosed or relapsed/refractory multiple myeloma
**Article References:** Wang, L., Yang, W., Wang, Y. et al. BMC Cancer 25, 836 (2025). https://doi.org/10.1186/s12885-025-13925-3
**DOI:** https://doi.org/10.1186/s12885-025-13925-3
**Image Credits:** Scienmag.com
**Keywords:** CD38 targeting in multiple myeloma; clinical daratumumab treatment patterns in China; effectiveness of daratumumab in multiple myeloma; immunomodulatory effects of daratumumab; monoclonal antibodies in cancer therapy; newly diagnosed multiple myeloma in Chinese patients; observational study on daratumumab; real-world analysis of multiple myeloma treatment; relapsed refractory multiple myeloma treatment options; safety of daratumumab regimens; standard care for multiple myeloma
