<p>The multicenter, noninterventional, observational MMY4032 study is a large-scale, real-world study exploring daratumumab (DARA) in Chinese patients (<i>n</i> = 212) with multiple myeloma (MM) who have received ≤ 3 prior lines of therapy. In the first interim analysis (median follow-up, 10.5 months), DARA was often initiated in second-line therapy, often given in combination with a proteasome inhibitor and/or immunomodulatory drug, and induced high response rates (overall response rate [ORR], 71.8%) and acceptable safety. Here, we report treatment patterns, efficacy, and safety from the second interim analysis with a longer median follow-up of 16.2 months. At the time of this analysis, median duration of DARA exposure was 8.2 months. Among 189 response-evaluable patients, the ORR was 74.1% and the very good partial response or better rate was 55.6%. Minimal residual disease–negativity rate was 60.0% among tested patients. Median progression-free and overall survival were 32.8 months and not reached, respectively; 12-month rates were 77.9% and 87.8%. Response and survival rates were higher with DARA initiation in earlier lines of therapy. Median time to next treatment was not reached with most DARA-based regimens. Adverse drug reactions and serious adverse events were reported in 20.3% and 15.6% of patients, respectively. Overall, with longer follow-up of the MMY4032 study, responses deepened, and survival rates remained high with DARA-based regimens, with more favorable outcomes observed with earlier DARA initiation. No new safety concerns were observed. These real-world data continue to support early use of DARA-based regimens as a standard of care for Chinese patients with MM.</p>

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Treatment patterns, effectiveness, and safety of daratumumab-based regimens in Chinese patients with multiple myeloma: longer follow-up of the real-world MMY4032 study

  • Wei Yang,
  • Luqun Wang,
  • Yafei Wang,
  • Ting Niu,
  • Rong Fu,
  • Yuping Zhong,
  • Wenbin Qian,
  • Kaiyang Ding,
  • Kai Sun,
  • Hong Liu,
  • Baijun Fang,
  • Hui Liu,
  • Yanhui Li,
  • Yishen Yang,
  • Jianmin Zhuo,
  • Xi Chen,
  • Bijie Xun,
  • Jin Lu

摘要

The multicenter, noninterventional, observational MMY4032 study is a large-scale, real-world study exploring daratumumab (DARA) in Chinese patients (n = 212) with multiple myeloma (MM) who have received ≤ 3 prior lines of therapy. In the first interim analysis (median follow-up, 10.5 months), DARA was often initiated in second-line therapy, often given in combination with a proteasome inhibitor and/or immunomodulatory drug, and induced high response rates (overall response rate [ORR], 71.8%) and acceptable safety. Here, we report treatment patterns, efficacy, and safety from the second interim analysis with a longer median follow-up of 16.2 months. At the time of this analysis, median duration of DARA exposure was 8.2 months. Among 189 response-evaluable patients, the ORR was 74.1% and the very good partial response or better rate was 55.6%. Minimal residual disease–negativity rate was 60.0% among tested patients. Median progression-free and overall survival were 32.8 months and not reached, respectively; 12-month rates were 77.9% and 87.8%. Response and survival rates were higher with DARA initiation in earlier lines of therapy. Median time to next treatment was not reached with most DARA-based regimens. Adverse drug reactions and serious adverse events were reported in 20.3% and 15.6% of patients, respectively. Overall, with longer follow-up of the MMY4032 study, responses deepened, and survival rates remained high with DARA-based regimens, with more favorable outcomes observed with earlier DARA initiation. No new safety concerns were observed. These real-world data continue to support early use of DARA-based regimens as a standard of care for Chinese patients with MM.