<p>Randomized clinical trials have shown ixazomib, lenalidomide and dexamethasone (IRd) to be efficacious and safe in Asian patients with relapsed/refractory multiple myeloma (RRMM); however, real-world data are limited. The APEX study was a multicenter, observational cohort study of IRd conducted at 16 sites across South Korea, Malaysia, and Thailand. Overall, 104 patients treated with IRd during 2016–2023 were enrolled; data were collected by retrospective chart review and 6-month prospective follow-up. Median age at IRd initiation was 64.0&#xa0;years. The primary endpoints of median time to next treatment (TTNT) and overall response rate (ORR) were 32.1&#xa0;months and 72.1%, respectively (though ORR varied across countries). The secondary endpoint of median progression-free survival was 27.7&#xa0;months, while median overall survival was not reached. Median TTNT and ORR were higher in elderly patients (≥65 and/or ≥70&#xa0;years) than in the overall population. Adverse events occurred in 90.4% and serious adverse events occurred in 29.8% of all patients; common Grade ≥ 3 adverse drug reactions were pneumonia (9.6%), neutropenia (7.7%), and gastroenteritis (2.9%). This study demonstrated that IRd was safe and effective in real-world practice in Asia, including for elderly patients, and the results are aligned with TOURMALINE-MM1 and other real-world studies.</p>

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Real-world effectiveness of ixazomib, lenalidomide and dexamethasone in Asians with relapsed/refractory multiple myeloma

  • Soo Chin Ng,
  • Joon-Ho Moon,
  • Sung Soo Park,
  • Youngil Koh,
  • Ji Hyun Lee,
  • Hyeon-Seok Eom,
  • Ho-Jin Shin,
  • Sung Hoon Jung,
  • Young Rok Do,
  • Gilbert Wilfred,
  • Azlan Husin,
  • Hyo Jung Kim,
  • SFadilah Abdul Wahid,
  • Myung-Won Lee,
  • Hye-won Heo,
  • Kihyun Kim,
  • Suporn Chuncharunee

摘要

Randomized clinical trials have shown ixazomib, lenalidomide and dexamethasone (IRd) to be efficacious and safe in Asian patients with relapsed/refractory multiple myeloma (RRMM); however, real-world data are limited. The APEX study was a multicenter, observational cohort study of IRd conducted at 16 sites across South Korea, Malaysia, and Thailand. Overall, 104 patients treated with IRd during 2016–2023 were enrolled; data were collected by retrospective chart review and 6-month prospective follow-up. Median age at IRd initiation was 64.0 years. The primary endpoints of median time to next treatment (TTNT) and overall response rate (ORR) were 32.1 months and 72.1%, respectively (though ORR varied across countries). The secondary endpoint of median progression-free survival was 27.7 months, while median overall survival was not reached. Median TTNT and ORR were higher in elderly patients (≥65 and/or ≥70 years) than in the overall population. Adverse events occurred in 90.4% and serious adverse events occurred in 29.8% of all patients; common Grade ≥ 3 adverse drug reactions were pneumonia (9.6%), neutropenia (7.7%), and gastroenteritis (2.9%). This study demonstrated that IRd was safe and effective in real-world practice in Asia, including for elderly patients, and the results are aligned with TOURMALINE-MM1 and other real-world studies.