Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma

Luciano J. Costa, Yi Lin, R. Frank Cornell, Thomas Martin, Saurabh Chhabra, Saad Z. Usmani, Sundar Jagannath, Natalie S. Callander, Jesus G. Berdeja, Yubin Kang, Ravi Vij, Kelly N. Godby, Ehsan Malek, Amarendra Neppalli, Michaela Liedtke, Mark Fiala, Hong Tian, Satish Valluri, Jennifer Marino, Carolyn C. JacksonArnob Banerjee, Ankit Kansagra, Jordan M. Schecter, Shaji Kumar, Parameswaran Hari

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: In the single-arm, phase 1b/2 CARTITUDE-1 study, ciltacabtagene autoleucel (cilta-cel), an anti-B-cell maturation antigen chimeric antigen receptor T-cell (CAR-T) therapy, showed encouraging efficacy in US patients with multiple myeloma (MM) who previously received an immunomodulatory drug, proteasome inhibitor, and anti-CD38 monoclonal antibody (triple-class exposed). Patients and Methods: A dataset of US patients refractory to an anti-CD38 monoclonal antibody (MAMMOTH) was used to identify patients who would meet eligibility for CARTITUDE-1 and received subsequent non-CAR-T therapy. The intent-to-treat (ITT) population in CARTITUDE-1 included patients who underwent apheresis (N = 113); the modified ITT (mITT) population was the subset who received cilta-cel (n = 97). Corresponding populations were identified from the MAMMOTH dataset: ITT population (n = 190) and mITT population of patients without progression/death within 47 days (median apheresis-to-cilta-cel infusion time) from onset of therapy (n = 122). Using 1:1 nearest neighbor propensity score matching to control for selected baseline covariates, 95 and 69 patients in CARTITUDE-1 ITT and mITT populations, respectively, were matched to MAMMOTH patients. Results: In ITT cohorts of CARTITUDE-1 vs. MAMMOTH, improved overall response rate (ORR; 84% vs. 28% [P <.001]) and longer progression-free survival (PFS; hazard ratio [HR], 0.11 [95% confidence interval (CI), 0.05-0.22]) and overall survival (OS; HR, 0.20 [95% CI, 0.10-0.39]) were observed. Similar results were seen in mITT cohorts of CARTITUDE-1 vs. MAMMOTH (ORR: 96% vs. 30% [P <.001]; PFS: HR, 0.02 [95% CI, 0.01-0.14]; OS: HR, 0.05 [95% CI, 0.01-0.22]) and with alternative matching methods. Conclusion: Cilta-cel yielded significantly improved outcomes versus real-world therapies in triple-class exposed patients with relapsed/refractory MM.

Original languageEnglish (US)
JournalClinical Lymphoma, Myeloma and Leukemia
DOIs
StateAccepted/In press - 2021
Externally publishedYes

Keywords

  • B-cell maturation antigen
  • CARTITUDE-1
  • Chimeric antigen receptor T-cell therapy
  • Ciltacabtagene autoleucel
  • MAMMOTH

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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