Adjusted Comparison of Outcomes between Patients from CARTITUDE-1 versus Multiple Myeloma Patients with Prior Exposure to PI, Imid and Anti-CD-38 from a German Registry

Maximilian Merz; Hartmut Goldschmidt; Parameswaran Hari; Mounzer Agha; Joris Diels; Francesca Ghilotti; Nolen J Perualila; Jedelyn Cabrieto; Benjamin Haefliger; Henrik Sliwka; Jordan M Schecter; Carolyn C Jackson; Yunsi Olyslager; Muhammad Akram; Tonia Nesheiwat; Lenka Kellermann; Sundar Jagannath

doi:10.3390/cancers13235996

Adjusted Comparison of Outcomes between Patients from CARTITUDE-1 versus Multiple Myeloma Patients with Prior Exposure to PI, Imid and Anti-CD-38 from a German Registry

Cancers (Basel). 2021 Nov 29;13(23):5996. doi: 10.3390/cancers13235996.

Authors

Maximilian Merz¹, Hartmut Goldschmidt², Parameswaran Hari³, Mounzer Agha⁴, Joris Diels⁵, Francesca Ghilotti⁶, Nolen J Perualila⁵, Jedelyn Cabrieto⁵, Benjamin Haefliger⁷, Henrik Sliwka⁸, Jordan M Schecter⁹, Carolyn C Jackson⁹, Yunsi Olyslager⁵, Muhammad Akram¹⁰, Tonia Nesheiwat¹⁰, Lenka Kellermann¹¹, Sundar Jagannath¹²

Affiliations

¹ Cell Therapy and Hemostaseology, Department of Hematology, University Hospital of Leipzig, 04103 Leipzig, Germany.
² Internal Medicine V and National Center for Tumor Diseases, University Clinic Heidelberg, 69120 Heidelberg, Germany.
³ Medical College of Wisconsin, Milwaukee, WI 53226, USA.
⁴ School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.
⁵ Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
⁶ Janssen-Cilag SpA, 20093 Cologno Monzese, Italy.
⁷ Cilag GmbH International, 6300 Zug, Switzerland.
⁸ Janssen-Cilag Pharma GmbH, 1020 Vienna, Austria.
⁹ Janssen R&D, Raritan, NJ 08869, USA.
¹⁰ Legend Biotech USA, Inc., Piscataway, NJ 08854, USA.
¹¹ Oncology Information Service (O.I.S), 79098 Freiburg, Germany.
¹² Mount Sinai Medical Center, New York, NY 10029, USA.

Abstract

Ciltacabtagene autoleucel (cilta-cel) is a Chimeric antigen receptor T-cell therapy with the potential for long-term disease control in heavily pre-treated patients with relapsed/refractory multiple myeloma (RRMM). As cilta-cel was assessed in the single-arm CARTITUDE-1 clinical trial, we used an external cohort of patients from the Therapie Monitor registry fulfilling the CARTITUDE-1 inclusion criteria to evaluate the effectiveness of cilta-cel for overall survival (OS) and time to next treatment (TTNT) vs. real-world clinical practice. Individual patient data allowed us to adjust the comparisons between both cohorts, using the inverse probability of treatment weighting (IPW; average treatment effect in the treated population (ATT) and overlap population (ATO) weights) and multivariable Cox proportional hazards regression. Outcomes were compared in intention-to-treat (HR, IPW-ATT: TTNT: 0.13 (95% CI: 0.07, 0.24); OS: 0.14 (95% CI: 0.07, 0.25); IPW-ATO: TTNT: 0.24 (95% CI: 0.12, 0.49); OS: 0.26 (95% CI: 0.13, 0.54)) and modified intention-to-treat (HR, IPW-ATT: TTNT: 0.24 (95% CI: 0.09, 0.67); OS: 0.26 (95% CI: 0.08, 0.84); IPW-ATO: TTNT: 0.26 (95% CI: 0.11, 0.59); OS: 0.31 (95% CI: 0.12, 0.79)) populations. All the comparisons were statistically significant in favor of cilta-cel. These results highlight cilta-cel's potential as a novel, effective treatment to address unmet needs in patients with RRMM.

Keywords: CAR-T; CARTITUDE-1; adjusted comparison; chimeric antigen receptor T-cell therapy; cilta-cel; ciltacabtagene autoleucel; indirect treatment comparison; relapsed or refractory multiple myeloma.