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Published on: February 17, 2022
KarMMa-RW: comparison of idecabtagene vicleucel with real-world outcomes in relapsed and refractory multiple myeloma
Sundar Jagannath1, Yi Lin2, Hartmut Goldschmidt3
1Mount Sinai Hospital, New York, NY, USA. sundar.jagannath@mountsinai.org.
Abstract:
Patients with relapsed and refractory multiple myeloma (RRMM) who are triple-class exposed (to an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody) have limited treatment options and there is no standard of care. Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T-cell therapy, demonstrated efficacy in triple-class exposed RRMM patients in the KarMMa trial (NCT03361748). In this retrospective study (KarMMa-RW), patient-level data from triple-class exposed RRMM patients were merged into a single data model and compared with KarMMa using trimmed stabilized inverse probability of treatment weighting. Endpoints included overall response rate (ORR; primary), rate of very good partial response or better (≥VGPR), progression-free survival (PFS), and overall survival (OS). Of 1949 real-world triple-class exposed RRMM patients, 190 received subsequent (index) line of therapy and met KarMMa eligibility criteria (Eligible RRMM cohort). With a median follow-up of 13.3 months in KarMMa and 10.2 months in Eligible RRMM, ORR, and ≥VGPR were significantly improved in KarMMa versus Eligible RRMM (ORR, 76.4% vs 32.2%; ≥VGPR, 57.9% vs 13.7%; both P < 0.0001) as were PFS (11.6 vs 3.5 months; P = 0.0004) and OS (20.2 vs 14.7 months; P = 0.0006). This study demonstrated that ide-cel significantly improved responses and survival compared with currently available therapies in triple-class exposed RRMM.
Insights
Idecabtagene vicleucel (ide-cel) significantly improved outcomes for patients with relapsed and refractory multiple myeloma (RRMM) who have exhausted standard treatments. This CAR T-cell therapy demonstrated superior response rates and survival compared to other available therapies in real-world data.
Area of Science:
- Hematology
- Oncology
- Immunotherapy
Background:
- Relapsed and refractory multiple myeloma (RRMM) patients who are triple-class exposed have limited therapeutic options.
- There is no established standard of care for this patient population.
Purpose of the Study:
- To evaluate the efficacy of idecabtagene vicleucel (ide-cel) in triple-class exposed RRMM patients.
- To compare real-world outcomes of ide-cel treatment with other available therapies in this patient group.
Main Methods:
- Retrospective analysis of patient-level data from the KarMMa-RW study.
- Comparison of real-world data with the KarMMa trial using stabilized inverse probability of treatment weighting.
- Evaluation of overall response rate (ORR), very good partial response or better (≥VGPR), progression-free survival (PFS), and overall survival (OS).
Main Results:
- Idecabtagene vicleucel (ide-cel) demonstrated significantly higher ORR (76.4% vs 32.2%) and ≥VGPR (57.9% vs 13.7%) compared to real-world data.
- Improved PFS (11.6 vs 3.5 months) and OS (20.2 vs 14.7 months) were observed with ide-cel treatment.
- These improvements were statistically significant (P < 0.0001 for ORR and ≥VGPR, P = 0.0004 for PFS, P = 0.0006 for OS).
Conclusions:
- Idecabtagene vicleucel (ide-cel) offers a significant therapeutic advancement for triple-class exposed RRMM patients.
- Ide-cel provides superior response rates and survival outcomes compared to current therapies in this challenging patient population.
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