CHMP Expresses Positive Opinion for Ide-Cel in R/R Multiple Myeloma

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A positive CHMP opinion may lead to an approval of idecabtagene vicleucel in the European Union for patients with relapsed/refractory multiple myeloma.

The European Commission will now review this recommendation to determine if ide-cel should be approved in the European Union for relapsed/refractory multiple myeloma.

The European Commission will now review this recommendation to determine if ide-cel should be approved in the European Union for relapsed/refractory multiple myeloma.

The Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency has recommended giving marketing authorization to idecabtagene vicleucel (ide-cel; Abecma) for patients with relapsed/refractory multiple myeloma who have received 2 or more prior therapies, according to a press release from Bristol Myers Squibb.1

Patients who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody would be eligible for treatment. The European Commission will now review this recommendation to determine if this treatment should be approved in the European Union.

“This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T-cell therapy, [ide-cel], to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” Anne Kerber, MD, senior vice president and head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), at Bristol Myers Squibb, said in the press release. “We look forward to working with the European Commission with the shared goal of delivering innovative treatment options to more patients with continued unmet need.”

Updated data on ide-cel from the phase 3 KarMMa-3 trial (NCT03651128) were presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition, which had a median follow-up of 30.9 months.2 There was an improved median progression-free survival of 13.8 months in the ide-cel arm vs 4.4 months in the standard regimen arm (HR, 0.49; 95% CI, 0.38-0.63).

In the ide-cel arm, the overall response rate was 71% (95% CI, 66%-77%), and 44% (95% CI, 38%-50%) of patients had a complete response (CR) or stringent CR. In the standard regimen arm, the ORR was 41% (95% CI, 34%-51%), with 5% (95% CI, 2%-9%) of patients achieving a CR or stringent CR.

Regarding safety, 88% of patients who received ide-cel had any grade cytokine release syndrome (CRS), and 4% had grade 3/4 toxicity. Of note, 1% of patients experienced grade 5 CRS. A total of 15% of patients had any grade neurotoxicity, and 3% had grade 3/4 events.

References

  1. Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma. News release. Bristol Myers Squibb. January 26, 2024. Accessed January 30, 2024. https://shorturl.at/abAMY
  2. Rodriguez Otero P, Ailawadhi S, Arnulf B, et al. Idecabtagene vicleucel (ide-cel) versus standard (std) regimens in patients (pts) with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): updated analysis from KarMMa-3. Blood. 2023;142(suppl 1):1028. doi.org/10.1182/blood-2023-178933
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