Mayo Clinic Reviews Outpatient Techniques for Monitoring Post CAR T-Cell Therapy

In a recent Training Academy, experts discussed how to incorporate bispecific antibodies into patients with multiple myeloma.

Pivotal Trials in the Space

• Phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098)1
  • Helped lead to the approval of teclistamab-cqyv (Tecvayli)
  • Top-line results:
    • Overall response rate (ORR) of 61.8% (95% CI, 52.1%-70.9%)
    • Median follow-up was 7.4 months
    • Duration of response rate was 90.6% (95% CI, 80.3%-95.7%) at 6 months and 66.5% (95% CI, 38.8%-83.9%) at 9 months
• Phase 2 MagnetisMM-3 trial (NCT04649359)2
  • Helped lead to the approval of elranatamab-bcmm (Elrexfio)
  • Top-line results:
    • ORR was 58%, and 82% of patients had responses lasting for at least 9 months.
• Phase 1/2 MonumenTAL-1 trial (NCT03399799; NCT04634552)3
  • Helped lead to the approval of talquetamab-tgvs (Talvey)
  • Top-line results:
    • A 0.8 mg/kg subcutaneous dose of the agent resulted in an ORR of 73.6% (95% CI, 63.0%-82.4%).
    • After a median follow-up of 6 months, the very good partial response rate (VGPR) was 58% and complete response (CR) rate or better was 33%.

• Corresponding ORR at subcutaneous-0.4 mg/kg dose was 73.0% (95% CI, 63.2%-81.4%), VGPR was 57%, and CR or better rate was 35% at a median follow-up of 14 months.

New Observation Advances at Mayo

• Patients at Mayo Clinic receiving chimeric antigen T-cell therapy can be remotely monitored using iPads to collect data with Bluetooth oximeter and blood pressure monitor.
• Helps monitor patients in an outpatient setting and check vitals between daily visits.
• Patients are told to stay between 15 and 30 minutes of the center during the first 1 to 2 weeks of treatment.
• If cytokine release syndrome develops, clinicians can be alerted quickly and patients will be enrolled as inpatient.

References

1. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. doi:10.1056/NEJMoa2203478
2. Pfizer’s Elrexfio receives U.S. FDA accelerated approval for relapsed or refractory multiple myeloma. News release. Pfizer. August 14, 2023. Accessed August 14, 2023. https://bit.ly/3DTCRIY
3. Chari A, Touzeau C, Schinke C, et al. Talquetamab, a G protein-coupled receptor family C group 5 member D x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM): phase 1/2 results from MonumenTAL-1. Blood. 2022;140(suppl 1):384-387. doi.10.1182/blood-2022-159707