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
- 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
- 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
- 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