A Phase 2 Study to Evaluate Outpatient Step-up Administration of Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results
Results: To date, 13 pts have been enrolled at 12 Sarah Cannon/US Oncology community sites. One pt developed diffuse bony lesions, weakness and pain due to rapidly progressing MM, did not complete the SUD regimen, and died on C1D40. Eleven pts have completed the SUD regimen per protocol and are included in the safety analysis. Median age was 70 (53-83) yrs; 5 pts were male; 6 pts were female, 1 Black, 6 White, 3 unknown, and 1 unreported. Pts had received a median of 4 (range, 4 to 6) prior lines of therapy. Hematologic adverse events (AEs) included neutropenia (1 pt gr 3, 3 pts gr 4) and lymphopenia (2 pts gr 1). No patients experienced febrile neutropenia. To date, no pts experienced CRS or ICANS or required hospitalization due to tec or Toci. A total of 7 infections, all gr 2, occurred in 4 pts. Seven pts developed IgG < 400 mg/dL, of whom 6 received IVIG replacement. Other AEs in >1 pt were fatigue, headache, and injection site reactions. Gr 2 hypotension (2 pts) was not attributed to CRS. Stopping criteria (gr > 3 CRS or NT/ICANS were not met. Seven pts are evaluable for clinical response (7/11); all 7 responded, achieving a complete response (CR) (n=1), very good partial response (VGPR) (n=5), or partial response (PR) (n=1). All 11 pts who have completed the SUD remain on study. Enrollment is ongoing.
Conclusion: Initial results from the OPTec study indicate that proToci may reduce the risk of CRS. None of the 11 subjects treated to date have experienced CRS or ICANS, and the safety profile is otherwise comparable to the pivotal MajesTEC-1 results. Enrollment is ongoing to determine if proToci may facilitate OP administration of the tec SUD schedule in an OP setting and increase patient accessibility in community centers. Additional data and follow-up in more pts, including PK data in the first 10 pts in addition to updated infection, IVIG use, and response data will be presented at ASH. The protocol is being amended to add a cohort of Talquetamab to determine if proToci can reduce CRS and facilitate OP SUDs across bispecific antibodies.