C004 | REALITEC: A MULTI-COUNTRY OBSERVATIONAL RETROSPECTIVE STUDY OF TECLISTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA OUTSIDE OF CLINICAL TRIALS

Teclistamab is the first approved BCMA-CD3 bispecific antibody for relapsed/refractory multiple myeloma. With a median follow-up of 30.4 months, the pivotal MajesTEC-1 trial showed deep and durable responses. Here, we report the first results of REALiTEC, a retrospective observational study of patients receiving teclistamab outside of clinical trials. REALiTEC is an international, non-interventional study that aims to describe the management and outcomes of patients treated with teclistamab in a nonclinical trial setting. Data were collected from patient medical records, including demographics, disease characteristics, prior therapies, effectiveness and safety. Informed consent was obtained for all patients. 113 eligible patients from 23 sites in 8 countries – including 13 patients from 3 Italian sites – were included in the study. Overall, 88.5% of patients received teclistamab as part of a pre-approval access program. Median age was 66 years, with a median of 6 prior lines of therapy. 78.8% and 44.2% of patients were triple and penta-class refractory, respectively, and 33.6% had previously received anti-BCMA treatments. With a median follow-up of 20.7 (range, 0.7–35.8) months, median treatment duration was 9.4 (0.3–35.8) months. After a median of 7 (0–18) months, 39.8% of patients switched from weekly to biweekly dosing, mostly due to achieving very good partial response or better (≥VGPR). ORR was 60.2%, with 52.2% of patients achieving ≥VGPR. Median time to first response was 1.6 (1.2–1.9) months, with a median time to best response of 3.7 (2.8–5.0) months. Median DoR was 20.3 (14.8–NE) months, median PFS was 9.7 (5.5–18.8) months and median OS was 26.2 (16.5–NE) months. Patients achieving ≥VGPR had longer DoR (median 26.1 months; 16.7–NE), with median PFS (Figure) and OS not reached and with an estimated 71.2% of patients being progression free and 83.1% alive at 12 months. Patients with no prior BCMA treatments had a median PFS of 14.2 (7.8–NE) months and median OS was not reached (26.2–NE). Most common adverse events were infections (all grade 71.7%; G3/4: 40.7%), CRS (all grade 55.7%; G3/4: 1.8%), neutropenia (all grade 35.4%; G3/4: 32.7%) and anemia (all grade 25.7%; G3/4:16.8%). REALiTEC shows similar clinical outcomes as those observed in MajesTEC-1 in a hard-to-treat, heavily pretreated patient population. Those outcomes also support the importance of reaching deep responses with teclistamab, associated with longer DoR, PFS, and OS.