Teclistamab (JNJ-64007957) is a bispecific antibody that targets BCMA, which is expressed in mature B lymphocytes, and CD3, which is expressed on T-cells.
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The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.
The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.
The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.
December 13, 2021
As of June 14, 2021, 159 pts (median age 64.0 y [range 33–84]; 15% ≥75 y; 59% male) were treated at the RP2D (phase 1: 40 pts; phase 2: 119 pts). Pts received a median of 5 prior lines of therapy (range: 2–15); 100% were triple-class exposed, 69% were penta-drug exposed, 77% were triple-class refractory, and 29% were penta-drug refractory.
As of the clinical cutoff, no new safety signals were identified in phase 2. The most common nonhematologic AEs in all 159 pts treated at the RP2D were CRS (67%; grade 1/2: 99%; 1 pt had a transient grade 3 event; median time to onset 2 days [range 1–6]; median duration 2 days [range 1–9]), injection site erythema (23%; all grade 1/2), and fatigue (22%; grade 3/4: 2%). The most common hematologic AEs were neutropenia (53%; grade 3/4: 45%), anemia (41%; grade 3/4: 27%), and thrombocytopenia (33%; grade 3/4: 18%). Four pts (2.5%) developed ICANS (all grade 1/2; all resolved). Pharmacokinetic and pharmacodynamic data from phase 2 support earlier phase 1 findings. Teclistamab exposure at the RP2D was sustained across the dosing interval and exceeded target exposure levels. Pharmacodynamic data for phase 1/2 pts treated at the RP2D showed induction of proinflammatory cytokines and T-cell activation, consistent with teclistamab’s mechanism of action.
At clinical cutoff for this abstract, efficacy data for the phase 2 study are immature. At a median follow-up of 8.2 mo (range 1.2–15.2), response rates in the 40 phase 1 pts treated at RP2D were consistent with previously presented data (ORR: 65% [95% CI 48–79]; ≥VGPR rate: 60% [95% CI 43–75]; complete response or better rate: 40% [95% CI 25–57]). Responses deepened over time, and with longer follow-up of responders compared with previously presented data (median follow-up of 9.5 mo vs 7.1 mo) remained durable (Figure). No additional responders had disease progression, and 85% (22/26) of responders are continuing on treatment, including 1 pt with 15.2 mo of follow-up. Median duration of response (DOR) has not been reached; the 6-month DOR rate is 90% [95% CI 63–97]. The efficacy data will be updated at the time of congress to include a minimum follow-up of ~6 mo for 150 pts treated at the RP2D (prior to March 19, 2021).