Belantamab mafodotin plus lenalidomide/dexamethasone in newly diagnosed intermediate-fit & frail multiple myeloma patients: Long-term efficacy and safety from the phase 1/2 BELARD clinical trial
Abstract
7512
Background:
We report the long-term safety & efficacy results of a novel, extended dosing schedule of belantamab mafodotin (belamaf) combined with Lenalidomide & Dexamethasone (Rd), in transplant-ineligible newly diagnosed Multiple Myeloma patients (pts).
Methods:
Phase 1/2 BelaRd trial (NCT04808037) Part 1 evaluated the safety/tolerability of belamaf 2.5/1.9/1.4 mg/kg plus Rd & established a recommended phase 2 dose (RP2D) of 1.9 mg/kg Q8W, extended to Q12W for Ocular Adverse Events (OAEs, Best Corrected Visual Acuity [BCVA] change from baseline & keratopathy). Dosing was led by ophthalmologist-assessed OAEs. In Part 2 RP2D is assessed in 2 groups: Dosing in Group A is guided as in Part 1 & in Group B by Vision-Related Anamnestic (a 9-question tool on pt-reported ocular symptoms & their impact on daily functioning) & ≥Gr3 OAEs. Safety/efficacy results from both Parts of the trial are presented.
Results:
Of Part 1 pts (n=36; median age: 72.5; male: 53%), 25 (69%) are ongoing & 11 (31%) discontinued (8 [22%] due to fatal events; 1 [3%] progressive disease; 2 [6%] withdrew consent). 17%/75% of pts had stage I/II disease per R-ISS & 8% high-risk cytogenetics (HRC). At a median follow-up (FU) of 36.2 months, Overall Response Rate (ORR) was 100%. Meaningful BCVA decline (Snellen <20/50 ) was recorded in 12% & Gr2/≥Gr3 keratopathy in 12%/3% of ocular exams. Median time to resolution was 1.9/1.1 months for ≥Gr2 BCVA/keratopathy OAEs, respectively. The most common (≥10%) Gr≥3…
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