Baseline ocular conditions and risk of ocular events in patients (pts) with relapsed/refractory multiple myeloma (RRMM) from the DREAMM-7 and DREAMM-8 trials of belantamab mafodotin (belamaf).

Abstract

7544 Background: Belamaf combinations were evaluated for RRMM in the phase 3 DREAMM-7 (belamaf + bortezomib + dexamethasone [BVd]; NCT04246047) and DREAMM-8 (belamaf + pomalidomide + dexamethasone [BPd]; NCT04484623) trials, and significant progression-free survival benefits were reported over standard of care, with significant overall survival benefit reported for BVd. Ocular events (e.g., ocular adverse events [oAEs], blurred vision, dry eye) occurred with belamaf and most resolved with dose holds and modifications. We examined the baseline eye health of pts with RRMM receiving BVd or BPd, and whether baseline ocular conditions affected rates of treatment-emergent (TE) oAEs. Methods: Pts with ≥1 prior therapy were eligible for DREAMM-7/8; pts with ocular conditions were eligible except for corneal epithelial disease (mild punctate keratopathy was allowed). Mandatory ophthalmic examinations (best corrected visual acuity [BCVA], slit lamp, and funduscopic exams) were performed in both arms of the trials at baseline and routinely during treatment. oAEs were graded by Common Terminology Criteria for Adverse Events. Regardless of presence/absence of baseline ocular conditions, the same protocol-defined strategies were used for ocular event management during the studies. Results: In 392 pts treated with belamaf (n=242 DREAMM-7 and n=150 DREAMM-8), baseline ocular conditions were reported in 62% of pts (n=135 and 106); baseline conditions included cataract 50% (n=101 and 96), keratopathy 14% (n=33 and 23), dry eye 14% (n=31 and 24), visual acuity of 20/50 or worse 6% (n=18 and 7), glaucoma 6% (n=11 and 13), blepharitis 2% (n=4 and 3), age-related macular degeneration 1% (n=3 and 2), and diabetic retinopathy <1% (n=0 and 2). Any TE oAE was reported in 74% (n=100/135) and 87% (n=92/106) of pts with baseline ocular conditions in DREAMM-7 and DREAMM-8, respectively, compared with 79% (n=85/107) and 91% (n=40/44) of pts without baseline ocular conditions (Table). Conclusions: The safety profiles of belamaf combinations for oAEs were similar between patients with vs without baseline ocular conditions, suggesting that these baseline ocular conditions did not increase the risk of TE oAEs. The effect of each baseline ocular condition on TE oAEs, as well as TE corneal exam findings and visual acuity changes, will be presented. Clinical trial information: NCT04246047 , NCT04484623 . TE ocular events in patients receiving a belamaf combination in DREAMM-7/8. DREAMM-7 DREAMM-8 With any baseline ocular condition, n=135 No baseline ocular condition, n=107 With any baseline ocular condition, n=106 No baseline ocular condition, n=44 Any oAE, n (%) 100 (74) 85 (79) 92 (87) 40 (91)