KEY TAKEAWAYS
- The BelaRd phase I/II trial aimed to assess ocular side effects and their impact on daily function in transplant-ineligible, newly diagnosed MM patients receiving belamaf.
- The study examined Snellen BCVA and slit lamp corneal evaluation.
- The result demonstrated that the belamaf schedule tackles dry eye and vision issues nearly without side effects, offering potent and lasting responses.
Belantamab (belamaf) often causes eye problems like blurry vision, irritation, and cornea damage, leading to dose adjustments. So, for a study, researchers aimed to assess ocular side effects and their impact on daily function in transplant-ineligible, newly diagnosed MM patients receiving belamaf.
In Part 1, 36 patients were randomly assigned in a 1:1:1 ratio to receive belamaf at doses of 2.5, 1.9, or 1.4 mg/kg. Belamaf was initially given every 8 weeks, with the option to adjust to every 12 weeks based on toxicity. Ocular evaluations involved Snellen best corrected visual acuity (BCVA) and slit lamp corneal assessment.
Ocular symptoms follow CTCAE v5.0 classification, and dry eye disease and activities of daily living (ADL) were measured using the Ocular Surface Disease Index (OSDI). This analysis included all participants from Part 1.
In cohorts receiving belamaf at doses of 2.5, 1.9, and 1.4 mg/kg, worse than 20/50 BCVA results (in the better-seeing eye) were observed in 10% (21/201), 10% (23/227), and 9% (18/192) assessments, respectively. BCVA ≤ 20/200 was noted in 1% (2/201), 1% (3/227), and 6% (11/192) of assessments, with a median time to resolution of 1 month. The most frequently reported ocular symptom ≥Gr 2 across all cohorts was dry eye (174/618, 28%), while ≥Gr3 keratopathy was noted in <2% of assessments.
For OSDI responses, “all/most of the time worst” responses in the ocular symptoms category were (3%)/6 (3%)/8 (4%), while in the ADL category, they were (3%)/4 (2%)/3 (2%). Regarding missed doses, among planned belamaf infusions, (39%)/41 (32%)/30 (27%) were skipped due to OAEs. The overall response rate(ORR) was 100%, and no disease progression was observed over a median follow-up of 18.7 months. VGPR was achieved by 81% (29/36) of patients, and at least CR was achieved by 42% (15/36), with a median time to first response of 1 month.
The result demonstrated that the belamaf schedule tackles dry eye and vision issues nearly without side effects, offering potent and lasting responses.
Clinical Trial: https://clinicaltrials.gov/study/NCT04808037
Terpos E. Ocular Adverse Events and Functional Impact in Transplant Ineligible, Newly Diagnosed Multiple Myeloma Patients Treated with Belantamab Mafodotin, Lenalidomide and Dexamethasone in BelaRd Trial. Presented at IMS 20th Annual Meeting and Exposition(2023); Megaron International Conference Centre, Athens, Greece.
