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ASCO 2024 Myeloma Oral Sessions Day 1

Welcome to the first day of our recap of the latest findings on myeloma treatments reported at the American Society of Clinical Oncology (ASCO) meeting that kicked off Friday in Chicago. This weekend gave us important updates on the use of Blenrep (belantamab mafodotin), a type of treatment called an antibody drug conjugate (ADC) that targets the protein BCMA, in patients with relapsed/refractory multiple myeloma (RRMM).

On Saturday, researchers from Spain presented from the phase 3 DREAMM-7 study that showed Blenrep in combination with Velcade (bortezomib) and dexamethasone (BVd) more than doubled progression-free survival (PFS), that is the time until disease progression, compared to Darzalex (daratumumab) in combination with Vd (36 vs 13 months). Results of the trial, which included 494 patients who had received 1 or more prior lines of therapy but no prior treatment with an anti-BCMA therapy, was simultaneously published in the New England Journal of Medicine (Hungria V).

Side effects of the BVd were consistent with previous clinical trials of individual agents. Most common side effects were low platelet counts (69%; 55% were severe grade), blurred vision (66%; 22% were severe grade), and dry eye (51%). Eye toxicity was generally reversible and manageable with dose modifications. Despite the higher incidence of eye toxicity in patients who received BVd, overall patient-reported health-related quality of life did not differ substantially between the treatment groups over time.

On Sunday, a late-breaking abstract (Abstract LBA105) presented by Canadian researchers showed Blenrep in combination with Pomalyst (pomalidomide) and dexamethasone (Pd).   lowered the risk of disease progression or death by 48% compared to Velcade (bortezomib) + Pd Results of the phase 3 DREAMM-8 trial, which included 302 patients who have tried at least one prior line of therapy, including Revlimid (lenalidomide), were simultaneously published in the New England Journal of Medicine (Dimopoulos M, NEJM 2024).

Side effects of the combination of Blenrep with Pd (BPd) were consistent with previous clinical trials of Blenrep.

Taken together, the results from the two clinical trials represent a second opportunity for Blenrep, which was taken off the US market in November of 2022 following the request of the U.S Food and Drug administration (FDA). This request was based upon the previously announced outcome of the DREAMM-3 phase 3 confirmatory trial which did not meet the requirements of the FDA Accelerated Approval regulations. Blenrep was originally granted accelerated approval in August 2020 by the FDA for relapsed/refractory patients who had received at least four prior treatments.

Results from these trials indicate that the original indication for Blenrep, which recommended administration once every three weeks at 2.5 milligrams per kilogram of body weight, had not been optimized for patients; these studies took a different approach, resulting in fewer side effects for patients. In DREAMM-8, the initial dose of Blenrep was the same, however subsequent doses were lowered to 1.9 milligrams per kilogram and administered every four weeks. Researchers noted that the dose reductions and the use of lubricating or moisturizing eye drops helped improve treatment outcomes in patients.

Stay tuned tomorrow for additional updates from trials evaluating treatment of patients with newly diagnosed and relapsed/refractory disease.