Hematology Xagena

Xagena Mappa
Xagena Newsletter

DREAMM-6: Safety and tolerability of Belantamab mafodotin in combination with Bortezomib / Dexamethasone in relapsed / refractory multiple myeloma

Belantamab mafodotin, a B-cell maturation antigen targeting immunoconjugate, has demonstrated clinically meaningful, single-agent activity in patients with heavily pre-treated relapsed / refractory multiple myeloma ( RRMM ) refractory to an immunomodulatory agent, a proteasome inhibitor, and refractory and/or intolerant to an anti-CD38 monoclonal antibody ( DREAMM-2, Lancet Oncol.2020 ).
The multimodal mechanism of action and manageable safety profile make Belantamab mafodotin a promising candidate for use in different RRMM combination regimens.

DREAMM-6 is an ongoing, two-part, two-arm, study evaluating the safety, tolerability, and clinical activity of Belantamab mafodotin in combination with Bortezomib / Dexamethasone ( BorDex ) and Lenalidomide / Dexamethasone in patients previously treated with greater than or equal to 1 prior therapy line.

Researchers have presented data for Belantamab mafodotin in combination with BorDex. Part 1 ( dose escalation ) and Part 2 ( dose expansion ) have evaluated Belantamab mafodotin ( 2.5 and 3.4 mg/kg ) administered as SINGLE ( Day 1 ) or SPLIT dose ( divided equally on Days 1 and 8 ) in combination with BorDex.

As of February 6, 2020, 52 patients were enrolled: 6 patients were enrolled at 2.5 mg/kg single dose and 7 at 3.4 mg/kg single dosing in Part 1, and 45 patients in Part 2.

No dose-limiting toxicities were observed. Corneal events ( including keratopathy, blurred vision, and dry eye ) and thrombocytopenia were the most frequently reported adverse effects and were clinically manageable.

In conclusion, in DREAMM-6, preliminary data have demonstrated that the combination of Belantamab mafodotin and BorDex has an acceptable safety profile, with no new safety signals identified. ( Xagena )

Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020