Emory University Hospital, Winship Cancer Institute, Atlanta, GA
Sagar Lonial , Hans Chulhee Lee , Ashraf Badros , Suzanne Trudel , Ajay K. Nooka , Ajai Chari , Al-Ola A. Abdallah , Natalie Scott Callander , Douglas Weston Sborov , Attaya Suvannasankha , Katja Weisel , Peter Michael Voorhees , Axel Hoos , Eric Zhi , January Baron , Trisha Piontek , Roxanne C. Jewell , Joanna Opalinska , Ira Gupta , Adam D. Cohen
Background: Single-agent belantamab mafodotin (B-cell maturation antigen targeting immunoconjugate) showed clinically meaningful activity and manageable safety in patients with heavily pre-treated RRMM (DREAMM-2, NCT03525678, Lancet Oncol.2020). We report updated results (median follow-up 9 months). Methods: DREAMM-2 is an ongoing single-agent belantamab mafodotin (2.5 or 3.4 mg/kg) study in patients with RRMM after ≥3 prior therapy lines and refractory to an immunomodulatory agent, a PI, and refractory and/or intolerant to an anti-CD38 mAb. Primary endpoint: overall response rate (ORR; ≥partial response per independent review committee). Results: ORR was 31% in the 2.5 mg/kg (19% with ≥very good partial responses [VGPR]) and 35% (24% with ≥VGPR) in the 3.4 mg/kg groups (Table). Duration of response (DoR) was not reached (NR) in the 2.5 mg/kg and 6.2 months in the 3.4 mg/kg groups; 1-year overall survival (OS) estimate was 53%. Common Grade 3/4 AEs ( > 10% in either group) were keratopathy (2.5: 29%; 3.5: 24%), thrombocytopenia (2.5: 21%; 3.4: 32%), anemia (2.5: 20%; 3.4: 27%), pneumonia (2.5: 6%; 3.4: 13%), and neutropenia (2.5: 11%; 3.4: 16%). AEs were managed with dose delays (2.5: 54%; 3.4: 62%) and reductions (2.5: 34%; 3.4: 43%); discontinuations due to AEs were uncommon (2.5: 9%; 3.4: 12%). Conclusions: Single-agent belantamab mafodotin was well-tolerated, and clinically meaningful responses were sustained despite dose modifications with longer follow-up. Funding: GlaxoSmithKline (205678). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Clinical trial information: NCT03525678.
2.5 mg/kg (n = 97)a | 3.4 mg/kg (n = 99)b | |
---|---|---|
Median number of cycles (range) | 3 (1–15) | 3 (1–14) |
ORR (97.5% CI), % | 31 (20.8–42.6) | 35 (24.8–47.0) |
DoRc, m | NR (4.2–NR) | 6.2 (4.8–NR) |
Probability of DoR ≥6 m, % (95% CI) | 70 (48–84) | 58 (39–72) |
Progression-free survival (PFS)c, m | 2.8 (1.6–3.6) | 3.9 (2.0–5.8) |
PFS: patients with ≥minimal responsec, % | NR (7.5–NR) | 8.4 (6.9–13.8) |
Probability of OS at 12 m, % (95% CI) | 53 (38–66) | 53 (41–63) |
a41 on study; 17/41 on treatment; b47 on study; 18/47 on treatment; cmedian (95% CI estimates). m, months
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