Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study

Lonial, Sagar; Lee, Hans C.; Badros, Ashraf; Trudel, Suzanne; Nooka, Ajay K.; Chari, Ajai; Abdallah, Al‐Ola; Callander, Natalie S.; Lendvai, Nikoletta; Sborov, Douglas W.; Suvannasankha, Attaya; Weisel, Katja; Karlin, Lionel; Libby, Edward N.; Arnulf, Bertrand; Facon, Thierry; Hulin, Cyrille; Kortüm, K. Martin; Rodríguez‐Otero, Paula; Usmani, Saad Z.; Hari, Parameswaran; Baz, Rachid; Quach, Hang; Moreau, Philippe; Voorhees, Peter M.; Gupta, Ira; Hoos, Axel; Zhi, Eric; Baron, January; Piontek, Trisha; Lewis, Eric; Jewell, Roxanne C.; Dettman, Elisha J.; Popat, Rakesh; Esposti, Simona Degli; Opalinska, Joanna; Richardson, Paul G.; Cohen, Adam D.

doi:10.1016/s1470-2045(19)30788-0

Cited by 635 publications

(851 citation statements)

References 25 publications

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“…Venetoclax is not approved for use in multiple myeloma, but is commercially available, and appears to have single‐agent activity in patients with t(11;14) subtype of multiple myeloma 157 . However, the results of a recent randomized trial found significantly higher mortality with venetoclax in relapsed myeloma, despite producing deeper responses and better PFS 158 . Therefore, venetoclax is best considered investigational, and its use should be restricted to patients with t(11;14) who have relapsed disease and limited options.…”

Section: Treatment Of Relapsed Multiple Myelomamentioning

confidence: 99%

Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management

2020

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Disease overview: Multiple myeloma accounts for approximately 10% of hematologic malignancies.Diagnosis: The diagnosis requires ≥10% clonal bone marrow plasma cells or a biopsy proven plasmacytoma plus evidence of one or more multiple myeloma defining events (MDE) namely CRAB (hypercalcemia, renal failure, anemia, or lytic bone lesions) features felt related to the plasma cell disorder, bone marrow clonal plasmacytosis ≥60%, serum involved/uninvolved free light chain (FLC) ratio ≥100 (provided involved FLC is ≥100 mg/L), or >1 focal lesion on magnetic resonance imaging (MRI). Risk stratification:The presence of del(17p), t(4;14), t(14;16), t(14;20), gain 1q, or p53 mutation is considered high-risk multiple myeloma. Presence of any two high risk factors is considered double-hit myeloma; three or more high risk factors is triple-hit myeloma.Risk-adapted initial therapy: In transplant eligible patients, induction therapy consists of bortezomib, lenalidomide, dexamethasone (VRd) given for approximately 3-4 cycles followed by autologous stem cell transplantation (ASCT). In high-risk patients, daratumumab, bortezomib, lenalidomide, dexamethasone (Dara-VRd) is an alternative to VRd. Selected standard risk patients can get additional cycles of induction, and delay transplant until first relapse. Patients not candidates for transplant are typically treated with VRd for approximately 8-12 cycles followed by lenalidomide; alternatively these patients can be treated with daratumumab, lenalidomide, dexamethasone (DRd).Maintenance therapy: After ASCT, standard risk patients need lenalidomide maintenance, while bortezomib-based maintenance is needed for patients with high-risk myeloma.Management of refractory disease: Most patients require a triplet regimen at relapse, with the choice of regimen varying with each successive relapse.

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Section: Treatment Of Relapsed Multiple Myelomamentioning

confidence: 99%

Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management

2020

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“…Although the response was worse in the daratumumab-refractory cohort, the result was still better than the 31% ORR seen in the evaluation for the other first treatment regimen after progression with anti-CD38 therapy, with a median PFS of just 3.4 months [111]. The recently published phase 2 DREAMM-2 study showed that 30 (31%; 97.5% CI 20.8-42.6) of 97 patients in the 2.5 mg/kg cohort and 34 (34%; 23.9-46.0) of 99 patients in the 3.4 mg/kg cohort achieved an overall response [112].…”

Section: Clinical Studiesmentioning

confidence: 99%

Immunotherapy in Multiple Myeloma

Soekojo

Ooi

Mel

et al. 2020

Cells

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“…PFS was 7.9 months for patients refractory to both IMIDS and PIs, 15.7 months in patients without prior daratumumab treatment, 6.8 months in patients with prior daratumumab treatment, and 6.2 months in those with prior daratumumab treatment and refractory to IMIDs and PIs. DREAMM-2 is an open-label, randomized, 2-arm, phase 2 study investigating efficacy and safety of GSK2857916 in patients with RRMM who have received a median of 3 prior lines of therapy (range 1-11), are refractory to a PI and an IMID, and have failed an anti-CD38 antibody (NCT03525678) [102]. The participants were randomized to receive either 2.5 mg/kg or 3.4 mg/kg of intravenous belantamab mafodotin every 3 weeks on day 1 of each cycle until disease progression or unacceptable toxicity.…”

Section: Gsk2857916 (Belantamab Mafodotin)mentioning

confidence: 99%

Monoclonal antibodies in relapsed/refractory myeloma: updated evidence from clinical trials, real-life studies, and meta-analyses

Musto

Rocca

2020

Expert Review of Hematology

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Introduction: In the last few years, monoclonal antibodies have rapidly modified the therapeutic strategies for treating patients with multiple myeloma. Areas covered: In this review, the most recent literature data regarding indications for which monoclonal antibodies are currently or will be shortly approved as salvage therapies in relapsed/refractory myeloma are discussed. In particular, updated results until March 22, 2020 of antibodies directed against CD38 (daratumumab and isatuximab), SLAMF7 (elotuzumab), BCMA (GSK2857916/belantamab mafodotin), and PD-1/PD-1 L axis (nivolumab and pembrolizumab) will be analyzed in detail. Expert opinion: Monoclonal antibodies represent a new, very effective approach that will open novel and dynamic treatment scenarios for myeloma patients in the coming years. Optimal positioning and selection of different antibodies that are or will be soon available, appropriate combinations and careful evaluation of possible new toxicities should be considered in the future management of these patients.

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Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study

Cited by 635 publications

References 25 publications

Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management

Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management

Immunotherapy in Multiple Myeloma

Monoclonal antibodies in relapsed/refractory myeloma: updated evidence from clinical trials, real-life studies, and meta-analyses

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