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DREAMM-2 clinical trial
BLENREP efficacy
For Great Britain (GB) healthcare professionals only - BLENREP is not available in Northern Ireland (NI).
BLENREP has a conditional marketing authorisation.
Learn how fast, deep and durable responses to BLENREP were in a triple-class refractory 5th line plus multiple myeloma (MM) patient population1-3
BLENREP is only available via the private market.
Table of contents
The DREAMM-2 clinical trial studied BLENREP as a single agent in triple-class refractory patients with multiple myeloma (MM) (n=97; final analysis) who had received a median of 7 prior lines of therapy.1
BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.2,3
This medicinal product has a conditional marketing authorisation.
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DREAMM-2 clinical trial design
- DREAMM-2 was an open-label, multicentre, phase 2 study in patients with relapsed/refractory multiple myeloma2
- Patients were refractory to an anti-CD38 antibody, a proteasome inhibitor, and an immunomodulatory agent2
HSCT, haematopoietic stem cell transplantation.
-
DREAMM-2 patient characteristics
Baseline characteristics in the recommended dose population2
Adapted from Lonial S, et al. Lancet Oncol. 2020. Data are n (%) unless otherwise specified.
eGFR, estimated glomerular filtration rate; IgG, immunoglobulin G; ISS, International Staging System.
*Data available for 47 patients in the 2.5 mg/kg cohort.2
†The number of previous lines of therapy is derived as the number of previous anticancer regimens received by a patient as reported on the electronic case report form. Combination therapy containing multiple components was counted as one regimen.2
‡Based on data available at the time of database lock; however, all patients were refractory to a proteasome inhibitor, immunomodulatory drug,and an anti-CD38 monoclonal antibody as per eligibility criteria.2
Primary endpoint: ORR1
32% of patients (n=31/97) responded to BLENREP in the final analysis (97.5% CI: 21.7-43.6). 58% (n=18) of responding patients achieved a VGPR or better.1
Adapted from Ramasamy, Ket al. BSH 2023
DREAMM-2 results at final analysis (40 months follow-up)
Secondary endpoint: OS1
The median OS was 15.3 months (95% CI: 9.9-18.9).1
Adapted from Ramasamy, Ket al. BSH 2023
CI, confidence interval; OS, overall survival.
OS by response category1
BLENREP delivered a mOS of 30.7 months in patients who achieved a VGPR or better (n=18)
Adapted from Ramasamy, Ket al. BSH 2023
CI, confidence interval; MR, minimal response; NE, not evaluable; OS, overall survival; PD, progressive disease; PR, patrial response; SD, stable disease; VGPR, very good partial response.
DREAMM-2 results at final analysis (40 months follow-up)
Duration of response (DoR)1
The median DoR was 12.5 months (95% CI; 4.2-19.3)
Adapted from Ramasamy, Ket al. BSH 2023
CI, confidence interval; DoR, duration of response; PR, partial response.
DREAMM-2 results at final analysis
Progression-free survival (PFS)1
Median PFS was 2.8 months (95% CI: 1.6-3.6). The estimated mPFS was 14.0 months in patients with a VGPR or better.1
Adapted from Ramasamy, Ket al. BSH 2023
CI, confidence interval; PFS, progression-free survival.
BLENREP delivered similar responses in patient sub-groups vs. the overall population in the 13-month follow up5
Analysis at 13 month follow up
*Analysis included patients with t(4;14), t(14;16), or 17p13del translocations. Evaluation of BLENREP in patients with these high-risk cytogenetics was a prespecified subgroup analysis and not adjusted for multiplicity. In a post-hoc analysis that also included patients with the 1q21+ abnormality, the ORR was 29% (n=12/41; 95% CI: 16.1–45.5).5
ORR based on renal function (post-hoc analysis of 13-month follow up)5
| Renal function | ORR |
|---|---|
| Normal renal function (≥90 mL/min/1.73 m2; n=19) |
37% (95% CI: 16.3-61.6) |
| Mild renal impairment (≥60–<90 mL/min/1.73 m2; n=48) |
33% (95% CI: 20.4-48.4) |
| Moderate renal impairment (≥30–<60 mL/min/1.73 m2; n=24) |
33% (95% CI: 15.6-55.3) |
Find out more about what BLENREP can offer your patients
Prescribing information can be found at the top of this webpage, or here.
BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.3
Abbreviations
CI, confidence interval; DoR, duration of response; DREAMM-2, DRiving Excellence in Approaches to Multiple Myeloma 2; eGFR, estimated glomerular filtration rate; GB, Great Britain; HSCT, haematopoietic stem cell transplantation; IgG, immunoglobulin G; ISS, International Staging System; MM, multiple myeloma; MR, minimal response; NI, Northern Ireland; OS, overall survival; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease; TTBR, time to best response; TTR, time to response; VGPR, very good partial response.
References
- Ramasamy, K et al. Poster presented at the British Society of Haematology (BSH) on the 63rd Annual Scientific Meeting, 23-25 April 2023, ICC in Birmingham.
- Lonial S, et al. Lancet Oncol. 2020;21(2):207–221.
- BLENREP Summary of Product Characteristics.
- Palumbo A, et al. Blood. 2011;118(17):4519–4529.
- Lonial S, et al. Cancer 2021;127(22):4198-4212
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or email us on UKSafety@gsk.com
© 2022 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.
February 2024 | PM-GB-BLM-WCNT-220003 (V5.0)
