BLENREP provided a clinically meaningful and durable response in heavily pretreated patients with relapsed/refractory multiple myeloma1,a

Study design

DREAMM-2 investigated BLENREP as a single agent in patients whose prior therapy included an anti-CD38 antibody, a proteasome inhibitor, and an immunomodulatory agent1

The primary endpoint was overall response rateb | Select secondary endpoints were duration of response and time to first response.1,2

Patient
Populationc

DREAMM-2 was an open-label, randomized study designed with 2 parallel dosing cohorts that included patients with RRMM who had undergone autologous stem cell transplant or were considered transplant ineligible
(N = 221). 

Prior
Treatments

Patients previously received 3 or more anti-myeloma treatment regimens, including an anti-CD38 antibody, and were refractory to an immunomodulatory agent and a proteasome inhibitor.

Dosing
Regimen

Patients received either BLENREP 2.5 mg/kg or 3.4 mg/kg by intravenous infusion over approximately 30 minutes every 3 weeks Dose was modified in some cases due to adverse reactions.

Treatment
Continuation

Treatment continued until disease progression or unacceptable toxicity. Efficacy analysis was based upon results in patients who received the recommended dosage of 2.5 mg/kg (N=97).

a
Refractory myeloma is defined as disease that is nonresponsive to primary or salvage therapy or progresses within 60 days of last therapy.3
b
As evaluated by an Independent Review Committee based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Patients had measurable disease by IMWG criteria.1
c Patients with corneal epithelial disease, except mild punctate keratopathy, at baseline were excluded from the study. Patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m2) at baseline were also eligible for the study.1

Patient characteristics

DREAMM-2 evaluated BLENREP in patients with a median 7 lines of prior therapy1

Patient characteristics N=97
Median age (yr) (range) 65 (39-85)
Gender 53% Male
ISS disease Stage II or III 77%
ECOG performance status of 2 16%
Median previous lines of therapy 7d
Patients with high-risk cytogeneticse 27%

dRange: 3 to 21.

eAny of the following cytogenetics: t(4;14), t(14;16), and 17p13del.

ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System. 

Efficacy

Nearly one-third of patients responded to BLENREP

Clinically meaningful and durable responses observed in a patient population with a median 7 lines of prior therapy

Visual Showing Overall Response Rate to BLENREP
  • Overall response rate with BLENREP was 31% (N = 30/97; 97.5% CI: 21%, 43%).1
  • Median time to first response was 1.4 months (95% CI: 1.0, 1.6).1
  • Clinically meaningful responses: The majority of responders, 60% (18/30), achieved depth of response with a very good partial response or better.1
  • Durable responses: 73% of responders had a duration of response ≥6 months at the time of data cutoff.1

Subgroup analysis: In this subgroup of 26 patients with high-risk cytogenetics*, an overall response rate of 38.5% (10/26; 97.5% CI: 18.3, 62.1) was observed.1,3

  • This was a prespecified, exploratory analysis not adjusted for multiplicity and not controlled for type 1 error. No efficacy conclusions can be drawn from this data.

*Presence of t[4;14], t[14;16], or 17p13del.