BLENREP provided a clinically meaningful and durable response in heavily pretreated patients with relapsed/refractory multiple myeloma1,2,a

Study design

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

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 and were refractory to an anti-CD38 monoclonal antibody, 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).

DREAMM-2 evaluated BLENREP in a broad range of patients with RRMM who were considered triple-class refractory and had a median 7 lines of prior therapy1

  • Patient characteristics

    Patient characteristics1,2

    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%

    Received prior ASCT

    87%

    Median previous lines of therapy

    7 (3 to 21)

    Refractory to daratumumab

    100%

    Refractory to lenalidomide

    90%

    Refractory to pomalidomide

    87%

    Refractory to bortezomib

    76%

    Refractory to carfilzomib

    65%

    Refractory to isatuximab

    3%

    Patients with high-risk cytogenetics2*

    42%

    1q21+

    26%

    17p13del

    16%

    t(4;14)

    11%

    t(14;16)

    7%

    Patients with renal impairment2†

    74%

    Mild impairment

    49%

    Moderate impairment

    25%

Efficacy

Nearly a third of patients with RRMM had a clinically meaningful response with BLENREP1

At 6 months, BLENREP demonstrated a 31% ORR with durable responses1,2

Visual Showing Overall Response Rate to BLENREP at 6 months
Visual Showing Overall Response Rate to BLENREP at 6 months

Median DoR NOT REACHED at 6 months of follow-up

  • Overall response rate: 31% (n = 30/97; 97.5% CI: 21%, 43%).1

  • Median time to first response: 1.4 months (95% CI: 1.0, 1.6).1

  • Depth of response: The majority of responders, 60% (18/30), achieved very good partial response or better.1

  • Duration of response: 73% of responders had a DoR ≥6 months at the time of data cutoff.1

At the 13-month follow-up, BLENREP demonstrated a 32% ORR and an estimated median DoR of 11 months3

Visual Showing Overall Response Rate to BLENREP at 13 months
Visual Showing Overall Response Rate to BLENREP at 13 months

Median DoR estimate was 11 MONTHS (95% CI: 4.2, NR)

  • Overall response rate: 32% (n = 31/97; 97.5% CI: 22%, 44%).3

  • Depth of response: 58% of responders (18/31) had a very good partial response or better; 7% (7/97) of patients treated with BLENREP had a complete response or better.3

  • Duration of response: Estimated median DoR of 11 months (95% CI: 4.2, NR).3

Subgroup analysis

The DREAMM-2 clinical trial included patients with high-risk cytogenetics2

42% of patients in the DREAMM-2 study had high-risk cytogenetics2*

In a post hoc analysis of 41 patients with high-risk cytogenetics2,3

  • At 6 months and at 13-month follow-up: an overall response rate of 29%
    was observed (12/41; 95% CI: 16.1, 45.5)2,3

These were exploratory analyses not adjusted for multiplicity and not controlled for Type 1 error. No efficacy conclusions can be drawn from these data.2,3

Patients included those with translocations 4;14 and 14;16, 17p13 deletions, and chromosome 1q21 amplification. The two most common cytogenetic risk factors in patients were 1q21 amplification and 17p13 deletions.2

  • 1q21+: 61% (25/41)

  • 17p13del: 39% (16/41)

  • t(4;14): 26% (11/41)

  • t(14;16): 17% (7/41)

DREAMM-2 evaluated heavily pretreated RRMM patients, including those with mild and moderate renal impairment2

74% of patients in the DREAMM-2 study had mild or moderate renal impairment2

In a post hoc analysis at 13 months:

Overall response rate for BLENREP 2.5 mg/kg by renal function3

Normal renal function
(>90 mL/min/1.73 m2)

37%

(n=7/19; 95% Cl: 16.3, 61.6)

Mild renal impairment
(≥60–<90 mL/min/1.73 m2)

33%

(n=16/48; 95% Cl: 20.4, 48.4)

Moderate renal impairment
(≥30–<60 mL/min/1.73 m2)

33%

(n=8/24; 95% Cl: 15.6, 55.3)