L-MIND: AN OPEN-LABEL, MULTICENTER, SINGLE-ARM, PHASE 2 STUDY1,2

  • L-MIND evaluated the efficacy and safety of MONJUVI + lenalidomide in adult patients with R/R DLBCL1

  1. Key inclusion criteria1

    • R/R DLBCL after 1 to 3 prior systemic DLBCL therapies, including a CD20-containing therapy
    • Not eligible for or refused ASCT
  1. Key endpoints1

    • Primary endpoint: ORR (CR + PR)
    • Select secondary endpoint: DoR
  1. Treatment regimen1

    • Cycle length=28 days
    • Patients received MONJUVI 12 mg/kg intravenously in combination with lenalidomide (25 mg orally on days 1 to 21 of each 28‑day cycle) for a maximum of 12 cycles, followed by MONJUVI as monotherapy, according to the following dosing schedule:
    • Cycle 1: MONJUVI on days 1, 4, 8, 15, and 22
      • Lenalidomide on days 1 to 21
    • Cycles 2 and 3: MONJUVI on days 1, 8, 15, and 22
      • Lenalidomide on days 1 to 21
    • Cycles 4 to 12: MONJUVI on days 1 and 15
      • Lenalidomide on days 1 to 21 for up to 12 cycles
    • After cycle 12 until disease progression or unacceptable toxicity: MONJUVI on days 1 and 15
    • Administer premedications, including acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids, 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize infusion-related reactions

ASCT=autologous stem cell transplant; ORR=overall response rate; CR=complete response rate; PR=partial response rate; DoR=duration of response.

Baseline characteristics of patients in the L-MIND study (N=71)

Scroll
to see
more
Median age (range)   71 years (41–86 years)
Prior therapies Refractory to last prior therapy 32 (45%)
  Refractory to rituximab 30 (42%)
Prior CD20-containing therapy   100%
Median number of prior therapies   2
Prior lines of therapy 1 49%
  2 to 4 51%
Prior ASCT   9 (13%)
Race* White 95%
  Asian 3%
Sex, male   55%
  Age 47%
Primary reasons patients
were not candidates for ASCT
Refractory to salvage chemotherapy 27%
were not candidates for ASCT Comorbidities 13%
  Refusal of high-dose chemotherapy/ASCT 13%

*Race was collected in 92% of the 71 patients.


BEST OVERALL Response Rates IN PATIENTS WITH R/R DLBCL (N=71)1†

L-MIND response rates graph. 37% CR; 18% PR; 55% ORR (n=39; 95% CI: 43%, 67%)

CI=confidence interval.


Duration of Response IN PATIENTS WITH R/R DLBCL (N=71)1†

  1. Median DoR: 21.7 months (range: 0, 24)

Assessed by an Independent Review Committee.

Kaplan-Meier estimates.