MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study.

1-year primary analysis in patients with R/R DLBCL (N=71)1*:

Review the 1-year primary analysis data here.

The 5-year analysis data from L-MIND have not been submitted to or reviewed by the FDA, and potential inclusion of these data in the final FDA-approved labeling has yet to be determined. This disclaimer applies to all data from the 5-year analysis below.

5-year ORR analysis2*

ORR in patients with R/R DLBCL (N=71)

L-MIND 5-year response rates graph in patients with R/R DLBCL (N=71). 37% CR; 17% PR; 54% best ORR (n=38; 95% CI: 41%, 66%).

The cutoff date for the 5-year follow-up analysis was November 14, 2022, and occurred after the last patient enrolled had completed 5 years of follow-up2

Response rates in 2L and 3L+2*

Response rates by line of therapy in 5-year analysis

L-MIND 5-year response rates graph by line of therapy in patients with R/R DLBCL (N=71). 2L (n=35): 49% CR; 14% PR; 63% ORR (n=22; 95% CI: 45%, 79%). 3L+ (n=36): 25% CR; 19% PR; 44% ORR (n=16; 95% CI 28%, 62%).

This analysis is exploratory in nature, and L-MIND was not designed or powered to evaluate and compare multiple subgroups. These results should be interpreted with caution given the small sample size, which may lead to estimates that are unstable.

Median DoR in patients with R/R DLBCL2,3

5-year follow-up analysis: median DoR not reached2,3*†

L-MIND duration of response Kaplan-Meier graph. A 5-year follow-up analysis in patients with R/R DLCBL (N=71). Median DoR not reached (median follow-up 53.8 months [95% CI: 31.8-58.7]).

*Assessed by an Independent Review Committee.1,3

†Kaplan-Meier estimates.1,3

The cutoff date for the 5-year follow-up analysis was November 14, 2022, and occurred after the last patient enrolled had completed 5 years of follow-up.2

Duration of response by patient3

DoR by patient from time of initial response3

This graph represents 38 out of the 71 patients in the L-MIND study who experienced a response; 33 patients did not experience a complete or partial response. For patients whose response has stopped, events may include tumor progression, death, or beginning of a new anti-cancer treatment.

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  • 68% of responding patients (26/38) achieved a best response of CR

  • 34% of responders (13/38) converted from a PR to a CR

  • 32% of responding patients (12/38) had a response of at least 4 years

This graph and these bullets represent 38 out of the 71 patients in the L-MIND study who experienced a response; 33 patients did not experience a complete or partial response.

For patients whose response has stopped, events may include tumor progression, death, or beginning of a new anti-cancer treatment. The study concluded on the 5-year analysis cutoff date of November 14, 2022.3

This analysis is exploratory in nature. These results should be interpreted with caution due to single-arm studies not adequately characterizing time-to-event endpoints, and the small sample size, which may lead to estimates that are unstable.

This analysis is exploratory in nature. These results should be interpreted with caution due to single-arm studies not adequately characterizing time-to-event endpoints, and the small sample size, which may lead to estimates that are unstable.

‡Two patients started a new anti-cancer treatment immediately after a response was recorded at the end of the treatment assessment.3

The initial assessment of efficacy/disease response was performed and recorded at Cycle 3, Day 1.4

The cutoff date for the 5-year follow-up analysis was November 14, 2022, and occurred after the last patient enrolled had completed 5 years of follow-up.3

L-MIND study design

See the full study design here.