EPKINLY delivered an ORR of 61%, with 38% of
patients achieving a deep response of CR1

61% of patients had a response (n=90/148; 95% CI, 53-69), 38% of patients had a complete response (n=56/148; 95% CI, 30-46), and 23% had a partial response (n=34/148; 95% CI, 17-31). Median DOR was 15.6 months (n=90/148; 95% CI, 9.7 months-NR).

*Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).

See the full EPCORE® NHL-1 study design

Responses in select prespecified subgroups were consistent with the overall population2

CAR T naïve patients (n=90) had a 67% overall response rate (n=60; 95% CI, 56-76), 41% had a complete response (n=37; 95% CI, 31-52), and 26% had a partial response (n=23).
CAR T exposed patients (n=58) had a 52% overall response rate (n=30; 95% CI, 38-65), 33% had a complete response (n=19; 95% CI, 21-45), and 19% had a partial response (n=11).
CAR T refractory patients (n=43) had a 42% overall response rate (n=18; 95% CI, 27-58), 26% had a complete response (n=11; 95% CI, 14-41), and 16% had a partial response (n=7).
Primary refractory patients (n=89) had a 52% overall response rate (n=46; 95% CI, 41-62), 28% had a complete response (n=25; 95% CI, 19-39), and 24% had a partial response (n=21).

Data Limitation: Study was not powered to evaluate these prespecified subgroups. Data are exploratory and descriptive in nature. No formal inferences can be drawn.

In overall responders (61%, n=90/148), EPKINLY delivered durable responses in heavily pretreated 3L+ DLBCL, NOS patients1

In overall responders (61%, n=90/148): Rapid, 1.4 months median time to response (range 1.0-8.4). Durable, mDOR 15.6 months (95% CI, 9.7 mo-NR). Sustained, 63% still responding at 9 months (estimated; 95% CI, 52-72).
  • In the efficacy population of 148 patients, the median number of prior therapies was 3 (range: 2-11), with 2 prior (30%), 3 prior (30%), and 4+ prior (40%). Prior therapies: autologous HSCT (18%), CAR T (39%). Refractory to last therapy (82%). Refractory to CAR T (29%)
  • The median follow-up for DOR was 9.8 months (range: 0-17.3 months)

In a pre-specified analysis of complete responders (38%, n=56/148)1,2:

In a pre-specified analysis of complete responders (38%, n=56/148): Rapid, 2.6 months median time to complete response (range 1.2­-10.2). Durable, mDOCR NOT REACHED (95% CI, 14.3 mo-­NR). Sustained, 89% still responding at 9 months (estimated; 95% CI, 75­-95).
In overall responders (61%, n=90/148): Rapid, 1.4 months median time to response (range 1.0-8.4). Durable, mDOR 15.6 months (95% CI, 9.7 mo-NR). Sustained, 63% still responding at 9 months (estimated; 95% CI, 52-72).
  • In the efficacy population of 148 patients, the median number of prior therapies was 3 (range: 2-11), with 2 prior (30%), 3 prior (30%), and 4+ prior (40%). Prior therapies: autologous HSCT (18%), CAR T (39%). Refractory to last therapy (82%). Refractory to CAR T (29%)
  • The median follow-up for DOR was 9.8 months (range: 0-17.3 months)

In a pre-specified analysis of complete responders (38%, n=56/148)1,2:

In a pre-specified analysis of complete responders (38%, n=56/148): Rapid, 2.6 months median time to complete response (range 1.2­-10.2). Durable, mDOCR NOT REACHED (95% CI, 14.3 mo-­NR). Sustained, 89% still responding at 9 months (estimated; 95% CI, 75­-95).
  • Complete responses were achieved as late as 10.2 months2
  • The median follow-up for DOCR was 9.7 months (range: 8.3-12.1 months)2

†Based on Kaplan-Meier estimate.

Long-term follow-up data3

Investigator-assessed DOR and DOCR at a median follow-up of 31 months

EPKINLY® long-term follow-up data shows 62% still in complete response at 24 months (estimated). 95% CI, 47.2-73.5 mo.

ORR=57.4%
(n=85/148; 95% CI, 49.0-65.5)

CR=40.5%
(n=60/148; 95% CI, 32.6-48.9)

PR=16.9%
(n=25/148; 95% CI, 11.2-23.9)

mDOCR† not reached

(95% CI, 19.3-NR)

mDOR† 20.8 months

(95% CI, 13.0-27.4)

Overall median study follow-up was 31.1 months (range: 0.3+, 38.8).‡

Efficacy results determined by Lugano criteria per investigator assessment (INV).

Data cutoff: October 2023

Long-term follow-up: Safety data3

  • With a median follow-up of 31 months, observations were consistent with the known epcoritamab safety profile. Discontinuation due to an adverse reaction occurred in 6% of patients
  • Serious infections were reported in 31% of patients. Serious infections ≥5% were COVID-19 events§ (15% of patients). Fatal infections occurred in 12 patients, of which 9 were COVID-19 events§

No inference can be drawn from this data set. Follow-up analysis is exploratory and data are descriptive in nature.
The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

*Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).

†Based on Kaplan-Meier estimate.

‡Median follow-up for DOR was 26.7 months (range: 26.2-27.6 months). Median follow-up for DOCR was 26.7 months (range: 24.1-27.3 months).||

§COVID-19 events represent COVID-19 and COVID-19 pneumonia.

||Based on reverse Kaplan-Meier estimate.

3L=third line; CAR T=chimeric antigen receptor T-cell therapy; CI=confidence interval; CR=complete response; DOCR=duration of complete response; DOR=duration of response; DLBCL=diffuse large B-cell lymphoma; HSCT=hematopoietic stem cell transplant; IRC=Independent Review Committee; mDOCR=median duration of complete response; mDOR=median duration of response; NOS=not otherwise specified; NR=not reached; ORR=overall response rate; PR=partial response.

Find out more about clinical trial treatment-related adverse reactions that occurred with EPKINLY

VIEW SAFETY PROFILE