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% of patients 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).

†Based on Kaplan-Meier estimate.

See the full EPCORE® NHL-1 study design
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Response Across Subgroups

ORR, CR, and PR rates observed across additional subgroups1,2*

The efficacy of EPKINLY was evaluated in EPCORE NHL-1, an open-label, multicohort, multicenter, single-arm trial in 148 patients with R/R DLBCL after 2 or more lines of systemic therapy.

CR, PR, ORR.
Patients aged <65 years (n=74) had a 53% overall response rate (95% CI, 41-64) (34% CR rate, 19% PR rate), patients aged 65 years to <75 years (n=45) had a 67% overall response rate (95% CI, 51-80) (38% CR rate, 29% PR rate) and patients aged ≥75 years (n=29) had a 72% overall response rate (95% CI, 53-87) (48% CR rate, 24% PR rate).
Patients with de novo DLBCL (n=97) had a 61% overall response rate (95% CI, 50-71) (37% CR rate, 24% PR rate), transformed DLBCL (n=40) had a 68% overall response rate (95% CI, 51-81) (45% CR rate, 23% PR rate), primary refractory had a 52% overall response rate (95% CI, 41-62) (28% CR rate, 24% PR rate) and double-hit/triple-hit (n=17) had a 41% overall response rate (95% CI, 18-67) (24% CR rate, 17% PR rate).
CAR T-naïve patients (n=90) had a 67% overall response rate (95% CI, 56-76) (41% CR rate, 26% PR rate), Car T-exposed (n=58) had a 52% overall response rate (95% CI, 38-65) (33% CR rate, 19% PR rate), Car T-refractory (n=43) had a 42% overall response rate (95% CI, 27-58) (26% CR rate, 16% PR rate).
Patients with 2 prior lines of treatment had a 61% overall response rate (95% CI, 45-76) (34% CR rate, 27% PR rate), with 3 prior lines of treatment had a 62% overall response rate (95% CI, 47-76) (38% CR rate, 24% PR rate) and with 4 or more prior lines of treatment had a 59% overall response rate (95% CI, 46-72) (41% CR rate, 18% PR rate).

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

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

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 prespecified analysis of complete responders (38%, n=56/148): 2.6 months median time to complete response (range 1.2-10.2). mDOCR NOT REACHED (95% CI, 14.3 mo-NR). 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 prespecified analysis of complete responders (38%, n=56/148): 2.6 months median time to complete response (range 1.2-10.2). mDOCR NOT REACHED (95% CI, 14.3 mo-NR). 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 study follow-up of 3 years*

Investigator-assessed DOR and DOCR at a median follow-up of 3 years: mDOR 20.8 months (95% CI, 13.0-32.0), mDOCR 36.1 (95% CI, 20.2-NR); 54% still in complete response at 30 months (estimated) (95% CI, 39.6-­66.6).

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†‡ 36.1 months

(95% CI, 20.2-NR)

mDOR†‡ 20.8 months

(95% CI, 13.0-32.0)

Overall median study follow-up was 37.2 months (range: 0.3+, 45.5).§

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

Data cutoff: May 3, 2024.

Data Limitations:

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.

Long-term follow-up data across subgroups4

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CAR-T–exposed CAR-T–exposed
CAR-T–refractory CAR-T–refractory
Transformed disease from FL Transformed disease from FL

CAR-T–exposed (n=58): Investigator-assessed DOR and
DOCR at a median study follow-up of 3 years

CAR-T-exposed (n equals 58): Investigator-exposed DOR and DOCR at a median study follow-up of 3 years: mDOR 24 months (95% CI, 4.2-NR), mDOCR not reached (95% CI, 17.7-NR) 68% still in complete response at 30 months (estimated) (95% CI, 39.1-85.3).

Overall median study follow-up was 37.2 months (range: 0.3+, 45.5).§

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

Data cutoff: May 3, 2024.

Data Limitations:

Study was not powered to evaluate these prespecified subgroups; data are exploratory and descriptive in nature and no formal inferences can be drawn.

The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

ORR=51.7% (n=30/58; 95% CI, 38.2-65.0)

CR=34.5% (n=20/58; 95% CI, 22.5-48.1)

PR=17.2% (n=10/58; 95% CI, 8.6-29.4)

mDOCR†∥ not reached

(95% CI, 17.7-NR)

mDOR†∥ 24.6 months

(95% CI, 4.2-NR)

Data Limitations:

Study was not powered to evaluate these prespecified subgroups; data are exploratory and descriptive in nature and no formal inferences can be drawn.

The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

CAR-T–refractory (n=43): Investigator-assessed DOR
and DOCR at a median study follow-up of 3 years

Car-T-refractory (n equals 43): Investigator-assessed DOR and DOCR at a median study follow-up of 3 years: mDOR 24.6 months (95% CI, 1.4-NR), mDOCR not reached (95% CI, 17.7-NR) 68% still in complete response at 30 months (estimated) (95% CI, 29.7-88.6).

Overall median study follow-up was 37.2 months (range: 0.3+, 45.5).§

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

Data cutoff: May 3, 2024.

Data Limitations:

Study was not powered to evaluate these prespecified subgroups; data are exploratory and descriptive in nature and no formal inferences can be drawn.

The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

ORR=41.9% (n=18/43; 95% CI, 27.0-57.9)

CR=27.9% (n=12/43; 95% CI, 15.3-43.7)

PR=14.0% (n=6/43; 95% CI, 5.3-27.9)

mDOCR†¶ not reached

(95% CI, 17.7-NR)

mDOR†¶ 24.6 months

(95% CI, 1.4-NR)

Data Limitations:

Study was not powered to evaluate these prespecified subgroups; data are exploratory and descriptive in nature and no formal inferences can be drawn.

The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

Transformed disease from FL (n=32): Investigator-assessed DOR and DOCR
at a median study follow-up of 3 years

Transformed disease from FL (n equals 32): Investigator-assessed DOR and DOCR at a median study follow-up of 3 years: mDOR not reached (95% CI, 10.6-NR), mDOCR not reached (95% CI, 9.7-NR), 60% still in complete response at 30 months (estimated) (95% CI, 25.3-82.7).

Overall median study follow-up was 37.2 months (range: 0.3+, 45.5).§

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

Data cutoff: May 3, 2024.

Data Limitations:

Study was not powered to evaluate these prespecified subgroups; data are exploratory and descriptive in nature and no formal inferences can be drawn.

The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

ORR=50.0% (n=16/32; 95% CI, 31.9-68.1)

CR=43.8% (n=14/32; 95% CI, 26.4-62.3)

PR=6.3% (n=2/32; 95% CI, 0.8-20.8)

mDOCR†# not reached

(95% CI, 9.7-NR)

mDOR†# not reached

(95% CI, 10.6-NR)

Data Limitations:

Study was not powered to evaluate these prespecified subgroups; data are exploratory and descriptive in nature and no formal inferences can be drawn.

The Kaplan-Meier estimates may be unreliable at the tail end of the curve due to a smaller number of patients at risk.

Long-term follow-up: Safety data3

  • With a median follow-up of 3 years, observations were consistent with the known epcoritamab safety profile. Discontinuation due to an adverse reaction occurred in 7.6% of patients
  • Serious infections were reported in 31% of patients. Serious infections ≥5% were COVID-19 events** (17% of patients) and pneumonia (5% of patients). Fatal infections occurred in 14 patients, of which 10 were COVID-19 events**

*Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).1

†Based on Kaplan-Meier estimate.4

‡Median follow-up for DOR was 33.6 months (range: 32.7-37.2 months). Median follow-up for DOCR was 33.4 months (range: 31.8-34.9 months).§

§Based on reverse Kaplan-Meier estimate.4

||Median follow-up for DOR was 33.4 months (95% CI, 24.2-34.8 months). Median follow-up for DOCR was 33.4 months (95% CI, 17.1-34.8 months).4§

Median follow-up for DOR was 31.7 months (95% CI: 4.4-34.8 months). Median follow-up for DOCR was 25.1 months (95% CI, 2.8-34.8 months).4§

#Median follow-up for DOR was 32.9 months (95% CI, 2.8-37.3 months). Median follow-up for DOCR was 27.9 months (95% CI, 1.4-36.6 months).4§

**COVID-19 events represent COVID-19 and COVID-19 pneumonia.3

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; FL=follicular lymphoma; HSCT=hematopoietic stem cell transplant; 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