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

61% of patients had a response, 38% of patients had a complete response, and 23% had a partial response.
See the full EPCORE™ NHL-1 study design

Responses in select prespecified subgroups were consistent with the overall population2

CAR T naïve patients had a 67% overall response rate, 41% had a complete response, and 26% had a partial response.
CAR T exposed patients had a 52% overall response rate, 33% had a complete response, and 19% had a partial response.
CAR T refractory had a 42% overall response rate, 26% had a complete response, and 16% had a partial response.
Primary refractory had a 52% overall response rate, 28% had a complete response, and 24% had a partial response.

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: 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 complete responders: 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: 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 complete responders: 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

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

†Based on Kaplan-Meier estimate.

 

3L=third line; CAR T=chimeric antigen receptor T-cell therapy; CI=confidence interval; CR=complete response; CRS=cytokine release syndrome; DLBCL=diffuse large B-cell lymphoma; 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.

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