EPKINLY delivered an ORR of 82%, with 60% of patients
achieving a deep response of CR1

82% of patients had a response (n=104/127; 95% CI, 74-88), 60% of patients had a complete response (n=76/127; 95% CI, 51-68), and 22% had a partial response (n=28/127; 95% CI, 15-30).

Rapid response1

  • In responders (n=104), the median time to first response was 1.4 months (range: 1-3 months)†

In a prespecified analysis of complete responders (n=76), the median time to complete response was 1.5 months (range: 1.2-11.1).2

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

†Median study follow-up was 17.4 months.3

The efficacy results of the 86 patients who received the recommended 3-step up dosage schedule in the EPCORE® NHL-1 dose optimization cohort were comparable to the primary efficacy population.1‡

  • Investigator-assessed efficacy outcomes3,4:
    • ORR: 86% (n=74/86; 95% CI, 76.9-92.6)
    • CR: 64% (n=55/86; 95% CI, 52.9-74.0)
    • PR: 22% (n=19/86)

‡Median study follow-up for the dose optimization cohort was 5.7 months.3

See EPCORE NHL-1 study design

Responses demonstrated in select refractory subgroups1,2

Response in prespecified subgroups. Double Refractory: yes (75% ORR [n=67/89; 95% CI, 65-84], 55% CR [n=49], and 20% PR [n=18]) and no (97% ORR [n=37/38; 95% CI, 86-100], 71% CR [n=27], and 26% PR [n=10]). Refractory to last therapy responses: yes (74% ORR [n=65/88; 95% CI, 63-83], 49% CR [n=43], and 25% PR [n=22]) and no (100% ORR [n=39/39]; 95% CI, 91-100), 85% CR [n=33], and 15% PR [n=6]).

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

  • Double refractory: Patients were refractory to both anti-CD20 and an alkylating agent
  • Refractory: Patient with no response or relapse within 6 months after therapy

EPKINLY delivered durable responses with mDOR not reached1,2§||

 

In overall responders (82%, n=104/127) mDOR not reached (95% Cl, 13.7-NR), 68% still responding at 12 months (estimated) (95% Cl, 57.6-77.0). The median follow-up for DOR was 14.8 months (range 0.0+, 27.2+). In prespecified analysis of complete responders (60%, n=76/127): mDOCR not reached (95% Cl, 21.4-NR), 84% still responding at 12 months (estimated) (95% Cl, 72.3-91.4). The median follow-up for DOCR was 13.2 months (range: 0.0+ - 26.3+).
68% DOR (estimated; 95% CI, 57.6-77.0). Duration of response in overall responders and complete responders plotted against probability of response: 12 months (84% DOCR [estimated; 95% CI, 72.3-91.4]).

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

||Based on Kaplan-Meier estimate.

Both lower and upper limits of the range indicate a censored value.

 

CI=confidence interval; CR=complete response; DOCR=duration of complete response; DOR=duration of response; FLIPI=Follicular Lymphoma International Prognostic Index; mDOCR=median duration of complete response; mDOR=median duration of response; NHL=non-Hodgkin lymphoma; NR=not reached; ORR=overall response rate; PR=partial response.

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