Even with a high enrollment of patients with difficult-to-treat disease,* 60% CR was observed in EPCORE® NHL-11-4

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

*Difficult-to-treat disease characteristics included age >65, double refractory, refractory to ≥2 consecutive lines of antilymphoma therapy, and POD24.1-4

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

‡Median study follow-up was 17.4 months.6

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).5†

*Difficult-to-treat disease characteristics included age >65, double refractory, refractory to ≥2 consecutive lines of antilymphoma therapy, and POD24.1-4

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

‡Median study follow-up was 17.4 months.6

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 outcomes6,7:
    • 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.6

See EPCORE NHL-1 study design
Select refractory subgroups Select refractory subgroups
Select additional subgroups Select additional subgroups

Responses demonstrated in select refractory subgroups1,5

Double
refractory

Double Refractory Response: yes (75 percent ORR [n equals 67 out of 89; 95 percent CI, 65 to 84], 55 percent CR [n equals 49], and 20% PR [n equals 18]) and no (97 percent ORR [n equals 37 out of 38; 95 percent CI, 86 to 100], 71 percent CR [n equals 27], and 26 percent PR [n equals 10]).

Refractory to
last therapy

Refractory to last therapy responses: yes (74 percent ORR [n equals 65 out of 88; 95 percent CI, 63 to 83], 49 percent CR [n equals 43], and 25 percent PR [n equals 22]) and no (100 percent ORR [n equals 39 out of 39]; 95 percent CI, 91 to 100), 85 percent CR [n equals 33], and 15 percent PR [n equals 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 agent6
  • Refractory: Patient with no response or relapse within 6 months after completing therapy6

ORR, CR, and PR rates observed across additional subgroups5

Response rates demonstrated in select additional subgroups. Patient response percentages for age in years: less than 65 years (n equals 61) (28 percent PR, 55 percent CR, 84 percent ORR [95 percent CI: 72 to 92]) and greater than or equal to 65 years (n equals 66) (16 percent PR, 64 percent CR, and 80 percent ORR [95 percent CI: 69 to 89]). For number of prior lines of treatment: 2 prior lines (n equals 46) (19 percent PF, 70 percent CR, and 89 percent ORR [95 percent Cl: 76 to 96]), 3 prior lines (n equals 41) (25 percent PR, 63 percent CR, and 88 percent ORR [95 percent Cl: 74 to 96]), and 4 or more prior lines (n equals 40) (23 percent PR, 45 percent CR, and 68 percent ORR [95 percent Cl: 51 to 81]). For progression within 2 years of any 1L therapy: Yes (n equals 66) (17 percent PR, 62 percent CR, and 79 percent ORR [95 percent CI: 67 to 88]) and No (n equals 61) (28 percent PR, 57 percent CR, and 85 percent ORR [95 percent CI, 74 to 93]).

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

EPKINLY delivered durable responses with mDOR not reached1,5†||

In overall responders (82 percent, n equals 104 out of 127) the median duration of response or mDOR was not reached (95 percent Cl, 13.7 to NR). The median follow-up for duration of response or DOR was 14.8 months (range 0.0 plus, 27.2 plus). In prespecified analysis of complete responders (60 percent, n equals 76 out of 127): the median duration of complete response or mDOCR was not reached (95 percent Cl, 21.4 to NR). The median follow-up for duration of complete response or DOCR was 13.2 months (range: 0.0 plus to 26.3 plus). Duration of response in overall responders and complete responders plotted against probability of response: 12 months (Of the 76 patients who achieved a complete response, 84 percent were still in CR at 12 months). Of the 104 patients who achieved an overall response, 68 percent were still responding at 12 months (estimated; 95 percent CI, 57.6 to 77.0).

Date of analysis: April 2023.

 

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

||Based on Kaplan-Meier estimate.

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

3L=third line; CI=confidence interval; CR=complete response; DOCR=duration of complete response; DOR=duration of response; FL=follicular lymphoma; mDOCR=median duration of complete response; mDOR=median duration of response; NHL=non-Hodgkin Lymphoma; NR=not reached; ORR=overall response rate; POD24=progression of disease within 24 months; PR=partial response.

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

VIEW SAFETY PROFILE