The power of superior PFS with fixed-duration EPKINLY + R2 vs R2 1*†

EPKINLY + R2 demonstrated a 79% reduction in the risk of disease progression or death vs R2 (HR=0.21‡; 95% CI, 0.13-0.33; P<0.0001§)

In a primary analysis, median PFS was not reached for EPKINLY plus R squared patients (95 percent CI, 21.9 months to not reached). Median PFS reached 11.2 months for R squared alone patients (95 percent CI, 10.5 months to NR). HR equals 0.21; 95 percent Cl, 0.13-0.33; P<0.0001.

Date of analysis: January 10, 2025.²

 

*Efficacy results determined by Lugano criteria (2014) as assessed by IRC and based on prespecified interim analysis.

†The median duration of study follow-up was 10.4 months in the ITT population.

‡Cox proportional hazards hazard ratio stratified by disease history and region.

§Log-rank P-value (one-sided) stratified by disease history and region.

EPKINLY + R2 PFS benefit was consistent between the pivotal and follow-up analyses1,2

EPCORE® FL-1 prespecified follow-up analysis PFS results*†

Data Limitation: These prespecified efficacy analyses are not multiplicity-controlled. Data are exploratory and descriptive in nature. No formal inferences can be drawn.

Date of analysis: May 24, 2025.
The median duration of study follow-up was 14.8 months.

 

*Efficacy results determined by Lugano criteria as assessed by IRC and based on a prespecified interim analysis.

†Based on Kaplan-Meier analysis.

‡Stratified by disease history/status. Hazard ratio is estimated using Cox proportional hazards model.

PFS observed across subgroups2

EPCORE® FL-1 prespecified follow-up analysis PFS results

PFS subgroups.

Arrows indicate that the confidence interval is extended more than current range.

Data Limitation: These prespecified analyses are not multiplicity-controlled. Data are exploratory and descriptive in nature. No formal inferences can be drawn.

*POD24 is defined as progression of disease ≤2 years from the date of initiation of first-line chemoimmunotherapy.

EPKINLY + R2 achieved remarkable responses with a 31% higher CR vs R2 1*

EPCORE® FL-1 pivotal analysis

EPCORE FL-1 pivotal analysis: EPKINLY plus R squared had a 89 percent ORR (n equals 216 out of 243; 95 percent CI, 84 to 93) and a 74 percent complete response (n equals 181 out of 243; 95 percent CI, 69 to 80). R squared alone had a 74 percent ORR (n equals 181 out of 245; 95 percent CI, 68 to 79) and a 43 percent complete response (n equals 106 out of 245; 95 percent CI, 37 to 50).
  • The median duration of follow-up was 10.4 months in the ITT population

EPCORE® FL-1 prespecified follow-up analysis2§

EPCORE FL-1 prespecified analysis: EPKINLY plus R squared had a 95 percent ORR (n equals 231 out of 243; 95 percent CI, 92 to 97) and a 83 percent CR (n equals 201 out of 243; 95 percent CI, 77 to 87). R squared alone had a 79 percent ORR (n equals 194 out of 245: 95 percent CI, 74 to 84) and a 50 percent CR (n equals 122 out of 245; 95 percent CI, 43 to 56).
  • The median duration of follow-up was 14.8 months in the ITT population

Data Limitation: No inference can be drawn from this data set. Follow-up analysis is exploratory, and data are descriptive in nature.

*Efficacy results determined by Lugano criteria (2014) as assessed by IRC and based on prespecified interim analysis.

†P-value is based on a prespecified analysis of the first 232 patients randomized.

‡P-value (one-sided) is from a Cochran-Mantel-Haenszel test stratified by disease history and region.

§95% CI is from the exact binomial distribution (Clopper-Pearson exact method).

EPKINLY + R2 provided sustained remission1-3*

mDOR mDOR
mDOCR mDOCR
Time to Next Treatment Time to Next Treatment

IRC-assessed DOR at a median study follow-up of 14.8 months*†

At 12 months (estimated) 89.2 percent of patients on EPKINLY plus R squared (n=243; 95 percent CI, 83.6 to 93.0) were still responding vs 48.5 percent of patients on R squared alone (n=245; 95 percent CI, 38.8 to 57.5). mDOR not reached for EPKINLY plus R squared patients (95% CI, NE to NE). mDOR was 11.5 months for R squared alone patients (95% CI, 8.5 to 18.6 months). Within the study, HR equals 0.19 (95 CI, 0.12 to 0.30).

Date of analysis: May 24, 2025.

*Efficacy results, inclusive of PFS and DOR assessed progressive disease (PD), determined by Lugano criteria as assessed by IRC and based on a prespecified interim analysis.

†Based on Kaplan-Meier estimate.

‡Stratified by disease history/status. Hazard ratio is estimated using Cox proportional hazards model.

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

IRC-assessed DOCR at a median study follow-up of 14.8 months*†

At 12 months (estimated) 91.2 percent of patients on EPKINLY plus R squared (n=243; 95 percent CI, 84.5 to 95.0) were in complete response vs 56.0 percent of patients on R squared alone (n=245; 95 percent CI, 42.4 to 67.6). mDOCR not reached for EPKINLY plus R squared patients (95% CI, NE to NE). mDOCR was 18.6 months for R squared alone patients (95% CI, 11.1 to NE). Within the study, HR equals 0.21 (95 percent CI, 0.11 to 0.39).

Date of analysis: May 24, 2025.

*Efficacy results, inclusive of PFS and DOR assessed progressive disease (PD), determined by Lugano criteria as assessed by IRC and based on a prespecified interim analysis.

†Based on Kaplan-Meier estimate.

‡Stratified by disease history/status. Hazard ratio is estimated using Cox proportional hazards model.

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

After 16 months, an estimated 93% of patients who received EPKINLY + R2 had not yet initiated any subsequent therapy, compared with 65% who received R2 *†

At 16 months (estimate) 92.8 percent of patients who received EPKINLY plus R squared had not started a new treatment (n equals 243; 95 percent CI, 88.3 to 95.6) versus 64.9 percent of patients on R squared alone (n equals 245; 95 percent CI, 57.1 to 71.6). mTTNT was not reached for EPKINLY plus R squared patients (95 percent CI, NE to NE). mTTNT was 24.3 months for R squared alone patients (95 percent CI 18.2 months to NE). Within the study, HR equals 0.15 (95 percent CI, 0.09 to 0.27).
  • The median duration of study follow-up was 14.8 months

Date of analysis: May 24, 2025.

*Efficacy results, inclusive of PFS and DOR assessed progressive disease (PD), determined by Lugano criteria as assessed by IRC and based on a prespecified interim analysis.

†Based on Kaplan-Meier estimate.

‡Stratified by disease history/status. Hazard ratio is estimated using Cox proportional hazards model.

2L=second line; CI=confidence interval; CR=complete response; HR=hazard ratio; IRC=Independent Review Committee; ITT=intent to treat; mDOCR=median duration of complete response; mDOR=median duration of response; NE=not evaluable; NR=not reached; ORR=overall response rate; PFS=progression-free survival; PR=partial response; R2=rituximab + lenalidomide; TTNT=time to next treatment.

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