EPKINLY: Broadest eligibility of any bispecific antibody in 3L+ FL1-4

  • The EPCORE® NHL-1 trial allowed for the inclusion of patients with ECOG PS 2, absolute neutrophil count ≥1 x 10⁹/L, creatinine clearance ≥45 mL/min, any hemoglobin level when starting EPKINLY, and significant pulmonary disease

An open-label, multicohort, multicenter, single-arm trial that included patients with R/R FL after 2 or more lines of systemic therapy

The study enrolled 213 patients with third line plus FL, which included a 2-step up dosage schedule cohort (n equals 127) and a 3-step up dosage schedule cohort (n equals 86). 2-step up dosage schedule cohort patients received 2-step up doses (0.16 mg and 0.8 mg) in Cycle 1. 3-step up dosage schedule cohort patients received 3 step up doses (0.16 mg, 0.8 mg, and 3 mg) in Cycle 1. Step up doses were followed by 48-mg full doses in 28-day Cycles (QW, C1 to 3; Q2W, C4 to 9; Q4W, C10 and beyond). Patients continued to receive subcutaneous EPKINLY until disease progression or unacceptable toxicity in both cohorts. In the 2-step up dosage schedule cohort, trial enrollment started June 2020, primary endpoint is ORR (CR plus PR) and secondary endpoints are CR rate, DOR, DOCR, and TTR. In the 3-step up dosage schedule cohort, trial enrollment started October 2022, primary endpoint is percentage of greater than or equal to grade 2 CRS events and all-grade CRS events. Secondary endpoints are ORR (CR plus PR). Key inclusion criteria included ECOG PS 0 to 2, prior CAR T and/or autologous HSCT allowed, and patients who received 2 or more therapies. Key exclusion criteria included CNS involvement of lymphoma, allogenic HSCT or solid organ transplant, ongoing active infection, known impaired T-cell immunity, creatinine clearance less than 45 mL per minute, alanine aminotransferase more than 3 times ULN, and cardiac ejection fraction less than 45 percent.

The 3-step up dosage schedule is the recommended dosage for patients with 3L+ FL. A separate dose optimization cohort evaluated the recommended 3-step up dosage schedule for CRS mitigation. See the recommended 3-step up dosage schedule for 3L+ patients with FL.

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

†Assessed by investigator (INV).

EPKINLY was studied in a population that included difficult-to-treat‡ patients with R/R FL1,5-7

EPKINLY was evaluated in patients with 3L+ FL with characteristics linked to a poor prognosis

Select patient characteristics

In the 2-step up dosage schedule cohort (n equals 127), patient demographics were stratified by age, stage of disease, bulky disease, ECOG performance status, and FLIPI scores. Treatment history was stratified by double refractory, refractory to last therapy, refractory to more or equal to 2 consecutive lines of antilymphoma therapy, refractory to prior anti-CD20 monoclonal antibody therapy, median number of prior therapies, progression of disease within 24 months, and prior therapy. In the 3-step up dosage schedule cohort (n equals 86), patient demographics were stratified by median age, gender, and ECOG performance status.

‡Difficult-to-treat disease characteristics included age >65, double refractory, refractory to ≥2 consecutive lines of antilymphoma therapy, and POD24.1,5-7

§Defined as refractory to both anti-CD20 monoclonal antibody and alkylator therapy.4

||Refractory: Patient with no response or relapse within 6 months after therapy.4

3L=third line; CAR T=chimeric antigen T-cell therapy; CD20=cluster of differentiation 20; CNS=central nervous system; CR=complete response; CRS=cytokine release syndrome; DOCR=duration of complete response; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; FL=follicular lymphoma; FLIPI=Follicular Lymphoma International Prognostic Index; HSCT=hematopoietic stem cell transplant; mAb=monoclonal antibody; mg=milligram; min=minute; mL=milliliter; NHL=non-Hodgkin lymphoma; ORR=overall response rate; PK=pharmacokinetics; POD24=progression of disease within 24 months; PR=partial response; R/R=relapsed/refractory; TTR=time to response; ULN=upper limit of normal.

Explore EPKINLY response rates and duration of response for this patient population

SEE THE CLINICAL TRIAL RESULTS