Epkinly

Diffuse large B-cell lymphoma (DLBCL) — relapsed or refractory, after two or more lines of systemic therapy; Follicular lymphoma (FL) — relapsed or refractory, after two or more lines of systemic therapy

Step-up (Cycles 1-3): Cycle 1 Day 1: 0.16 mg SC, Day 8: 0.8 mg SC, Day 15: 48 mg SC; Cycle 2: 48 mg SC Days 1, 15; Cycle 3: 48 mg SC Days 1, 15
Cycles 4-9: 48 mg SC Day 1 (every 28 days)
Cycle 10+: 48 mg SC Day 1 (every 28 days) until progression
Pre-medication: Corticosteroid, acetaminophen, antihistamine for step-up doses and first full dose
Hospitalize 24 hours after each C1 dose

Injection: 4 mg/0.8 mL and 48 mg/0.8 mL solution in single-dose vials

None listed.

• CRS: 51% (2.5% Grade ≥3). Primarily during Cycle 1 (most with first full dose). Median onset: 18 hours.
• Immune Effector Cell-Associated Neurotoxicity (ICANS): 6% (1% Grade ≥3). Including confusional state, tremor, aphasia.
• Infections: 44% (16% Grade ≥3). Including COVID-19, pneumonia, sepsis. Fatal infections reported.
• Cytopenias: Neutropenia 14% (11% Grade 3-4). Monitor CBC.
• Tumor Flare: 3% in FL patients.

CRS (51%), fatigue (26%), musculoskeletal pain (25%), injection site reactions (21%), infections (44%), abdominal pain (16%), nausea (15%), diarrhea (14%), pyrexia (11%), neutropenia (14%)

CRS in 50% (Grade 3 in 2.4%). Median onset 17 hours. ICANS in 6%. Serious infections in 15% (including fatal). HBV reactivation screening required.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 50% (Grade 3 in 2.4%). Median onset 17 hours. ICANS in 6%. Serious infections in 15% (including fatal). HBV reactivation screening required.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Epcoritamab is a subcutaneously administered bispecific IgG1 antibody that binds CD20 on B cells and CD3 on T cells. It engages T cells to kill CD20-positive tumor cells through directed T-cell cytotoxicity. The subcutaneous administration differentiates it from glofitamab (IV) and provides dosing convenience.

Half-life: approximately 19 days at 48 mg target dose. Non-linear PK during step-up doses. Steady-state by approximately Cycle 4. Clearance decreases with depletion of CD20-positive cells.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• EPCORE NHL-1 — Epcoritamab in relapsed/refractory large B-cell lymphoma. Phase I/II.
  🔬 NCT03625037 ↗ 📄 Primary Publication ↗

Epkinly has FDA-approved indications across the following cancer types covered on PipelineEvidence: