Genmab : Epcoritamab Combo Shows High Response Rates In 1b/2 Trial For R/R Follicular Lymphoma
Genmab A/S has disclosed promising new findings from the EPCORE NHL-2 clinical trial, which is in its Phase 1b/2 stage. The trial investigates the efficacy of epcoritamab, a T-cell engaging bispecific antibody delivered through subcutaneous injection, in combination with lenalidomide and rituximab (R2) for adult patients grappling with relapsed or refractory follicular lymphoma (FL).
The study’s outcomes revealed an impressive overall response rate (ORR) of 96% and a complete response (CR) rate of 87% among 111 participants, after a median monitoring period of two years. Furthermore, the projected progression-free survival (PFS) rate over 21 months stood at 80%, while the two-year overall survival (OS) rate was 90%.
Additional observations from the trial highlighted that approximately 89% of those who achieved a complete response to the therapy maintained this status through 18 months.
During the enrollment and treatment phases, most participants were enrolled amid the global COVID-19 pandemic. COVID-19 was diagnosed in 57% of the patients, resulting in 13% having to discontinue epcoritamab. Tragically, five instances of COVID-19 constituted fatal treatment-emergent adverse events. Other prevalent treatment-emergent adverse events included neutropenia (62%) and cytokine release syndrome (CRS; 51%).
The occurrence of cytokine release syndrome, when adhering to the two-step step-up dose regimen, was primarily of low severity, with 38% at Grade 1, 12% at Grade 2, and 2% at Grade 3. These events mostly took place after the administration of the initial full dose and were all resolved. One instance of immune effector cell-associated neurotoxicity syndrome (ICANS) was noted, classified as Grade 1. These cytokine release syndrome and ICANS cases did not culminate in discontinuation of the treatment regimen.
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