Elahere

Elahere is a drug for which a marketing authorization application was submitted on 29 September 2023. It received orphan medicinal product designation on 19 March 2015, with a CHMP positive opinion date of 19 September 2024. Elahere is indicated for FRα tumour status of ≥75% in ovarian cancers, which are present in 72% of cases.

Efficacy findings include an Objective Response Rate (ORR) ranging from 14% to 22%, with a pooled ORR of 13.8%. The median Overall Survival (OS) was reported as 13.2 months (45.9 weeks or 9 months). In an OV-90 xenograft model, MIRV demonstrated 33% tumor growth inhibition (%T/C) at 2.5 mg/kg and extended survival by 40 days at 5 mg/kg. Total log cell kill (LCK) in the same model was 1.2 at 2.5 mg/kg and 1.9 at 5 mg/kg.

Safety data indicates that 50% of patients receiving MIRV experienced at least one treatment-emergent adverse event leading to dose reduction or delay. Common adverse events included Respiratory, thoracic and mediastinal disorders (37% for MIRV vs. 29% for Chemotherapy by INV choice) and Peripheral neuropathy (20% for MIRV vs. 14% for Chemotherapy by INV choice). Nervous system disorders were reported in 34% of patients receiving Chemotherapy by INV choice. DM4 hERG current inhibition was 3.1 ± 0.4% at 10 μM and 16.6 ± 0.7% at 60 μM. The shelf-life for the finished drug product is 60 months, and diluted solution stability (1-2 mg/mL) is 8 to 24 hours.