ABSTRACT NUMBER – 3501
The Phase II DESTINY-CRC02 study, presented at the 2023 ASCO Annual Meeting, reported that administering ENHERTU (Fam-trastuzumab deruxtecan-nxki) at a dosage of 5.4 mg/kg demonstrated higher effectiveness in HER2-positive metastatic colorectal cancer (mCRC) patients compared to the 6.4 mg/kg dosage of the same treatment.
In this study, patients were initially randomized to receive either ENHERTU at a dose of 5.4 mg/kg or 6.4 mg/kg every three weeks. The primary objective was to evaluate the confirmed objective response rate (cORR), while secondary objectives included assessing the duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.
The findings revealed that the lower dose of 5.4 mg/kg showed preferable efficacy for this specific patient group. Among patients receiving the 5.4 mg/kg dose, the cORR was 37.8% compared to 27.5% for those receiving the 6.4 mg/kg dose. The median duration of response was similar between the two doses, both resulting in a DoR of 5.5 months.
The disease control rate (DCR) was high in both dosage groups, with 86.6% for 5.4 mg/kg and 85.0% for 6.4 mg/kg. The majority of patients in both groups had stable disease (SD), and a small portion experienced progressive disease (PD).
Median progression-free survival (PFS) was 5.8 months in the 5.4 mg/kg group and 5.5 months in the 6.4 mg/kg group. The median overall survival (OS) could not be estimated for the 6.4 mg/kg group.
Regarding safety, almost all patients in both dosage cohorts experienced treatment-emergent adverse effects (TEAEs), with a similar incidence of grade 3 or higher TEAEs. The occurrence of serious TEAEs was slightly higher in the 6.4 mg/kg cohort compared to the 5.4 mg/kg cohort.
These findings highlight the potential benefits of administering ENHERTU at a lower dosage of 5.4 mg/kg for HER2-positive mCRC patients, demonstrating improved efficacy while maintaining an acceptable safety profile.
