Safety evaluation
death, toxicity, malignancy, affections of the nervous and the vascular system, PD
DISEASE PROGRESSION, ADVERSE EVENTS, EVENT, MYELODYSPLASTIC SYNDROME (MDS), SECONDARY, MULTIORGAN FAILURE
Over the whole course of therapy, treatment-related grade 1, 2, 3 and 4 AEs were observed in 16.7%, 25.0%, 33.3% and 8.3% of the patients, respectively. 16.7% of patients didn’t develop any treatment-related AEs. Serious AEs (SAEs) occurred in the blood and lymphatic system, the gastrointestinal system, or presented as multiorgan failure, disease progression or affections of the nervous and the vascular system (Table Serious adverse events.Serious adverse events, highest grade as experienced by trial participants.At the time of the analysis, 41 patients had died, 4 of them during treatment and 37 during the follow-up. 35/41 (85.4%) died from PD, 2/41 (4.9%) died of other (non-drug related) reasons and in 4/41 (9.8%) reason of death was unknown. One trial patient was diagnosed with myelodysplastic syndrome (MDS) about 3.5 years after completing 10 cycles on anti-EGFR-ILs-dox. We interpreted this as a secondary malignancy related to the study drug. The patient started treatment with azacytidine and venetoclax in november 2021. The patient was still alive and the event reported as resolved by the investigator on 10.03.2022. We have no further follow-up information. Otherwise, there were no new toxicity signals compared to the previous phase 1 trial assessing anti-EGFR ILs-dox.