ARMO BioSciences Presents Efficacy Data from its Phase 1b Trial in Patients with Metastatic Renal Cell Carcinoma at ESMO
ARMO BioSciences, Inc., a late-stage immuno-oncology company, today announced additional clinical trial results on its lead investigational immuno-oncology drug AM0010 (pegilodecakin) in metastatic renal cell carcinoma (mRCC). In patients with metastatic RCC, AM0010 induced durable objective tumor responses as a monotherapy with an overall response rate (ORR) of 25% (4 of 16 patients) and an ORR of 41% (14 of 34 patients) when used in combination with anti-PD-1 immune checkpoint inhibitors, with no significant increase in the adverse event profile over either agent as a monotherapy. While not fully mature, the median progression free survival (PFS) is 16.7 months in later-stage mRCC patients treated with AM0010 plus pembrolizumab (n=8) and has not been reached for the AM0010 plus nivolumab cohort (n=29). The median overall survival (OS) has not yet been reached for these cohorts after a median follow-up time of 29.4 months and 13.8 months, respectively.
“While we are very pleased with the data we have generated to date in RCC, it is particularly exciting to see these high, durable responses in intermediate to poor risk advanced RCC patients who have received 2 or more prior therapies given the high unmet medical need for these patients,” said Joseph Leveque, MD, Chief Medical Officer of ARMO Biosciences. “In addition to the objective tumor responses, early survival data are also very encouraging.”