REDWOOD CITY, Calif., Dec. 8, 2017 /PRNewswire/ — 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.”
These data will be presented today at a proffered paper (oral presentation) session at the European Society of Medical Oncology (ESMO) Immuno Oncology Congress being held in Geneva, Switzerland, December 7-10, 2017. Details of the presentation are as follows:
Proffered Paper (Oral Presentation) Title: Efficacy of PEGylated Human IL-10 (AM0010) in Combination with anti-PD-1 Blockade in Patients (pts) with Metastatic Renal Cell Carcinoma (mRCC): A phase 1b Trial
Presenter: Aung Naing, Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Presentation Date and Time: Friday, Dec. 8, 2017 at 8:30 am CEST – 8:45 am CEST
Location: Room A, Geneva Palexpo, Geneva, Switzerland
The presentation will be available on the ARMO website at: http://www.armobio.com/news-presentations.php.
About AM0010 Immunotherapy
AM0010 (pegilodecakin) is a long-acting PEGylated form of recombinant human Interleukin-10 (IL-10). Due to its enhanced half-life, AM0010 has strong immune-stimulating effects that induce the activation, proliferation, and survival of intra-tumoral, tumor-reactive, cytotoxic CD8+ T cells in patients. CD8+ T cells mediate the cancer cytotoxic effect of