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 this immuno-oncology agent and an abundance of tumor infiltrating CD8+ T cells improves the prognosis and lengthens the survival of cancer patients. In a large Phase 1/1b clinical trial, more than 350 advanced cancer patients have been treated with AM0010 demonstrating a good safety/tolerability profile and sustained anti-tumor effects in patients across several different cancer types. In 2017, the Company commenced SEQUOIA, a pivotal Phase 3 randomized clinical trial in pancreatic cancer patients in combination with folinic acid, 5-fluorouracil plus oxaliplatin (FOLFOX), a standard of care in this patient population in the second line setting. The study compares a combination of AM0010 plus FOLFOX to FOLFOX alone as a second-line therapy after tumor progression during or following a gemcitabine-containing regimen.
The U.S. Food and Drug Administration (FDA) and the European Commission (EC) have granted AM0010 Orphan Drug designation for the treatment of pancreatic cancer. The FDA also granted Fast Track designation for AM0010 in combination with FOLFOX as second-line therapy in patients with pancreatic cancer.
About ARMO BioSciences
ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates that activate the immune system of cancer patients to recognize and eradicate tumors. The Company's lead product candidate, AM0010 (pegilodecakin, PEGylated Interleukin-10), is being evaluated in a large ongoing Phase 1/1b clinical trial as a therapy for pancreatic cancer, non-small cell lung cancer, renal cell carcinoma, colorectal carcinoma and melanoma. In addition, AM0010 is being evaluated in a Phase 3 randomized pivotal clinical trial in pancreatic cancer patients, which compares a combination of AM0010 and FOLFOX to FOLFOX alone, as a second-line therapy after tumor progression during or following a gemcitabine-containing regimen. The company also has a number of other immuno-oncology product candidates aimed at treating a variety of cancers in combination with standard of care treatments and emerging immunotherapies. These candidates are in various stages of pre-clinical development, and include: AM0001, an anti-PD-1 monoclonal antibody; AM0003, an anti-LAG-3 checkpoint inhibitor; AM0015, form of recombinant human Interleukin-15 (IL-15); and AM0012, a form of recombinant human Interleukin-12 (IL-12).
For more information, please visit www.armobio.com.
SOURCE ARMO BioSciences, Inc.