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ARMO BioSciences Presents Data from its Phase 1b Trial in Non-Small Cell Lung Cancer at ESMO Immuno Oncology Congress 2017

ARMO BioSciences Presents Data from its Phase 1b Trial in Non-Small Cell Lung Cancer at ESMO Immuno Oncology Congress 2017

REDWOOD CITY, Calif., Dec. 9, 2017 /PRNewswire/ -- ARMO BioSciences, Inc., a late-stage immuno-oncology company, today released additional clinical trial results on its lead investigational immuno-oncology drug AM0010 (pegilodecakin) in non-small cell lung cancer (NSCLC).

In 27 NSCLC patients who had received a median of two prior therapies, AM0010 in combination with either nivolumab or pembrolizumab induced a durable rate of tumor shrinkage (overall response rate, ORR) of 41%.  Patients with tumors that showed high levels of  PD-L1 expression (>50%) achieved an ORR of 80% (n=4/5) and patients with non-PD-L1 expressing tumors (<1%) achieved an ORR of 33% ORR (n=4/12).  Previously published studies of pembrolizumab monotherapy indicate typical response rates of 44% and 9% in each of these patient subgroups, respectively.

"We have observed ORRs for AM0010 in combination with anti-PD-1 immune checkpoint inhibitors that are higher than reported for immune checkpoint inhibitors alone at all levels of PD-L1 expression," said Joseph Leveque, MD, Chief Medical Officer of ARMO Bioscience.  "We also are encouraged by responses in patients with liver metastases and low tumor mutational burden (TMB), two subsets of patients that are less responsive to current therapies.  Six of eight patients with NSCLC metastases to the liver had a reduction of the liver metastases of more than 50%.  Five of eight patients (62.5%) with low or intermediate TMB had a tumor reduction of at least 50%."

Data are being presented at a poster discussion session at the European Society of Medical Oncology (ESMO) Immuno Oncology Congress being held in Geneva, Switzerland, December 7-10, 2017. Details of the poster discussion session are as follows:

Poster Title: PEGylated human IL-10 (AM0010, Pegilodecakin) in Combination with an anti-PD-1 in Advanced NSCLCLead Author:  Deborah J. Wong, M.D. Ph.D., Health Sciences Assistant Clinical Professor, Division of Hematology-Oncology, David Geffen School of Medicine at UCLAPoster Session Date and Time: December 9, 2017, 18:00 - 19:00 CESTPoster Discussion Date and Time: December 9, 2017, 18:34 – 18:54 CESTLocation: Room A, Geneva Palexpo, Geneva, SwitzerlandPresentation Number: 9PD

The poster will be available on the ARMO website at:

About AM0010 ImmunotherapyAM0010 (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 BioSciencesARMO 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).

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