— 10.2 Months Median Overall Survival and 47% One-year Survival Observed in Patients with Advanced Pancreatic Cancer when Treated with AM0010 in Combination with FOLFOX in Ongoing Phase 1/1b Trial –

REDWOOD CITY, CA, USA I June 29, 2017 I ARMO BioSciences, Inc., a late-stage immuno-oncology company, today announced clinical data on its lead investigational immuno-oncology drug AM0010 (pegilodecakin, PEGylated Interleukin-10) at the ESMO 19th World Congress on Gastrointestinal Cancer, taking place June 28 through July 1, 2017 in Barcelona, Spain.  AM0010 is being evaluated in an ongoing Phase 1/1b clinical trial that has enrolled 352 advanced cancer patients and in a Phase 3 clinical trial that is enrolling patients with advanced pancreatic cancer.

“In an ongoing Phase 1/1b clinical trial, AM0010 in combination with FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin) chemotherapy has demonstrated extremely promising efficacy and safety data to date in patients with advanced pancreatic cancer,” said J. Randolph Hecht, M.D., Professor of Clinical Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California and an investigator for the Phase 3 clinical trial.  “The median follow-up on this study is 14.2 months (range 6.8-18.9 months) and 10 of 21 patients (47%) are still alive after more than one year.”

“We are very encouraged that we continue to see such promising data trends from the patients in this trial,” said Dr. Van Vlasselaer, Ph.D.  “These Phase 1/1b data provide the rationale for our ongoing pivotal Phase 3 clinical trial of AM0010 in combination with FOLFOX as second-line therapy for advanced metastatic pancreatic cancer.”

Phase 1/1b Clinical Trial Results in Advanced Pancreatic Cancer
In this ongoing Phase 1/1b clinical trial, 47 patients with advanced pancreatic ductal adenocarcinoma (PDAC) have been treated with either AM0010 alone or AM0010 in combination with FOLFOX chemotherapy. Twenty-two patients with PDAC were treated with AM0010 monotherapy and twenty-one patients with PDAC who had not received a prior platinum-containing regimen were treated with AM0010 in combination with FOLFOX.  AM0010 treatment was well tolerated in PDAC patients either alone or in combination with FOLFOX.  Grade 3/4 treatment-related adverse events associated with daily dosing of AM0010 included thrombocytopenia, anemia, and neutropenia were transient and reversible.  AM0010 plus FOLFOX with a modified AM0010 dose schedule (5 days on, 2 days off) was tested without grade 3/4 hematologic adverse events.  This modified dose schedule is being used in the ongoing Phase 3 clinical trial.

As of May 1, 2017, results from patients with PDAC enrolled in the Phase 1/1b clinical trial are as follows:

Treatment Prior Therapies
Median (Range)











1 year




3 (2-6) 53% 0 0 1.7 3.8 22%

AM0010 + FOLFOX4


2 (1-5) 79% 16% 11% 3.5 10.2 47%

(1) n = number of evaluable patients / number of enrolled patients
(2) Disease Control Rate (DCR), Objective Response Rate (ORR), and Complete Response Rate (CR) are based on evaluable patients
(3) Median Progression Free Survival (mPFS) and median Overall Survival (mOS) are based on intent to treat patients
(4) Study in progress.  Data as of May 1, 2017.  Median follow-up is 14.2 months (range 6.8-18.9 months)

AM0010 in combination with FOLFOX increased immune stimulatory cytokines in the serum of patients and an increase of new T cell clones not previously detected in the patients. The expansion of new T cell clones correlated with a longer overall survival of patients.

These data are being presented during oral and poster sessions this week.

Title: Immunologic and Objective Tumor Responses to PEGylated Human IL-10 (AM0010) with 5- FU/LV and Oxaliplatin (FOLFOX) in Metastatic Pancreatic Adenocarcinoma (PDAC)
Lead Author: J. Randolph Hecht, M.D., Professor of Clinical Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California
Poster Session II: Cancer of the Pancreas and Bile Ducts
Location: The International Convention Center of Barcelona
Oral Presentation Time: Wednesday, June 28, 2017, 5:30 PM – 6:00 PM CEST
Poster Presentation Times: Thursday, June 29, 2017, 11:10 AM – 11:40 AM and 04:20 PM – 04:50 PM CEST

About AM0010 Immunotherapy
AM0010 (pegilodecakin) is a long-acting form of recombinant human Interleukin-10 (IL-10), which has shown sustained anti-tumor effects and a good safety/tolerability profile in patients with multiple oncology indications. 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.

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 the Phase 3 Trial of Immunotherapy AM0010 for Advanced Pancreatic Cancer
ARMO is conducting an international Phase 3 randomized clinical trial with AM0010 in combination with FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin), which will be compared with FOLFOX alone, as second-line therapy in patients with pancreatic ductal adenocarcinoma that has progressed during or following a first-line gemcitabine-containing regimen.  The Company plans to enroll 566 patients and evaluate overall survival as the primary endpoint. Progression-free survival, overall response rate and safety are the secondary endpoints.  Exploratory endpoints will evaluate biomarkers that may correlate with tumor response, immune activation and relationships to clinical efficacy outcomes.

For more information about the clinical trial, please visit www.clinicaltrials.gov and use identifier NCT02923921.

About ARMO BioSciences
ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary products that activate the immune system of cancer patients to recognize and eradicate tumors. The Company’s lead product candidate, AM0010 (pegilodecakin), stimulates the survival, expansion and killing (cytotoxic) potential of a particular type of white blood cell in the immune system called CD8+ T cells.  CD8+ T cells recognize and kill cancer cells and an increased presence of intra-tumoral CD8+ T cells may result in improved prognosis and survival in patients.

In addition, ARMO is developing a robust immuno-oncology pipeline that includes validated product candidates aimed at treating a variety of cancers in combination with standard of care treatments and emerging immunotherapies.

SOURCE: ARMO Biosciences