ARMO BioSciences Announces Encouraging Survival Data Observed in Patients with Advanced Pancreatic Cancer in Phase 1/1b Trial of Immunotherapy AM0010

REDWOOD CITY, Calif., June 3, 2017 /PRNewswire/ -- 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) in combination with FOLFOX chemotherapy for the treatment of patients with advanced pancreatic cancer. These data are being presented in a poster session today at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2017 in Chicago, Illinois. AM0010 is being evaluated in an ongoing Phase 1b clinical trial that has enrolled 352 advanced cancer patients.

"We are very encouraged that our novel immunotherapy AM0010 in combination with FOLFOX induced prolonged objective responses, including partial and complete responses, and led to a median overall survival of 10.0 months in patients with advanced pancreatic cancer that previously had been treated with a median of two prior therapies," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences.  "We are excited to conduct our ongoing pivotal Phase 3 clinical trial of AM0010 in combination with FOLFOX as second-line therapy for advanced metastatic pancreatic cancer. We are committed to our goal of developing new immune-based treatment options for patients living with difficult-to-treat solid tumors."

Phase 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 (folinic acid, 5-fluorouracil and oxaliplatin) chemotherapy.

In this trial, 21 patients with PDAC who had not received a prior platinum containing regimen were treated with AM0010 in combination with FOLFOX.  The patients had progressed previously on a prior gemcitabine-containing regimen and had a median number of 2 prior therapies (ranging from 1 to 5 therapies).  In this ongoing Phase 1/1b clinical trial, the median progression-free survival was 3.5 months and the estimated median overall survival was 10.0 months, with a median follow-up of 11.0 months (ranging from 5.8 to 16.3 months).  The one-year survival rate estimated by the Kaplan-Meier method is 43%. Patients with a higher number of intra-tumoral CD8+ T cells had longer median overall survival.  Of the 19 patients evaluable for tumor responses, 16% had objective responses, including 2 compete responses, and 58% had stable disease for 8 weeks or longer.  

The 22 patients with advanced PDAC treated with AM0010 monotherapy had a median number of 3 prior therapies (ranging from 2-6 therapies) and the median overall survival (OS) was 3.8 months. In addition, 4 patients (18%) remain alive for more than one year, with 2 of 4 alive more than 18 months after starting treatment.

AM0010 treatment was well tolerated in advanced pancreatic cancer 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 adverse events.  This modified dose schedule is being used in the ongoing Phase 3 clinical trial.

These data will be presented today and the poster will be available at the ARMO website at http://www.armobio.com/news-presentations.php.

Abstract Title: Efficacy, safety, and immune activation with PEGylated human IL-10 (AM0010) plus FOLFOX in metastatic pancreatic adenocarcinoma (PDAC). (Abstract #4111)
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: Gastrointestinal (Non-colorectal) Cancer
Location: Hall A, Poster Board #103
Date:Saturday, June 3, 2017, 8:00 – 11:30 a.m. Central Time

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 a 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 (OS) as the primary endpoint. Progression-free survival (PFS), overall response rate (ORR) 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 Pancreatic Cancer
According to the American Cancer Society's estimates, pancreatic cancer is estimated to be the third leading cause of cancer-related death in the United States in 2017.  An estimated 53,670 people will be diagnosed and 43,090 people will die from this form of cancer in the United States in 2017.

Cancer of the pancreas usually develops without early symptoms until the cancer has already spread to other organs.  As a result, more than half of patients are diagnosed at a late stage, when the five-year survival rate for exocrine pancreatic cancer is only about 1%.

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.

For more information, please visit www.armobio.com.

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SOURCE ARMO BioSciences, Inc.