ARMO BioSciences’s Phase 1b Trials Demonstrate Continued Promising Response Rates and Survival in Patients with Advanced Pancreatic Cancer, NSCLC, and RCC

Four Months of Additional Data from Phase 1b Trials, Including Updated Overall Survival, to be Presented at ESMO 2017 Congress

Redwood City, CA, September 9, 2017 —ARMO BioSciences, Inc., a late-stage immuno-oncology company, today announced that clinical trial results on its lead investigational immuno-oncology drug AM0010 (pegilodecakin, PEGylated Interleukin-10) are being reported at the European Society of Medical Oncology (ESMO) 2017 Congress being held in Madrid, Spain, September 8-12, 2017. These presentations will include additional clinical trial results from the ongoing Phase 1b studies of AM0010 in pancreatic cancer, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).

“As we continue to treat and follow up patients for longer durations in the Phase 1/1b clinical trial of our immunotherapy AM0010, we remain very encouraged by the response rates, survival observations, and safety profile that we observe in patients with different types of advanced cancer,” said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. “Our Phase 1/1b study of AM0010 has enrolled more than 350 advanced cancer patients and we are pleased to present updates at ESMO 2017. In patients with advanced pancreatic cancer, AM0010 in combination with FOLFOX has demonstrated promising efficacy and safety data to date, with a median overall survival of 10.2 months and one year survival rate of 43% after a median follow-up time of 17.6 months (range 11.3-21.3 months). In advanced NSCLC and metastatic RCC, the combination of AM0010 with either nivolumab or pembrolizumab induced high response rates and durable objective responses. It is particularly promising to see these high, durable responses in advanced NSCLC patients with low as well as high PD-L1 expression and in intermediate to poor risk advanced RCC patients who have received 2 or more prior therapies.”

AM0010 Immunotherapy Presentations at the ESMO 2017 Congress

First Author

Abstract Title

Poster Session Details

J. Hecht

Overall survival and immunologic responses in metastatic pancreatic adenocarcinoma (PDAC) on PEGylated human IL-10 (AM0010) with 5-FU/LV and oxaliplatin (FOLFOX)

Gastrointestinal tumours, non-colorectal
Saturday, September 9, 2017
Presentation time: 13:15-14:15
Location: Hall 8
Abstract # 744P

D. Wong

Efficacy and immune activation with PEGylated human IL-10 (AM0010) in combination with an anti-PD1 in advanced NSCLC: Update

NSCLC, metastatic
Saturday, September 9, 2017
Presentation time: 13:15-14:15
Location: Hall 8
Abstract # 1316P

A. Naing

Immune correlates for the efficacy of PEGylated Human IL-10 (AM0010) with nivolumab in renal cell cancer

Genitourinary tumours, non-prostate
Sunday, September 10, 2017
Presentation time: 13:15-14:15
Location: Hall 8
Abstract # 874P

Posters 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). In a large Phase 1/1b clinical trial, AM0010 was dosed in more than 350 advanced cancer patients and showed a good safety/tolerability profile and sustained anti-tumor effects in patients across different cancer types. 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 evaluating AM0010 in combination with FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin) versus 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 study expects to enroll approximately 566 patients and will 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 such as an anti-PD-1 monoclonal antibody, aimed at treating a variety of cancers in combination with standard of care treatments and emerging immunotherapies.

Contact

ARMO BioSciences, Inc.
Scott Ogg, PhD
Vice President Corporate Development and Operations
+1-650-779-5075