ARMO BioSciences Announces Promising Response Rates and Survival Data in Patients with Advanced NSCLC and RCC from Phase 1/1b Trial for Immunotherapy AM0010 with Checkpoint Inhibitors

Redwood City, CA, May 30, 2017 —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 immune checkpoint inhibitors for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (RCC). These data are being presented in poster sessions during the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2017 in Chicago, Illinois. Five poster presentations with clinical data on AM0010 are being presented at the 2017 ASCO Annual Meeting. AM0010 immunotherapy is being evaluated in an ongoing Phase 1/1b clinical trial that has enrolled 352 advanced cancer patients.

“As we continue to treat and follow up patients for longer durations in the Phase 1/1b clinical trial of our immunotherapy AM0010, we are very encouraged by the response rates, survival indicators, and safety profile we are observing in patients with different types of advanced cancer,” said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences.  “In advanced NSCLC and metastatic RCC, the combination of our immunotherapy AM0010 with either of the checkpoint inhibitors nivolumab or pembrolizumab induced high response rates and durable objective responses. It is particularly promising to see these high response rates in advanced NSCLC patients, even those with low PD-L1 expression, who have the highest unmet medical need. In this ongoing Phase 1/1b clinical trial, we look forward to continuing to monitor the survival of these patients living with advanced NSCLC and RCC and we are excited by the very promising trends seen to date in these difficult-to-treat types of cancers.”

Phase 1b Clinical Trial Results in Advanced Non-small Cell Lung Cancer (NSCLC)

In the Phase 1b clinical trial, 43 patients with advanced NSCLC were treated with AM0010 immunotherapy alone or in combination with an anti-PD-1 checkpoint inhibitor. Five patients were treated with AM0010 in combination with pembrolizumab after a median of 2 prior therapies (range 0-5 therapies) and 29 patients were treated with AM0010 in combination with nivolumab after a median of 2 prior therapies (range 1-3 therapies).

In this ongoing Phase 1b clinical trial, the preliminary objective response rate (ORR) was 38.5% in 26 evaluable patients with advanced NSCLC treated with AM0010 and an anti-PD-1 checkpoint inhibitor. In patients with PD-L1 <1%, the ORR was 27.3%, in patients with PD-L1 1-49% the ORR was 50.0%, and in patients with PD-L1 ≥50% the ORR was 80.0%. The median progression free survival (PFS) was 10.9 months (range 3.7 to 24.9+ months) and 4 of 5 advanced NSCLC patients treated with AM0010 and pembrolizumab are alive, with a median follow-up of 25.2 months (range 24.5-26.9 months). The median PFS and median overall survival (OS) have not been reached for advanced NSCLC patients treated with AM0010 and nivolumab, with a median follow-up of 12.0 months (range 3.7-19.8 months).

AM0010 in combination with an anti-PD-1 has been well tolerated and there was no exacerbation of autoimmune treatment-related adverse events observed in combination anti-PD-1 checkpoint inhibitors in patients with advanced NSCLC. Grade 3/4 treatment-related adverse events included thrombocytopenia, fatigue, anemia, and hypertriglyceridaemia and were transient and reversible.

Phase 1b Clinical Trial Results in Metastatic Renal Cell Carcinoma (RCC)

In the Phase 1b clinical trial, 56 patients with metastatic RCC were treated with AM0010 immunotherapy alone or in combination with an anti-PD-1 checkpoint inhibitor. Eight patients were treated with AM0010 in combination with pembrolizumab after a median of 2 prior therapies (range 0-5 therapies) and 29 patients were treated with AM0010 in combination with nivolumab after a median of 1 prior therapy (range 1-3 therapies).

In this ongoing Phase 1b clinical trial, the preliminary ORR was 50.0% and 34.6% in advanced RCC patients treated with AM0010 and either pembrolizumab or nivolumab, respectively. The median PFS was 16.7 months (range 3.7-22.6+ months) and the median OS has not been reached for advanced RCC patients treated with AM0010 and pembrolizumab, with a median follow-up of 22.8 months (range 12.3-26.5 months).  The median PFS and median OS have not been reached for advanced RCC patients treated with AM0010 and nivolumab, with a median follow-up of 7.7 months (range 0.5-13.7 months).

AM0010 in combination with an anti-PD-1 has been well tolerated and there was no exacerbation of autoimmune treatment-related adverse events observed in combination anti-PD-1 checkpoint inhibitors in patients with advanced RCC. Grade 3/4 treatment-related adverse events included anemia, thrombocytopenia, and hypertriglyceridaemia and were transient and reversible.

AM0010 Immunotherapy Presentations at the 2017 ASCO Annual Meeting

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

Abstract Title: Efficacy, safety, and immune activation with PEGylated human IL-10 (AM0010) in combination with an anti-PD1 in advanced NSCLC (Abstract #9091)
Lead Author: Deborah J. Wong, M.D., Ph.D., Division of Hematology-Oncology, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California
Poster Session: Lung Cancer—Non-Small Cell Metastatic
Location: Hall A, Poster Board #417
Date: Saturday, June 3, 2017, 8:00 - 11:30 a.m. Central Time

Abstract Title: PEGylated human IL-10 (AM0010) monotherapy in refractory metastatic colorectal cancer (Abstract #3571)
Lead Author: Jeffrey R. Infante, M.D., Director, Drug Development Program, Principal Investigator, Sarah Cannon Research Institute, Nashville, Tennessee
Poster Session: Gastrointestinal (Colorectal) Cancer
Location: Hall A, Poster Board #194
Date: Saturday, June 3, 2017, 8:00 - 11:30 a.m. Central Time

Abstract Title: Efficacy and safety of PEGylated human IL-10 (AM0010) in combination with an anti-PD-1 in renal cell cancer (Abstract #4567)
Lead Author: Aung Naing, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Poster Session: Genitourinary (Nonprostate) Cancer
Location: Hall A, Poster Board #245
Date: Sunday, June 4, 2017, 8:00 - 11:30 a.m. Central Time

Abstract Title: PEGylated human IL-10 (AM0010) in combination with pembrolizumab in anti-PD1 and CTLA-4 refractory melanoma (Abstract #3084)
Lead Author: Aung Naing, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Poster Session: Developmental Therapeutics - Immunotherapy
Location: Hall A, Poster Board #179
Date: Monday, June 5, 2017, 8:00 - 11:30 a.m. Central Time

Posters will be available at the start of each poster session on the ARMO website.

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 from 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 tumor clearing 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 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.

Contact

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