ARMO BioSciences Announces First Patient Dosed in Pivotal Phase 3 Trial of Immunotherapy AM0010 for Advanced Pancreatic Cancer
- Category: Proteins and Peptides
- Published on Wednesday, 29 March 2017 17:38
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REDWOOD CITY, CA, USA I March 29, 2017 I ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the first patient has been dosed in the Company's international Phase 3 pivotal clinical trial to evaluate its lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) in combination with FOLFOX as second-line treatment for patients with advanced pancreatic cancer.
"Dosing the first patient in a Phase 3 trial is an important milestone in our effort to develop our novel immunotherapy for this very aggressive form of cancer," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO. "We chose pancreatic cancer for our first pivotal Phase 3 trial based on encouraging Phase 1/1b data with AM0010 as a single agent and in combination with FOLFOX. Pancreatic cancer has the highest mortality rate of all major cancers and we are committed to the development of new immune-based treatment options for difficult-to-treat solid tumors. In our clinical experience with AM0010, we observed durable clinical responses in several cancer types. Additionally, we observed systemic and intra-tumoral stimulation of CD8+ T-cell survival, expansion and cytotoxic activity. Our clinical development strategy is designed to support global regulatory filings for AM0010 and we are eager to treat patients with advanced pancreatic cancer with our next-generation immunotherapy in this pivotal study."
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 have 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 expected 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%.
AM0010 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, 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