Combining ARMO BioSciences‘ AM0010, or PEGylated Interleukin-10, with immune checkpoint inhibitors induces better objective response rates and disease control rates in kidney cancer patients, than any of the drugs alone, according to new data from a Phase 2 trial.
Aung Naing, MD, of the MD Anderson Cancer Center, presented the findings at the 12th European International Kidney Cancer Symposium, held April 21-22 in Munich, Germany. As announced in a press release, the presentation was titled “PEGylated Human IL-10 (AM0010) in Combination with Nivolumab in Renal Cell Cancer.”
The data shows that AM0010 has a good anti-tumor activity as a single agent in renal cell cancer patients, inducing an objective response rate (ORR) of 26.7% after a median follow-up of 22.4 months, and a disease control rate (DCR) of 60%.
However, when this agent was combined with immune checkpoint inhibitors, the responses were significantly better. Patients treated with AM0010 and Keytruda (pembrolizumab) had an ORR of 50% after a median follow-up of 20.5 months, and a DCR of 100%, meaning that no patient had disease progression. Median progression-free survival (PFS) in those patients was 16.7 months.
Similarly, those treated with AM0010 and Opdivo (nivolumab) had an ORR of 35% after a median follow-up of 4.9 months, and a DCR of 81%. Median PFS and ORR had not yet been reached in this cohort due to limited follow-up time.
Based in Redwood City, Calif., ARMO is a biopharmaceutical company focused on the development and marketing of new proprietary products for cancer treatment. Designed to have specific properties that allow them to activate the patient’s immune system to recognize and destroy tumors, the company’s products are suitable to target several cancers, such as renal cell cancer, non-small cell lung cancer, and other solid cancers. In addition, ARMO is testing its anti-cancer products to be used as monotherapy or in combination with standard-of-care treatments and emerging immunotherapies.
Human Interleukin-10 (IL-10) has shown effective anti-tumor effects and good safety and tolerability profiles. ARMO has modified the IL-10 structure by adding a sequence of polyethylene glycol, or PEG, increasing IL-10’s stability and prolonging the time it lasts in circulation.
Because of its enhanced stability, this new therapeutic drug it has a long-lasting effect inducing the activation, survival and expansion of a particular subset of immune cells, called CD8+ T-cells. These immune cells are cytotoxic, which means they can recognize and kill cancer cells. By increasing the number of CD8+ T cells within tumors it may be possible to improve prognosis and survival of patients with cancer.
The U.S. Food and Drug Administration (FDA) and the European Commission (EC) have granted Orphan Drug status to AM0010 for the treatment of pancreatic cancer. In addition, the FDA granted AM0010 Fast Track designation, in combination with FOLFOX chemotherapy, as a second-line therapy for patients with pancreatic cancer.
In a prior Phase 1/1b clinical trial (NCT02009449), which enrolled 350 cancer patients with more than 14 different cancer types, showed this new therapy has the ability to increase the number of CD8+ T-cells in the blood and within tumors. Treatment as a single agent, or in combination with chemotherapeutic drugs or anti-PD-1 checkpoint inhibitors, was found to induce objective tumor responses, including partial and complete responses.
The company has started an international Phase 3 (NCT02923921) clinical trial on AM0010 in combination with FOLFOX for the treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDAC).