ARMO BioSciences announced new clinical data on its drug AM0010, which has shown promising therapeutic potential both as a monotherapy and in combination with standard of care chemotherapy or anti-programmed cell death protein (PD-1) monoclonal antibodies in a variety of cancers.
The results were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting June 3-7 in Chicago.
ARMO’s AM0010, a PEGylated form of Interleukin-10, has been shown to induce strong immune-stimulating effects, promoting the proliferation, activation, and survival of cytotoxic CD8-positive T-cells within the tumors, which also helps to prime the tumor site to immune-mediated therapies.
AMD0010’s safety, tolerability, and efficacy have been addressed in a Phase 1b, non-randomized, multi-cohort study, where more than 300 patients with 12 different types of cancer were enrolled.
In a poster discussion session, Aung Naing, M.D., of The University of Texas MD Anderson Cancer Center, revealed data from 19 patients with melanoma, renal cell carcinoma, or non-small cell lung carcinoma (NSCLC), who were treated with AM0010 in combination with the checkpoint inhibitor anti-PD-1.
The overall response rate was 42 percent, and durable responses were found in four of the eight RCC patients and two of five NSCLC patients. This was accompanied by an increase in the number and proliferation of cytotoxic CD8 T-cells, and a reduction in regulatory T-cells.
In another poster session, Kyriakos Papadopoulos, M.D., of START Center for Cancer Care, presented data of AM0010 as a monotherapy for patients with immune-resistant cancers. The Phase 1 trial included 27 patients with colorectal cancer and 38 patients with advanced pancreatic ductal adenocarcinoma.
Among the pancreatic cancer patients, 22 of them were given daily doses of AM0010 as a monotherapy, and 16 received AM0010 in combination with either FOLFOX, capecitabine, or gemcitabine/nab-paclitaxel. AMD0010 monotherapy reduced CA 19-9 antigen levels and induced a median overall survival of 3.8 months when given in third- to fifth-line therapy.
Importantly, 87 percent of patients treated with AM0010 plus chemotherapy had stable disease, and the remaining 13 percent had a partial response.
In patients with colorectal cancer, AM0010 monotherapy induced a median overall survival of 11.4 months.
“These positive results from our ongoing Phase 1 study further demonstrate the promise of AM0010 to engage the immune system to fight cancer cells, even in the most difficult-to-treat immune-resistant cancers,” Peter Van Vlasselaer, Ph.D., president and CEO of ARMO BioSciences, said in a press release.
Previously, AM0010 was shown to induce comprehensive T-cell activation and demonstrated encouraging therapeutic efficacy as a monotherapy, and this new clinical data shows AM0010’s ability to induce objective tumor responses when used in combination with anti-PD-1 checkpoint inhibitors.
“In addition, AM0010 showed both mechanistic and clinical efficacy in patients with cancers that do not respond to checkpoint inhibitors,” Van Vlasselaer added. “As this Phase 1 trial continues to progress, we look forward to initiating the first registration-enabling trial of AM0010 in patients with advanced solid tumors, potentially as early as the end of this year.”