AM0010 Shows Promise in Phase 1 Trial for Advanced Metastatic Renal Cell Carcinoma

AM0010 Shows Promise in Phase 1 Trial for Advanced Metastatic Renal Cell Carcinoma

New data from a Phase 1 clinical trial shows that ARMO BioSciences‘  immunotherapy AM0010 (pegilodecakin), alone or in combination with immune checkpoint inhibitors, shows high and durable clinical responses in patients with advanced renal cell carcinoma (RCC).

The data were presented during the European Society of Medical Oncology (ESMO) Immuno Oncology Congress 2017, Geneva, Switzerland, on Dec. 8.

Aung Naing, MD, from The University of Texas MD Anderson Cancer Center delivered the presentation  “Efficacy of PEGylated Human IL-10 (AM0010) in Combination with anti-PD-1 Blockade in Patients (pts) with Metastatic Renal Cell Carcinoma (mRCC): A phase 1b Trial.

The ongoing Phase 1b trial (NCT02009449) is an open-label, dose-escalation study designed to evaluate both the safety and tolerability of AM0010 in patients with advanced solid tumors, including metastatic renal cell carcinoma (mRCC).

When delivered alone, AM0010 induced an overall response rate of 25 percent. However, patients treated with AM0010, in combination with either Keytruda (pembrolizumab) or Opdivo (nivolumab), showed an overall response rate of 41 percent.

Combining AM0010 with either Keytruda or Opdivo showed no additional adverse effects compared to the monotherapy.

After a median follow-up of 2.5 years for patients in the Opdivo arm, and roughly one year for those in the Keytruda arm, the median overall survival has not been reached, meaning that more than half of patients in those groups are still alive.

Patients treated with AM010 plus Keytruda lived for a median of 16.7 months without worsening of their disease. In the Opdivo arm, more than half of patients are still alive and progression-free.

“While we are very pleased with the data we have generated to date in RCC, it is particularly exciting to see these high, durable responses in intermediate to poor risk advanced RCC patients who have received 2 or more prior therapies given the high unmet medical need for these patients,” Joseph Leveque, MD, chief medical officer of ARMO Biosciences, said in a press release. “In addition to the objective tumor responses, early survival data are also very encouraging.”

AM0010 (pegilodecakin) is a modified version of the human interleukin-10 (IL-10) protein. The therapy has a long-lasting activity and works by activating a special group of immune cells, called CD8+ T-cells, which are potent killers of tumor cells.

The therapy has received orphan drug designation by both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for pancreatic cancer.