Polaris Submits Application for New Mesothelioma Treatment
Multinational biopharmaceutical company Polaris Group announced their application for a rolling submission of a new mesothelioma treatment this month. The Biologic License Application for the experimental drug ADI-PEG 20 is the first step in U.S. Food and Drug Administration approval.
The application outlines the use of ADI-PEG 20 for non-epithelioid mesothelioma alongside treatment with pemetrexed and platinum chemotherapy. Non-epithelioid subtypes include sarcomatoid and biphasic cell types, historically the most resistant to treatment.
Polaris stated in a press release, “Polaris Group’s development program for ADI-PEG 20 is focused on demonstrating its safety and efficacy in addressing the pressing medical needs of patients facing this challenging condition. Three Phase 3 clinical studies with ADI-PEG 20 in other hard-to-treat cancers are currently ongoing.”
Biologic License Application Could Hasten FDA Approval
Polaris’s BLA submission follows a successful phase 3 clinical trial that met its progression-free and overall survival goals. Rolling submission allows for a streamlined approach to the regulatory review process, which could reduce the time until the drug’s approval. The company will finalize the remaining chemistry, manufacturing and controls in the coming months.
“Pegargiminase [ADI-PEG 20] is designed to disrupt cancer cell metabolism, providing a novel approach to treating a wide range of cancers heavily influenced by metabolic pathways,” the company said. “Our mission is to revolutionize the treatment of complex diseases like cancer by concentrating on their metabolic foundations, ultimately striving to enhance patient outcomes globally.”
Howard Chen, CEO and Chairman of Polaris Group, said about the BLA submission, “We are fully committed to addressing the urgent medical needs of patients facing malignant pleural mesothelioma. If approved by the FDA, this therapy would be a welcome addition to treatment options for patients and an important step forward for our work in hard-to-treat cancers.”
Dr. John Bomalaski, Executive Vice President of Medical Affairs at Polaris Group, expressed optimism, stating, “Our clinical trials have demonstrated promising results, with ADI-PEG 20 showing statistically significant potential to address the medical needs of patients with malignant pleural mesothelioma.”
Phase 3 Trial Led to 30% Improved Survival for Pleural Mesothelioma
ATOMIC Meso, an international multicenter trial, studied the effects of AGI-PEG 20, an enzyme that limits arginine. Mesothelioma tumors use the amino acid arginine to fuel growth and cell production.
The clinical trial found that AGI-PEG could extend survival in mesothelioma patients with treatment-resistant subtypes. Researchers compared the efficacy of traditional pemetrexed and cisplatin chemotherapy to a combination of ADI-PEG 20 and chemotherapy in previously untreated, unresectable patients diagnosed with sarcomatoid or biphasic mesothelioma.
Speaking to The Mesothelioma Center, Dr. Peter Szlosarek, principal investigator and medical oncologist at UK Barts Cancer Institute in London, England, expressed surprise at the results. “The results were astonishing to me. The response was robust from the beginning,” said Szlosarek.
Results revealed that patients treated with ADI-PEG 20 and chemotherapy exhibited a median survival of 9.3 months compared to 7.6 months for those receiving only chemotherapy. Progression-free survival for ADI-PEG 20 patients was 6.1 months, surpassing the 5.5 months observed in the placebo control arm.
Remarkably, some patients in the study lived for more than three years, a groundbreaking outcome for the targeted mesothelioma subtypes. There were few dose-limiting toxicities in the mesothelioma clinical trial. Most of the adverse side effects seen were considered mild to moderate, and many were related to the chemotherapy and not the ADI-PEG 20.