Polaris Group recently announced an application for a rolling submission of a new mesothelioma treatment. The Biologic License Application is the first step in becoming approved by the Food and Drug Administration. The treatment, known as ADI-PEG 20, is for the use on non-epithelioid mesothelioma patients alongside pemetrexed and platinum chemotherapy. The non-epithelioid subtypes of mesothelioma include sarcomatoid and biphasic cell types, which are known to be the most resistant to treatment. Polaris is trying to demonstrate the safety and efficacy of the treatment for the treatment of mesothelioma. It is also testing ADI-PEG 20 on three different hard to treat cancers.
The Polaris BLA submission comes after a successful phase 3 clinical trial that met its progression free and overall survival goals. Rolling submission into the trial allows for a streamlined regulatory process, potentially helping to reduce the time it takes to approve the drug. The company will finalize the remaining chemistry, manufacturing, and controls in the near future. ADI-PEG 20 works by disrupting cancer cell metabolism. This allows it to treat cancers influenced by metabolic pathways. The goal of the company is to revolutionize cancer treatment by concentrating on its metabolic foundations, which could potentially enhance patient outcomes globally. The CEO of Polaris Group recently said that the company is fully committed to addressing the needs of patients with pleural mesothelioma. The treatment, if approved by the FDA, would be a welcome addition to the limited treatment options for patients and would be a step forward in the treatment of hard-to-treat cancers.
ATOMIC Meso, which is an international multicenter trial, looked at the effects of AGI-PEG 20, an enzyme that limits arginine. Arginine helps mesothelioma tumors with growth and cell production. Information from the trial showed that AGI-PEG 20 was able to extend the survival in patients with treatment resistant subtypes of pleural mesothelioma. The efficacy of AGI-PEG 20 combined with chemotherapy was compared to standard treatments pemetrexed and cisplatin chemotherapy in previously untreated patients that could not receive surgery diagnosed with sarcomatoid or biphasic mesothelioma. Researchers found that there was a good response to the treatment from the start. The median survival of patients receiving ADI-PEG 20 and chemotherapy was 9.3 months compared to 7.6 months for patients receiving only chemotherapy. Progression free survival was also higher at 6.1 months compared to 5.5 months in the placebo control group. Some patients in the study lived for three years, which is groundbreaking for mesothelioma treatment of the targeted subtypes. There were adverse side effects to the treatment and some dose limiting toxicities, but most adverse events were considered mild to moderate and were mostly from the chemotherapy and not the ADI-PEG 20 treatment.
