Press by Polaris Group

• Phase 2/3 ATOMIC study met its primary endpoint with statistically significant improvement in Overall Survival
• Study also met key secondary endpoint showing statistically significant improvement for ADI-PEG 20 Group vs. Control Group in Progression Free Survival and ADI-PEG 20 had safety profile similar to that observed in previous trials
• Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration and European Medicines Agency

Polaris Group (TWSE: 6550), a multinational biopharmaceutical company focused on research and development of novel biological drugs for cancer and other metabolic diseases, today announced top-line efficacy and safety data from the Phase 2/3 ATOMIC Study, a global, multi-center, randomized, double-blind, placebo-controlled trial of ADI-PEG 20 in combination with Pemetrexed and Cisplatin in patients with unresectable Malignant Pleural Mesothelioma (MPM) with biphasic or sarcomatoid histology. The ATOMIC trial demonstrated that patients randomized to the combination of ADI-PEG 20 plus cisplatin and pemetrexed had a median OS of 9.3 months ( 95% confidence interval [CI], 7.85-11.79), versus 7.66 months (95% confidence interval [CI]:6.14-9.53) for the placebo plus cisplatin and pemetrexed control arm. (hazard ration [HR]=0.71; 95% CI, 0.55-0.93; p=0.0234). The difference in the primary efficacy endpoint of Overall Survival (OS) is statistically significant.

  ATOMIC also met its secondary endpoint, showing statistically significant median Progression Free Survival (PFS) of 6.11 (95% confidence interval [CI], 5.75-7.43) months for ADI-PEG 20 group and 5.59 months (95% confidence interval [CI], 4.14-5.85) for the placebo control arm. (hazard ration [HR]=0.65; 95% CI, 0.47-0.90; p-value=0.0159.) The safety profile of ADI-PEG 20 observed in ATOMIC was similar to that of the previous clinical trial. Given these results, Polaris Group will proceed with regulatory submissions in the United States in 2023. In 2022, ADI-PEG 20 received fast track designation from the FDA. 

  “We are pleased to report the Phase 2/3 data showing that ADI-PEG 20 can significantly extend overall survival benefits in patients with MPM. ADI-PEG-20 is the first arginine-degrading therapeutic to show positive topline results in a pivotal trial as a combination therapy for the treatment of MPM”, said Howard Chen, chairman of Polaris Group. “The results pave the way towards our working with the regulators to bring this novel biologic to patients with MPM”.

  “As this study evaluate a new mechanism of action to treat cancer, the endpoints reach statistical significance is a remarkable finding. We plan to accelerate our pipeline projects and expand to other indications leveraging this unique mechanism of action to starve cancer cells by making use of combination with other chemotherapy and radiation”, said Shaw Chen, M.D., Ph.D., chief executive officer of Polaris Group.

For full release please visit polarispharma.com