TAIPEI, Taiwan and SAN DIEGO, Calif., September 21, 2022 — 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-PEG20 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 evaluates a new mechanism of action to treat cancer, having 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. Polaris Group is extremely grateful for the invaluable contributions of all of the study’s participants, their families and caregivers, and the clinical investigators.”, said Shaw Chen, M.D., Ph.D., chief executive officer of Polaris Group.
About ADI-PEG 20
ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, some cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine dependency.
About the ATOMIC trial
ATOMIC is a randomized, double-blind, placebo-controlled global pivotal Phase II/III Study evaluating ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo with cisplatin and pemetrexed as a first-line treatment in patients with malignant pleural mesothelioma (MPM).
The primary endpoint of the trial is OS. Secondary endpoints include progression-free survival (PFS), and safety.