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Hansoh Pharma, EQRx Planning Regulatory Talks After Positive Phase III Aumolertinib Data in NSCLC

NEW YORK – Hansoh Pharma and EQRx said on Wednesday that they will begin discussions about their EGFR inhibitor aumolertinib with regulators around the world after it improved outcomes in EGFR-mutated non-small cell lung cancer patients compared to gefitinib (AstraZeneca's Iressa) in a Phase III trial.

The randomized Phase III AENEAS trial of more than 400 EGFR-mutated, stage IIIB and IV NSCLC patients demonstrated a median progression-free survival of 19.3 months for those on aumolertinib in the first-line setting, versus 9.9 months for those receiving gefitinib. After one year of treatment, 69 percent of patients on aumolertinib were alive without disease progression versus 46 percent in the gefitinib arm. The progression-free survival improvement with aumolertinib was observed in patients with brain metastases as well, and the drug was well tolerated.

Hansoh, based in China, and EQRx, based in Massachusetts, will present these data at the American Society of Clinical Oncology's annual meeting in June. Last year, China's National Medical Products Administration approved aumolertinib (previously called almonertinib) in the second-line setting for patients with NSCLC harboring EGFR-T790 mutations. That approval was based on the results of the single-arm Phase II APOLLO study.

The two firms have since partnered to develop the drug globally. "Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability," Vincent Miller, EQRx's physician-in-chief, said in a statement.