CAMBRIDGE, Mass. & SHANGHAI – Detailed results from the Phase III AENEAS trial showed that treatment with aumolertinib resulted in a clinically significant improvement in progression-free survival (PFS) as compared to gefitinib in first-line treatment of patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with the most common types of EGFR mutations. In addition, the encouraging safety findings of less frequent rash and diarrhea confirmed the previously reported findings in the second-line APOLLO study. Aumolertinib is already approved in China in the second-line setting and is being jointly developed by EQRx and Hansoh Pharma globally.
These results will be discussed in a Poster Discussion Session during the American Society of Clinical Oncology (ASCO) 2021 Virtual Annual Meeting on June 4, 2021 (abstract #9013).
Hansoh Pharma and EQRx have partnered to expand global access to aumolertinib and plan to pursue regulatory discussions in multiple countries. The Companies will continue investigation of applications for aumolertinib across a variety of monotherapy and combination trials that are ongoing or planned.
“EGFR TKIs are the standard of care for treating EGFR-mutant NSCLC. Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability,” commented Vincent Miller, M.D., physician-in-chief of EQRx. “At EQRx, our focus is to ensure that more patients have access to and can benefit from the latest innovative medicines, starting with oncology—one of the disease areas with the highest cost burden for treatments. Our mission is closely aligned with this year’s ASCO focus on equity, and these results are a significant step toward our goal of more equitable access to medicine.”
“We’re excited to build upon the success of this therapy in the second-line setting with the potential for patients to benefit from aumolertinib now also in the first-line setting,” said Aifeng Lyu, Ph.D., president of Jiangsu Hansoh Pharmaceutical Group Co., Ltd., a subsidiary of Hansoh Pharma. “These Phase III results are compelling as we work to continuously improve the patient experience through innovative treatments. We look forward to working with EQRx to bring aumolertinib to more patients with advanced lung cancer in China and around the world.”
AENEAS is a double-blind randomized phase III trial comparing aumolertinib 110 mg once daily (n=214) to gefitinib 250 mg once daily (n=215) in patients with EGFR-mutated NSCLC. AENEAS met its primary endpoint of prolongation of PFS at the time of the pre-specified event driven analysis. The median PFS was estimated at 19.3 months for aumolertinib and 9.9 months for gefitinib with a hazard ratio 0.46 (p<0.0001). At a landmark one-year analysis, 69 percent of patients treated with aumolertinib were free of disease progression compared to 46 percent of patients treated with gefitinib. Improvement in PFS in patients who received aumolertinib over gefitinib was observed across relevant subgroups of patients, including those with brain metastases. The study has not yet met the cutoff for overall survival.
Aumolertinib was well-tolerated. Adverse events that caused patients to temporarily stop or discontinue treatment altogether were less common with aumolertinib than with gefitinib. Aumolertinib was associated with lower incidence of commonly observed EGFR-related adverse events of rash and diarrhea and no new safety signals were identified. These results further suggest aumolertinib to be an excellent choice for combination studies and studies in the adjuvant setting in this subset of patients with NSCLC.
Aumolertinib (proposed INN, formerly almonertinib) 110 mg once-daily tablet is a medicine approved in China as AMEILE® for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by a genomic test, who have progressed on or after prior EGFR TKI therapy. Aumolertinib has demonstrated high potency and nanomolar inhibitory activity against common EGFR mutations, as well as drug-resistant T790M mutations.
Aumolertinib is a novel, irreversible EGFR-TKI that selectively inhibits both EGFR sensitizing and resistance mutations with high selectivity over wild-type EGFR. The agent was approved in China in March 2020 based on a large single arm Phase II study entitled APOLLO in second-line settings. Based on these results, the Phase III AENEAS trial was initiated.
Hansoh Pharma and EQRx have partnered to expand global access to aumolertinib.
EQRx is committed to catalyzing a market-based solution to one of society’s biggest healthcare challenges by developing important new medicines and offering them at lower prices. Through strategic partnerships with stakeholders from across the healthcare system and cutting-edge science and technology, the Company aims to provide high-quality, patent-protected medicines more efficiently and cost-effectively than ever before. EQRx is a purpose-built disruptor at scale, remaking medicine to bend the cost curve in drug pricing. To learn more, visit www.eqrx.com and follow us on social media: Twitter: @EQRxInc, LinkedIn, Instagram: @eqrxinc.
ABOUT HANSOH PHARMA
Hansoh Pharma (3692.HK), a leading biopharmaceutical company in Asia, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 9,000 dedicated employees in China and the United States.
Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, central nervous system (CNS) disorders, infectious diseases, gastrointestinal disorders, diabetes, and autoimmune diseases, among others. With the support of over 1,600 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including morinidazole (迈灵达®), a third-generation nitroimidazole antibiotic; PEG-loxenatide (孚来美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; flumatinib (昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML); and aumolertinib (阿美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations.
For more information, please visit www.hspharm.com.