On May 19, 2021 EQRx reported that 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 (Press release, EQRx, MAY 19, 2021, View Source [SID1234580301]). 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.

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"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."

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These results will be discussed in a Poster Discussion Session during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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.

ABOUT AUMOLERTINIB

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.