By Fineline Cube US-based pharma EQRx Inc. (Nasdaq: EQRX) has revealed its latest plans to accelerate the US market development of two innovative drugs licensed from Chinese partners. The company’s Q2 2022 financial report shows that a US-led Phase IIIb bridging study has recently been initiated for aumolertinib as a first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
Aumolertinib Study Details
Notably, the Phase IIIb study initiated by EQRx will include one arm evaluating aumolertinib’s clinical comparability against AstraZeneca’s Tagrisso (osimertinib), alongside another arm assessing the potential clinical benefit of adding chemotherapy to aumolertinib in the first-line setting. During the firm’s earnings conference call, EQRx’s Chief Physician Executive Eric Hedrick noted that the aim is to “assess the potential differences in the risk-benefit profile between these two third-generation EGFR inhibitors, particularly in regards to tolerability differences related to different metabolic profiles of aumolertinib and osimertinib.”
Drug Background
Developed by Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) and licensed to EQRx for ex-China development in 2020, aumolertinib is the world’s second innovative third-generation EGFR tyrosine kinase inhibitor (TKI) after Tagrisso. It won its first market approval in China in March 2020 for use in T790M-mutated locally advanced or metastatic NSCLC following EGFR-TKI treatment, and later as a first-line treatment for NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation cases. EQRx filed aumolertinib for approval in the UK in June 2022 – EQRx’s first-ever marketing approval application. That filing is focused on the drug’s use as a first-line treatment of EGFR-positive NSCLC, and for NSCLC with disease progression in patients previously treated with an EGFR TKI and T790M mutation positive, backed by the AENEAS study compared with gefitinib.
Sugemalimab Development
Meanwhile, planning and discussions with the US FDA are underway to put CStone’s programmed death-ligand 1 (PD-L1) inhibitor sugemalimab into a US-led, randomized, comparative clinical trial in Stage IV NSCLC against other approved checkpoint inhibitors. The aim is to assess the applicability of the GEMSTONE-302 study results (a China-based Phase III study for sugemalimab) to current US medical practice and patient population. EQRx expects to make its first regulatory filing for sugemalimab outside of the US during H2’22, for Stage IV NSCLC. CStone licensed sugemalimab and its PD-1 inhibitor CS1003 to EQRx in a 2020 deal worth up to USD1.3 billion.-Fineline Info & Tech