Biotech
Thursday, August 11th, 2022 9:03 am EDT
Dive Brief:
- EQRx, which aims to bring to market new medicines at “radically lower prices,” said it’s started a study to test its experimental lung cancer drug against AstraZeneca’s top-selling Tagrisso.
- The U.S.-led Phase 3 trial will focus on a subset of patients with non-small cell lung cancer whose tumors express the protein EGFR. Researchers will sort patients into three groups, testing EQRx’s aumolertinib against Tagrisso and a combination of aumolertinib and chemotherapy.
- Both Tagrisso and EQRx’s drug work in a similar way, targeting EGFR to stop the proliferation of tumor cells. Tagrisso has quickly become a drug of choice for oncologists; its sales rocketed to $2.7 billion in the first half of 2022.
Dive Insight:
While EQRx has already demonstrated aumolertinib can outperform a similar drug, Pfizer’s Iressa, the company has yet to show how the medicine can outperform Tagrisso, which is now a standard treatment. EQRx acquired aumolertinib from China’s Hansoh Pharmaceutical Group, which conducted the Iressa trial in Beijing.
The new study is designed to address how the results of that Phase 3 trial, called AENEAS, can be applied to “current U.S. medical practice and patient population,” EQRx said Thursday.
Relying on the AENEAS trial results alone might not be enough to win entry into the U.S. market. Food and Drug Administration officials have become increasingly vocal about the need to run international studies instead of focusing on just one country, like China, where the results may not be applicable to U.S. patients.
In March, the FDA rejected an experimental cancer immunotherapy from Eli Lilly and Innovent Biologics because their application relied on results from China. The agency asked the companies to run an additional, international trial.
EQRx said Thursday it’s also planning to start a U.S.-led trial of its other top drug, sugemalimab, in non-small cell lung cancer. The company licensed sugemalimab from China’s CStone Pharmaceuticals. EQRx said it’s engaged in “constructive conversations with the FDA to gain greater clarity on the regulatory path forward” for both aumolertinib and sugemalimab.
Meanwhile, the company is exploring approvals in other parts of the world. The U.K.’s Medicines and Healthcare products Regulatory Agency recently accepted EQRx’s application for review of aumolertinib, which marked the company’s first submission to a regulatory agency. EQRx said Thursday its first submission for sugemalimab will be outside of the U.S. in the second half of this year.
This post has been syndicated from a third-party source. View the original article here.
