EQRx Announces Acceptance of Marketing Authorization Application by the UK's Medicines and Healthcare Products Regulatory Agency for Aumolertinib in EGFR-Mutated Non-small Cell Lung Cancer
EQRx Announces Acceptance of Marketing Authorization Application by the UK’s Medicines and Healthcare Products Regulatory Agency for Aumolertinib in EGFR-Mutated Non-small Cell Lung Cancer
- Marketing authorization application is EQRx’s first submission to a regulatory agency
- Application is based on data from pivotal Phase 3 AENEAS trial in the first-line treatment of EGFR-mutated non-small cell lung cancer
EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices, today announced that the United Kingdom (U.K.)’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review the marketing authorization application (MAA) for aumolertinib, a third-generation EGFR-tyrosine kinase inhibitor (TKI), in development for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
“This acceptance of the marketing authorization application for aumolertinib by the MHRA is our first regulatory filing and a significant milestone for EQRx,” said Melanie Nallicheri, president and chief executive officer of EQRx. “In the U.K., approximately 39,000 people are diagnosed with lung cancer each year, and about 10 to 15 percent of these patients have EGFR-sensitizing mutations. Given its promising clinical activity and tolerability profile, we believe that, if approved, aumolertinib would represent an additional and differentiated treatment option for patients in the U.K. who have EGFR-mutated NSCLC. We aim to expand access to third generation EGFR inhibitors and look forward to working with the MHRA as it conducts its review.”
The MAA is primarily supported by data from the pivotal Phase 3 AENEAS trial that evaluated aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC.1 Results from AENEAS were recently published in Journal of Clinical Oncology, and new data from the study on aumolertinib’s activity in central nervous system metastases were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2
In 2021, aumolertinib was granted Innovation Passport designation in the U.K. through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations including the MHRA. The ILAP was established in early 2021 to accelerate the development and access to promising medicines in the U.K., with benefits including the potential for an accelerated MAA assessment as well as rolling review and a continuous benefit-risk assessment.
Aumolertinib is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets both EGFR-sensitizing and T790M resistance mutations with high selectivity over wild-type EGFR.3 Aumolertinib is being investigated in several ongoing clinical trials, including studies in first- and second-line EGFR-mutated non-small cell lung cancer (NSCLC). Aumolertinib is approved by the National Medical Products Administration (NMPA) of China for both first-line and second-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC. Aumolertinib was discovered by Hansoh Pharmaceuticals, and EQRx has partnered with Hansoh Pharmaceuticals on global development of aumolertinib with the goal of expanding access worldwide. EQRx holds the development and commercialization rights to aumolertinib outside of Greater China.
About the AENEAS Trial
AENEAS (NCT03849768) is a randomized, double-blind, multicenter, Phase 3 study designed to evaluate the efficacy and safety of aumolertinib versus gefitinib as first-line treatment for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The study was conducted by Hansoh Pharmaceuticals and enrolled 429 patients who were randomized to receive either aumolertinib (n=214) or gefitinib (n=215). The study met its primary endpoint, demonstrating statistically significant improvement in progression-free survival as compared to gefitinib.1 Secondary endpoints include overall survival, overall response rate and safety.
EQRx is a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices. Launched in January 2020, EQRx is purpose-built, at scale, with a growing catalog of medicines in development in high-cost drug categories and emerging partnerships with leading payers and health systems. Leveraging cutting-edge science and technology and strategic partnerships with stakeholders from across the healthcare system, EQRx aims to provide innovative, patent-protected medicines more efficiently and cost-effectively than ever before. To learn more, visit www.eqrx.com and follow us on social media: Twitter: @EQRxInc, LinkedIn, Instagram: @eqrxinc.
EQRx™ and Remaking Medicine™ are trademarks of EQRx.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements may be identified by the use of words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “design,” “strategy,” “future,” “opportunity,” “continue,” “aim,” “goal,” “plan,” “may,” “look forward,” “should,” “will,” “would,” “will be,” “will likely result,” and similar expressions. These forward-looking statements include, but are not limited to, express or implied statements regarding obtaining regulatory approval for aumolertinib, aumolertinib’s potential as a treatment option for NSCLC, EQRx’s ability to expand access to aumolertinib worldwide with its partner Hansoh, and EQRx’s ability to develop and deliver innovative medicines at radically lower prices, among others. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to risks associated with the timing and outcome of EQRx’s planned interactions with MHRA and other regulatory authorities; EQRx’s ability to successfully demonstrate the safety, tolerability, and efficacy of aumolertinib and its other drug candidates; delays of any current and future clinical trials or the development of aumolertinib or EQRx’s other drug candidates; the results of prior clinical trials not being predictive of future results; EQRx’s relationships with Hansoh and its other existing and future collaboration partners; EQRx’s ability to otherwise implement its business plans, including risks associated with its growth strategy; and other risks associated with its plans to create a new kind of pharmaceutical company, among others. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section in EQRx’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as well as any other filings with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and EQRx assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
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1 Lu S, et al. Journal of Clinical Oncology. 2022. doi: 10.1200/JCO.21.02641
2 Lu S, et al. Journal of Clinical Oncology. 40, no. 16_suppl (June 01, 2022) 9096-9096. doi: 10.1200/JCO.2022.40.16_suppl.9096
3 Lu S, et al. J Thorac Oncol. 2022;17(3):411-422. doi: 10.1016/j.jtho.2021.10.024