UK’s MHRA Accepts Marketing Authorization Application for Aumolertinib in EGFR+ Advanced NSCLC

Results from the phase 3 AENA trial led to the United Kingdom’s Medicine and Healthcare products Regulatory Agency accepting a marketing authorization application for aumolertinib for review in patients with locally advanced or metastatic non–small cell lung cancer with activating EGFR mutations, and those with locally advanced or metastatic EGFR T790M mutation–positive non–small cell lung cancer.

The United Kingdom’s Medicine and Healthcare products Regulatory Agency (MHRA) has accepted a marketing authorization application for aumolertinib for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with activating EGFR mutations, and locally advanced or metastatic EGFR T790M mutation-positive NSCLC, according to a press release from EQRx.1

The phase 3 AENAS trial (NCT03849768), which was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, enrolled 429 patients to receive either aumolertinib (n = 214) or gefitinib (Iressa; n = 215) as a first-line treatment for adults with metastatic EGFR-mutated NSCLC.2

In the aumolertinib group, the progression-free survival (PFS) was significantly longer compared with the gefitinib group (HR, 0.46; 95% CI, 0.36-0.60; P <.0001). The median PFS in the aumolertinib group was 19.3 months (95% CI, 17.8-20.8) vs 9.9 months (95% CI, 8.3-12.6) in the gefitinib group. The objective response rates were 73.8% vs 72.1%, and the disease control rates were 93.0% vs 96.7% in the aumolertinib and gefitinib groups, respectively.

“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 [United Kingdom] 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,” Melanie Nallicheri, president and chief executive officer of EQRx, concluded in the press release.

References

  1. EQRx announces acceptance of marketing authorization application by the UK’s Medicine and Healthcare products Regulatory Agency for aumolertinib in EGFR-mutated non–small cell lung cancer. News Release. EQRx. June 14, 2022. Accessed June 21, 2022. https://bit.ly/3HDT1Y4
  2. Lu S, Dong X, Jian H, et al. AENEAS: A randomized phase III trial of aumolertinib versus gefitinib as first-line therapy for locally advanced or metastatic non-small-cell lung cancer with EGFR exon 19 deletion or L858R mutations. J Clin Oncol. Published online May 17, 2022 doi:10.1200/JCO.21.02641