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June 10, 2021

ASCO 2021: low-cost, me-too TKIs as new options for EGFR+ NSCLC

EQRx and Hansoh's aumolertinib is expected to capture a share of the non-small cell lung cancer (NSCLC) market if approved.

By GlobalData Healthcare

In the crowded space of tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC), some new entrants intend to use low prices as their main competitive advantage. At this year’s virtual annual American Society of Clinical Oncology conference (ASCO 2021) on 4–8 June, EQRx and Hansoh Pharma’s aumolertinib, a novel epidermal growth factor receptor (EGFR) TKI, achieved its primary endpoint of improving progression-free survival (PFS) over AstraZeneca’s Iressa (gefitinib). The randomised Phase III trial, AENEAS, included previously untreated locally advanced or metastatic NSCLC patients with EGFR exon 19 deletion or L858R mutations (EGFR-mut).

In AENEAS, 214 patients treated with aumolertinib had a median PFS of 19.3 months, compared with 9.9 months in the Iressa arm, at a hazard ratio (HR) of 0.46. Overall survival (OS) data were not presented due to not reaching maturity. Adverse events (AEs) leading to treatment discontinuation were similar between arms, at 3.7% for aumolertinib and 5.1% for Iressa, as were the grade ≥ 3 AEs, at 36.4% and 35.8% respectively. The incidence of rash or diarrhoea, however, was markedly lower for aumolertinib.

Aumolertinib is a third-generation mutant-specific, irreversible EGFR inhibitor, most aptly compared to AstraZeneca’s Tagrisso (osimertinib). Tagrisso has demonstrated a median PFS of 18.9 months, and a median OS of 38.6 months in its pivotal FLAURA trial. While a cross-trial comparison would be inappropriate, aumolertinib seems to be a strong contender for competing against Tagrisso in the first line.

In the US and the five largest European markets, namely Germany, France, Italy, Spain and the UK, Tagrisso has mostly replaced Iressa as the standard of care in the first line of treatment. EQRx’s market strategy is to offer aumolertinib at a significant discount to Tagrisso, but whether this will be enough to compel appropriate organisations to use it instead of Tagrisso, especially in the absence of OS data, remains to be seen.

EQRx intends to use the AENEAS data to discuss the next registrational steps with global regulatory bodies and to expand the available applications for aumolertinib in the future with planned or ongoing trials in the adjuvant EGFR setting, as well as advanced setting in combination with chemotherapy or other targeted agents. The drug is co-developed with Hansoh Pharma in China, with Hansoh maintaining its marketing rights in China (marketed as Ameile for EGFR-mut patients in the second line of therapy).

While price competition is a risky strategy in a field with imminent generic entrants, given the fact that its main competitor, Tagrisso, is set to maintain patent protection well into the 2030s, aumolertinib may end up successfully competing on price alone. With Tagrisso posting $4.33bn in global sales last year, GlobalData expects aumolertinib to capture a share of this lucrative market upon receiving regulatory approval.

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