AZ posts first-line combo data for lung cancer drug Tagrisso


AstraZeneca’s top-selling drug Tagrisso is already widely used on its own as a first-line treatment for EGFR-mutated lung cancer, but new data suggests there can be benefits from combining it with chemotherapy.

The results of the FLAURA2 trial found that the combination of Tagrisso (osimertinib) with pemetrexed and either cisplatin or carboplatin was ore effective than Tagrisso alone at reducing disease progression or death in patients with locally-advanced or metastatic EGFR-positive non-small cell lung cancer (NSCLC).

Lead investigator Pasi Jänne of the Dana-Farber Cancer Institute in the US said that the combination could offer a new option for patients that “can further delay treatment resistance and disease progression”. Almost all patients with this type of cancer eventually relapse because of resistance to EGFR therapy.

The full data will have to wait for a future medical conference, but suggest that AZ may be able to extend the label for Tagrisso in the first-line setting as it faces the threat of competition from other EGFR-targeting drugs, notably Johnson & Johnson’s bispecific EGFR/MET-targeting antibody Rybrevant (amivantamab).

Rybrevant is currently approved only for a subcategory of EGFR+ NSCLC patients with exon 20 mutations – a niche indication not on Tagrisso’s label – but J&J is running trials that could put the drug in direct competition with AZ’s drug.

That includes the MARIPOSA study of Rybrevant with an EGFR inhibitor licensed from Yuhan Corp – Leclaza (lazertinib) – as a first-line therapy for an all-comer population of EGFR-mutated NSCLC patients that includes a head-to-head comparison with Tagrisso.

The trial is due to read out either later this year or early in 2024, and if positive could give J&J an opportunity to try to dislodge Tagrisso from its dominant position. With the new combo data, AZ now has a chance to push back if that happens.

AZ said it would share the results with regulatory authorities to extend the label of Tagrisso, which is also approved as adjuvant therapy for EGFR+ NSCLC, as well as for second-line use in relapsed patients. Sales of the drug came in at over $1.4 billion in the first quarter of this year.

“These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing,” commented Susan Galbraith, AZ’s head of oncology R&D.

“This meaningfully builds on successive trials which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer,” she added.