AstraZeneca’s TAGRISSO® (osimertinib) has shown positive results in the LAURA Phase III trial, demonstrating a significant and clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) following chemoradiotherapy (CRT), compared to placebo. While overall survival (OS) data is favoring TAGRISSO, it is not mature yet and will continue to be evaluated as a secondary endpoint of the trial.
The findings suggest TAGRISSO could be the first targeted treatment option for patients with Stage III EGFR-mutated NSCLC. Suresh Ramalingam, MD, emphasized the advancement these results represent for patients who face early disease progression and brain spread, and the lack of available targeted therapies for this stage.
Susan Galbraith from AstraZeneca noted that these trial outcomes could cement TAGRISSO as foundational therapy in treating EGFR-mutated lung cancer, with data from the ADAURA study emphasizing the importance of early diagnosis and treatment.
The safety and tolerability profile of TAGRISSO aligns with its established profile in the LAURA trial, and no new safety concerns surfaced for its maintenance treatment after CRT. The data will be presented at a forthcoming medical meeting and discussed with global regulatory authorities.
TAGRISSO’s recent US approval, based on the FLAURA2 Phase III trial in combination with chemotherapy, adds to AstraZeneca’s ongoing efforts to address lung cancer in its early stages. TAGRISSO is also being explored in the neoadjuvant setting via the NeoADAURA Phase III trial and the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial, with results anticipated later in the year.
Lung cancer, typically split into NSCLC and small cell lung cancer, remains the leading cause of cancer death, with most NSCLC patients diagnosed at an advanced stage. EGFR-TKIs like TAGRISSO are crucial therapies for patients with EGFRm NSCLC, a subgroup highly sensitive to treatments that inhibit tumor cell growth signaling pathways. The progress in the LAURA trial indicates potential advancement in treating lung cancer at earlier stages, particularly for those with specific genetic mutations.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
