AstraZeneca's Tagrisso (osimertinib) has received FDA approval for use in combination with chemotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. This decision expands the therapeutic options for patients with this common type of lung cancer, which constitutes approximately 15% of all NSCLC cases. The approval is based on clinical trial results demonstrating a significant improvement in progression-free survival (PFS) with the Tagrisso-chemotherapy combination compared to Tagrisso monotherapy, which is the current standard of care.
Clinical Trial Data Supporting Approval
The FDA's approval was supported by data from a pivotal clinical trial. The results indicated that adding chemotherapy to Tagrisso extended progression-free survival by approximately nine months compared to Tagrisso alone. Furthermore, the combination therapy exhibited a more pronounced effect in reducing the risk of cancer growth in the central nervous system (CNS).
Tagrisso's Role in Early-Stage NSCLC
In addition to its use in advanced disease, Tagrisso has also shown promise in earlier stages of NSCLC. New clinical trial data presented by AstraZeneca revealed that Tagrisso outperformed placebo in patients with Stage 3 EGFR-mutated NSCLC that was not surgically removable, following chemoradiotherapy. The trial, known as LAURA, demonstrated a "statistically significant and highly clinically meaningful improvement in progression-free survival" with Tagrisso compared to placebo in this setting. While overall survival (OS) data favored Tagrisso, the results were not yet final at the time of the announcement.
Susan Galbraith, head of oncology R&D at AstraZeneca, emphasized the significance of these findings, stating, "These highly impactful results for the Laura trial in this potentially curative early lung cancer setting further entrench Tagrisso as the backbone therapy for EGFR-mutated lung cancer."
Implications for Treatment Paradigm
The approval of Tagrisso in combination with chemotherapy could establish a new standard of care in the first-line metastatic setting for EGFR-mutated NSCLC. This development is particularly relevant in light of recent trial results from Johnson & Johnson, which showed that their drug combination outperformed Tagrisso monotherapy. With the availability of Tagrisso plus chemotherapy, physicians may now consider this combination as the appropriate comparator in future clinical trials and treatment decisions.
Benjamin Solomon, a medical oncologist at the Peter MacCallum Cancer Center in Australia, noted that data supporting Tagrisso's use in the adjuvant setting "mandate testing for EGFR mutations in patients with early-stage non-small cell lung cancer."
