Efficacy

Tagrisso (Osimertinib) Efficacy in Lung Cancer

Tagrisso (osimertinib) is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that has shown significant efficacy in the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. Clinical trials have demonstrated that osimertinib is particularly effective in patients with NSCLC harboring EGFR T790M mutations, which are a common cause of resistance to earlier generations of EGFR inhibitors. In the AURA3 study, osimertinib significantly improved progression-free survival compared to platinum-based chemotherapy in patients with T790M-positive advanced NSCLC who had disease progression after first-line EGFR TKI therapy.

Furthermore, the FLAURA trial showed that osimertinib as a first-line treatment significantly prolonged progression-free survival compared to standard EGFR TKIs (gefitinib or erlotinib) in patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. The overall survival benefit of osimertinib was also confirmed, making it a preferred first-line therapy for patients with these specific mutations.

Lumakras (Sotorasib) Efficacy in Lung Cancer

Lumakras (sotorasib) represents a breakthrough in the treatment of NSCLC with a specific mutation known as KRAS G12C, which had been considered "undruggable" for decades. As the first approved targeted therapy for KRAS G12C-mutated NSCLC, sotorasib has shown promising efficacy in clinical trials. The CodeBreaK 100 trial, which led to the accelerated approval of sotorasib by the FDA, demonstrated a significant objective response rate in patients with previously treated KRAS G12C-mutated NSCLC. Patients in this trial had shown disease progression on or after an immune checkpoint inhibitor and/or platinum-based chemotherapy.

While the overall response rate was a key measure of efficacy in the CodeBreaK 100 trial, the durability of response and disease control rate were also encouraging. These results suggest that sotorasib provides a meaningful clinical benefit in a patient population with limited treatment options. Ongoing studies are further evaluating the long-term efficacy and potential combination strategies to enhance the therapeutic potential of sotorasib in this challenging subset of lung cancer.