Efficacy

Tagrisso (Osimertinib) Efficacy in Lung Cancer

Tagrisso (osimertinib) is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) 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 effective in patients with NSCLC harboring exon 19 deletions or exon 21 L858R mutations, which are common EGFR mutations associated with lung cancer. The FLAURA trial, a pivotal phase III study, showed that osimertinib significantly improved progression-free survival compared to standard first-generation EGFR-TKIs in patients with previously untreated, EGFR mutation-positive NSCLC.

Moreover, osimertinib has shown efficacy in the central nervous system (CNS), which is particularly relevant as brain metastases are common in patients with EGFR-mutated NSCLC. Osimertinib is able to cross the blood-brain barrier and has demonstrated a higher CNS response rate compared to earlier-generation EGFR-TKIs. This characteristic makes osimertinib a valuable option for patients with CNS involvement. Additionally, it has been approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR-TKI therapy.

Gavreto (Pralsetinib) Efficacy in Lung Cancer

Gavreto (pralsetinib) is a selective RET kinase inhibitor used in the treatment of NSCLC with RET gene fusions, a less common driver mutation in lung cancer. The efficacy of pralsetinib was evaluated in the ARROW trial, which included patients with RET fusion-positive metastatic NSCLC. The results of this trial showed that pralsetinib achieved robust and durable responses in both treatment-naive and previously treated patients. The overall response rate was significant, indicating that pralsetinib is highly effective in shrinking tumors in patients with RET fusion-positive NSCLC.

Pralsetinib has also demonstrated activity against brain metastases, which is crucial for improving outcomes in patients with advanced disease. Its ability to provide systemic and intracranial disease control makes it a promising therapeutic option for patients with RET-driven lung cancers. The FDA has granted accelerated approval to pralsetinib for the treatment of adult patients with metastatic RET fusion-positive NSCLC, which underscores its potential as a targeted therapy in this specific patient population.