Summary

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• Tagrisso (osimertinib) is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.
• This summary is based on the review of 23 systematic review(s)/meta-analysis(es). ^[1-23]
• Progression-Free Survival (PFS): Adding bevacizumab to osimertinib did not significantly prolong PFS (HR = 1.00, 95% CI: 0.78-1.27). Osimertinib was superior to other first, second, and third-generation TKIs and chemotherapy regimens (HRs: 0.09-0.61). Afatinib provided a more profound and durable PFS benefit compared to osimertinib in patients with uncommon EGFR mutations (11.0 vs. 7.0 months, P=0.044).
• Overall Survival (OS): The combination of osimertinib and bevacizumab did not significantly improve OS (HR = 1.01, 95% CI: 0.73-1.41). Osimertinib demonstrated superior OS benefits for patients with T790M mutations compared to other EGFR-TKIs (HR = 0.66).
• Objective Response Rate (ORR): Afatinib had a slightly higher ORR compared to osimertinib (60.6% vs. 50.3%). The addition of bevacizumab to osimertinib did not improve ORR (risk ratio = 1.12, 95% CI: 0.90-1.38).
• Disease Control Rate (DCR): Osimertinib showed a pooled DCR of 93% (95% CI 88% to 97%) in patients with leptomeningeal metastases.
• Adverse Events (AEs): Increased incidence of nausea, oral mucositis, hypertension, and proteinuria were observed with osimertinib combined with bevacizumab. Common AEs for osimertinib alone included rash (53%), diarrhea (45%), paronychia (35%), decreased appetite (35%), and dry skin (27%).
• Severe Adverse Events (SAEs): Osimertinib had a lower incidence of severe AEs compared to other treatments, with a pooled incidence of serious AEs reported as less than 2%. Combination treatments, particularly erlotinib plus bevacizumab, were associated with higher overall toxicity.
• Subgroup Considerations: Osimertinib was ranked highly in avoiding severe AEs in Asian populations and demonstrated an acceptable safety profile in patients with brain metastases.
• There is no population types or subgroups information available in the reviewed studies.