Afatinib Plus Carboplatin and Pemetrexed Demonstrates Efficacy, Safety Among Patients WIth Advanced EGFR-Mutated Non-Small Cell Lung Cancer
According to results from the NEJ025B study, afatinib plus carboplatin and pemetrexed demonstrated promising efficacy and safety among patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) who experienced disease progression after first-line treatment with osimertinib.
“Osimertinib is commonly used as a first-line treatment for EGFR-mutated advanced [NSCLC]...However, the optimal treatment strategy following osimertinib failure remains unclear,” stated Hiromi Nagashima, MD, Iwate Medical University, Shiwa-gun, Japan, and coauthors.
In this study, 35 patients with EGFR-mutated NSCLC and exon 19 deletions or L858R mutations who experienced disease progression after first-line treatment with osimertinib were assigned to receive 20 mg of once daily afatinib plus carboplatin (AUC 5 mg/mL/min) and pemetrexed (500 mg/m2) once every 3 weeks followed by maintenance afatinib plus pemetrexed until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Key secondary end points included objective response rate (ORR), disease control rate, duration of response, overall survival (OS), and safety.
At analysis, the 6-month PFS rate was 57.1%. The median PFS was 8.2 months and long-term PFS of ≥ 1 year occurred in 28.6% of patients. The ORR was 51.4% and the disease control rate was 88.6%. Duration of response was 5.6 months, and the median OS was 22.5 months. The most frequently observed adverse events included diarrhea (52.8%) and anorexia (47.2%), both of which were manageable. Interstitial pneumonia occurred in 3 patients. Two deaths occurred due to sepsis and interstitial pneumonia.
“The combination of afatinib and the platinum doublet demonstrated satisfactory efficacy with manageable adverse events in tumors refractory to osimertinib,” concluded Dr Nagashima et al.
Source:
Nagashima H, Fukuhara T, Utsumi Y, et al. A phase II study of afatinib in combination with pemetrexed and carboplatin in patients with EGFR mutation-positive non-squamous, advanced non-small cell lung cancer (NSCLC) refractory to first-line osimertinib treatment: NEJ025B study. Eur J Cancer. Published online: August 20, 2025. doi: 10.1016/j.ejca.2025.115693
