Details Regarding Pneumonitis With High-Dose Aumolertinib—Reply

In Reply In the ACHIEVE study, 2 patients (3.2%) discontinued treatment due to grade 2 pneumonia. Both were never-smoking women with L858R-mutated adenocarcinoma. The first patient, a woman aged 57 years with stage IVA disease, developed chest tightness after physical activity. Radiologic examinations revealed scattered inflammatory opacities. Differential diagnosis suggested a high probability of drug-related interstitial lung disease (ILD). This event occurred 137 days after initiation of tyrosine kinase inhibitor (TKI) therapy and resolved within 20 days with oral prednisone administration. The second patient was a woman aged 73 years with stage IVB disease who presented with chest tightness and shortness of breath after physical activity. Based on imaging and medical history, ILD was the primary diagnostic consideration. This ILD event occurred 202 days after initiation of targeted therapy. Following prednisone administration, her pneumonia improved to grade 1 by week 2 and resolved completely by week 5. To ensure patient safety, the study protocol stipulates in the treatment discontinuation section (Protocol 7.8.1, line 843) that patients who develop interstitial pneumonia should permanently discontinue study treatment. In accordance with protocol requirement, treatment was permanently discontinued and both patients were withdrawn from the study, even though the ILD had recovered in both cases.