Hello, my name is Rosario Aljera-Campelo, I am a medical oncologist in the University Hospital of La Coruña in the northwest of Spain. It's a great pleasure, a great honor on behalf of my co-authors to present the data of most certainty in EFR-XON20 insertion positive metastatic non-small cell lung cancer patient reported outcomes from the Sclain extension core. Here you have my disclosures. You already know EFR-XON20 insertion mutations account for up to 12% of non-small cell lung cancer tumors with EFR mutations. Most of these patients are treated in first line with a platinum-based schedule, but their disease unfortunately progresses very rapidly. At the time of this recording, there are no approved targeted therapies for this population outside of the United States. Moxertinib is one of these new agents, a first-in-class oral EFR tyrosine kinase inhibitor that has shown durable responses in platinum-protreated EFR-XON20 insertion positive metastatic non-small cell lung cancer with a very nice median overall survival of 24 months. The objective of this analysis was to evaluate patient-reported outcomes in a phase 1-2 study of moxertinib in this difficult-to-treat population. Patient-reporting outcomes were assessed in the Sclain extension cohort of this phase 1-2 study, which included 96 previously treated patients with EFR-XON20 insertion mutations. Moxertinib was administered at 160 mg once daily in 28-day cycles. The PRO instruments used in the study are shown here, and they are focused on cancer-related symptoms and general health-related quality of life. The PRO-CTCAE also assessed symptomatic toxicity of moxertinib treatment. Here you may see the main patient's characteristics. Patients were primarily female, Asian, with no history of smoking, and PSO1. The endocarcinoma would be expected was the predominant histology. At the time of the TACATOV, 26% of patients remained on moxertinib with a median time on treatment of 6.8 months. Treatment with moxertinib resulted in statistically significant and clinically meaningful improvements in lung cancer symptoms. Clinically meaningful improvements from baseline were observed for dyspnea in 50% of the patients, cough in 46%, and pain in chest in 38.9%. Improvements in lung cancer symptoms were evident from the start of cycle 2 and were maintained throughout treatment. More than half of patients receiving moxertinib had at least stable or improved symptoms of dyspnea, cough, and pain in the chest throughout all study cycles. Global health status was maintained or improved in most patients during treatment with moxertinib. And as shown here, there was little change in ERTC-QLK-C30 global health quality of life scores during treatment. The least squares mean change from baseline was not statistically significant. For the PRO-CTCAE, patients related specific adverse events by severity, interference with activities of daily living, and frequency. Diarrhea, dry skin, rash, and decreased appetite were the most common symptoms reported as worsening during treatment. Most adverse events reported were not only in the two highest categories for severity, interference, and frequency. Diarrhea and dry skin worsened to the two highest categories in 22% and 11% of patients, respectively. Worsening of other symptoms occurred in fewer than 10% of patients. Overall, general health-related quality of life assessed by the EQ5D visual analog scale remained stable throughout moxertinib treatment. In conclusion, PROs were used to evaluate key aspects of the patient experience while receiving moxertinib in previously treated patients with EFR-XON20 insertion positive metastatic non-small cell lung cancer. Improvements in core non-small cell lung cancer symptoms were observed within two months. These improvements were consistent with concomitant improvements in clinical status. Overall, health-related quality of life was maintained during therapy despite the occurrence of adverse events such as rash and gastrointestinal-related symptoms. I would like to thank the patients, all their families, and their caregivers. And of course, we also like to thank the study investigators and their team members at each study site. Many thanks for your kind attention.

Dr. Rosario Aljera-Campelo

patient-reported outcomes

Sritan extension core phase 1-2 study

Moxeritinib

metastatic non-small cell lung cancer