Leora Horn, MD, MSc, discusses the real-world data outcomes compared with clinical trial data of mobocertinib from a retrospective study in patients with refractory non–small cell lung cancer with EGFR exon 20 insertions.
Leora Horn, MD, MSc, assistant director of the Educator Development Program and clinical director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, discusses the real-world data outcomes compared with clinical trial data of mobocertinib (TAK-788) from a retrospective study in patients with refractory non–small cell lung cancer (NSCLC) with EGFR exon 20 insertions.
This analysis looked at the 160 mg daily dose of mobocertinib, which will be used in further studies, from a phase 1/2 trial (NCT02716116)versus real-world data of traditional chemotherapy in the same population. The investigators looked at progression-free survival (PFS), overall survival, toxicity, and overall response rates. According to Horn, in all the different areas, it seemed that mobocertinib was a more effective agent in terms of response, the median PFS, and a reasonable safety profile.
A head-to-head comparison of this regimen is needed against the standard of care to say whether it is definitively better. Horn feels that for rare populations such as patients with EGFR exon 20 insertions, investigators will have to use retrospective data to help patients make informed decisions if this drug gets accelerated approval. When comparing it with chemotherapy or other EGFR tyrosine kinase inhibitors, they will have to help patients decide therapy, if mobocertinib receives approval prior to the phase 3 trial.