Leora Horn, MD, MSc

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 data accrued from Flatiron and from a phase 1/2 trial (NCT02716116)of patients with refractory non–small cell lung cancer (NSCLC) with EGFR exon 20 insertions receiving mobocertinib (TAK-788) compared with currently approved therapies.

The phase 1/2 study of about 100 patients and the data from Flatiron showed that patients treated with mobocertinib had a higher response rate than those treated with chemotherapy, chemotherapy and immunotherapy, or EGFR tyrosine kinase inhibitors. The response rate was about 40% with mobocertinib versus around 15% with chemotherapy. The median progression-free survival was about 7 months and 4 months with mobocertinib and chemotherapy, respectively. Horn says that while recognizing this is a heterogeneous patient population since it is from Flatiron, their findings demonstrate that mobocertinib is a potentially more effective treatment in the second line for patients with EGFR exon 20 insertions than the approved therapies.

Currently, there is an ongoing phase 3 trial of mobocertinib compared with chemotherapy for patients with NSCLC and exon 20 insertions. Horn thinks this trial will take some time to accrue since EGFR exon 20 is a rare mutation. This trial will be looking at mobocertinib in the first-line setting since patients have shown to do better with agents that target their mutations over traditional chemotherapy, according to Horn.

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Leora Horn, MD, MSc, discusses the data accrued from Flatiron and from a phase 1/2 trial of patients with refractory non–small cell lung cancer with EGFR exon 20 insertions receiving mobocertinib compared with currently approved therapies.

NSCLC With EGFR Exon 20 Shows Benefit With Mobocertinib Over Chemotherapy

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 

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 

 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.

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.

Author | Leora Horn, MD, MSc

Articles

NSCLC With EGFR Exon 20 Shows Benefit With Mobocertinib Over Chemotherapy

Real-World Comparison Assesses Mobocertinib in NSCLC With EGFR Exon 20