Novel TKI Promising in Early Study of HER2-Mutant NSCLC

The investigational tyrosine kinase inhibitor (TKI) BAY 2927088 induced responses in previously treated HER2-mutant non-small cell lung cancer (NSCLC) and had a favorable safety profile, according to phase I data presented at the American Society of Clinical Oncology (ASCO) annual meeting.

In this MedPage Today video, Nicolas Girard, MD, PhD, of Institut Curie in Paris, shares findings from the SOHO-01 study.

Following is a transcript of his remarks:

SOHO-01 is a phase I study assessing BAY 2927088, which is a TKI directed against HER2. It was assessed in patients with advanced non-small cell lung cancer, and who were treatment-naive for any kind of HER2-directed agents. So these patients were pretreated, mostly receiving chemotherapy.

This is a cohort of 34 patients, mostly in the second- and third-line setting. These patients received the drug at a 20 milligram dose twice daily.

Very interestingly, we have a high response rate in those patients; 70% of patients showed an objective response, and we have, in addition, 15% of the patients who had stable disease. So the disease control rate is 85%, which is promising in this patient population.

We have data regarding the duration of response. Median was not reached, and we have a PFS [progression-free survival] of 8.1 months. We looked also at the ctDNA [circulating tumor DNA] in those patients — ctDNA clearance at baseline and during treatment. And this was, as expected, correlated with objective response.

So we have a radiological response and a biological response in those patients.

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