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Novel TKI Promising in Early Study of HER2-Mutant NSCLC

— Nicolas Girard, MD, PhD, explains the SOHO-01 study

MedpageToday

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.

Nicolas Girard, MD, PhD, of Institut Curie in Paris, shares findings from the .

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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