WCLC 2024 | SOHO-01: BAY 2927088, a novel TKI, in HER2-mutant NSCLC

So SOHO-01 trial is a Phase I/II study evaluating BAY 88 which is a small molecule inhibitor in HER2 mutation non-small cell lung cancer patients HER2 mutation occurs in around like 3% of all lung cancers and those mutations usually they respond to TKI. However currently the approval is in the chemotherapy and ADC means antibody drug conjugates so there is a clear and unmet need that we need a small molecule inhibitor for this patient population.

So here the BAY-88 is a oral medication have good SC as penetrance and evaluating if that BAY- 88 can work in the same as metastatic HER2 mutation patient population. Based on earlier data actually the BAY-88 has received both us FDA and the China MPA breakthrough designation for HER2 so this time I’m presenting a cohort D from BAY 88 uh study from the SOHO-01 study. In this cohort we enrolled non-small cell lung cancer patient with HER2 mutation in the tumor. Those patient received prior chemo or immunotherapy but never received any anti-HER2 treatment.

In this particular cohort we find that response rate with BAY-88 is 72% with a disease control rate of 84% really is really excellent efficacy. There most of the patient derive clinical benefit and then the response is early and usually happen in the first assessment. The progression free survival is 7.5 months and the duration of response is 8.7 months. One last point I do want to add is that that we have a early efficacy observation in a subgroup of HER2 mutation called YVMA. In this group of patients the response rate is 90% with uh PFS 9.9 month so very encouraging data. So overall this drug has showed safety toxicity profile to be quite manageable and this time we’re reporting really good clinical efficacy data