ASCO 2025 | SOHO-01: safety & efficacy updates of BAY 2927088 in HER2-mutant NSCLC

So this is a trial for patients with HER2 mutations. It’s very important to remember that these patients, they have an unmet need because we have only one option for these patients in first-line chemotherapy and chemotherapy is not a very good option for them. And we have trastuzumab deruxtecan. It’s a very interesting second-line option. A major problem is you have to go through first-line to get to second-line and then we don’t know what to do after trastuzumab deruxtecan. So what we have, the drug is called, right now, thank God they’ve got a name for it because the letters and numbers were so difficult to say, but it’s called sevabertinib. It’s also an oral drug, a TKI, that provided a 59%, 60% response rate. There were two different cohorts. First cohort was for patients that were pre-treated but naive to HER2 targeted therapies. And the first one, the other one, just for first-line, it’s a trial that has a very limited follow-up for the first cohort, the pre-treated patients. It’s about eight months with a median duration of response of six months. But maybe just because we’re talking about a drug, a trial actually, that had a lot of patients being included recently. When we look back at this year’s ELCC, last year’s WCLC, we got even better responses like 70%, 71% because maybe there were less patients on trial and now we are waiting for a longer follow-up. And it’s interesting because a drug can be used after trastuzumab deruxtecan, and it becomes another option. I don’t think T-DXd is so bad to use compared to amivantamab. It’s not as tough to use. Bad is not a very good word. It’s not so tough to use. But once again, it’s an intravenous drug. So you have to go to the clinics, you have to cope with maybe pneumonitis, you have to cope with nausea, fatigue. And once again, it’s a drug that causes rash, diarrhea. It’s a very straightforward profile of TKIs. And well, I think it’s another option. And once again, we have trials in the first-line being run right now. We have the trial with zongertinib, which is a drug from Boehringer, which is called the Beamion LUNG-1. We have the SOHO-01 in first-line as well with sevabertinib. And we also have the DESTINY-Lung04 which is trastuzumab deruxtecan in first-line. And once again, we are anxiously awaiting that because maybe getting a TKI to patients previously, getting a good response, getting a good duration of response can make patients’ lives a little better.

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