Treatment with BAY 2927088 led to durable responses in patients previously treated HER2-mutant NSCLC

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Published: 8 Apr 2025
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Prof Nicolas Girard - Institut Curie, Paris, France

Prof Nicolas Girard speaks to ecancer about the phase I/II SOHO-01 study of BAY 2927088 in patients with previously treated HER2-mutant NSCLC: Safety and efficacy results from 2 expansion cohorts.

Cancer treatment is evolving with a focus on specific patient subsets and effective dosing strategies.

Early administration of targeted agents shows promise, with new data indicating significant treatment outcomes.

The study showed that the safety profile of BAY 2927088 was manageable across cohorts. Treatment with BAY 2927088 led to durable responses in patients naïve to HER2-targeted therapy and those who had received a HER2-targeted ADC.

Advancements in immune checkpoint inhibitors are also highlighted, enhancing patient quality of life and underscoring the importance of multidisciplinary discussions in thoracic oncology.

Treatment with BAY 2927088 led to durable responses in patients previously treated HER2-mutant NSCLC

Prof Nicolas Girard - Institut Curie, Paris, France

At ELCC 2025 I also presented the results of the SOHO-01 trial which is a phase I/II study with BAY 2927088 which is an oral tyrosine kinase inhibitor targeting HER2. We know that HER2-mutated non-small cell lung cancer is a specific subset of patients, more frequently never smokers, young patients, and we do not have any standard of care for the management of those patients.

At ELCC I presented some expansion cohorts from the SOHO-01 trial and patients received BAY 2927088 at a dosing of 20mg twice daily which was chosen after a dose escalation and [??] cohort. Cohort D was a cohort of patients who were HER2-directed therapy naïve. So these patients had previously received chemotherapy for all of them, some patients, two-thirds of them, had received immune checkpoint inhibitors. 46% of those patients did receive BAY 2927088 as second-line treatment.

In this cohort we see a high response rate of 72% together with a disease control rate of 82% which is obviously very high and shows the potency of this agent to control HER2-mutated non-small cell lung cancer. We have a median duration of treatment of 9.7 months which is obviously meaningful in the clinic.

I also reported the results from Cohort E, which is a cohort of patients, heavily pretreated patients. Most of these patients received BAY 2927088 as first-line treatment and beyond after chemotherapy, after immunotherapy and after at least one line of antibody-drug conjugate, mostly T-DXd . In this cohort we see a quite high response rate of 35%, a disease control rate of 53% and median duration of treatment of again 9 months which is unexpected in this context of heavily pretreated patients.

So this compound, BAY 2927088, is highly promising, not only in the late-line setting but also in the first-line setting. We know in the clinic that targeted agents are more effective when given early in the treatment sequencing and the SOHO-02 trial is ongoing that compares in a phase III trial BAY 2927088 to standard of care chemotherapy.

Is there anything else you would like to add?

I think during this ELCC 2025 meeting we see many new data, many data regarding targeted agents. We have also many studies reporting on the treatment of KRAS mutated non-small cell lung cancer patients. We have new data regarding immune checkpoint inhibitors, especially delivered in a subcutaneous formulation which is obviously highly promising for the healthcare organisation and the patient quality of life. So a multidisciplinary discussion, very nice, and an important meeting for the thoracic oncology community.