ESMO 2026 | INSPIRE-LM: intrathecal trastuzumab/pertuzumab for HER2+ leptomeningeal disease
Kamran Ahmed, MD, Moffitt Cancer Center, Tampa, FL, discusses results from the Phase II INSPIRE-LM (NCT04588545) trial evaluating radiation therapy followed by intrathecal trastuzumab and pertuzumab in patients with HER2-positive breast cancer and leptomeningeal metastasis. The study met its predetermined overall survival endpoint, reporting the longest median survival to date in this setting, with durable leptomeningeal disease control and complete responses in a subset of patients. Treatment was well tolerated, with few higher-grade adverse events. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.
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Transcript
so HER2 POSITIVE leptomenangial metastases is a challenging diagnosis with limited treatment options. And we previously reported phase one results from the current study where we found the recommended phase two dose of IT-pertuzumab to be 80 milligrams in combination with 80 milligrams of IT trastuzumib. And here at Asthma 2026, we’re presenting the phase two results that are reporting the primary endpoint of overall survival...
so HER2 POSITIVE leptomenangial metastases is a challenging diagnosis with limited treatment options. And we previously reported phase one results from the current study where we found the recommended phase two dose of IT-pertuzumab to be 80 milligrams in combination with 80 milligrams of IT trastuzumib. And here at Asthma 2026, we’re presenting the phase two results that are reporting the primary endpoint of overall survival. So we found this study endpoint to be met. So the primary endpoints. was overall survival. We found that to be 36 .2 months. So that met the study endpoint. Our historical control for overall survival was 4 .4 months. The median leptomeningeal progression-free survival was 19 .3 months. And the best leptomeningeal response was a complete response in five patients. And additionally, we found five patients to have a partial response. Stable disease was found in 17 or 57 percent of patients. Overall, study therapy was well tolerated. The primary side effects that we found were headache, fatigue, as well as nausea and vomiting.
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