ESMO Asia 2025 | Tepotinib in MET-amplified NSCLC: real-world outcomes from Australia

So essentially, what we did in this study is that we collected a group of patients who enrolled on the Merck cost-share program to access topotinib. In Australia, there is no other way to access a MET inhibitor for MET-amplified non-small cell lung cancer. We have access to topotinib on our government registration scheme for MET exon 14 skipping mutant non-small cell lung cancer. And we know that from the VISION study, there was a call of patients with MET amplified, de novo MET amplified, who actually benefited from treatment. We also know from the INSIGHT-2 trial, which was in patients who had developed and acquired MET amplification in the context of EGFR inhibition with osimertinib, that there was benefit from the addition of both agents. We have seen a similar story in the SACHI trial, the phase three SACHI trial, which is looking at Osimertinib plus savolitinib in that same patient cohort demonstrated a significant progression-free survival benefit. So here we took 15 patients who enrolled in the cost-share program, of which a third, so five patients, had de novo metastatic disease, and the other two-thirds, or 10 patients, had acquired MET amplification in the context of having progressed on osimertinib. There were various cut-offs used, but mostly MET amplification was measured by using next-generation sequencing panels. And we saw some really encouraging activity whereby on average, our median progression sort of duration of response really ranged anywhere from three months to about 26 months. However, our data cutoff was at about anyone who had still been treated for at least three months. So very encouraging activity. And in addition to that, we also saw that it was quite a well-tolerated treatment with mostly grade one toxicities that were managed with supportive care medications and very few to no dose reductions on the particular therapy. In fact, to add to that, I should have mentioned that the objective response rate ranged anywhere from 80 to 90%. So this really showed us that topotinib either as a treatment for de novo MET-amplified non-small cell lung cancer or for MET-amplified acquired resistance in the context of EGFR inhibition was safe and demonstrated promising efficacy. And hopefully once we start seeing the readout from the global phase three trials, especially in that MET-amplified acquired space, such as through the Saffron trial, we will be able to accommodate this treatment more into standard practice.

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