At the 2023 ASCO Annual Meeting, Paul Paik, MD, Memorial Sloan Kettering Cancer Center, New York, New York, shared long-term outcomes from the phase 2 VISION study, evaluating the MET inhibitor tepotinib among patients with MET exon 14 non-small cell lung cancer.

Dr Paik stated, "these long-term data outcomes really do show that there are durable and consistent response signals that we've seen to back up the approval indication. And [tepotinib] remains a quite effective therapy in the first-line setting and beyond, for patients with MET exon 14 skipping-positive advanced non-small cell lung cancers."

Transcript:

Hello, my name is Paul Palk. I'm an associate attending and clinical director of the thoracic oncology service at Memorial Sloan Kettering Cancer Center. And on behalf of my co-authors, I had presented a poster at the 2023 ASCO Annual Meeting, entitled "Long-term outcomes of tepotinib in patients with MET exon 14 skipping non-small cell lung cancer From the VISION Study."

As many of you know, MET exon 14 skipping alterations are one of the newest actionable alterations that we've identified in non-small cell lung cancers, happening in about 3% to 4% of all patients. The VISION study is a phase 2 single-arm study that began several years ago that led to FDA approval in 2021 in this particular indication for MET exon 14 skipping-positive non-small cell lung cancer patients. All patients received tepotinib as this was a single arm study. Patients were eligible if they received up to 2 prior lines of therapy. Patients were stratified by analysis by different lines of therapy. The data that we presented is first-line data, second-line-plus data, and then the aggregate data as well. Patients were eligible molecularly by 2 methodologies. One was liquid biopsy, and the other was a tissue biopsy. And so data have been parsed out in this way also, that's not part of this presentation, but these are data that we presented also in the past.

The important part of this poster is that it's a long-term outcome update with a median follow-up in this patient population of 26.1 months. And this also includes a data update for 2 different cohorts, which are essentially equivalent, cohort A and cohort C, for a total of 313 patients.

The bottom line is the signal that we found persists, and has been stable with longer term follow-up. The overall response rate in all 313 patients is 51.4% with a median progression-free survival of just a little over 11 months, and a median overall survival of 19.6 months. The data, when stratified by lines of therapy, showed that the first-line data are a little bit better. Overall response rate here is 57%. Median progression-free survival is 15.9 months, and the median overall survival is 21.3 months. There's a little bit of a diminution in response rate in the second-line-plus data, down to 45%. But the median progression-free survival holds up at 11 months, and the median overall survival also holds up at 19.3 months. As frame of reference, we know that patients with these alterations tend to skew towards the older population, and the median overall survival in other data sets in the upfront setting is somewhere between 9 to 10 months. It's really an extension, up to 20 plus months is quite good.

We also took a look at safety metrics and quality of life data, and the safety signals have remained consistent and stable as well, with peripheral edema, as many of you know, as the primary side effect. Most of these events are grade 1 or grade 2. And we presented also on different ways to manage this peripheral edema. In terms of quality of life metrics by the EORTC QLQ-LC13, and the QLQ-C30, and the EQ-5D-5L, these metrics have been stable, with a qualitative improvement in cough in this patient population.

In summary, these long-term data outcomes really do show that there are durable and consistent response signals that we've seen to back up the approval indication. And this remains a quite effective therapy in the first-line setting and beyond, for patients with MET exon 14 skipping positive advanced non-small cell lung cancers. Thank you.

Source:

Paik PK, Garassino MC, Le X, et al. Long-term outcomes of tepotinib in patients with MET exon 14 skipping NSCLC from the VISION study. Presented at 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL; Abstract #9060