Tepotinib demonstrates robust response for lung cancer subset in long-term follow-up
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Key takeaways:
- Tepotinib demonstrated robust response in long-term follow-up among patients with NSCLC with MET exon 14 skipping.
- The safety profile was manageable, consistent with earlier research.
CHICAGO — Long-term follow up shows that response to tepotinib remains robust in patients with MET exon-14 skipping non-small cell lung cancer, according to research presented at ASCO Annual Meeting.
“We’ve previously reported robust and durable activity of tepotinib from our phase 2 VISION study with a median follow-up of 26.1 months,” Paul K. Paik, MD, clinical director of the thoracic oncology service at Memorial Sloan Kettering Cancer Center, said during a presentation. “Now, we report long-term outcomes from VISION based on the latest data cut from November 2022.”
Paik and colleagues assessed long-term outcomes of the VISION study, a single-arm phase 2 trial of tepotinib (Tepmetko, Merck/EMD Serono) in patients with advanced NSCLC with MET exon 14 skipping identified by a tissue and/or liquid biopsy. Patients included in the study were either treatment naive or had previously received up to two lines of prior therapies.
The researchers found that among the 313 patients assessed with a median age of 72 years, the median treatment duration with tepotinib was 11.5 months and median follow-up period was 32.6 months.
Among the 164 patients who received tepotinib as a first-line treatment, the mean treatment duration was 12.4 months. In this patient population, the objective response rate was 57.3% (95% CI, 49.4-65.), median duration of response was 46.4 months (13.8 to not estimable), median PFS was 12.6 months (9.7-17.7), and median OS was 21.3 months (14.2-25.9).
For the 111 patients who were treatment naive and received tepotinib and were MET exon 14 skipping positive in tissue/liquid biopsy, the ORR was 58.6% (48.8-67.8), median duration of response was 46.4 months (15.2 to not estimable), median PFS was 15.9 months (11-49.7), and median OS was 29.7 months (18.8 to not estimable).
In the 149 patients who received tepotinib as a second- or later-line therapy for a mean 10.5 months, the ORR was 45% (36.8053.3) and median duration of response was 12.6 months (9.5-18.5).
Paik and colleagues found that among all 313 patients, the ORR was 51.4% (45.8-57.1), median duration of response was 18 months (12.4-46.4), median PFS was 11.2 months (9.5-13.8) and median OS was 19.6 months (16.2-22.9).
The researchers noted that there were no new safety concerns identified.
“In the long-term follow-up of the largest clinical trial targeting MET exon 14 skipping to date — the VISION study — tepotinib continues to show robust and durable activity across different treatment lines, [and] the time-dependent endpoints appeared longest in the treatment-naive or the first-line setting in patients with MET exon 14 skipping detected by tissue biopsy,” Paik said during the presentation.
He added that “tepotinib demonstrated a manageable safety profile, which was consistent with earlier observations with known safety signals.”
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Paik PK, et al. Abstract 9060. Presented at: ASCO Annual Meeting 2023; June 2-6, 2023; Chicago.
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