31May

Merck presented the data from VISION study to support its FDA approval in patients with NSCLC with METex14 skipping

Primary efficacy and biomarker analyses from the VISION study of tepotinib in patients (pts) with non-small cell lung cancer (NSCLC) with METex14 skipping.


Abstract No. : 9556

Abstract : Poster Session

Indication : METex14 mutated NSCLC

Intervention : Tepotinib

Company : Merck KGaA

Technology : Small Molecule


Results:

By data cutoff (1 Oct 19) 151 pts received tepotinib (safety set); 99 L+/T+, 66 L+, 60 T+ pts comprised the 3 ITT sets with $6-month [m] follow-up. Across treatment lines (n = 44 1L, n = 55 $2L), primary ORR & mPFS [95% CI] in 99 L+/T+ pts were 43% [34–54] & 8.6 m [6.9–11.0] by IRC and 56% [45–66] & 9.5 m [6.7–13.5] by INV. ORR was similar in L+ or T+ pts (table) or in T+L2 pts (n = 25): 40% [21–61] by IRC and 48% [28–69] by INV. Only 2 pts were T2L+. Outcomes were also comparable in pts with BM (n = 11): IRC ORR 55% [23–83] & mPFS 10.9 m [8.0–ne]. 34/51 pts (67%) with matched BL/ontreatment L+ samples had deep MR strongly associated with clinical response: 32/34 pts (94%) with MR had disease control (INV), including 29/34 pts (85%) with OR; 2/34 pts had progressive disease. Further biomarker data will be presented. Grade $3 treatment-related adverse events (TRAEs) were reported by 37/151 pts (25%). 13 pts (9%) discontinued due to TRAEs.


Conclusion:

Tepotinib is a promising targeted therapy with durable clinical activity and manageable toxicity in pts with METex14 skipping NSCLC L+ or T+, including pts with BM. High ORR & DCR in pts with ctDNA molecular responses support that MET inhibition in METex14+ tumor cells can lead to clinical benefit.


Commentary:

Tepotinib is a promising targeted therapy with durable clinical activity in patients with METex14 skipping NSCLC. The efficacy of tepotinib in patients with brain metastases was comparable to the overall population


Refer to Non Small Cell Lung Cancer Market report for detailed Insights.