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
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