Background: Tepotinib, an oral MET TKI, is approved in the European Union for advanced/metastatic METex14 skipping NSCLC after immunotherapy (IO) and/or platinum-based chemotherapy (CT), and regardless of prior treatments in other countries including the UK and Switzerland. The VISION study showed robust and durable efficacy and safety of tepotinib in patients with ≥3 years follow-up. We report long-term efficacy data prior/peri/post-tepotinib, treatment interruption details, and data on long-term responders in VISION (data cut-off: May 20, 2024).
Methods: Patients received tepotinib 500 mg (450 mg active moiety) QD. Primary endpoint was objective response (RECIST v1.1) by IRC. Prior/post-tepotinib treatment was investigator’s choice; outcomes were reported per investigator.
Results: Of 313 patients (median age 72.0 years), 164 received tepotinib in 1L with ORR of 57.9%, mDOR of 31.7 months, and mPFS of 12.6 months while 149 received it in 2L+ with ORR of 45.0%, mDOR of 12.6 months, and mPFS of 11.0 months. For patients receiving tepotinib in 2L+ in VISION, 104 patients had previously received platinum-based CT alone, 59 IO monotherapy, and 22 IO-CT. Across all prior treatment lines, ORR was 28.9%, mDOR was 6.0 months, and mPFS was 5.0 months; outcomes with tepotinib in 2L+ were improved.
The median time on treatment was 7.5 months; 19 (6.1%) patients received tepotinib for ≥48 months (maximum 83 months).
Overall, 295 (94.2%) patients discontinued tepotinib. TRAEs led to dose reductions in 104 (33.2%) patients, treatment interruptions in 137 (43.8%) patients, permanent discontinuation in 49 (15.7%) patients, and death in 3 (1.0%) patients. Of patients who discontinued tepotinib, 145 started subsequent treatments; 65 received MET inhibitors.
Conclusions: In VISION, outcomes with tepotinib across treatment lines in patients with ≥3 years follow-up demonstrated robust and durable efficacy (consistent with previously reported findings), particularly in the 1L-setting, supporting its early use in the treatment sequence.