Latest analyses of Vitrakvi reaffirm powerful efficacy and tolerability profile for both adult and pediatric patients with TRK fusion cancer.
An updated analysis with longer follow-up (data cut-off July 20, 2020) among 130 evaluable from a total of 140 adult patients across 20 different non-central nervous system (CNS) tumor types confirms the robust and highly durable tumor-agnostic efficacy with extended survival benefits in adult patients with TRK fusion cancer, including those with CNS metastases.
A post-hoc subgroup analysis of investigator-assessed overall response rate (ORR), duration of response (DoR) and progression-free survival (PFS) stratifying adult and pediatric patients (n=218) by prior lines of therapy and baseline performance status shows that larotrectinib benefitted patients across those criteria with the highest response rates observed in patients receiving first-line larotrectinib (ORR=81%; 95% CI 69–91; n=58) and being Eastern Cooperative Oncology Group performance status (ECOG PS) 0 (ORR=85%; 95% CI 77–91; n=114). A matching-adjusted indirect comparison (MAIC) evaluating efficacy endpoints such as overall survival (OS), PFS, ORR, complete responses and DoR as well as safety observed in clinical trials with larotrectinib and entrectinib confirmed the impact of larotrectinib for TRK fusion cancer patients.
Separately, a safety analysis on the incidence of fractures in adult and pediatric patients add to the body of evidence for the compound. These results were presented at the ESMO Congress 2021, to be held between September 16-21, 2021.
“As we continue to see ongoing analyses of larotrectinib across a wide range of solid tumors and ages, its consistent results in NTRK fusion-positive cancers support its efficacy and safety in adults and children”, said Alexander Drilon, M.D., Medical Oncologist and Chief of Early Drug Development Service at Memorial Sloan Kettering Cancer Center*. “These data reinforce the importance of early comprehensive genomic testing to uncover actionable oncogenic drivers, including NTRK gene fusions, to help identify patients who are most likely to benefit from a targeted treatment approach".