Alexander Drilon, MD presents updated results from a pooled analysis of TRK fusion-positive cancers treated with larotrectinib from the 2021 American Society of Clinical Oncology annual meeting.
Alexander Drilon, MD, discusses data from the following poster:
Long-term efficacy and safety of larotrectinib in an integrated data set of patients with TRK fusion cancer (Hong, et al. ASCO 2021. Poster 3108.)
The objective of this poster is to report pooled data from 3 clinical trials (NCT02576431, NCT02122913, NCT02637687) of patients with TRK fusion–positive cancers treated with larotrectinib.
Baseline characteristics
Patient population by tumor type (n = 218): soft tissue sarcoma, 26%; infantile fibrosarcoma, 20%; thyroid, 13%; salivary gland, 11%; lung, 9%; colon, 4%; melanoma, 3%; breast, 3%; and other, 3%
In all evaluable patients (n = 206), the overall response rate (ORR) was 75%, including 45 (22%) complete responses, 109 (53%) partial responses, 33 (16%) with stable disease, 13 (6%) with progressive disease, and 6 (3%) not determined; responses were durable with a median progression-free survival (PFS) of 35.4 months and a median duration of response of 49.3 months. Median overall survival (OS) was not reached.
The 36-month rates for duration of response, PFS, and OS were 54%, 48%, and 77%, respectively.
In patients with central nervous system metastases (n = 15), the ORR was 73%, including 11 (73%) partial responses, 2 (13%) with stable disease, and 2 (13%) with progressive disease.
Conclusions: safety
There were no new or unexpected safety signals.
Treatment-related adverse events (TRAEs) were predominantly grade 1 to 2.
Grade 3 and 4 TRAEs were reported in 18% of patients, with the most common being decreased neutrophil count (7%), increased aminotransferase (3%), and increased aspartate aminotransferase (2%).