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Larotrectinib Is Safe, Effective in Patients With TRK–Positive Lung Cancer
Nearly three-quarters of patients with tropomyosin receptor kinase (TRK)–positive lung cancer had an objective response (OR) to larotrectinib, according to an analysis of 2 small studies.
Larotrectinib received tumor-agnostic approval for the treatment of TRK–positive cancers in 2018 based on favorable antitumor efficacy observed in phase 1 and 2 trials. “However, the prospective efficacy and safety of larotrectinib solely in patients with TRK fusion–positive lung cancers have not been published,” wrote lead author Alexander Drilon, MD, Memorial Sloan Kettering Cancer Center, New York City, and colleagues.
Researchers analyzed data from 20 patients who had participated in 2 global, multicenter, registrational clinical trials: the first was a phase 1 study, while the second was phase 2 basket trial (NAVIGATE).
All patients in the cohort had adenocarcinoma, except one who had neuroendocrine carcinoma. Half of the patients had central nervous system (CNS) metastases, 2 of whom were previously treated with brain radiotherapy.
Of the cohort, 16 patients had fusions involving NTRK1 (6 had TPM3, 2 had EPS15, 2 had IRF2BP2, and 1 each had NOS1AP, SQSTM1, TPR, CD74, CLIP1, and PRDX1); while 4 others had fusions involving NTRK3.
The cohort was treated with single-agent larotrectinib administered at 100 mg twice daily in continuous 28-day cycles.
However, only 15 patients were evaluable for purposes of determining the OR rate (ORR). The ORR by investigator assessment was 73% (95% CI, 45 to 92); 10 patients had a partial response, 1 had a complete response, and 3 had stable disease. Median duration of response, progression-free survival, and overall survival were 33.9 months (95% CI, 5.6 to 33.9), 35.4 months (95% CI, 5.3 to 35.4), and 40.7 months (95% CI, 17.2 to not estimable), respectively.
Among patients with baseline CNS metastases, the ORR was 63% (95% CI, 25 to 91).
Source:
Drilon A, Tan D, Lassen U, et al. JCO Precis Oncol. 2022 Jan;6:e2100418. doi:10.1200/PO.21.00418.
