ROZLYTREK is the first and only approved agent to deliver a meaningful response with intracranial efficacy in ROS1+ NSCLC1
ROZLYTREK delivered a clinically meaningful ORR of 67.1%1
ROZLYTREK delivered a median PFS of almost 16 months, with a 12-month survival rate of 81%1,2
ROZLYTREK delivered an intracranial response in almost 80% of patients with measurable CNS metastases at baseline, with responses maintained for at least 12 months in over half of these1
In ROS1+ advanced NSCLC, up to 40% of patients have CNS metastases at diagnosis.6
ROZLYTREK delivers clinically meaningful responses in NTRK fusion+ solid tumours, irrespective of baseline CNS metastases1,7
ROZLYTREK delivered a clinically meaningful ORR of 63.5%1
ROZLYTREK delivered 11.2 months PFS, with nearly
2 years overall survival7
ROZLYTREK delivered an intracranial ORR of 62.5%,*1 and high rates of CNS disease progression-free time8
NTRK is emerging as an actionable biomarker and oncogenic driver across a wide range of tumour types,9–16 with NTRK fusions identified in at least 25 tumour types in adult and paediatric patients9–11, 14–16
ROZLYTREK was well tolerated in clinical trials, with the majority of adverse events manageable7
- Most adverse events were of grade 1 or 2
- 27.0% of patients required dose interruption due to TRAEs
- 24.6% of patients required dose reduction due to TRAEs
- Permanent discontinuation of ROZLYTREK due to a TRAE occurred in 4.6% of patients.
Adults: Recommended dose is 600 mg orally once-daily.
Children: Recommended dose for paediatric patients aged 12 years and older is 300 mg/m2 orally once-daily for those who can swallow whole capsules.
- For paediatric patients with body surface area of 1.11 m2 - 1.50 m2, recommended dose is 400 mg once-daily
- For paediatric patients with body surface area of ≥1.51 m2, recommended dose is 600 mg once-daily
Can be taken with or without food.
*In patients with measurable CNS metastases.
CNS, central nervous system; NSCLC, non-small cell lung cancer; NTRK, neurotrophic tropomyosin receptor kinase; ORR, overall response rate; PFS, progression-free survival; P-gp, P-glycoprotein; ROS1, c-ros oncogene 1; TRAE, treatment-related adverse event; TRK, tyrosine kinase.
- ROZLYTREK® Summary of Product Characteristics, F, Hoffman-La Roche, 2020.
- Krebs MG, et al. Efficacy and safety of entrectinib in locally advanced/metastatic ROS1 fusion-positive NSCLC: an updated integrated analysis. Poster 1287P.
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- Drilon A, et al. Lancet Oncol 2020;21:261–270.
- Fischer H, et al. Neuro Oncol 2020;22:819–829.
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- Patel M, et al. Ann Oncol 2020;31(Suppl 3):232–233.
- Rolfo C, et al. Efficacy and safety of entrectinib in patients with NTRK Fusion-Positive (NTRK-fp) solid tumours: an updated integrated analysis. Poster P335.
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- Khotskaya YB, et al. Pharmacol Ther. 2017;173:58–66.
- de Lartigue J. TRK inhibitors advance rapidly in “tumor-agnostic” paradigm. OncologyLive. 2017;18. Available at: https://www.onclive.com/publications/oncology-live/2017/vol-18-no-15/trk-inhibitors-advance-rapidly-in-tumoragnostic-paradigm (Accessed August 2020).
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- Kummar S, Lassen UN. Target Oncol 2018;13:545–556.
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