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Association details:
| Biomarker: | ROS1 positive |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Rozlytrek (entrectinib) (ALK inhibitor, TrkB receptor inhibitor, TrkC kinase inhibitor, TrkA receptor inhibitor, ROS1 inhibitor, JAK2 inhibitor, TNK2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Entrectinib (Rozlytrek) is accepted for use within NHSScotland
Published date:
12/04/2020
Excerpt:
Entrectinib (Rozlytrek) is accepted for use within NHSScotland...as monotherapy for the treatment of adult patients with ROS1 positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Source:
Published date:
07/31/2020
Excerpt:
Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Source:
Published date:
04/30/2020
Excerpt:
ROZLYTREK is used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC)....ROZLYTREK...for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Source:
Published date:
08/15/2019
Excerpt:
ROZLYTREK is a kinase inhibitor indicated for the treatment of...Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
Source:
Title:
Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
Published date:
08/12/2020
Excerpt:
Entrectinib is recommended, within its marketing authorisation, as an option for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors.
Source:
Excerpt:
The NCCN NSCLC Panel recommends crizotinib, entrectinib, or ceritinib (all are category 2A) as first-line therapy options for patients with ROS1-positive metastatic NSCLC…
Source:
Title:
FDA grants Priority Review to Roche’s personalised medicine entrectinib
Published date:
02/19/2019
Excerpt:
Roche...announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of...ROS1-positive non-small cell lung cancer (NSCLC).
Source:
Title:
DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers.
Excerpt:
...Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated sequencing technique....
Trial ID:
Source:
Title:
MA13.04 - Entrectinib in Patients with ROS1 Fusion-Positive (ROS1-fp) NSCLC: Updated Efficacy and Safety Analysis
Published date:
07/12/2022
Excerpt:
The efficacy-evaluable population comprised 172 patients with ROS1-fp NSCLC who were ROS1 TKI-naïve; median duration of survival follow-up: 37.8 months. Median age was 54.5 years (range 20-86); 61 patients (35%) were current/former smokers; 40 patients (23%) had received ≥2 prior lines of therapy; 60 patients (35%) had investigator-assessed baseline CNS metastases. Entrectinib demonstrated efficacy in patients with ROS1-fp NSCLC with and without investigator-assessed baseline CNS metastases (Table). In patients with BICR-assessed baseline CNS metastases (n=51), median IC-ORR was 49% (25/51; 95% CI 34.8-63.4); median IC-DoR was 12.9 months (95% CI 7.6-22.5); median IC-PFS was 12.0 months (95% CI 6.7-15.6). In patients who received entrectinib as first-line treatment (n=67; exploratory analyses; Table), ORR was 69% (95% CI 56.2-79.4), median DoR was 35.6 months (95% CI 13.9-38.8); median PFS was 17.7 months (95% CI 11.8-39.4). In this updated analysis with longer follow-up and a larger patient population, entrectinib continues to demonstrate overall and intracranial efficacy, and a manageable safety profile in patients with ROS1-fp NSCLC.
Source:
Title:
Efficacy and safety exposure-response analyses of entrectinib in patients with advanced or metastatic solid tumors
Published date:
02/03/2022
Excerpt:
Among the 89 patients with evaluable efficacy data included in the exposure-efficacy analysis, 73% (65/89) achieved a complete or partial response….Model-described tumor shrinkage rates were 8-12 times greater than growth rates in both ROS-1-positive NSCLC patients and NTRK fusion-positive solid tumor patients. Entrectinib exposure distribution was similar in responders and non-responders....These analyses supported that entrectinib at 600 mg/day provides an acceptable benefit-risk ratio in adults with NTRK-, ROS1-, or ALK-positive tumors, considered as rare disease.
DOI:
10.1007/s00280-022-04402-w.
Source:
Title:
540P - Entrectinib in patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) or NTRK fusion-positive solid tumours: Analysis of response by line of therapy
Published date:
09/14/2020
Excerpt:
161 pts with ROS1+ NSCLC (data cut-off: 1 May 2019; median treatment duration 10.7mo)...While pt numbers are relatively small, these data demonstrate similar responses to entrectinib in pts with ROS1+ NSCLC and NTRK+ solid tumours regardless of prior therapy exposure, supporting its use irrespective of number of prior lines of systemic therapy; ORR was >70% in pts receiving entrectinib as first-line therapy. Table: 540P
Source:
Title:
64P - Entrectinib in locally advanced/metastatic ROS1 and NTRK fusion-positive non-small cell lung cancer (NSCLC): Updated integrated analysis of STARTRK-2, STARTRK-1 and ALKA-372-001
Published date:
11/23/2019
Excerpt:
As of 30 Oct 2018 (additional 5 months’ follow-up), BICR ORR: ROS1+ 79.2% (95% CI 65.9–89.2) and NTRK+ 70.0% (95% CI 34.75–93.33) with complete responses in 5 (9.4%) pts and 1 (10.0%) pt, respectively….In line with the primary data, in pts with ROS1+ and NTRK+ NSCLC after an additional 5 months of follow-up, entrectinib was well tolerated and showed clinically meaningful, durable systemic and intracranial responses.
