Health Canada grants market authorization to ROZLYTREK® (entrectinib) for ROS1-positive, locally advanced or metastatic non-small cell lung cancer patients, not previously treated with crizotinib(1) Français
Data show responses in 73% of patients who were treated with Rozlytrek1
MISSISSAUGA, ON, May 20, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorization to Rozlytrek® (entrectinib) for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC), not previously treated with crizotinib.1
Lung cancer is the leading cause of cancer death among Canadians, with NSCLC being the most common type of the disease, accounting for approximately 80-85% of cases.2,3 ROS1 gene fusions are generally found in 2% of NSCLC cases, with young, never-smokers having the highest incidence of these rearrangements.4 Unfortunately, up to 36% of patients with this form of cancer will have brain metastases at diagnosis, resulting in a poor prognosis.5,6 The estimated five-year survival for patients with highly advanced metastatic NSCLC is 2-13%.7
This new authorization is based on an integrated analysis from three single-arm, open-label clinical trials evaluating Rozlytrek in the treatment of ROS1-positive advanced NSCLC adult patients, not previously treated with crizotinib.1 The data show that the overall response rate was 73.4% (69/94) in patients who were treated with Rozlytrek.1 In patients with central nervous system (CNS) metastases at baseline who were treated with Rozlytrek, the intracranial response rate was 50% (17/34).1
"ROS1-positive lung cancer typically occurs in younger, non-smokers compared to the usual lung cancer patient, where the development of brain metastases can be devastating to the ability of these patients to work and function normally," said Dr. Geoffrey Liu, Medical Oncologist, Alan Brown Chair in Molecular Genomics, Princess Margaret Cancer Centre. "I am excited because the data indicate that entrectinib (Rozlytrek) is not only well tolerated, but is effective against ROS1 tumours in the brain, as well as the body."
The presence of ROS1-positive gene fusions in patients are confirmed by physicians through biomarker testing.8 Various testing methods include, immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS) and real-time polymerase chain reaction (RT-PCR).9,10,11,12,13,14,15 Once the ROS1 gene fusion is identified in a patient, treatments like Rozlytrek can specifically target it, potentially inhibiting the growth of cancerous cells.1
About the integrated analysis
The efficacy of Rozlytrek was evaluated in a pooled subgroup of patients with ROS1-positive advanced NSCLC who received Rozlytrek 600 mg orally once daily in three single-arm, open-label clinical trials: ALKA, STARTRK-1 and STARTRK-2.1
All patients were assessed for CNS lesions at baseline. The efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) according to evaluation criteria in solid tumours (RECIST v1.1) as assessed by blinded independent central review (BICR). Progression free survival (PFS) was also evaluated as a part of the integrated analysis.1
Intracranial response according to RECIST v1.1 was assessed by BICR. Tumour assessments with imaging were performed every eight weeks. The integrated efficacy analyses set comprised of 94 patients with ROS1-positive NSCLC not previously treated with crizotinib.1
Of the 94 patients, 88 (94%) received the recommended Rozlytrek dose 600 mg daily. ORR for patients receiving Rozlytrek were observed in 73.4% (95% CI: 63.3, 82.0) of patients treated with 11 (11.7%) patients achieving a complete response and 58 (61.7%) patients achieving a partial response. The median DOR was 15.3 months (Range:1.8-36.8 months).1 Median progression free survival was 15.7 months (Range:11.9-26.3).1
Of the 34 patients with measurable and non-measurable brain metastases at baseline, the intracranial response rate was 50% (95% CI: 32.4, 67.6) with 5 (14.7%) patients achieving a complete response and 12 (35.3%) patients achieving a partial response. Median intracranial DOR was 12.9 (95% CI: 5.6, NE) months in those with brain metastases at baseline.1
The most common adverse drug reactions (>10 % for all grades) with Rozlytrek seen in the clinical trials were fatigue (47.9%), constipation (45.9%), dysgeusia (43.7%), edema (39.7%), dizziness (38.3%), diarrhea (34.6%), nausea (34.4%), dysesthesia (29.0%), dyspnea (29.9%), pain (28.2%), anemia (27.9%), cognitive disorders (25.9%), weight increased (24.8%), vomiting (24.2%), cough (23.9%), blood creatine increased (23.1%), pyrexia (21.4%), arthralgia (21.1%), visual disorders (20.8%), myalgia (20.6%), peripheral sensory neuropathy (17.7%), headache (17.7%), hypotension (17.7%), ataxia (16.6%), aspartate aminotransferase increased (16.1%), sleep disorders (14.4%), alanine aminotransferase increased (14.1%), lung infection (13.2%), decreased appetite (13.0%), urinary tract infection (12.7%), abdominal pain (12.7%), muscular weakness (12.1%), neutropenia (12.1%), rash (11.3%), dehydration (10.1%), mood disorders (10.1%), and dysphagia (9.9%).1
About Rozlytrek
Rozlytrek (entrectinib) is an oral potent tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK, ROS1 or ALK proteins, whose activating fusions drive proliferation in certain types of cancer.1 Rozlytrek can potently block the TRK kinases, ROS1, and ALK, and may result in the death of cancer cells.1
In addition to its approval for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in patients who have not received crizotinib, Rozlytrek is conditionally approved for the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.
About Roche in Lung Cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help with disease management. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. In Canada, we currently have four medicines that have been granted marketing authorization by Health Canada to treat types of lung cancer and additional medicines are under development to combat the disease.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof, combined with a focus on innovation, have made Roche the leader in personalized healthcare – a strategy that aims to provide patients with timely access to their best possible healthcare solution.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.
Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.
All trade-marks mentioned are the property of their respective owners.
© Copyright 2020; Hoffmann-La Roche Limited
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SOURCE Hoffmann-La Roche Limited (Roche Canada)
Bridget Wells, Roche Canada, T: 905-542-5072, E: [email protected]; Sydney Dubin, Proof Inc., T: 416: 969-2816, E: [email protected]
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