Health Canada approves VITRAKVI® (larotrectinib), the first tumour agnostic cancer treatment for advanced solid tumours harbouring an NTRK gene fusion

MISSISSAUGA, ON, July 30, 2019 /CNW/ - Bayer announced today that there is now a treatment in Canada for Tyrosine Receptor Kinase (TRK) fusion protein-driven childhood and adult cancers. Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions can result in the production of TRK fusion proteins that can lead to uncontrolled cell growth and cancer.

Health Canada issued a Notice of Compliance with Conditions (NOC/c) for VITRAKVI^® (larotrectinib). VITRAKVI^® is approved for the treatment of adult and pediatric patients with solid tumours that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory treatment options. Treatment with VITRAKVI^® should be initiated following confirmation of an NTRK gene fusion in a tumour specimen using a validated test. 

This is the first time Health Canada has approved a tumour agnostic treatment, such that patients with advanced solid tumours harbouring an NTRK gene fusion may be eligible for treatment with VITRAKVI^®, across multiple tumour types and ages. VITRAKVI^® is a first-in class oral and highly selective TRK inhibitor that may shrink the tumour, or may slow or stop it from growing.

In the clinical trials that were the basis for this approval, TRK fusion cancer patients treated with larotrectinib experienced clinical benefit across numerous tumour types, including lung, thyroid, melanoma, GIST (gastrointestinal stromal tumour), colon, soft tissue sarcoma, salivary gland, and infantile fibrosarcoma. The overall response rate (ORR) was 75% (95% CI, 64%, 85%) with 22% of patients experiencing a complete response (CR) to treatment. The ORR observed was 90% in pediatrics and 69% in adults, and responses were rapid and durable. In the larger safety analysis set consisting of patients with and without TRK fusion cancer, the most commonly reported treatment emergent adverse events (TEAEs) (≥ 20%), in order of decreasing frequency, were fatigue, nausea, dizziness, vomiting, anemia, liver enzymes increased, cough, constipation, and diarrhea. 

"The strong clinical data to date that supports VITRAKVI to target TRK fusion cancer is very encouraging. This is the first Health Canada approved tumour agnostic treatment," says Dr. Sébastien Perreault, Clinical Assistant Professor, Department of Neurosciences, Faculty of Medicine, University of Montreal and Clinical Researcher, CHU Sainte-Justine. "As a neuro-oncologist treating patients with TRK fusion cancer, this medication represents a new approach to treatment."

"The approval of a tumour-agnostic treatment is a major milestone in cancer treatment for pediatric and adult patients in Canada," says Jackie Manthorne, President and Chief Executive Officer, Canadian Cancer Survivor Network. "Canadians with TRK fusion cancer across a variety of cancer types now have a meaningful treatment option. This underlines the importance of getting genomic testing, if appropriate."

VITRAKVI^® received approval under Health Canada's NOC/c policy. This policy facilitates earlier access to promising new medicines that treat, prevent or diagnose serious, life-threatening and/or severely debilitating diseases for which there is no alternative medicine available in Canada, or where the new medicine offers a significant improvement through its risk/benefit profile over existing medicines. 

Canadian Contribution
Twenty years ago, Dr. Poul Sorensen (then at BC's Children's Hospital, and now a Distinguished Scientist at the British Columbia Cancer Research Centre, Vancouver) and his team published a seminal paper (Knezevich et al, 1998) that reported on the discovery that led to the development of a new class of tyrosine kinase inhibitors, called TRK inhibitors.

"By using a molecular-based approach to studying a cancerous tumour, we were able to identify the NTRK gene fusion as the driver of what is now known as TRK fusion cancer," says Dr. Sorensen. "This validated the idea of studying rare tumours and represented a new approach to cancer drugs and their regulation with one drug intended for a wide variety of cancers."

Dr. Sorensen's discovery uncovered the molecular and cellular pathways characterizing NTRK genes (and their encoded receptors, TrkA, TrkB, and TrkC) as oncogenic drivers that when altered through a gene fusion event can result in what oncologists and pathologists now refer to as TRK fusion cancer.

"The approval of VITRAKVI is reflective of Bayer's commitment to being a leader in precision medicine and providing Canadians with innovative treatment solutions," says Dr. Shurjeel Choudhri, Senior Vice President and Head, Medical & Scientific Affairs for Bayer Inc.

What is TRK Fusion Cancer?
TRK fusion cancer is rare and occurs when an NTRK gene fuses with another unrelated gene, producing a TRK fusion protein that becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer, regardless where it originates in the body. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumours with varying frequency, including lung, thyroid, gastrointestinal cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (mammary analogue secretory carcinoma) and pediatric cancers (infantile fibrosarcoma and soft tissue sarcoma). TRK fusion proteins are rare in common cancers and common in rare cancers.

The full VITRAKVI^® product monograph is available at https://www.bayer.ca/omr/online/vitrakvi-pm-en.pdf.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.ca.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

SOURCE Bayer Inc.

For further information: Bayer Inc., Communications Department, [phone], [email protected]; Lauren Hayes, Cohn & Wolfe, [phone] ext. 4015, [email protected]

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