Mississauga, ON, November 6, 2019 – Bayer Inc. is disappointed in pCODR’s October 31, 2019 final recommendation to not reimburse VITRAKVI^® (larotrectinib). This final recommendation is a reversal of pCODR’s initially positive recommendation of August 31, 2019 to fund VITRAKVI^® in four tumour types: infantile fibrosarcoma, adult/pediatric soft tissue sarcoma, adult/pediatric salivary gland tumours, and cellular congenital mesoblastic nephroma. 

VITRAKVI^® is the first tumour-agnostic cancer treatment approved by Health Canada and evaluated by pCODR. The clinical benefit of VITRAKVI^® is supported by the NAVIGATE (TRK fusion cancer in adolescents and adults) and SCOUT (TRK fusion cancer in children from one-month to age 21 years) clinical studies, which are on-going. The interim results of these studies resulted in accelerated and conditional regulatory approvals in major global regulatory jurisdictions. Health Canada granted a Notice of Compliance with conditions (NOC/c) on July 10, 20191 . VITRAKVI^® has the largest and longest-term data for any TRK fusion cancer inhibitor, including the broadest range of tumour types and ages studied. pCODR’s rationale for its final recommendation can be found here: https://www.cadth.ca/sites/default/files/pcodr/Reviews2019/10159LarotrectinibNTRK%2BSolidTumours_fnRec_REDACT_31Oct201_ChairApproved_final.pdf

Bayer understands there is a need for treatment for TRK fusion cancers

“NTRK fusion proteins have unequivocally been shown to be oncogenic drivers, as defined by their clear ability to transform normal cells into cancerous cells, both in the petri plate and in animal models of NTRK-driven tumours. There is no question that drugging this alteration, i.e. targeting the root cause or genomic driver of cancer rather than the traditional modality of broadly treating a cancer based on its presumptive tissue type of origin, represents a major step forward in cancer therapeutics. To deny patients, including very young pediatric cancer patients, access to this highly effective drug is puzzling, and demonstrates a disconnect of the invigilators with the science behind the original discovery of NTRK fusions” explains Dr. Poul Sorensen, Professor of Pathology and Laboratory Medicine at University of British Columbia, who first discovered the most commonly-diagnosed NTRK gene fusion (ETV6-NTRK3), leading to the eventual commercialization of VITRAKVI^® nearly two decades later. For his research, Dr. Sorensen was awarded the 2019 Bloom Burton Award.

“Most patients in the VITRAKVI^® clinical trials had failed previous treatments for their tumour type including surgery, radiation and systemic treatments like chemotherapy, or there simply was no appropriate treatment for the patient. For VITRAKVI^® to show this level of benefit in this type of patient population is remarkable in my experience with oncology clinical trials. To also see VITRAKVI’s^® benefit in childhood TRK fusion cancer within a specifically-designed pediatric oncology clinical trial is also noteworthy, as there are relatively few treatment options and clinical trials in childhood cancers,” explains Dr. Rod Rassekh, pediatric oncologist at BC Children’s Hospital, and Clinical Assistant Professor at the University of British Columbia.

"Few cancer therapies are explicitly developed for children with cancer, and VITRAKVI® was an exception being studied and submitted for both pediatric and adult patients at the same time. VITRAKVI^® offers an effective treatment option for TRK fusion cancer patients that have exhausted all traditional therapeutic options. An adolescent TRK fusion thyroid cancer patient had his life given back to him after being treated with VITRAKVI^®. He spent months of his life being isolated due to chemotherapy and recovering from surgery. VITRAKVI® gave him the ability to live, flourish, and be a teenager again. VITRAKVI^® answers the need of a rare and underserved patient population. The decision by CADTH to reverse access is a stunning blow to the pediatric TRK fusion cancer patient population," says Antonia Palmer, Co-founder of Ac2orn: Advocacy for Canadian Childhood Oncology Research Network.

Bayer’s commitment to support Canadian TRK fusion cancer patients

Bayer is committed to working with the provincial cancer agencies to address the uncertainties raised by pCODR. Bayer is prepared to engage with the provincial cancer agencies, the Cancer Drug Implementation Advisory Committee, and the pan-Canadian Pharmaceutical Alliance, in meaningful and constructive dialogue to find the best path forward to allow access to VITRAKVI^® for adult and pediatric TRK fusion cancer patients.

As part of this commitment, Bayer offers to risk-share with provincial cancer agencies to ensure that they only pay for VITRAKVI^® for those TRK fusion cancer patients who respond to treatment. In parallel, as outlined to pCODR and Health Canada, Bayer will continue to collect data, including real-world evidence, on the effectiveness and safety of VITRAKVI^®. Together, this will provide certainty of patient benefit and appropriate use of public funds. 

In the interim, Bayer will continue to provide its TRAKTION Patient Support Program to help eligible patients, and will continue to fund FastTRK, the NTRK fusion testing program. However, these are not long-term, sustainable solutions for adult and pediatric patients with TRK fusion cancer who rely on public coverage.

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About VITRAKVI^®

VITRAKVI^® has received approval under the Notice of Compliance with conditions policy 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 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, and creates a mechanism for the appropriate completion of confirmatory trials to verify the clinical benefit of a drug authorized under the policy while ensuring transparency. The complete product monograph can be found at https://www.bayer.ca/omr/online/vitrakvi-pm-en.pdf.

About 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.

TRAKTION Patient Support Program

Bayer’s VITRAKVI^® TRAKTION Program offers a single point of contact nurse for patients and the health care community. Services include investigation of reimbursement options, including support with reimbursement applications as well as personalized delivery services for VITRAKVI^®. 

The TRAKTION Program also currently offers a bridging program, which provides VITRAKVI^® at no cost to patients who meet the program criteria until such time as public or private coverage is available and secured.

FastTRK: the NTRK fusion testing program

The recently launched, Bayer-funded FastTRK program is a clinical testing program for the diagnosis of NTRK gene fusions. Sponsored by Bayer, this is a complimentary service for clinicians to determine whether their patients’ cancer has an NTRK gene fusion. Solid tumour samples from eligible patients (in the form of a solid tumour block or prepared slides) will be tested by immunohistochemistry (IHC) and/or next generation sequencing (NGS). The FastTRK program will be supported at least until the end of 2021. For more information on this program, please email fasttrk@bayer.com.

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.

Contact:

Bayer Inc.

Communications Department

(905) 282-5541

mediacanada@bayer.com

• 1VITRAKVI has been issued marketing authorization in Canada with conditions, pending the results of trials to verify its clinical benefit.