Toronto, ON (October 16, 2019) – Updated clinical data for larotrectinib in adult and pediatric patients with TRK fusion cancer showed a high response rate with an overall response rate (ORR) of 79% (95% CI: 72–85) with 16% complete responses (n=24) and 63% partial responses (n=97). These results, which are based on 153 evaluable patients at a data cut-off of February 19, 2019, makes it the largest dataset and longest follow-up data of any TRK inhibitor to-date. Among the patients with confirmed responses (n=108), those responses continued to be durable with a median duration of response of nearly three years (35.2 months; 95% CI: 22.8–NE). ¹ For the integrated dataset (n=159), median progression free survival was 28.3 months (95% CI: 22.1–NE) and median overall survival was 44.4 months (95% CI; 36.5–NE), with 88% (95% CI: 83–94) of patients being still alive at one year after the start of therapy. The data were presented in a poster discussion at the 44^th European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain (EU) from September 27 – October 1, 2019.

“Larotrectinib exemplifies the idea that precision oncology treatments can deliver meaningful, long-term efficacy and safety,” said Ulrik Lassen, MD, PhD, Head of the Department of Oncology, Rigshospitalet, Copenhagen. “It is exciting to see the consistency in larotrectinib’s durability and response rates as we continue to expand to more patients across a wide range of tumour types and ages, which demonstrates the value in testing our patients for genomic alterations, like NTRK gene fusions.”

In a subanalysis from the integrated dataset (n=12), larotrectinib showed a high ORR of 75% in solid tumours with brain metastases.¹ Larotrectinib activity was previously reported in primary CNS tumours (ASCO 2019, Drilon et al.) CNS tumours are aggressive and larotrectinib has achieved disease control in this patient population over an extended period of time.

The safety data presented at the ESMO 2019 Congress encompassed the entire larotrectinib safety database in cancer patients (n=260), continuing to show a favourable safety profile even as the patient population increases. The majority of adverse events (AE) reported were grade 1 or 2. No treatment-related grade 3 or 4 AEs occurred in more than three percent of patients, and no treatment-related deaths were reported.¹

“With a patient population that is now three times our initial analysis, VITRAKVI continues to demonstrate impressive efficacy,” said Scott Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. “We are committed to bringing VITRAKVI to patients around the world, as demonstrated through the recent approvals in multiple global markets.”

Larotrectinib is approved in Canada, the U.S., Brazil, and the European Union under the brand name VITRAKVI®, with additional filings in other regions underway or planned.

About Larotrectinib

Health Canada issued a Notice of Compliance with Conditions (NOC/c) for VITRAKVI^® (larotrectinib) in July 2019, pending the results of trials to verify its clinical benefit. 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. 

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

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer has obtained the exclusive licensing rights for the global development and commercialization, including in the U.S., for larotrectinib and the investigational TRK inhibitor selitrectinib (BAY 2731954, previously LOXO-195) progressing through clinical development.

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.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer in Canada now expands to four marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

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.

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Hyman, David M., van Tilburg, Cornelis M., Albert, Catherine M., et al. Durability of response with larotrectinib in adult and pediatric patients with TRK fusion cancer. European Society of Clinical Oncology 2019; September 28, 2019. Barcelona, Spain. Abstract 445PD.

Drilon A, Laetsch TW, Kummar S et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children; N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.

Hyman, David M., van Tilburg, Cornelis M., Albert, Catherine M., et al. Durability of response with larotrectinib in adult and pediatric patients with TRK fusion cancer. European Society of Clinical Oncology 2019; September 28, 2019. Barcelona, Spain. Abstract 445PD.

Drilon A, Laetsch TW, Kummar S et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children; N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.