September 25, 2018

IASLC 19th World Conference on Lung Cancer

Sub-analysis shows rapid and durable responses to larotrectinib in patients with NSCLC harboring a NTRK gene fusion
  • Sub-analysis in lung cancer patients confirm marked and durable efficacy for larotrectinib across different tumor types, regardless of site of origin
  • Data presented at the IASLC 19th World Conference on Lung Cancer
  • Larotrectinib is under Priority Review in the U.S. for the treatment of patients with TRK fusion cancer; Marketing Authorization Application (MAA) submitted in the EU

Toronto, September 24, 2018 – Bayer announced results from a sub-group analysis from larotrectinib studies, which found that treatment with larotrectinib resulted in partial or complete response in three out of four patients with non-small cell lung cancer (NSCLC) harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The patients’ disease had progressed after one or more lines of platinum-based chemotherapy for advanced disease, as confirmed on a subsequent scan. Responses were rapid and robust, with time to response ranging between 49 and 56 days. This data was presented at the IASLC 19th World Conference on Lung Cancer (WCLC), taking place in Toronto, Canada from September 23-26, 2018. Larotrectinib is a highly selective tropomyosin receptor kinase (TRK) inhibitor being jointly developed by Bayer and Loxo Oncology.

“Non-small cell lung cancer with NTRK gene fusions are rare, but these cancers appear to be highly sensitive to TRK inhibition. It is very encouraging to see that among previously treated patients with TRK fusion NSCLC, larotrectinib is highly active and well-tolerated,” said Dr. Anna F. Farago, lead author and oncologist at Massachusetts General Hospital Cancer Center. “The positive results seen in this patient population support the need to incorporate testing for NTRK gene fusions as part of routine genomic testing, so patients can be matched to a therapy specifically designed to target the genomic abnormality driving their cancer.”

In the analysis, three out of four patients had a partial or complete response, confirmed on a subsequent scan, and one patient with a possible brain metastasis demonstrated reduction of mass on an MRI. At the time of analysis, three patients continued to have an ongoing response ranging between 5.7 and 12 months. The other patient had stable disease and progressed outside of the central nervous system (CNS) after 300 days of treatment and continued larotrectinib for clinical benefit. Larotrectinib was well tolerated, with three of the four patients having grade one adverse events only.

Bayer and Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company from Stamford (Connecticut, U.S.), are jointly developing larotrectinib, which is being studied globally for the treatment of patients across a wide range of cancers that harbor a NTRK gene fusion. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Loxo Oncology, and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a NTRK gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).

Bayer has submitted a Marketing Authorization Application (MAA) in the European Union and additional filings in other regions are underway.

About Larotrectinib (LOXO-101)

Larotrectinib is an investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes can become abnormally fused to other genes, producing a TRK fusion protein that can lead to the development of solid tumors across multiple sites of the body. In clinical trials, based on the integrated pooled analysis (n=55 patients), larotrectinib demonstrated an 80 percent investigator-assessed confirmed overall response rate (ORR) and a 75 percent centrally-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade one or two.

In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, another novel TRK inhibitor in clinical development. Bayer and Loxo Oncology will jointly develop the two products with Loxo Oncology leading the ongoing clinical studies, and filing in the U.S., and Bayer leading regulatory activities outside of the US including Canada, as well as worldwide commercial activities. In the U.S., Bayer and Loxo Oncology will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov or www.loxooncologytrials.com. Larotrectinib has not been approved by Health Canada, the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

About TRK Fusion Cancer

TRK fusion cancer occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein. The altered protein, or TRK fusion protein, becomes active, triggering a signaling cascade. These TRK fusion proteins are drivers of the spread and growth of tumors in patients with TRK fusion cancer. TRK fusion cancer is not limited to certain types of tissues, which means it can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumors with varying frequency, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer and various sarcomas.

Only specific tests can reliably detect TRK fusion cancer. Next-generation sequencing (NGS) can provide comprehensive molecular profiling of genomic alterations across a large number of genes. Fluorescence in situ hybridization (FISH) can also be used to test for TRK fusion cancer and immunohistochemistry (IHC) can be used to detect the presence of TRK proteins. For further information, go to www.trkcancer.com.

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 includes 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.

About Bayer

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.ca.

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