Updated larotrectinib pediatric Phase I clinical trial data demonstrates response in TRK fusion cancers

WHIPPANY, N.J., Dec. 4, 2017 /PRNewswire/ -- Bayer and Loxo Oncology, Inc., (NASDAQ: LOXO), today announced updated clinical data from the larotrectinib (LOXO-101) pediatric Phase I SCOUT trial (NCT02637687). These data are being presented today at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer Research in Atlanta. Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

"The promising data presented today highlights the potential of larotrectinib in TRK fusion cancers for this patient population," said Carsten Brunn, president of Bayer Pharmaceuticals, Americas region. "Our strategic collaboration with Loxo Oncology delivers on our strong commitment to advance a diverse portfolio of cancer treatments on behalf of patients."

As of the July 17, 2017 data cut-off date, 24 pediatric patients were enrolled in the dose escalation portion of the Phase I trial, including 17 patients with TRK fusion cancers. TRK fusion patients carried primary diagnoses of infantile fibrosarcoma, thyroid cancer, and various soft tissue sarcomas. Among the 17 patients with TRK fusion cancers, 94 percent either remain on drug or received surgery with curative intent; four patients have been followed greater than one year and 12 have been followed greater than six months.  The Overall Response Rate (ORR = PR + CR, Partial Response + Complete Response) in the TRK fusion patients was 93 percent as assessed by both the investigators and an independent review committee.

The larotrectinib adverse event profile is consistent with data previously presented publicly. The most common treatment-related adverse events at the Phase II dose included increased liver function tests, nausea, and neutropenia.

These data are being presented in a poster session on December 4, 2017 and an oral presentation on December 5, 2017. The poster and presentation will be available online at https://www.loxooncology.com/focus/publications-abstracts at the time of their scheduled presentations.

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is an investigational oral, selective investigational drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

Larotrectinib is an investigational drug that is being developed between Bayer and Loxo Oncology. Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) by the US Food and Drug Administration.

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

In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration on the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor in clinical development. Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and Bayer will lead ex-U.S. regulatory activities as well as worldwide commercial activities. In the U.S. Bayer and Loxo Oncology will co-promote the products. Loxo Oncology will remain responsible for the filing in the U.S.

Bayer: Science For A Better Life
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 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

© 2017 Bayer
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Contact:
Rose Talarico, phone +862.404.5302
Email: rose.talarico@bayer.com

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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