Bayer Launches Regorafenib Arm in International GBM AGILE Platform Trial for Glioblastoma Patients

BERLIN, June 26, 2019 /PRNewswire/ --Bayer on June 19Announced that the regorafenib treatment arm of the platform trial “GBM AGILE” (Global Adaptive Clinical Innovation Trial System for Glioblastoma) has been launched in the United States for newly diagnosed and recurrent glioblastoma, thisInvasive and CommonOpen enrollment is available for patients with primary brain cancer. This marks the launch of an international, innovative study initiated by the Global Coalition for Adaptive Research (GCAR), employing a seamless Phase II/III design to rapidly identify effective treatments for patients with glioblastoma multiforme (GBM). Bayer provides support in terms of the investigational drug and funding required for the trial. Bayer’s regorafenib will be the first drug evaluated in this study. By the end of 2019, GBM AGILE will have opened at more than 40 academic medical centers and community-based research sites in the United States, with plans to expand to Europe, China, Canada, and Australia by 2020.

“We are pleased that the regorafenib arm is the first treatment group to enroll patients in the GBM AGILE trial, and we look forward to seeing how regorafenib can help these patients who are in urgent need of treatment options,” said Dr. Scott Z. Fields, Senior Vice President of Bayer Pharmaceuticals Division and Head of Oncology Development. “Bayer actively supports clinical research on regorafenib across multiple tumor types to explore its therapeutic potential, thereby helping more patients in need.”

Therapeutic options for glioblastoma are extremely limited, and patient prognosis has not significantly improved over the past few decades; 95% of patients die within five years of diagnosis, and more than half die within the first 15 months. In the randomized, multi-institution, investigator-initiated phase II REGOMA clinical trial published in The Lancet Oncology in December 2018, regorafenib demonstrated preliminary efficacy comparable to that of standard therapy.

The Henry Ford Cancer Institute is one of the largest cancer research institutions in Michigan and serves as the first clinical center for GBM AGILE. “GBM is an aggressive brain tumor with few effective treatment options,” said Tom Mikkelsen, M.D., Medical Director of Precision Medicine and Clinical Trials at Henry Ford Health System. “We are pleased that GBM AGILE is now open to these patients in urgent need and is evaluating new therapeutic approaches.”

Regorafenib, marketed under the brand name Stivarga, has been approved in more than 90 countries, including the United States, European Union member states, China, and Japan, for the treatment of metastatic colorectal cancer, metastatic gastrointestinal stromal tumors, and hepatocellular carcinoma.^®（Stivarga^®） 。

AboutGBM AGILETrial

GBM AGILE is an international, innovative platform trial designed to more rapidly identify effective treatments for patients with glioblastoma through response-adaptive randomization and a seamless Phase II/III design. Conducted under a master protocol, the trial allows for the simultaneous evaluation of multiple therapies or treatment combinations from various pharmaceutical partners. The roster of investigational regimens will expand or contract over time. This trial design and infrastructure are regarded as a more efficient approach to evaluating new therapies for GBM, accelerating the delivery of potentially beneficial new treatments to patients. Although GBM AGILE will assess multiple investigational drugs throughout the course of the trial, it will commence in 2019 with the enrollment of patients into the regorafenib treatment arm. This arm will be led by Principal Investigators Dr. Patrick Wen of Dana-Farber Cancer Institute and Harvard Medical School, and Dr. Andrew Lassman of the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center.

Regarding the Global Adaptive Research Alliance (GCAR）

The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) non-profit charitable organization composed of some of the world’s leading physicians, clinical researchers, and scientists, united to accelerate the discovery and development of treatments for rare and fatal diseases. As its primary initiative, GCAR is launching GBM AGILE, a trial targeting glioblastoma (GBM) --This common and fatalan adaptive platform trial for patients with malignant primary brain tumors. GCAR’s vision is to expand and replicate the knowledge gained from innovative GBM models to benefit patients with other rare and fatal diseases. To learn more about GCAR, please visit:www.gcaresearch.org。 

About Regorafenib (Stivarga^®）

Regorafenib is an oral multi-kinase inhibitor that blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), tumor proliferation (KIT, RET, RAF-1, BRAF), tumor metastasis (VEGFR3, PDGFR, FGFR), and tumor immunity (CSF1R).

Currently, regorafenib has been approved in more than 90 countries for the treatment of metastatic colorectal cancer (mCRC), under the brand name Stivarga.^®（Stivarga^®), approved countries include the United States, EU member states, China, and Japan. In addition, the product has been approved in more than 80 countries for the second-line treatment of metastatic colorectal cancer (GIST) and advanced hepatocellular carcinoma (HCC), including the United States, Japan, EU member states, and China.

In the European Union, regorafenib as monotherapy is indicated for adult patients with metastatic colorectal cancer who have previously been treated with, or are not candidates for, available therapies including fluoropyrimidine-based chemotherapy, anti-VEGF therapy, and anti-EGFR therapy; for adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who have experienced disease progression following prior treatment with imatinib mesylate and sunitinib, or who are intolerant to these prior treatments; and for adult patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.

Regorafenib is a compound developed by Bayer. In 2011, Bayer reached an agreement with the biopharmaceutical company Onyx. Under the agreement, Onyx would receive royalties based on the global net sales of regorafenib in the oncology field.

About Bayer Oncology

Bayer upholds its mission of “Science For A Better Life” by continuously optimizing its portfolio of innovative products. Bayer’s Oncology division currently comprises five oncology products and several other compounds at various stages of clinical development. Together, these products exemplify the company’s research approach, which prioritizes targets and signaling pathways with the potential to transform cancer treatment.

About Bayer

As a multinational corporation, Bayer possesses core competencies in health and nutrition within the life sciences sector. The company is dedicated to helping people overcome the major challenges posed by global population growth and aging through its products and services, thereby benefiting humanity. Meanwhile, the Group enhances profitability and creates value through technological innovation and business growth. Bayer is committed to sustainable development. Worldwide, the Bayer brand stands for trust, reliability, and quality. In the 2018 fiscal year, Bayer had approximately 117,000 employees, with sales amounting to €39.6 billion, capital expenditures of €2.6 billion, and research and development investments of €5.2 billion. For more information, please seewww.bayer.com。

Forward-Looking Statements

This press release includes forward-looking statements made by the management of Bayer AG based on current assumptions and forecasts. Various known and unknown risks, uncertainties, and other factors could cause the company’s actual future operating results, financial position, development, or performance to differ materially from the estimates presented in such forward-looking statements. These factors include those listed on Bayer’s official websitehttp://www.bayer.com/the various reports of Bayer publicly disclosed. The Company has no obligation to update these forward-looking statements or to conform them to future events or developments.