Bayer Stivarga becomes first drug to be tested in brain cancer patients in multi-arm cooperation trial

Bayer's Stivarga will be the first drug to be evaluated in this trial.

New Delhi: Bayer announced today that the Stivarga (regorafenib) arm of the platform trial GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) has opened enrollment for patients with newly diagnosed and recurrent glioblastoma, the most aggressive and common form of primary brain cancer.

The opening of the first clinical trial site, at Henry Ford Cancer Insititute in Detroit, marks the start of the international clinical trial program sponsored by the Global Coalition for Adaptive Research (GCAR). Bayer's Stivarga will be the first drug to be evaluated in this trial.

Glioblastoma treatment options and patient outcomes have remained largely unchanged over several decades. Ninety-five per cent of patients die within five years of diagnosis and more than half die within the first 15 months after diagnosis.

"GBM is an aggressive brain tumour with few effective therapies. We are excited to open GBM AGILE and test new treatment options for our patients, who so desperately need them," said Tom Mikkelsen, M.D. of the Henry Ford Cancer Institute and medical director of Precision Medicine and Clinical Trials at Henry Ford Health System.

Bayer will provide drug supply and support the clinical trial at sites enrolling patients in the Stivarga arm. By the end of 2019, GBM AGILE will open in over 40 academic medical centres and community-based institutions across the United States, with plans to expand across Europe, China, Canada, and Australia through 2020.

"We are excited that the regorafenib arm of the GBM AGILE trial is the first to enroll patients and are looking forward to seeing how regorafenib can potentially help these patients in need of treatment options," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer's Pharmaceuticals Division.

"Bayer actively supports the clinical research of regorafenib in a range of different tumour types to explore the potential of this drug to help even more patients in need," Scott added.

In April 2017, Stivarga was approved for use in patients with hepatocellular carcinoma who have been previously treated with Nexavar (sorafenib). In the United States, Stivarga is also indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

Stivarga is approved in more than 90 countries.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

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