Bayer announced that new data from the continued research on Stivarga (regorafenib) and Nexavar (sorafenib) in advanced liver, colorectal and biliary tract cancers will be presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancer Symposium taking place on January 18 – 20 in San Francisco.

The Bayer data include analyses from the RESORCE trial in hepatocellular carcinoma (HCC) in addition to the LiverT study in HCC. Additionally, exploratory analyses from independent phase II studies examining the dosing and sequencing in metastatic colorectal cancer (mCRC) as well as the activity in advanced biliary tract cancer (aBTC) will be presented.

The announcement of its latest research examining Bayer’s kinase inhibitors in HCC and CRC confirms the company’s continued commitment to investigating and providing additional treatment options for patients who need it most. As part of the ongoing research, Bayer has initiated a Phase Ib trial of regorafenib in combination with pembrolizumab as a potential first line systemic treatment option for patients with HCC. The study will explore the safety, tolerability and tumor response of the combination in patients with advanced liver cancer (NCT03347292). Patient enrollment is expected to be started by the second quarter of 2018.

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

Regorafenib is approved under the brand name Stivarga® in more than 90 countries worldwide, including the US, countries of the EU, China and Japan for the treatment of metastatic colorectal cancer (mCRC). The product is also approved in over 80 countries, including the U.S., countries of the EU, China and Japan, for the treatment of metastatic gastrointestinal stromal tumors (GIST). In 2017, the product received approval in more than 50 countries, including the US, countries of the EU, China and Japan for the second-line treatment of HCC.

In the EU, Stivarga is indicated as monotherapy for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib, and for the treatment of adult patients with HCC who have been previously treated with sorafenib.

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.

Sorafenib, an oral anti-cancer therapy, is approved under the brand name Nexavar for the treatment of certain forms of hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma. Whilst licenses may differ from country to country, across all indications Nexavar is approved in more than 100 countries worldwide. In countries of the EU., Nexavar is approved for the treatment of hepatocellular carcinoma (HCC); for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; and for progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.

Bayer has worldwide exclusive marketing rights for Nexavar, with Bayer paying a royalty on US sales to Amgen Inc. Outside the US, Bayer and Amgen share profits globally, excluding Japan.