Bayer announced the latest research from across its growing oncology portfolio that will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress taking place September 8-12 in Madrid, Spain. The studies presented will include new preclinical and clinical data on already approved or late-stage compounds as well as research from two earlier pipeline projects.
Notable data for the company’s existing product portfolio include results from two ongoing trials for radium-223 dichloride (Xofigo) injection, including an interim read-out from the observational REASSURE trial, analyzing real-world metastatic castration-resistant prostate cancer patient characteristics and safety profile.
Additionally, multiple exploratory analyses of the Phase III RESORCE trial of Stivarga (regorafenib) in hepatocellular carcinoma (HCC) will be presented. In August, the European Commission (EC) granted marketing authorization for Stivarga for the treatment of adult patients with HCC who have been previously treated with Nexavar (sorafenib), the first new treatment for HCC in a decade. The product has also received regulatory approvals for second-line HCC in other markets, including the US and Japan.
Bayer will also present subgroup results from the pivotal Phase II CHRONOS-1 study of copanlisib in patients with relapsed or refractory indolent B-cell non-Hodgkin’s lymphoma. Copanlisib is a novel pan-class I PI3K inhibitor with predominant inhibitory activity against PI3K-a and PI3K-d isoforms and has been granted priority review by the FDA. The compound is not approved by the FDA, the European Medicines Agency or any other health authority.
Radium-223 dichloride is a Targeted Alpha Therapy that has been approved under the brand name Xofigo in more than 50 countries worldwide, including the US, countries of the EU and Japan. In countries of the EU, it is approved for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Radium-223 is also being studied in additional trials for men with prostate cancer as well as in phase II studies for women with breast cancer and patients with multiple myeloma.
Regorafenib, an oral mult-kinase inhibitor, is approved under the brand name Stivarga® in more than 90 countries worldwide, including the U.S., 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 the EU, Stivarga is indicated 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.
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 European Union, 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 U.S., Bayer and Amgen share profits globally, excluding Japan.
Copanlisib is an investigational anti-cancer agent developed by Bayer currently in Phase III of clinical development. The U.S. Food and Drug Administration (FDA) granted Priority Review designation for Bayer’s New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory FL patients who have received at least two prior therapies, based on the data from the Phase II CHRONOS-1 study. The compound is not approved by the FDA, the European Medicines Agency or any other health authority.
Darolutamide is a novel investigational oral androgen receptor (AR) antagonist, currently investigated in two Phase III studies in non-metastatic castration resistant prostate cancer as well as metastatic hormone-sensitive prostate cancer. The compound is not approved by the European Medicines Agency, U.S. Food and Drug Administration or any other health authority.
Anetumab ravtansine is an antibody-drug conjugate (ADC) that specifically targets mesothelin, a surface marker protein overexpressed in many cancers. The compound is currently being investigated in a variety of mesothelin-positive tumors, including malignant pleural mesothelioma, ovarian cancer and six other types of advanced solid tumors. The compound is not approved by the European Medicines Agency, U.S. Food and Drug Administration or any other health authority.
Rogaratinib (BAY 1163877) is an oral, small molecule pan-fibroblast growth factor receptor (FGFR) inhibitor of FGFRs 1-4 with antineoplastic activity demonstrated in preclinical studies. Rogaratinib is currently being investigated in patients with advanced solid tumors with high FGFR mRNA expression (NCT01976741). The compound is not approved by the European Medicines Agency, US Food and Drug Administration or any other health authority.