Data from Bayer’s growing oncology portfolio will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place from May 29-31, 2020. Presentations will feature data across approved products, exploring therapies across different tumor types and treatment settings. Information on the registration as well as the virtual scientific program can be found here.
Data on the final analysis of overall survival (OS) from the Phase III ARAMIS trial investigating darolutamide (Nubeqa™) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) will be presented in a virtual poster discussion on May 29, 2020. In January 2020, it was announced that results showed a statistically significant improvement in OS in patients receiving darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. A separate analysis on safety outcomes between darolutamide, apalutamide and enzalutamide using matching-adjusted indirect comparison (MAIC), a method to perform indirect treatment comparisons adjusting for cross-trial heterogeneity, will also be presented. Darolutamide, an oral androgen receptor inhibitor (ARi) developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, is indicated for the treatment of men with nmCRPC, who are at high risk of developing metastatic disease. The compound is approved under the brand name Nubeqa™ in the European Union (EU), U.S., Australia, Brazil, Canada, and Japan.
Updated efficacy and safety data for larotrectinib (Vitrakvi®) from an expanded set of adult patients with TRK fusion cancer and a quality of life (QoL) analysis in adult and pediatric patients treated with larotrectinib will be presented at the meeting. Vitrakvi is approved in the U.S., Canada, Brazil and the EU. While local labels might differ, the product indication spans across all solid tumors that harbor an NTRK gene fusion. Additional filings in other regions are underway or planned.
Additional presentations from Bayer’s other brands include data from the Phase II trial studying radium-223 dichloride (Xofigo®) and niraparib in metastatic castration-resistant prostate cancer (mCRPC) with and without prior chemotherapy and a second interim analysis from radium-223 REASSURE study evaluating safety and OS in patients with mCRPC. The trial design of the ongoing Phase III collaboration DORA study of docetaxel versus docetaxel and radium-223 dichloride is also presented. An investigator-initiated Phase I study of regorafenib (Stivarga®) in combination with vincristine and irinotecan in pediatric patients with recurrent or refractory solid tumors is featured as an oral presentation. Preliminary results of an investigator-initiated Phase II study (REGOMUNE) investigating regorafenib plus avelumab in a certain colorectal cancer (CRC) cohort will provide additional insights into the combination of regorafenib with an immune checkpoint inhibitor.
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