•A new extended release tablet of oprozomib, an oral proteasome inhibitor, is being assessed in an ongoing Phase 1b/2 trial in hematologic malignancies including multiple myeloma. Preliminary data are expected to be submitted to a medical conference in the first half of 2013.
Stivarga® (regorafenib) tablets
•In September 2012, the U.S. FDA approved Bayer's Stivarga® (regorafenib) tablets for the treatment of patients with mCRC who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy). The approval of Stivarga is based on results from the pivotal Phase 3 CORRECT study that demonstrated improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies.
•In May 2012, Bayer submitted an application for European marketing authorization for regorafenib for the treatment of patients with mCRC.
•In September 2012, the Japanese Ministry of Health, Labor and Welfare (MHLW) granted priority review of Bayer's New Drug Application (NDA) for regorafenib for the treatment of patients with mCRC.
•In the fourth quarter of 2012, Bayer submitted a supplemental NDA for priority review to the FDA and a NDA to the Japanese MHLW for regorafenib in a second potential indication for metastatic and/or unresectable gastrointestinal stromal tumors.
•As part of a broad development program, Bayer has communicated plans to initiate two additional Phase 3 trials in 2013, in second-line hepatocellular carcinoma (HCC) and in CRC following resection of liver metastases.
Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.
Nexavar® (sorafenib) tablets
•Last week, Onyx and Bayer announced top-line results from the DECISION trial in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. The study met its primary endpoint of improving progression-free survival. Full results are expected to be presented at an upcoming medical meeting. The companies anticipate that this data will form the basis for regulatory submission of Nexavar in the treatment of RAI-refractory differentiated thyroid cancer.
•In the first half of 2013, enrollment is expected to complete in the RESILIENCE trial, a Phase 3 study comparing capecitabine (Xeloda®) in combination with sorafenib or placebo for treatment of locally advanced or metastatic HER2-negative breast cancer.
Nexavar is co-developed by Onyx and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.
•Pfizer Inc. has announced plans to begin a Phase 3 study in 2013 of PD-0332991 (PD-991), a CDK 4/6 inhibitor, for patients with estrogen receptor-positive, HER2-negative advanced breast cancer. Based on a collaboration agreement between the two companies, Onyx would receive a single-digit royalty on any future net sales worldwide if commercialized, as well as milestone payments.
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