The HealthCare unit at Bayer (BAYRY - Analyst Report) and partner Onyx Pharmaceuticals, Inc. recently announced that their candidate regorafenib (BAY 73-4506) fared well in a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The disease had progressed in the evaluated patients in spite of being previously treated by Novartis’ (NVS - Analyst Report) Gleevec and Pfizer’s (PFE - Analyst Report) Sutent.
Results from the randomized, double-blind, placebo-controlled, multi-center, cross-over study revealed that there was a significant improvement in progression-free survival in patients treated with regorafenib (160 mg) plus the best supportive care (BSC) compared to those in the placebo + BSC arm.
Bayer intends to present detailed data from the study at a medical conference shortly. Based on data from the study, Bayer intends to seek marketing approval for regorafenib for the GIST indication.
We note that GIST might prove to be fatal if the tumor has spread to other body parts or has not been removed properly. The disease, which affects only 11 to 20 people annually in a million, is extremely difficult to diagnose.
Apart from GIST, Bayer/Onyx are evaluating regorafenib in patients suffering from metastatic colorectal cancer (mCRC). Earlier in the year, the companies had announced encouraging data from a phase III study (CORRECT: n=760), which evaluated regorafenib in mCRC patients whose disease had progressed even after treatment with the standard drugs for the disease. (Please refer to Bayer/Onyx Announce Cancer Data ). Bayer intends to seek approval for the candidate for the mCRC indication in the first half of 2012.
Neutral on Bayer, Onyx
Currently, we have Neutral recommendations in the long-run for both Bayer and Onyx. However, the short-term ratings differ. While Bayer carries a Zacks #2 Rank (Buy rating), Onyx carries a Zacks #3 Rank (Hold rating) in the short run.