Roche set the stage for its upcoming review of new mid- and late-stage data on vemurafenib--its closely watched experimental treatment for skin cancer licensed in from Plexxikon-at the annual ASCO meeting. For the first time Roche scientists will detail data from a Phase III study along with updated data from a mid-stage trial which produced jaw-dropping efficacy results.
We already know that vemurafenib (PLX4032) hit its co-primary endpoints for overall survival and progression-free survival compared to those who received dacarbazine chemotherapy. Roche says that the data will demonstrate a statistically significant improvement in patients with previously untreated BRAF V600 mutation-positive metastatic melanoma. "The safety profile was generally consistent with previous vemurafenib studies," Roche notes. "Possible serious side effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats and allergic reactions."
This is a big year for Roche, which intends to use ASCO to showcase that it's lost none of its old R&D mojo in the wake of its merger with the oncology wunderkind Genentech. This year is particularly important as the pharma giant stumbled badly in the clinic last year. Analysts will also be watching closely to see how Avastin data looks on ovarian cancer.
Roche filed for an approval of vemurafenib a week ago and analysts have been clearly impressed with its potential.
- check out the Roche release
- here's the story from Reuters
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