Bayer wants liver cancer patients who've failed on its blockbuster Nexavar to turn to its newer med Stivarga. And now, it has data showing that’s not a bad idea.
In a Phase III study, Stivarga showed it could increase overall survival by a median of 10.6 months in patients with inoperable hepatocellular carcinoma (HCC). That's compared with the 7.8 months posted in placebo patients--an improvement of 2.8 months. Stivarga also won out in the progression-free survival category, putting up a median mark of 3.1 months; patients in the control group saw their disease worsen after a median 1.5 months, Bayer said. That's a difference of 1.6 months.
The German pharma plans to submit findings from the study--dubbed RESORCE--to regulators this year as the backbone for a label expansion, and coming up with one could be lucrative. With HCC representing 70% to 85% of liver cancer worldwide--and more than 780,000 global diagnoses of liver cancer per year--an indication could significantly widen the patient pool for Stivarga, which is currently approved to treat metastatic colorectal cancer and metastatic gastrointestinal stromal tumors.
Bayer has long counted the cancer-fighter among its pharma unit’s Big 5 growth products, alongside next-gen anticoagulant Xarelto, eye superstar Eylea, pulmonary arterial hypertension treatment Adempas and fellow cancer med Xofigo. While the Leverkusen-based drugmaker has said it expects its sales to tick upward by just a medium single-digit percentage for the year to pass €47 billion--a prediction that hit below the guidance range analysts expected--industry-watchers think Bayer might just be keeping expectations on the low side to give new CEO Werner Baumann a chance to get settled.
Either way, though, Stivarga may have to do more work going forward to help the Big 5 meet their mark, now that Adempas has hit a snag. In May, Bayer nixed a trial of the product in PAH patients with idiopathic interstitial pneumonias on the recommendation of an independent data monitoring committee, which pointed out that patients in the study’s Adempas arm could face an increased risk of death or other serious adverse events. And that dashed any hopes of a label expansion, which could have given the slow-launching med a boost.
- read the release
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