Roche’s Gazyva fell short in a late-stage lymphoma trial, jeopardizing the company’s expansion plans for the Rituxan follow-up. The newer med failed to best gold-standard Rituxan in previously untreated patients with diffuse large B-cell lymphoma, according to topline results from a new trial.
As a new-and-improved version of Rituxan, Roche’s best-selling drug, Gazyva is the Swiss drugmaker’s answer to impending biosimilar competition. If Gazyva wants to grab significant market share from its predecessor, it will need to expand into new groups of patients--and this lymphoma type was meant to be one of them.
The results from the GOYA trial put a crimp in those ambitions. The large trial--more than 1,400 patients--tested Gazyva alongside standard “CHOP” chemotherapy against Rituxan with the same chemo regimen. Gazyva didn’t hit its goal of holding off the disease--progression-free survival--or reducing the risk of death better than Rituxan did.
Rituxan is the gold-standard therapy in this group of patients, and it’s been used for years, which means oncologists are comfortable with it. Unseating the older drug could take some impressive data, and that’s one reason why analysts see the drug peaking at just 1.7 billion Swiss francs per year, compared with Rituxan’s 7 billion CHF-plus, 5.5 billion of which comes from its oncology indications. In fact, analysts see Rituxan remaining among the top 20 drugs worldwide at least through 2020, though biosimilars are expected to take a bigger bite as time goes on.
There’s a silver lining to this new data, as Bernstein analyst Ronny Gal pointed out early Monday morning in a note. Investors weren’t expecting much from GOYA, and long-term sales estimates for Gazyva generally don’t include a big contribution from diffuse large B-cell lymphoma. Follicular lymphoma, where Gazyva already boasts an approval, is a larger population. Read rest of article...
Mr. Magomana graduated with an MBA from The University of Illinois at Urbana-Champaign. He holds an MPH in Public Administration and an MA in International Relations. He got his BA from Grinnell College in 2007.