Lymphoma trial failure endangers Roche's Gazyva growth plans as Rituxan biosims loom

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. 

There’s also a potential spillover effect onto Gazyva’s data from GALLIUM, a follicular lymphoma trial where the newer med beat Rituxan.

Only topline results are available from that trial, which, like GOYA, tested Gazyva in previously untreated patients. The failure in GOYA could give investors pause about Gazyva’s usefulness in previously untreated follicular lymphoma patients, too, Gal figures. Currently approved for second-line use in follicular lymphoma, Gazyva is aiming for the bigger first-line market. The Roche drug is also approved in chronic lymphocytic leukemia.

“GOYA’s failure is likely to make investors cautious on the robustness of GALLIUM’s results, which have yet to be released in full,” Gal pointed out.

That makes the details from GALLIUM even more important. “If GALLIUM results are strong, then even with a failed GOYA study, consensus Gazyva forecasts can likely be met,” the analyst said.

“If GALLIUM results are not viewed as being very clinically meaningful,” he added, “then investors will write off Gazyva even more.”

- see the Roche release

Special Report: The top 20 drugs by 2020--worldwide sales - Rituxan

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