Top-line data point to Roche's Gazyva success in NHL indication
This article was originally published in Scrip
Roche's anti-CD20 product Gazyva/Gazyvaro (obinutuzumab) has hit its primary endpoint in a Phase III study in the additional indication of non-Hodgkin's lymphoma, top-line data show.
The GADOLIN study (NCT01059630) has been stopped early after a pre-planned analysis by the data monitoring committee showed that it had met the progression-free survival (PFS) primary endpoint early. The study was comparing treatment with obinutuzumab plus bendamustine followed by obinutuzumab alone, with treatment with bendamustine alone in 413 patients with indolent non-Hodgkin's lymphoma whose disease progressed during or following MabThera/Rituxan (rituximab)-based therapy. Secondary endpoints include response rate, best response and overall survival (OS).
Gazyva reached the market last year in the US, EU and Switzerland for patients with previously untreated chronic lymphocytic leukemia, and is also in development for diffuse large B-cell lymphoma. It is a third-generation, type II glycoengineered, humanized anti-CD20 MAb, and is the company's follow-on to its blockbuster rituximab, a type I anti-CD20 MAb.
The GADOLIN data, due to be submitted for presentation at an upcoming medical meeting, will be used to support approval applications to the FDA, EMA and other regulators, Roche said.
Gazyva is also in other trials ongoing in this indication in all lines of therapy, including the 1,400-patient GALLIUM study in previously untreated patients with advanced disease, but this is not due to report for some years.
The GADOLIN data build on the Phase II results from the GAUSS study in which patients receiving Gazyva for second-line treatment achieved better overall survival rates than those receiving rituximab, but with a higher rate of infusion-related reactions.
They are good news in that they bode well for this new disease setting, but the newer product still needs to prove its worth over rituximab in more indications to justify the benefits of glycoengineering, say analysts at Datamonitor Healthcare.
Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva's potential in combination with bendamustine for people whose MabThera/Rituxan-based therapy failed to adequately control their disease."