- Swiss pharmaceutical giant Roche said Monday its blood cancer drug Gazyva failed to meet its primary goal in a Phase 3 trial, setting back hopes of securing a market advantage for the newer medicine.
- Treatment with Gazyva failed to improve progression-free survival in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), compared to treatment with Roche's older blockbuster drug Rituxan. Both drugs were given in combination with chemotherapy.
- Sales of Gazyva grew sharply last year, but totaled only about $130 million. Gazyva is part of a crop of new drugs aimed at buffering the impact of looming biosimilar competition to Roche's top-selling cancer meds
Similar to Rituxan, Gazyva targets the CD20 protein, which is found on some B-cell cancers. It is already approved for use against chronic lymphocytic leukemia in dozens of countries, as well as for follicular lymphoma in the U.S.
DLBCL, however, is the most common form of non-Hodgkin lymphoma, accounting for roughly a third of that patient population, according to the company.
"Two previous studies showed Gazyva helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening compared to Rituxan, when each was combined with chemotherapy," said Sandra Horning, chief medical officer at Roche.
"We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care."
The Phase 3 study tested Gazyva plus CHOP chemotherapy compared to Rituxan plus CHOP in 1,418 previously untreated patients with CD20-positive DLBCL.
Full data from the study, known as GOYA, will be released at an "upcoming medical meeting."
A number of companies, including Novartis, Pfizer and Samsung Bioepis, are developing biosimilar versions of Rituxan, threatening a revenue stream which generated $7.2 billion in sales last year.
Although the failure of the Goya study is a setback, Roche did get positive results in May from another Phase 3 trial. That study, called GALLIUM, showed Gazyva was superior to Rituxan in improving progression-free survival for patients with follicular lymphoma. The drug won approval for that indication in Europe last month.
While biosimilar competition is on the horizon, Roche has managed to increase global sales of its three major cancer drugs by low single digit percentage gains. And srong sales growth from the breast cancer drug Perjeta as well as FDA approval of the new checkpoint inhibitor Tecentriq have raised expectations for the company in oncology.