CHICAGO--In February, Roche ($RHHBY) said its Rituxan follow-up, Gazyva, had succeeded in a late-stage study involving non-Hodgkin lymphoma (NHL) patients, extending their remission period. And it wasn't kidding.
In patients with relapsed, slow-growing NHL who no longer derived benefit from Rituxan, adding Gazyva to Teva ($TEVA) chemo drug Treanda more than doubled the average length of remission to 29.2 months, according to interim Phase III study results announced Saturday at ASCO. That far outdid the 14 months solo Treanda posted, spurring investigators to halt the 396-patient trial early.
"It definitely exceeded our expectations," Nancy Valente, Genentech's global head of hematology development, told FiercePharma. "We had planned the study assuming not as great a benefit as was seen, so we were really pleasantly surprised that the combination was so beneficial for patients."
The data will provide the basis for a regulatory filing in NHL, Valente said, with the hope that Gazyva will one day be able to supplant Rituxan on the front line. To that end, the company has two large Phase III studies in the works, pitting Gazyva head-to-head with its predecessor in previously untreated patients with slow-growing and more aggressive NHL.
An NHL indication would boost Roche's cancer lineup and build on the 49 million Swiss francs ($52.1 million) Gazyva generated in 2014, with "sales potential in the $500 million to $1 billion range," analysts at Deutsche Bank wrote in a February note seen by Reuters.
While Roche's oncology arsenal is already formidable one--it includes three of the best-selling drugs in the oncology field in Rituxan, Avastin and Herceptin--some of the company's cancer heavyweights are aging, and Rituxan is on that list. Biosimilars makers have been chomping at the bit to get their hands on a piece of the company's blockbuster revenues, And that's where Gazyva has come in: The Basel-based drugmaker has been billing it as a more effective version of its top seller in order to keep its market share intact.
So far, data have backed that up in chronic lymphocytic leukemia (CLL), for which Gazyva nabbed an initial FDA approval in late 2013. Since then, the agency has updated the drug's label to reflect a superior first-line performance to its predecessor when combined with chemotherapy.
- read the release
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