fiercepharmaNovember 05, 2018
Tag: Rituxan , biosimilar , lymphoma , REVLIMID
Celgene’s Revlimid may have slipped in tandem with Roche’s Rituxan in previously untreated follicular lymphoma patients. But in the second-line setting, the drug has a win.
Thursday, detailed results from the phase 3 Augment study—which looked at the combo, known as R2 for short, in relapsed and refractory FL patients—hit the American Society of Hematology website in advance of the group’s annual meeting in December. And they showed big-time benefits for the regimen over solo Rituxan.
Patients in the R2 arm went a median 39 months without their cancer worsening versus just 14 months for patients in the Rituxan-only arm. In other words, the pairing reduced the risk of disease progression or death by 54%. More patients responded to therapy in the R2 group, too, with 78% responding compared with Rituxan’s 34%.
The data impressed Leerink Partner analyst Geoffrey Porges, for one, who wrote to investors previously that a 24-month progression-free survival mark would be "very positive." With the 39-month benefit, "Revlimid use in the 2L follicular lymphoma setting should increase," he wrote Thursday to clients, adding that the result "suggests Revlimid’s use should go beyond the unfit/elderly population that is often addressed" by Rituxan.
There’s more good news: R2’s performance in the setting "appears to be superior" to what’s expected from immunotherapy-chemo combos in the same patient group "based on historical results," Porges wrote, which means Celgene may not have to fret much about forthcoming competition. All things considered, Porges expects the new data to drive an additional $600 million in yearly revenue for the drug.
Celgene will certainly take it, especially with biosimilar rivals to its key moneymaker advancing. The New Jersey biotech has been working to drum up additional revenue opportunities for its superstar, but in follicular lymphoma, it hit a stumbling block last December when R2 failed to stave off cancer progression against a Rituxan-chemo marriage.
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