This protocol addresses a specific and therapeutically challenging subset of follicular lymphoma: patients whose disease has relapsed and who meet the criteria for rituximab resistance.
Rituximab resistance (Rit-R) is defined as no response to, or progression during or within 6 months after, treatment with rituximab or a rituximab-containing regimen. Therapeutic options for people with relapsed disease are more limited in this setting.
The protocol involves idelalisib, an oral targeted agent — a first-in-class selective inhibitor of PI3Kδ. This monotherapy approach has demonstrated meaningful activity in heavily pre-treated patients, including those who are Rit-R.
Therapeutic options for people with relapsed disease are more limited for those who are resistant to rituximab (Rit-R), i.e., people who did not respond or who progressed during or within 6 months after treatment with rituximab or a rituximab-containing regimen.
Idelalisib is a first-in-class, selective, oral inhibitor of PI3Kδ.
At a dose of 100 mg twice-daily or more, responses are observed in approximately 45% of people with FL who have been heavily pre-treated, including those who are Rit-R and alkylator refractory, with the median PFS reported to be 16 months.
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