Gilead Sciences, Inc. GILD today announced results from a Phase 2
study (Study 101-08) evaluating idelalisib (formerly GS-1101), an
investigational, targeted, oral inhibitor of PI3K delta, in combination with
rituximab for older patients with treatment-naïve chronic lymphocytic leukemia
(CLL). This regimen achieved a complete response (CR) rate of 19 percent and
an overall response rate (ORR) of 97 percent, with estimated progression-free
survival (PFS) at 24 months of 93 percent. Detailed results will be presented
during an oral session at the 2013 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago (Abstract #7005).
CLL is a slow-growing cancer that induces the production of too many mature
white blood cells. It is the second most common type of leukemia in the United
States and can lead to life-threatening complications, including serious
infection. Currently, patients with CLL are usually treated first with
rituximab in combination with one or more chemotherapy agents.
Among the 64 patients in the study, Kaplan-Meier estimated PFS at 24 months
was 93 percent. The median time on treatment was 14 months, with 33 patients
remaining on treatment. The median time to response was two months. No
relapses on study have been reported. The nine patients with chromosome 17p
deletion (del 17p) (n=6) or mutation in the TP53 gene (n=3), which have been
linked to poor prognosis, all responded to therapy including three with a
complete response. Ninety-four percent of patients with thrombocytopenia at
baseline responded to treatment (16/17), as did all patients with anemia at
baseline (17/17). Of patients with systemic symptoms such as extreme fatigue,
fever, night sweats or weight loss (known as “B symptoms”) at baseline, 77
percent (20/26) were asymptomatic by eight weeks.
Patients completing 48 weeks of therapy without progression could continue to
receive idelalisib in an extension study. Forty-three patients completed 48
weeks of treatment (21 discontinued – 17 due to adverse events, three due to
death and one due to other reasons); 40 patients entered the extension study
and 33 remain on treatment.
During the primary and extension study, Grade 3 diarrhea and/or colitis was
reported in 33 percent of patients, Grade ≥3 pneumonia in 17 percent and Grade
≥3 transaminase elevations (measure of liver function) in 23 percent of
patients.
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