Gilead Sciences, Inc.
) recently presented encouraging data on its pipeline candidate
idelalisib (formerly GS-1101) from a phase II study (study
101-08: n=64). The study is evaluating idelalisib combined with
Roche Holding AG
) Rituxan/MabThera (rituximab) in treatment-naïve patients (aged
≥65 years) suffering from chronic lymphocytic leukemia (CLL).
CLL, the second most common leukemia form in the US, refers to a
slow-growing cancer. It stimulates the production of multiple
mature white blood cells.
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The results stated that the regimen achieved an overall response
rate of 97% with estimated progression-free survival of 93% at 24
months. Encouraged by the results of the phase II study, Gilead
intends to evaluate idelalisib for the indication in phase III
Gilead plans to present detailed results from the phase II study
at the annual meeting of the American Society of Clinical
Oncology. The primary endpoint of the open-label, single-arm
phase II study is the overall response rate. It refers to the
proportion of patients achieving a complete or partial response
with this regimen. As per the provisions of the trial, patients
who complete 48 weeks of the combination therapy without the
disease worsening could continue to receive idelalisib in an
Successful development and commercialization of idelalisib for
the indication would boost Gilead's top line since the CLL market
offers significant commercial potential. Apart from CLL,
Idelalisib is also being evaluated in other oncology indications
such as indolent non-hodgkin's lymphoma and mantle cell lymphoma.
Gilead carries a Zacks Rank #3 (Hold). The companies that look
Cubist Pharmaceuticals Inc.
). Both are Zacks Rank #2 (Buy) stocks.