Gilead Unveils GS-9973 Data - Analyst Blog

Gilead Sciences GILD announced updated interim data on its oncology candidate GS-9973 from an ongoing open-label, single-arm, safety and efficacy phase II study (102). Detailed results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO).

The study is assessing the candidate, a spleen tyrosine kinase (Syk) inhibitor, in patients suffering from relapsed or refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL: indolent NHL, diffuse large B-cell lymphoma and mantle cell lymphoma).

Data from the study revealed that treatment with the candidate (as a monotherapy) resulted in an overall response rate of 49% with a progression-free survival rate of approximately 70% at 24 weeks in previously treated CLL patients. Adverse events like fatigue, dyspnea, pneumonia, nausea, atrial fibrillation and chest pain were observed during the study.

Following the data from the study, Gilead intends to initiate new CLL study cohorts including patients who have relapsed after being treated with other inhibitors of the b-cell receptor BCR pathway.

Gilead had also presented encouraging data on its most interesting pipeline candidate idelalisib at ASCO 2014.

A second interim analysis of a phase III study evaluating idelalisib and Roche's (RHHBY) Rituxan for relapsed CLL showed significant improvement in progression free survival PFS and overall response rate (ORR) compared to placebo plus Rituxan, with acceptable safety. Idelalisib is under priority review for this indication with a response expected by Aug 6.

Gilead apart, many other companies had presented data at the ASCO. The meeting, held in Chicago from May 30 – Jun 3, provides companies with a platform to showcase their data to scientists, physicians, the investment community and others.

Gilead carries a Zacks Rank #1 (Strong Buy). Allergan AGN and Osiris Therapeutics OSIR carry the same rank as Gilead in the healthcare space.