Gilead Sciences, Inc. GILD announced positive data from a randomized, controlled, open-label phase III study (Study 119) evaluating the efficacy and safety of Zydelig in combination with Novartis’ (NVS) Arzerra in treatment-experienced patients suffering from chronic lymphocytic leukemia (CLL). The primary endpoint of the study was progression-free survival (PFS).
Study 119 showed that the Zydelig-Arzerra combination improved overall and lymph node response rates significantly along with PFS in treatment-experienced CLL patients. Median PFS in the Zydelig/Arzerra arm was 16.3 months compared to only 8 months in the Arzerra monotherapy arm. In combination with Arzerra, Zydelig led to a 73% reduction in the risk of disease progression or death compared to Arzerra alone. However, a statistically significant difference in median overall survival was not achieved (20.9 months versus 19.4 months).
Gilead filed a supplemental new drug application with the FDA to include data from Study 119 in the U.S. label of Zydelig. The company intends to submit a supplemental filing to the European Medicines Agency later in 2015.
We note that Zydelig has accelerated approval in the U.S. for relapsed follicular lymphoma or small lymphocytic lymphoma (as monotherapy) in patients who have received at least two prior systemic therapies, and full approval for relapsed CLL (in combination with Rituxan) in patients with comorbidities. It is also approved in the EU for follicular lymphoma (as monotherapy) in patients who are refractory to two prior lines of treatment, and for CLL patients (in combination with Rituxan) who have received at least one prior therapy or in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemoimmunotherapy.
Meanwhile, Zydelig is being studied in combination with standard-of-care and novel therapies in seven phase III studies (ongoing or completed) for B-cell malignancies.
For the first three months of 2015, Zydelig generated revenues of $26 million. Label expansion of the product should further boost sales.
Gilead carries a Zacks Rank #1 (Strong Buy). Other well-ranked stocks in the health care sector include Valeant Pharmaceuticals International, Inc. VRX, Actelion Ltd. ALIOF and Acorda Therapeutics, Inc. ACOR. While Valeant and Actelion carry the same Zacks Rank as Gilead, Acorda holds a Zacks Rank #2 (Buy).
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