Gilead Sciences Inc. (GILD - Free Report) announced long-term follow-up data from a phase II study, evaluating its chimeric antigen receptor T-cell (CAR-T) therapy, Yescarta (axicabtagene ciloleucel), for treatment of patients with refractory large B-cell lymphoma. Detailed results from this study were presented at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta.
Notably, the drug was added to Gilead’s portfolio following the acquisition of Kite Pharma in early October. Subsequently, it received an FDA approval later in the same month for treating refractory aggressive non-Hodgkin lymphoma, which includes DLBCL, transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). The drug is also under review in the EU with a tentative approval expected in the first half of 2018.
Shares of Gilead have outperformed the industry so far this year. The stock has gained 3.6% against the broader industry’s 2.6% increase.
The updated data from the ZUMA-1 study showed that the drug with a single infusion of axicabtagene ciloleucel demonstrated an overall response rate (ORR) of 42%, including 40% of patients achieving complete remission at a median follow-up of 15.4 months. The study was conducted on a total of 108 patients. Notably, the previously reported data from the study showed an overall response rate (ORR) of 72%, including 95% of patients achieving complete remission at a median follow-up of 7.9 months.
We remind investors that Novartis (NVS - Free Report) has also received an FDA approval for its CAR-T therapy, Kymriah (tisagenlecleucel), in August for treatment of patients aged up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later stage relapse.
Additionally, Juno Therapeutics (JUNO - Free Report) is developing cell-based cancer immunotherapies based on its CAR-T technologies in partnership with Celgene (CELG - Free Report) for curing adults with r/r aggressive NHL, including r/r DLBCL. Hence Gilead is expected to face a fierce competition from these products in the long run.
Gilead carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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