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Gilead's (GILD) Yescarta Gets EC Nod for Follicular Lymphoma

·3-min read

Gilead Sciences, Inc. GILD recently announced that the European Commission (“EC”) has approved its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for a third indication.

Yescarta has been approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

The approval is supported by data from the pivotal ZUMA-5 study, which demonstrated an overall response rate of 91% and a complete response rate of 77% in patients who received Yescarta after three or more lines of therapy.

Yescarta is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for treating adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. It is also indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from FL.

The therapy represents a significant advancement for the patient population in Europe with limited treatment options.

The use of engineered T cells as a potential cancer treatment is a recent development and is complex but promises potential. Gilead has one more cell therapy in its portfolio – Tecartus.

Cell therapy product sales increased by 43% to $274 million in the first quarter of 2022, primarily due to the continued uptake of Yescarta for the treatment of relapsed or refractory LBCL in the United States and Europe, and follicular lymphoma in the United States. The increase was also driven by higher Tecartus sales volumes resulting from the expansion of use in Europe for mantle cell lymphoma and continued adoption in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in the United States.

Gilead’s stock has lost 14.3% so far in the year compared with the industry's decline of 23.3%.

 

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We note that Gilead is making efforts to develop its oncology business to diversify its revenue base as competition is stiff in the legacy HIV business.

However, while this is a lucrative space, competition is formidable from the likes of Novartis’ NVS CAR-T cell therapy Kymriah (tisagenlecleucel), among others.

Novartis recently obtained FDA’s approval for Kymriah for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.  In early May 2022, the EC approved Kymriah for treating adult patients with r/r FL after two or more lines of systemic therapy, the third indication for which Kymriah is available to patients in the European Union.

Gilead currently carries a Zacks Rank #4 (Sell).

A couple of better-ranked stocks are Sesen Bio SESN and Geron Corporation GERN. While Sesen sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Loss estimates for SESN for 2022 have narrowed to 44 cents from a loss of 46 cents in the past 60 days. Sesen surpassed estimates in all of the trailing four quarters, the average surprise being 69.94%.

Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.




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