Gilead's (GILD) CAR T Cell Therapy Gets Positive CHMP Opinion

Gilead Sciences’ GILD company, Kite, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to its Marketing Authorization Application (MAA) for KTE-X19, a chimeric antigen receptor (CAR) T cell therapy.

The MAA is seeking approval of the candidate as a potential treatment for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

KTE-X19 is an autologous, anti-CD19 CAR T cell therapy, which is an individualized method of treatment that harnesses the body’s own immune system to target cancer cells.

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node. It mostly affects men above the age of 60. Per estimates, approximately 7,400 people are diagnosed with mantle cell lymphoma each year.

The CHMP recommendation was based on the positive benefit-risk for KTE-X19 as demonstrated by the safety and efficacy results of the ZUMA-2 trial. The recommendation will now be reviewed by The European Commission and the final decision is expected in the coming months.

In July 2020, the FDA granted accelerated approval to KTE-X19 under the brand name Tecartus for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Tecartus is also currently in phase I/II trials in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).

We note that Gilead’s Yescarta, a CAR T cell therapy, is already approved for non-Hodgkin lymphoma.

Competition is stiff in the CAR T cell therapy space from the likes of Novartis’ NVS Kymriah.

Gilead’s shares have lost 6.6% in the year so far compared with the industry’s decline of 0.2%.


The company and biotech giant Regeneron Pharmaceuticals REGN were in the news earlier in the week, after President Trump tested positive for COVID-19 and was being treated with experimental treatments from both companies. Gilead’s investigational antiviral Veklury (remdesivir) has been in focus since the outbreak of the coronavirus pandemic and was granted an Emergency Use Authorization (EUA) for the COVID-19 infection.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Vertex Pharmaceuticals VRTX, which currently carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex’s earnings estimates grew 13 cents for 2020 in the past thirty days and 18 cents for 2021 in the same time frame.

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