Gilead (GILD) Kite Reports Positive Data on CAR T-Cell Therapy
Gilead Sciences’ GILD Kite announced encouraging three-year follow-up results from the ZUMA-3 study of the CAR T-cell therapy Tecartus (brexucabtagene autoleucel).
Tecartus is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on an overall response rate and durability of the response. The continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
It is also indicated for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
ZUMA-3 is an ongoing international single-arm, open-label, registrational phase I/II study of Tecartus in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission (CR) or complete remission with incomplete hematological recovery by central assessment. The secondary endpoints are duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate and alloSCT rate.
The three-year follow-up results showed a median overall survival (OS) of 26 months and demonstrated that responses remained durable in adults with relapsed/refractory B-cell ALL, with a consistent safety profile observed since the two-year analysis.
The median follow-up was 38.8 months in the phase II-treated patient cohort (n=55). The OS rate at 36.0 months was 47.1%, with a median OS of 26.0 months among all treated phase II patients and 38.9 months in patients with CR or CR with incomplete hematologic recovery.
Management stated that the continued durable response and significant improvement in survival indicated by these new data bode well for Tecartus as a new standard of care for adult patients living with this aggressive form of leukemia.
Gilead’s stock has gained 37.9% in the past year against the industry's decline of 10.1%.
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The company recently reported better-than-expected fourth-quarter results, driven by continued solid demand for its HIV portfolio with further share growth for flagship HIV therapy Biktarvy and oncology revenues driven by the cell therapy franchise and Trodelvy. Cell therapy franchises comprise Yescarta and Tecartus.
Gilead is looking to diversify its viral business into the lucrative oncology space. Competition is stiff for the HIV business from the likes of GSK plc GSK, among others. Strong patient demand for the new HIV medicines (Dovato, Cabenuva, Juluca, Rukobia and Apretude) boosted GSK’s HIV franchise in 2022.
Novartis’ NVS Kymriah is also a CD19 directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B cell precursor ALL that is refractory or in second or later relapse. Novartis also obtained FDA’s accelerated approval for Kymriah for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy approval.
Gilead currently 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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