▎WuXiEdited by Kant Content Team

Today, AstraZeneca announced that it will present clinical results from several of its hematology pipeline products at this year's American Society of Hematology (ASH) Annual Meeting. Among them,AstraZeneca's Next-Generation T-Cell Engager AZD0486 Demonstrates Up to 96% Overall Response Rate in Relapsed/Refractory Follicular Lymphoma (R/R FL) Patients, which is expected to enhance the treatment of lymphoma patients in current clinical practice.

AZD0486 is a CD19 x CD3 targeted bispecific T-cell engager.Results from a Phase 1 clinical trial showed that R/R FL patients had a high response to AZD0486 at doses of 2.4 mg and above.The total response rate of patients was as high as 96%, with a complete response rate of 85%. Additionally, the minimal residual disease (MRD)-negative rate was very high.In addition, the interim results of the Phase 1 trial also showed,Heavily pretreated diffuse large B-cell lymphoma (DLBCL) patients also showed a high response rate to AZD0486, with a high complete response (CR) rate.Latest data also shows that AZD0486 has good safety, and the double-dose escalation regimen can effectively alleviate the occurrence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events in patients.

AstraZeneca will also present the latest data on its novel BCMA x CD19 dual-targeting autologous CAR-T therapy, AZD0120 (GC012F), at the ASH Annual Meeting.AstraZeneca reached an acquisition agreement with Gracell Bio in December 2023 and obtained this therapy.AZD0120 adopts Gracell Bio's FasTCAR rapid production platformDevelopment, its early data shows the potential of this therapy as a first-line treatment for newly diagnosed multiple myeloma (MM) elderly patients who cannot undergo transplantation.Preliminary results from the ongoing investigator-initiated trial indicate that patients exhibit a deep response and acceptable safety to AZD0120 treatment. No ICANS or CRS events of grade ≥2 were observed in this patient population.

At this year's European Hematology Association (EHA) Annual Meeting, the trial data reported by Gracell Biotechnologies showed that at a median follow-up of 25.2 months (range: 13.5-35.3),Among 22 high-risk, transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients treated with AZD0120, the overall response rate was 100%, and the minimal residual disease-negative stringent complete response rate (MRD-sCR) reached 95%.

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References:

[1] AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024. Retrieved November 7, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-showcases-strength-of-haematology-portfolio-and-pipeline-at-ash-2024.html

[2] AstraZeneca to acquire Gracell, furthering cell therapy ambition across oncology and autoimmune diseases. Retrieved November 7, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-to-acquire-gracell-furthering-cell-therapy-ambition-across-oncology-and-autoimmune-diseases.html

[3] A phase I open-label single-arm study of dual targeting BCMA and CD19 FasTCAR-T AZD0120 (GC012F) as first-line therapy for transplant-eligible newly diagnosed high-risk multiple myeloma. Retrieved November 7, 2024 from https://www.gracellbio.com/uploads/2024/06/171858971995112.pdf

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