ImmunityBio Submits sBLA for ANKTIVA in BCG-Unresponsive NMIBC; BriaCell Reports Positive Phase 2 Data for Bria-IMT Cancer Vaccine in Metastatic Breast Cancer

AnktivaIs an interleukin-15（IL-15) Superagonist. The therapy in2019Year AwardFDAGranted Breakthrough Therapy Designation, used withBCGCombined therapy previously forBCGPatients with non-muscle-invasive carcinoma in situ of the bladder who respond poorly.2024Year4Month, United StatesFDAApprovalAnktivaAndBCGCombined use for the treatment ofBCGNo response and accompanied by carcinoma in situ (CIS) ofNMIBCAdult patients, with or without papillary tumors.It is worth mentioning that,Industry MediaEvaluateOnce listed this therapy as2024Expected to be approved in10A Potential Blockbuster TherapyOne of.

This submission toFDAThe data shows,AcceptAnktivaUnitedBCGAmong the patients treated, there88%Bladder removal was avoided within two years after treatment.82%No need for surgical bladder removal within three years.Due to the high mortality and morbidity associated with radical cystectomy, this treatment option, which has the potential for long-term bladder preservation, is expected toBCGPatients with no response and papillary lesions have significant clinical benefits and improved quality of life.

Cancer Vaccine Combination Therapy2Positive Results of Phase Trial Announced

Recently,BriaCell TherapeuticsThe company announced that its cancer vaccine therapy under researchBria-IMTCombined Immune Checkpoint Inhibitors (CPI) In2Positive survival data achieved in the clinical research phase, in hormone receptor-positive (HR+) Metastatic Breast Cancer (MBC) patients, showing superiority over existing antibody-drug conjugatesDrug (ADC) Efficacy.

In the company's treatment for late-stage metastatic breast cancer2In the clinical trial phase, a total of37Patients receivedBria-IMTTreatment, wherein25Name confirmed asHR+Breast cancer patients. The analysis shows,This25The median overall survival (17.3months) better than currentADCStandard TreatmentTrodelvy（14.4Months).In triple-negative breast cancer (TNBC) patients,Bria-IMTSurvival data for the combination immunological checkpoint inhibitor treatment regimen is consistent withTrodelvyComparable, but still significantly better than the chemotherapy group, with a survival rate increase of approximately70%。As of now, no reports have been made due toBria-IMTTreatment interruption events caused by.

References:

[1] ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia. Retrieved April 17, 2025 from https://immunitybio.com/immunitybio-announces-fda-submissions-of-supplemental-bla-for-nmibc-papillary-disease-and-for-expanded-access-of-anktiva-to-treat-lymphopenia/

[2] BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer. Retrieved April 17, 2025 from https://www.globenewswire.com/news-release/2025/04/16/3062447/0/en/BriaCell-Phase-2-Survival-Data-Beats-Leading-Standard-in-HR-Breast-Cancer.html

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