Johnson & Johnson announced new clinical and real-world evidence data will be featured in 18 abstracts at this year's ASCO GU Symposium (San Francisco, January 25-27), highlighting the Company's commitment to transform the science of genitourinary (GU) cancers. Key presentations will include new real-world evidence data adding to the strong and differentiated clinical profile of ERLEADA®? (apalutamide) in the treatment of various stages of prostate cancer, patient-reported outcomes data from the Phase 3 MAGNITUDE study of niraparib plus abiraterone acetate given with prednisone, and updates on targeted releasing systems TAR-200 and TAR-210.

ASCO GU presentations showcase innovative targeted releasing systems TAR- 200 and TAR-210, and new real-world evidence data on the proportion and prognosis of fibroblast growth factor receptors (FGFR) alterations in Japan. Highlights include: Insights on the reasons for refusal or ineligibility for radical cystectomy from an analysis of the SunRISe-1 study evaluating TAR-200, a gemcitabine-containing targeted releasing system being studied in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) (Abstract #701). Preliminary results evaluating a novel urine-based screening assay to detect FGFR alterations and select patients who may respond to TAR-210, an erdafitinib-containing targeted releasing system being study in patients with NMIBC with select FGFR alterations (Abstract #676).

The complete list of Company-sponsored abstracts follows: ERLEADA®? (APA) (apalutamide) Prostate-specific antigen (PSA) response in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) or abiraterone acetate (ABI) in an oncology database: ROMA study. ERLEADA (apalutamide) is an androgen receptor signaling inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

ERLEADA®received U.S. FDA approval for nmCRPC in February 2018, and received  U.S. FDA approval for mCSPC in September 2019. To date, more than 150,000 patients worldwide have been treated with ERLEADA®. Additional ongoing Phase 3 studies include ATLAS, evaluating ERLEADA® for patients with localized prostate cancer with radiation therapy, and PROTEUS, evaluating ERLEADA® for patients with localized prostate cancer treatment after radical prostatectomy. AKEEGA is a combination, in the form of a dual-action tablet (DAT), of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.  AKEEGA® together with prednisone or prednisolone was approved in April 2023 by the European Medicines Agency, and in August 2023 by the U.S. FDA, for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Additional marketing authorization applications are under review across a number of countries globally.  Additional ongoing studies include the Phase 3 AMPLITUDE study, evaluating AKEEGA® with prednisone or prednisolone in a biomarker-selected patient population with metastatic castration-sensitive prostate cancer (mCSPC). BALVERSA (erdafitinib) is a once-daily, oral FGFR kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease progressed on or after at least one line of prior systemic the rapy.

BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-(L)1 inhibitor therapy.  Patients are selected for therapy based on an FDA-approved companion diagnostic for BALVERSA.