J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Niraparib is also sold by GSK under the name Zejula in other indications. In April 2016, Janssen Biotech, Inc. struck a worldwide collaboration (excluding Japan) and license agreement with niraparib developer Tesaro (acquired by GSK in 2019) for exclusive rights to the drug in prostate cancer.

Prostate cancer is one of the most common cancers in the US with an estimated 288,300 new cases and nearly 35,000 deaths expected in 2023. Approximately 10 to 15 percent of patients with mCRPC have alterations in the BRCA gene — this subset of patients is likely to have aggressive disease, poor outcomes and a shorter survival time, according to information in a press release from Johnson & Johnson announcing Akeega’s FDA approval.

Akeega received its first global authorization from the European Commission (EC) in April this year.

The treatment is the second win in oncology this month for Johnson & Johnson, which received approval for its bispecific antibody Talvey (talquetamab-tgvs) last week for the treatment of refractory or relapsed multiple myeloma.

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“This milestone, which marks the approval of Janssen’s third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC,” Kiran Patel, Janssen’s VP of clinical development, solid tumors, said in the press release.

Akeega’s FDA approval was based on positive data from the Phase III MAGNITUDE study, which revealed that BRCA-positive patients treated with Akeega plus prednisone had a 47 percent lower risk for radiographic progression-free survival or death compared to placebo plus Zytiga plus prednisone.

Additionally, at the second interim analysis, with median follow-up at 24.8 months in the BRCA-positive subgroup, Akeega plus prednisone led to a radiographic progression-free survival of 19.5 months compared with 10.9 months for placebo.

There was also improvement in the secondary endpoints of time to symptomatic progression and time to initiation of cytotoxic chemotherapy with Akeega plus prednisone compared with Zytiga alone, with a trend towards improvement in overall survival (OS).

Related: Talvey Becomes J&J’s Second Multiple Myeloma Bispecific to Score FDA Approval

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” said Kim Chi, medical oncologist at BC Cancer – Vancouver and principal investigator of the MAGNITUDE study. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with Akeega and to help us understand how we can potentially achieve better health outcomes for patients.”

Johnson & Johnson said the observed safety profile of the combination was consistent with the known safety profile of each of the monotherapies.

Akeega will be going up against AstraZeneca and Merck’s Lynparza (olaparib) along with Pfizer’s Talzenna (talazoparib), both PARP inhibitors and in the same indication.

Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair (HRR) gene mutations. In June 2023, it was authorized for use in patients with BRCA mutations as part of a combination therapy with abiraterone and prednisone.

On the other hand, Talzenna’s approval is broader as it includes other mutations in the homologous recombination deficiency family. Talzenna is approved in combination with Xtandi (enzalutamide), which Pfizer developed in partnership with Astellas.