FDA Approves Erleada to Treat Metastatic Castration-sensitive Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved Erleada (apalutamide) for the treatment of men with metastatic, castration (hormone)-sensitive prostate cancer (mCSPC), or those whose cancer still responds to androgen deprivation (hormonal) therapy (ADT).

The decision is based on the double-blind TITAN Phase 3 trial (NCT02489318), as it showed that adding Janssen’s Erleada to ADT significantly extended both overall survival and progression-free survival (PFS) – the period without cancer progression –, which were the trial’s primary goals. Based on results from the SPARTAN clinical trial, Erleada had already been approved in 2018 as a treatment for patients with non-metastatic (localized) castration (hormone)-resistant prostate cancer in both the United States and the European Union.

Compared to ADT and a placebo, treatment with Erleada and ADT reduced the risk of death by 33%, and the likelihood of disease worsening (as assessed by radiography) or death by 52%. After a median follow-up of 22.7 months, 84% of the patients on Erleada and ADT reached the two-year mark alive, compared to 78% of those on ADT and placebo. In this indication, Earleada decreased the risk of cancer spreading or death by 72 percent compared to a placebo, and delayed the cancer’s metastasis by more than two years. The frequency of serious adverse events was 19.8% for Erleada and 20.3% for placebo.

Erleada is an oral therapy that targets the androgen receptor, blocking its activation by androgens such as testosterone. Its chemical structure and mode of action are similar to that of enzalutamide (Xtandi). In turn, ADT, a mainstay of prostate cancer treatment, reduces the amount of androgens in the body.

TITAN included 1,052 mCSPC patients regardless of extent of disease and of being newly diagnosed or having been treated with up to six cycles of docetaxel (taxotere). It was funded by Johnson & Johnson-owned Aragon Pharmaceuticals and Janssen Research and Development (also owned by Johnson & Johnson). The study’s findings were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.

“Prostate cancer is more difficult to treat once it spreads, and for patients with castration (hormone)-sensitive disease, it is clear that androgen deprivation therapy (ADT) alone is often not enough,” Kim Chi, principal investigator in TITAN and medical oncologist at BC Cancer-Vancouver, said in a press release. “Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with Erleada in addition to ADT.”

Most information in this post appeared in the September 19th, 2019 Prostate Cancer News Today by Jose Marques Lopes, Ph.D.

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