With a new Phase 3 victory for Erleada (apalutamide), Johnson & Johnson offers a solution to a long-standing gap in prostate cancer treatment.
Surgical removal of the prostate (radical prostatectomy) is an important standard treatment, along with radiation therapy, for patients with high-risk localized or locally advanced prostate cancer. However, nearly half of patients who proceed with curative surgery end up having their cancer return, requiring additional treatment and potentially missing out on a potential cure.
Additional treatments often intervene only after the cancer has spread, limiting their potential to improve long-term outcomes. This has essentially been the status quo since prostatectomy was introduced 125 years ago in 1904, Biljana Naumovic, M.D., director of U.S. solid tumor oncology at J&J, told Fiers in an interview on the sidelines of the 2026 American Society of Clinical Oncology (ASCO) annual meeting.
In J&J’s Phase 3 Proteus trial, J&J sought a solution, a way to meet “the only chance to cure this patient,” Dr. Mark Wildgast, J&J’s vice president of global medical oncology, said in a joint interview.
At Proteus, when Erleada was given to patients with high-risk localized or locally advanced disease alongside hormone therapy (androgen deprivation therapy, or ADT) for six months before and after surgery, the drug was able to produce significant improvements in “important short- and long-term clinical outcomes,” the company said in a May 31 release.
The company said patients who received Erleada in combination with hormone therapy were nine times more likely to have “little to no” residual cancer at the time of surgery compared to patients who received hormone therapy alone, and the treatment group had a pathological complete response/minimal residual disease rate of 8.9% compared to 1% in the hormone therapy group.
J&J also reported that the regimen reduced the risk of metastasis and death by 20% and extended the time before patients required additional treatment by more than six years. The latter figure is nearly double the 3.5 years experienced by those receiving hormone therapy alone.
The results are “most impactful” because they “have the potential to reduce the need for subsequent treatment and associated side effects, as well as potentially increase cure rates,” lead researcher Mary Ellen Taplin, Ph.D., of Dana-Farber Cancer Institute and Harvard Medical School, commented in a statement. “This approach, which combines systemic therapy and surgery, is already standard in other aggressive cancers and has proven beneficial for patients with this disease.”
The study results were presented at an ASCO plenary session and simultaneously published in the New England Journal of Medicine.
Wildgast said participating in the conference was no small feat and signals that ASCO is “heralding a fundamental change in the way these patients are treated.” Although it was well known that Erleada had the potential to fill a decades-long treatment gap, “no one in the field had had the audacity” to run a 2,000-patient Phase 3 trial, the executive said.
“We were convinced that Erleada was different,” Wildgast said.
J&J said work is underway to “further contextualize these results” with additional analyzes from the Proteus study, including “ongoing evaluations” that stack up the regimen compared to surgery alone.
“Apalutamide has already shown an overall survival benefit in advanced disease, and we are now seeing efficacy when used early in conjunction with surgery,” Yousri Elsayed, MD, J&J’s global therapeutic area head of oncology, said in the release. “As the first therapy of this class to demonstrate efficacy in this setting, these data support the differentiated profile of apalutamide and the need to move beyond surgery-only approaches for early treatment and improved long-term outcomes.”
The company believes that adding Erleada to existing treatment approaches could work because in real-world practice, patients schedule their surgeries weeks in advance.
“Instead of waiting six to eight weeks, if you actually treat the patient right away and schedule the surgery six months later, the results are incredible,” Naumovic explained.
Approximately 330,000 people are diagnosed with prostate cancer each year in the United States, and up to 40% are classified as high risk. It is estimated that more than 36,000 patients will die from the disease this year, “reiterating the importance of early selection of the best treatment,” the company said.
Erleada is in the same androgen receptor blocker class as many competitors, including Bayer’s Nubeqa and Pfizer’s Xtandi, which is affiliated with Astellas Pharma. But Wildgast said Erleada is “differentiated” and “unique” and rejects the notion that the drugs are “any kind of interchangeable.”
This is also evidenced in direct analysis with other drug classes, such as the February dataset in which J&J pitted Erleada against Nubeqa using real-world data. Survival benefits ultimately favored Erleada in metastatic castration-sensitive prostate cancer. Bayer challenged J&J’s analysis in a lawsuit earlier this year.
Erleada first entered the market in 2018 with approval for non-metastatic castration-resistant prostate cancer and gained a second indication for metastatic castration-sensitive prostate cancer the following year. To date, the drug has treated more than 340,000 patients worldwide, according to J&J.
In 2025, Erleada’s global sales were $3.57 billion, an increase of 19.2% compared to 2024. The drug is one of a handful of drugs that J&J is putting at the center of its ambitious oncology efforts to become “the No. 1 oncology company by 2030,” as CEO Joaquín Duato said in an appearance on CNBC on Friday.
