With a new phase 3 win for Erleada (apalutamide), Johnson & Johnson is proposing a solution to a longstanding prostate cancer treatment gap.
For patients with high-risk localized or locally advanced prostate cancer, surgical removal of the prostate (radical prostatectomy) is a key standard treatment alongside radiation therapy. But nearly half of patients who move forward with curative-intent surgery ultimately see their cancer return, requiring additional treatment and potentially missing the window in which a cure is possible.
Additional therapies often intervene only after the cancer has spread, limiting the chance to improve long-term outcomes. This has been the status quo essentially since the prostatectomy was introduced 125 years ago in 1904, J&J’s U.S. president of oncology for solid tumors, Biljana Naumovic, M.D., told Fierce in an interview on the sidelines of the 2026 American Society of Clinical Oncology (ASCO) annual meeting.
With its phase 3 Proteus study, J&J sought a solution—a way to meet the “one chance for curing this patient,” Mark Wildgust, Ph.D., J&J’s VP of global medical affairs for oncology, said in the joint interview.
In 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 provide significant improvements in “key short- and long-term clinical outcomes,” the company said in a May 31 release.
Patients who used Erleada and hormone therapy were nine times more likely to have “little to no” cancer remaining at the time of surgery compared with those on hormone therapy alone, with the treatment arm linked to a 8.9% rate of pathologic complete response/minimal residual disease compared to 1% among the hormone therapy-only group, the company said.
The regimen also reduced the risk of developing metastasis or death by 20% and extended the time before patients required additional therapy to more than six years, J&J reported. That latter figure nearly doubled the three and a half years experienced by those on hormone therapy alone.
This result is “most impactful,” as it “may reduce the need for subsequent therapies and related side effects, while also increasing potential cure rates,” principal trial investigator Mary-Ellen Taplin, Ph.D., of Dana-Farber Cancer Institute and Harvard Medical School, commented in the release. “This approach, which combines systemic therapy with surgery, is already standard in other aggressive cancers and now has proven benefit in patients with this disease.”
The findings were unveiled at a plenary session at ASCO and simultaneously published in the New England Journal of Medicine.
Inclusion in the plenary is no small feat, as it represents ASCO “heralding that we are seeing a fundamental change in how we have treated these patients,” Wildgust said. The decades-long treatment gap Erleada could potentially fill has been well-known, but until now, “nobody had the audacity” to run a phase 3, 2,000-patient study in the space, according to the exec.
“We had the conviction that Erleada is different,” Wildgust said.
Additional analyses from the Proteus study, such as “ongoing evaluations” stacking up the regimen against surgery alone, are in the works to “further contextualize these findings,” according to J&J.
“Apalutamide has already shown an overall survival benefit in advanced disease. Now we’re seeing its impact when used earlier, alongside surgery,” Yusri Elsayed, M.D., Ph.D., J&J’s global therapeutic area head for oncology, noted in the release. “As the first therapy in its class to show benefit in this setting, these data reinforce apalutamide’s differentiated profile and the need to move beyond a surgery-only approach to treating earlier and improving long-term outcomes.”
The company figures that adding Erleada to the existing treatment approach could work well because in real-world practice, patients schedule surgeries weeks ahead of time.
“Instead of waiting for six to eight weeks, you actually give them treatment right away, and then after six months you schedule the surgery and the results are incredible,” Naumovic explained.
About 330,000 people in the U.S. are diagnosed with prostate cancer each year, with up to 40% classified as high-risk. More than 36,000 patients are estimated to succumb to their disease this year, which “reinforces the importance of choosing the best possible therapy early,” the company emphasized.
Erleada sits in the androgen receptor inhibitor drug class that many of its competitors, such as Bayer’s Nubeqa and Pfizer’s Astellas-partnered Xtandi, also occupy. But Erleada, Wildgust said, is “differentiated” and “unique,” rejecting the notion that the drugs are “all kind of interchangeable.”
This has also been proven by head-to-head analyses against others in the drug class, such as February’s data set in which J&J used real-world data to pit Erleada against Nubeqa. The survival benefit ultimately favored Erleada in metastatic castration-sensitive prostate cancer. Bayer disputed J&J’s analysis in a lawsuit earlier this year.
Erleada first hit the scene in 2018 with an approval for non-metastatic castration-resistant prostate cancer, nabbing its next indication in metastatic castration-sensitive prostate cancer the following year. So far, the drug has treated more than 340,000 patients worldwide, J&J said.
In 2025, Erleada generated global sales of $3.57 billion, up 19.2% from 2024. The drug is one of a few that J&J is centering its ambitious oncology efforts in as it looks to become the “number 1 company in oncology by 2030,” as CEO Joaquin Duato put it on a Friday appearance on CNBC.