Bayer’s Nubeqa continues to deliver promising results across an expanding range of prostate cancer indications.
According to new phase 3 data, the androgen receptor inhibitor improved metastasis-free survival in patients with very high-risk prostate cancer.
The results were presented at the European Society for Medical Oncology (ESMO) Congress in Madrid. The DASL-HiCaP trial enrolled more than 1,000 patients with very high-risk localized or biochemically recurrent prostate cancer. Among the participants, 29% had cancer that had spread to the pelvic lymph nodes, 15% had undergone radical prostatectomy and required additional radiation therapy, and 73% had a Gleason score of 9 or 10, indicating highly aggressive disease.
“These patients had to meet strict eligibility criteria, what we call DASL high risk,” said Tamim Niazi, M.D., an associate professor in the Department of Oncology at McGill University and co-chair of the trial.
Among patients receiving Nubeqa alongside standard-of-care androgen deprivation therapy (ADT) and radiation, 27 experienced disease progression or death, compared with 63 in the control group receiving radiation and ADT alone. At four years, the metastasis-free survival rate was 95% in the Nubeqa group, compared with 88% in the control group.
“This basically translates to a 58% risk reduction,” Niazi told Fierce. The results suggest patients could achieve better disease control and potentially face a lower risk of dying from prostate cancer, he said.
Meanwhile, adverse events were “pretty similar” between the two treatment groups, according to Niazi, meaning the “toxicity burden is very limited” but the clinical benefit is robust.
“That is, to me as a clinician, very important and I can comfortably offer this to my patients,” he said.
Nubeqa was first approved in 2019 for nonmetastatic castration-resistant prostate cancer. In 2022, the FDA expanded its label to include metastatic castration-sensitive prostate cancer (mCSPC) in combination with chemotherapy and ADT. The drug surpassed blockbuster sales in 2024, and in 2025, the FDA cleared its use in mCSPC without chemotherapy.
Nubeqa has since become one of Bayer’s primary growth drivers alongside Kerendia as the company contends with patent expirations and declining sales of Xarelto and Eylea. Nubeqa generated 2.39 billion euros in sales in 2025, up 57% from the previous year, growth that has added fuel to its rivalry with Johnson & Johnson’s Erleada.
Another androgen receptor inhibitor, Erleada competes with Nubeqa in several prostate cancer treatment settings. Earlier this year, the two pharmas became embroiled in a heated legal battle after J&J published head-to-head real-world data comparing survival rates among patients receiving Erleada and Nubeqa. Bayer alleged that the promotional claims amounted to false advertising, but a court denied its request for an injunction.
Neither drug is the market leader. That distinction belongs to Pfizer and Astellas’ similarly-classed Xtandi, which generated a reported $6.4 billion in sales in 2025 but faces patent expirations beginning next year.
Bayer has not disclosed its regulatory plans for Nubeqa in very high-risk localized prostate cancer, saying it must first comprehensively evaluate the data. Still, a potential label expansion could provide a significant commercial opportunity as Xtandi approaches its patent cliff. Patients with very high-risk localized disease represent a substantial potential market for Bayer.
The latest data are not the end of Bayer’s DASL-HiCaP trial, Niazi said. The final analysis of the primary endpoint, five-year metastasis-free survival, is expected in 2027. The study will also continue evaluating several long-term secondary endpoints, including overall survival, prostate cancer-specific survival, prostate-specific antigen (PSA) progression-free survival and health-related quality of life.