During the full presentation of the abstract on Friday, Janssen will show that treatment with Erleada significantly improved rPFS with a reduction in the risk of death by 52%. Additionally, in overall survival, the TITAN data showed Erleada and ADT significantly improved OS with a 33% reduction in risk of death.
A little more than a year after winning regulatory approval for a non-metastatic prostate cancer treatment, Janssen Pharmaceuticals is aiming to gain approval for the same medication as a treatment for metastatic castration-sensitive prostate cancer (mCSPC).
In April, the Johnson & Johnson subsidiary announced it had submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking approval for Erleada (apalutamide) for the aforementioned treatment of mCSPC. The sNDA is based on findings from the Phase III TITAN study, presented at the American Society of Oncology meeting today. TITAN was designed to determine whether Erleada, a selective next-generation androgen receptor inhibitor, plus androgen deprivation therapy (ADT) improves radiographic progression-free survival (rPFS) and overall survival (OS) compared with placebo plus ADT in patients with mCSPC. ADT is the backbone of treatment for this condition but the addition of supporting medications, such as Erleada has certainly improved the outcomes of care. The data from Janssen’s TITAN study is certainly impressive. And what the data shows is impressive, Joaquin Casariego Garcia Luben, J&J’s medical affairs director for prostate cancer for Europe, the Middle East and Africa, told BioSpace in an exclusive interview.
During the presentation of the abstract, Janssen showed that treatment with Erleada significantly improved (rPFS) with a reduction in the risk of death by 52 percent. Additionally, in overall survival, the TITAN data showed Erleada and ADT significantly improved OS with a 33 percent reduction in risk of death. The dual primary endpoints of the study are rPFS and OS, both of which were hit. The data showed that the combination of Erleada and ADT significantly improved radiographic progression-free survival and overall survival. The secondary endpoint of prolonged time to cytotoxic chemotherapy in patients treated with Erleada plus ADT was also met, with a 61 percent risk reduction compared with placebo plus ADT, Janssen said. Overall, the data suggests that treatment with Erleada prolongs overall survival and delays disease progression in patients with mCSPC.
Based on the trial results, the independent data monitoring committee recommended unblinding the study in order to allow those patients on placebo and ADT to receive the combination of Erleada and ADT.
“Both endpoints go together, it really shows the strength of the efficacy of this treatment,” Casariego told BioSpace in a telephone interview from Spain, ahead of his journey to ASCO in Chicago. Casariego noted that an IDMC rarely recommends unblinding a study unless the data is exceptional. He said the IDMC’s decision was made due to the “magnitude” of the results.
Janssen’s sNDA is being reviewed by the FDA through its Real-Time Oncology Review program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application.
Casariego said Janssen’s goal, as well as the goal of other companies developing treatments for cancer, is to provide a treatment that can cheat death out of as many years as possible from patients.
“It’s about adding years to life, as well as life to years. This is the main challenge,” he said. “These results are promising to that. We are stealing years to death and we keep investing in research to do this.”
Prostate cancer is the second most common cancer in men worldwide, with about 164,000 expected diagnoses in the United States this year. Erleada was the first FDA-approved treatment for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). In the trial that won it the first approval, Erleada demonstrated a 72 percent reduction in risk of distant metastasis or death. Metastatic prostate cancer is cancer that has spread to another part of the body. mCSPC refers to prostate cancer that still responds to ADT. Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth. Patients with mCSPC tend to have a poor prognosis, with a median OS of less than five years, which underscores the need for new treatments, Luben said.
Now 49, Casariego said he is of an age where he will begin to receive regular prostate examinations. If a doctor discovers anything that could indicate cancer, he said he is glad to know that there are an increasing number of treatment options for this disease. Any treatment, he said, that can steal time from death, is a good thing for patients.
