When given in combination with androgen deprivation therapy or ADT, Erleada (apalutamide) significantly prolonged the lives of men with metastatic hormone-sensitive prostate cancer (mHSPC) — without compromising their quality of life — according to final data from a Phase 3 trial.
Findings from the study, called TITAN (NCT02489318), also showed that the combination treatment significantly delayed disease progression or death among trial participants, according to Johnson & Johnson, the therapy’s developer.
The combo therapy also delayed the time to castration resistance, or a tumor’s resistance to ADT in these patients, the data showed.
“The results of the TITAN final analysis demonstrate that apalutamide with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer,” Catherine Taylor, Johnson & Johnson’s vice president of medical affairs in the therapeutic area strategy for Europe, Middle East and Africa, said in a press release.
Final data from TITAN were presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), held online Feb. 11–13. The oral presentation was titled “Final analysis results from TITAN: A phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT).”
Erleada is a form of oral hormone therapy that works by blocking the activity of androgen receptors — protein receptors that normally interact with male hormones — to prevent these receptors from sending signals that promote prostate cancer cell growth.
Developed by Janssen, a subsidiary of Johnson & Johnson, it is approved in the U.S. and Europe, in combination with ADT, for treating people with mHSPC. ADT is a standard treatment for prostate cancer that reduces the levels of male hormones in the body.
The approval was supported by data from TITAN, a large randomized, placebo-controlled Phase 3 trial that compared the combination of Erleada and ADT to that of ADT plus a placebo in a group of 1,052 men with mHSPC.
The initial results from TITAN showed that the combination therapy was superior to ADT alone at prolonging the time these patients lived, as well as delaying disease worsening.
A secondary analysis of the study also showed the addition of Erleada to ADT did not compromise patients’ quality of life nor change their tolerability to treatment.
Janssen now presented data from a final analysis of TITAN that confirmed the superiority of the combination therapy after a median of 44 months (nearly four years).
Overall, the addition of Erleada to ADT was found to lower the risk of death by 35% compared with ADT alone. This percentage increased to 48% after data was adjusted to take into account the 39.5% of patients who were originally assigned to receive ADT alone but crossed over to Erleada during the study.
In addition to prolonging patients’ survival, the combination therapy also lowered the risk of disease progression or death after a subsequent treatment by 38%, as well as the risk of castration resistance by 66%.
Additional analyses also confirmed that Erleada did not have a negative impact on participants’ quality of life.
Moreover, safety assessments demonstrated that Erleada’s safety profile was consistent with that of previous reports. Some of the observed side effects included fractures, falls, and skin rash.
“The TITAN final analysis is a welcome development for the management of metastatic hormone-sensitive-prostate cancer as the data show us that apalutamide with ADT improves long-term clinical benefit and prolonged overall survival, without compromising health-related quality of life for these patients,” said Axel Merseburger, chairman of the urology clinic at Universitatsklinikum Schleswig-Holstein, in Germany, and one of the trial’s investigators.
“The results also demonstrate an established safety profile which is encouraging for the management of patients living with advanced forms of prostate cancer,” Merseburger added.
Thus far, Erleada has been administered to more than 2,000 patients across multiple Phase 3 trials, including SPARTAN (NCT01946204), where it was found to be safe and effective at prolonging the survival of men with non-metastatic castration-resistant prostate cancer.