PROVEN RESULTS IN nmCRPC
nmCRPC stands for non-metastatic castration-resistant prostate cancer
NUBEQA was studied in patients with nmCRPC
The ARAMIS study looked at NUBEQA and hormone therapy* in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) compared to hormone therapy* alone with a prostate-specific antigen doubling time (PSADT) of ≤ 10 months.
- 1509 men between the ages of 48 and 95 were included in the study, with a median† age of 74
- The study included men who were newly diagnosed and men who had been living with prostate cancer for more than 28 years, with a median time of 7 years
- 69% (1041 men) were still physically able to do things they could before their disease‡
About half of the patients in the study took NUBEQA and hormone therapy, while the other half did not.
NUBEQA group (955 men)
NUBEQA + hormone therapy†
Placebo group (554 men)
Hormone therapy†
*Hormone therapy includes drug treatments or surgery to lower testosterone.
†Median is the middle value in a set of numbers, not the average.
‡According to the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale. 31% of patients had an ECOG performance status score of 1, meaning they were restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
In the ARAMIS study, NUBEQA helped keep cancer from spreading
Men in the NUBEQA group experienced metastasis-free survival (MFS) for 3.4 years (median)† compared with 1.5 years (median)† for men in the placebo group.
In the same study, NUBEQA also helped men live longer
Men with nmCRPC who added NUBEQA to hormone therapy had a 31% lower risk of dying than men in the placebo group.
Median† for the treatment groups were: NR (not reached) for NUBEQA + hormone therapy (56.1, NR) and NR (46.9, NR) for placebo + hormone therapy.
At the time of analysis, 15% (148 out of 955) of patients in the NUBEQA with ADT group died compared to 19% (106 out of 554) of patients in the placebo plus ADT group.
In the same study, NUBEQA delayed pain progression§
It took 15 extra months for pain to get worse for men in the NUBEQA group compared with men in the placebo group (median† duration 40.3 months vs 25.4 months).
§Pain progression was defined as:
- An increase of 2 or more points of the worst pain felt in a 24-hour period, measured twice in a row, 4 weeks apart, OR an initiation of opioids for at least 7 days in a row for patients without pain
- An increase of 2 or more points, from a pain score of 4 or more, of the worst pain felt in a 24-hour period, measured twice in a row, 4 weeks apart, OR an initiation of opioids for at least 7 days in a row for patients with pain and a pain score of 1 or more
Patients who used opioids within 4 weeks were removed from the analysis, with 19% removed from the NUBEQA + docetaxel arm and 18% removed from the placebo + docetaxel arm.
NUBEQA delayed the need for chemotherapy
There was a 42% reduction in the time to first use of chemotherapy for patients receiving NUBEQA versus patients receiving ADT alone.
