PROVEN RESULTS IN nmCRPC
nmCRPC=prostate cancer that has not spread (non-metastatic) and does not respond to hormone therapy*
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 2/3 of the patients in the study took NUBEQA and hormone therapy, while the 1/3 did not.
NUBEQA group (955 men)
NUBEQA + hormone therapy*
Placebo group (554 men)
Hormone therapy*
*Hormone therapy includes drug treatments to lower testosterone or surgery.
†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
(median† 3.4 years vs 1.5 years)
At the time of analysis, 23% (221 out of 955) of men taking NUBEQA + hormone therapy had cancer spreading or were no longer living compared to 39% (216 out of 554) of men taking hormone therapy alone.
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† not reached for both groups)
At the time of analysis, 15% (148 out of 955) of men taking NUBEQA + hormone therapy were no longer living compared to 19% (106 out of 554) of men taking hormone therapy alone.
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.
