PROVEN RESULTS
IN NON-METASTATIC PROSTATE CANCER THAT DOES NOT RESPOND TO ADT*
NUBEQA® was studied in men with prostate cancer that has not spread (non-metastatic) and does not respond to ADT
In a clinical study, men who took NUBEQA + ADT were compared to men who took ADT 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 two thirds of the men in the study took NUBEQA and ADT, while the others did not.
NUBEQA group (955 men)
NUBEQA + ADT
Placebo group (554 men)
ADT
*ADT refers to a medical or surgical treatment that lowers 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 PS 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.
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 + ADT had cancer spreading or were no longer living compared to 39% (216 out of 554) of men taking ADT alone.
In the same study, NUBEQA helped men live longer
Men who added NUBEQA to ADT 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 + ADT were no longer living compared to 19% (106 out of 554) of men taking ADT alone.
NUBEQA also helped delay 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 men receiving NUBEQA vs men receiving ADT alone.
