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A cleaner version of abiraterone held the cancer back on scans for five extra months and did not make anyone live longer. It is the clearest warning in prostate cancer that scans are not survival.
ELM-PC 4 randomised 1,560 chemotherapy-naive men with progressive metastatic castration-resistant prostate cancer to orteronel 400 mg with prednisone twice daily (781) or placebo with prednisone (779), stratified by region and by radiographic disease progression at baseline.
Median radiographic progression-free survival was 13.8 months (95 percent confidence interval 13.1 to 14.9) with orteronel and 8.7 months (8.3 to 10.9) with placebo, hazard ratio 0.71 (0.63 to 0.80, p<0.0001). After a median 20.7 months, median overall survival was 31.4 months (28.6 to not estimable) against 29.5 months (27.0 to not estimable), hazard ratio 0.92 (0.79 to 1.08, p=0.31).
A 5.1-month improvement in radiographic progression-free survival with no effect on survival is a very large dissociation, and it happened in a trial of 1,560 men with 611 deaths, so it is not a power problem.
Toxicity was worse with orteronel: grade 3 or worse increased lipase in 137 of 784 men (17 percent) against 14 of 770 (2 percent), increased amylase in 77 (10 percent) against nine (1 percent), fatigue in 50 (6 percent) against 14 (2 percent) and pulmonary embolism in 40 (5 percent) against 27 (4 percent). Serious adverse events occurred in 358 (46 percent) against 292 (38 percent). Takeda stopped development in this indication on these and the ELM-PC 5 data.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,560 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival (median)primary | Orteronel with prednisone | 781 | 13.8 months | 0.71 (0.63 to 0.8) | <0.0001 | link |
| Placebo with prednisone | 779 | 8.7 months | ||||
| Overall survival (median)primary | Orteronel with prednisone | 781 | 31.4 months | 0.92 (0.79 to 1.08) | 0.31 | link |
| Placebo with prednisone | 779 | 29.5 months |
Shares COU-AA-302, Androgen receptor pathway inhibitor (ARPI), Prednisone, Castration-resistant prostate cancer (CRPC).
Shares CYP17A1 (17-alpha-hydroxylase/17,20-lyase), Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.
Shares 10TASQ10, Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares CYP17A1 (17-alpha-hydroxylase/17,20-lyase), Androgen receptor pathway inhibitor (ARPI), Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC).
Shares COU-AA-302, Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Androgen deprivation & AR pathway inhibitors.
Shares Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC), Androgen deprivation & AR pathway inhibitors.
Shares 10TASQ10, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Androgen receptor pathway inhibitor (ARPI), Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.