Prostate Cancer, Early, Recurrent

February 12, 2018

Astellas Pharma and Pfizer announced results from the Phase III PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The Phase III randomized, double-blind, placebo-controlled, multi-national trial enrolled approximately 1,400 patients with M0 CRPC. The primary endpoint of the PROSPER trial, metastasis-free survival (MFS), is a measure of the amount of time that passes until a cancer can be radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. Secondary endpoints included time to PSA progression, time to first use of antineoplastic therapy and overall survival. The results show that the use of XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. The median for the primary endpoint MFS, was 36.6 months for men who received XTANDI compared to 14.7 months with ADT alone (n=1401; HR=0.29 [95% CI: 0.24-0.35]; p<0.0001). Marketing applications based on the results of the PROSPER study have been submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

March 6, 2017

Augmenix reported results of a phase III trial of SpaceOAR System hydrogel for maintaining sexual function and potency following intensity modulated radiation therapy (IMRT) during prostate radiotherapy. Studies have shown a correlation between radiation dose to the penile bulb, a structure at the base of the penis, and post-radiotherapy impotence. In the SpaceOAR System trial, the median radiation dose to the penile bulb was reduced by 49% in SpaceOAR treated patients (21 Gy for Control vs. 11 Gy for SpaceOAR treated, p=0.036). Among men who were potent at baseline, the analysis showed that SpaceOAR treated men were better able to maintain erections sufficient for intercourse through three years of follow-up (p=0.03). Of the men treated with SpaceOAR, 66.7% were able to have erections sufficient for intercourse at three years compared to 37.5% in the Control arm, a 77.8% improvement.

February 27, 2017

OncoGenex Pharmaceuticals reported results of apatorsen in two randomized phase II clinical trials for bladder and prostate cancer. The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (overall survival hazard ratio (HR)=0.80; 80% CI: 0.65-0.98; p=0.078). Partial or complete responses occurred in 16.2% patients receiving apatorsen plus docetaxel compared to 10.9% patients receiving docetaxel alone with median response durations of 6.2 months versus 4.4 months, respectively. Higher baseline serum heat shock protein 27 (Hsp27) levels were significantly prognostic for indicating an almost two-fold higher risk of death (HR=1.96; p=0.0001). In an exploratory analysis on a subset of patients (20% of total) who completed at least two treatment cycles and had either a decrease in serum Hsp27 levels from baseline or had only a 20.5% increase in serum Hsp27 levels from baseline, the reduction in risk of death with apatorsen treatment was 71% (HR=0.29: 80% CI: 0.18-0.48; interaction p=0.0727). The Pacific trial evaluated the ability of apatorsen, when added to Zytiga (abiraterone acetate), to reverse or delay treatment resistance in 72 men who were experiencing a rising PSA on Zytiga alone. The primary endpoint evaluated the proportion of patients who were progression free (clinical and radiologic) at study day 60 with apatorsen added to Zytiga, compared to continuing Zytiga alone. In men receiving apatorsen, 33% were progression free at study day 60 compared to 17% for those men receiving Zytiga alone. For patients with five circulating tumor cells (CTCs) at baseline, 22% vs 11% of patients had a CTC reduction to less than five CTCs when apatorsen was added to Zytiga vs Zytiga alone, respectively. Clinical data from trials in bladder and prostate cancers demonstrated apatorsen was well-tolerated and improved patient outcomes when administered in combination with standard-of-care treatments.

March 28, 2016

Janssen-Cilag International issued phase III results of ZYTIGA (abiraterone acetate) plus prednisone for early and less aggressive chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). COU-AA-302 was an international, randomized, double-blind, placebo-controlled study that included 1,088 men with mCRPC who had not received prior chemotherapy and were randomized to receive ZYTIGA (abiraterone acetate) 1,000 milligrams (mg) administered orally once-daily plus prednisone 5mg administered twice-daily or placebo plus prednisone 5mg administered twice-daily. The co-primary endpoints of the study were rPFS and OS. The post-hoc analysis used the final dataset for the intent-to-treat population (n=1,088), to stratify patients into Group 1 (BPI 0-1, PSA <80 ng/ml and GS <8) and Group 2 (BPI=2 and/or PSA=80ng/ml and/or GS=8). The study provided an 11.8 months overall survival (OS) benefit (53.6 months vs. 41.8 months; HR=0.61 [95% CI, 0.43-0.87]; p=0.0055), compared to an active control of placebo plus prednisone. The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in Group 1 were in an earlier, less advanced and less symptomatic stage of the disease (which was defined as having a Brief Pain Inventory [BPI] Short Form score of 0-1, prostate-specific antigen [PSA] below 80ng/ml and a Gleason score [GS] of below 8). Those in Group 2 were in a later, more advanced and more symptomatic stage of the disease (defined as a having a BPI of 2 or over and/or PSA of 80ng/ml or above, and/or a GS of 8 or more). The analysis revealed that patients in both groups experienced an OS benefit when treated with ZYTIGA plus prednisone, compared to placebo plus prednisone (Group 1: 11.8 months; HR=0.61 [95% CI, 0.43-0.87]; p=0.0055) (Group 2: 2.8 months; HR=0.84 [95% CI, 0.72-0.99]; p=0.0321).

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