CA184-095 Clinical Trial

The results of this randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naïve castration-resistant prostate cancer were published on online on October 10, 2016.

The following summary is an excerpt from the original report which can be found in the The Journal of Clinical Oncology.

Results: Four hundred patients were randomly assigned to ipilimumab and 202 to placebo; 399 were treated with ipilimumab and 199 with placebo. Median OS was 28.7 months (95% CI, 24.5 to 32.5 months) in the ipilimumab arm versus 29.7 months (95% CI, 26.1 to 34.2 months) in the placebo arm (hazard ratio, 1.11; 95.87% CI, 0.88 to 1.39; P = .3667). Median progression-free survival was 5.6 months in the ipilimumab arm versus 3.8 with placebo arm (hazard ratio, 0.67; 95.87% CI, 0.55 to 0.81). Exploratory analyses showed a higher prostate-specific antigen response rate with ipilimumab (23%) than with placebo (8%). Diarrhea (15%) was the only grade 3 to 4 treatment-related adverse event (AE) reported in > 10% of ipilimumab-treated patients. Nine (2%) deaths occurred in the ipilimumab arm due to treatment-related AEs; no deaths occurred in the placebo arm. Immunerelated grade 3 to 4 AEs occurred in 31% and 2% of patients, respectively.

Conclusion: Ipilimumab did not improve OS in patients with metastatic castration-resistant prostate cancer. The observed increases in progression-free survival and prostate-specific antigen response rates suggest antitumor activity in a patient subset.

Clinical Trials Unit at PASO participated in this study between August 2010 – December 2015 and recruited 15 participants.

TH3RESA Clinical Trial

First results from a phase III clinical trial of the combination drug, T-DM1, show that it significantly improves the length of time before the disease worsens in women with advanced HER2 positive breast cancer whose cancer has recurred or progressed despite previous treatments, including trastuzumab and lapatinib.

In a late-breaking presentation to the 2013 European Cancer Congress (ECC2013) Professor Hans Wildiers will say: “This study shows that even in heavily pre-treated women, 75% of whom had cancer that has spread to the internal organs, T-DM1 nearly doubles progression-free survival – the length of time before disease progression or death, whichever occurs first – compared to standard therapy, and with a more favourable safety profile. Few drugs have been able to achieve both improved progression-free survival and a better toxicity profile. These results indicate this drug has important clinical benefit for patients.”

Clinical Trials Unit at PASO was the only centre in Victoria participated in that study and recruited 9 participants.

COUGAR (COU-AA-302) Clinical Trial

COU-AA-302 randomly assigned 1,088 patients with metastatic castration-resistant prostate cancer to treatment with abiraterone plus concurrent prednisone at 5 mg or placebo plus the same dose of prednisone. The study was unblinded after an interim analysis by an independent data monitoring committee found a significant difference in radiographic progression-free survival and a trend toward improved overall survival. At that time, patients in the placebo arm were allowed to cross over to active treatment.

At the third interim analysis, radiographic progression-free survival was significantly improved in the abiraterone-treated group: 16.5 vs 8.2 months in the placebo group, representing a 48% risk reduction of disease progression and death for abiraterone (P < .0001). At that time, it appeared that there would be an overall survival benefit as the data matured, Dr Ryan said. “A clear-cut benefit for [abiraterone] was observed for all secondary endpoints,” he noted.

Clinical Trials Unit at PASO participated in that study and recruited 8 participants.