Presented at the Genitourinary Cancers Symposium in San Francisco, which ends today. [1]
“This was the first combination trial of two immune checkpoint therapies in prostate cancer,” Padmanee Sharma, MD, professor in the department of genitourinary medical oncology, division of cancer medicine at The University of Texas MD Anderson Cancer Center, said in a press release.
That's odd, since there was a Johns Hopkins study published in 2018 [2]:
"Ipilimumab plus nivolumab demonstrated encouraging efficacy in AR-V7-positive prostate cancers with DRD mutations, but not in the overall study population."
"In the current study, Sharma and colleagues evaluated the safety and efficacy of nivolumab (Opdivo, Bristol-Myers Squibb), which targets PD-1, plus ipilimumab in two cohorts of men with metastatic castration-resistant prostate cancer. Men received 1 mg/kg nivolumab plus 3 mg/kg ipilimumab every 3 weeks for four doses, followed by 480 mg nivolumab monotherapy every 4 weeks.
"The first cohort included asymptomatic or minimally symptomatic men who had progressed after treatment with second-generation hormone therapy and had not received chemotherapy (n = 45; median age, 69 years; range, 48-85). The second cohort consisted of men who progressed after taxane-based chemotherapy (n = 45; median age, 65 years; range, 46-84).
"Objective response rate and radiographic PFS based on Prostate Cancer Working Group 2 criteria served as the study’s coprimary endpoints. Safety served as a secondary endpoint.
"Seventy-eight men had a follow-up of at least 6 months. Median follow-up was 11.9 months for the first cohort and 13.5 months for the second cohort.
"ORR among men with baseline measurable disease was 25% (95% CI, 11.5-43.4) in the first cohort and 10% (95% CI, 2.1-26.5) in the second cohort.
"Median time to response was 1.9 months in the first cohort and 2.1 months in the second cohort.
"Six patients (17.6%; 95% CI, 6.8-34.5) in the first cohort and four (10%; 95% CI, 2.8-23.7) in the second cohort achieved PSA response, defined as a PSA decline of at least 50% from baseline.
"Five patients in the first cohort and two patients in the second cohort demonstrated a PSA of less than 0.2 ng/mL. Of these patients, four from the first cohort and one from the second cohort also had ongoing objective responses, Sharma said."
-Patrick