The METACURE trial cohorts B2 and the B2 expansion looked at the combination of intensified hormonal therapy and radiation in patients with oligometastatic prostate cancer. So we increasingly are using radiation in combination with hormonal therapy, either ADT or ADT and an ARSI in patients with hormone-sensitive but low-volume oligometastatic prostate cancer. There’s uncertainty about the intensity of hormonal therapy and the duration of hormonal therapy that’s most appropriate for these patients...
The METACURE trial cohorts B2 and the B2 expansion looked at the combination of intensified hormonal therapy and radiation in patients with oligometastatic prostate cancer. So we increasingly are using radiation in combination with hormonal therapy, either ADT or ADT and an ARSI in patients with hormone-sensitive but low-volume oligometastatic prostate cancer. There’s uncertainty about the intensity of hormonal therapy and the duration of hormonal therapy that’s most appropriate for these patients. And in this context, the METACURE trial was designed. This is a multi-center, multi-arm randomized phase two trial that enrolled patients across multiple cohorts. And today I presented the results on the cohort B2 and the B2 expansion. The B2 cohort randomized 10 patients in an exploratory fashion to one of two intensified hormonal therapy approaches. That was ADT and apalutamide or ADT, apalutamide, and abiraterone for a total of 10 months of hormonal therapy in combination with metastasis-directed radiation. This cohort was later expanded and enrolled an additional 26 patients to receive six months of treatment with ADT and apalutamide. The goal of this was to test intensified hormonal therapy to get an early readout of treatment efficacy in these patients with a 12-month primary endpoint of undetectable PSA but recovered testosterone. This primary endpoint was achieved in 11 of 26 patients, so 43% of patients on the B2 expansion cohort, and 5 of 10 patients on the combined B2 cohorts that received either the doublet hormonal therapy or the triplet hormonal therapy. And this response was also durable in a number of patients. So secondary endpoints included the rate of PSA progression-free survival at 24 months and that was seen in 60% of patients across arms on this trial despite a very stringent definition of PSA progression of a PSA of less than just 0.2. And also notably a total of 16 of the 36 patients that enrolled on this trial had recovered testosterone but had not yet recurred with a PSA of greater than 0.2 or radiographic progression either at completion of follow-up at three years or remained on study and in follow-up and median follow-up for these patients was well over two years. We think that metastasis-directed therapy with short but intensified hormonal therapy is a promising approach for the treatment of patients with oligometastatic hormone-sensitive prostate cancer.
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