New clinical data presented at ESMO 2026 and published in leading journals confirm major advances in metastatic prostate cancer care. Real-world findings from a 3,709-patient French program validate the safety and efficacy of 177Lu-PSMA-617 radiopharmaceutical therapy, achieving an 82% disease control rate. Meanwhile, the global DASL-HiCaP trial demonstrates that adding darolutamide reduces four-year relapse risk by 58%, and early trials of Johnson & Johnson's novel oral drug JNJ-6143 report strong tumor response rates.
Lu-PSMA-617 real-world efficacy
- ▪A study published in The Journal of Nuclear Medicine confirmed that 177Lu-PSMA-617 radiopharmaceutical therapy is safe and effective for metastatic castration-resistant prostate cancer in routine clinical practice.
- ▪In a study profiling 57 metastatic castration-resistant prostate cancer patients treated with 177Lu-PSMA-617, predicted PSMA expression declined in 11 of 17 paired progression samples evaluated by Precede Biosciences.
- ▪Precede Biosciences presented liquid biopsy data from 57 metastatic castration-resistant prostate cancer patients at the ESMO Congress 2026 showing distinct molecular states associated with 177Lu-PSMA-617 treatment response.
French early-access program outcomes
- ▪Patients in the French early-access program achieved an 82% disease control rate by PSA criteria and a median progression-free survival of 7.6 months compared to 8.7 months in the VISION trial.
- ▪The French early-access program evaluated 3,709 metastatic castration-resistant prostate cancer patients across 46 centers receiving up to six cycles of 177Lu-PSMA-617 from December 2021 to April 2025.
- ▪French early-access program data revealed a flare-up phenomenon where prostate-specific antigen levels temporarily progressed after the first 177Lu-PSMA-617 cycle before declining after the second cycle.
Darolutamide DASL-HiCaP trial results
- ▪Prostate cancer mortality after four years was 5% among DASL-HiCaP trial participants treated with darolutamide compared to 14% among participants given a placebo.
- ▪In the 1,106-patient DASL-HiCaP trial, 95% of patients receiving darolutamide had not developed metastatic prostate cancer after four years compared to 88% of patients receiving a placebo.
- ▪Adding darolutamide to standard therapies in the global DASL-HiCaP trial reduced the risk of prostate cancer relapse and spread by 58% after four years in high-risk patients.
JNJ-6143 experimental treatment responses
- ▪In Johnson & Johnson's early trial of JNJ-6143 presented at ESMO, 69% of patients with measurable tumors achieved a confirmed complete or partial response.
- ▪Johnson & Johnson presented early-stage clinical trial data showing its experimental oral prostate cancer drug JNJ-6143 produced PSA reductions of at least 50% in 77% of evaluable patients at a 50-mg dose.
- ▪Johnson & Johnson acquired the experimental prostate cancer drug JNJ-6143 through its $3.05 billion acquisition of biotechnology company Halda Therapeutics.
Metastatic prostate cancer therapies
- ▪Darolutamide functions as an androgen receptor pathway inhibitor by binding to antigen receptors in prostate cancer cells to block testosterone from fueling cancer growth.
- ▪177Lu-PSMA-617 became the first approved radiopharmaceutical therapy for metastatic castration-resistant prostate cancer in 2022 following clinical results from the VISION trial.
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