Janssen's First-in-Class Radioligand Therapy JNJ-69086420 Reports Four Patient Deaths in Phase I Trial for Metastatic Castration-Resistant Prostate Cancer

Recently, Johnson & Johnson presented for the first time at the ASCO meeting Phase I study data on its potential first-in-class radioligand therapy JNJ-69086420 for metastatic castration-resistant prostate cancer (mCRPC). The study focuses on heavily pretreated mCRPC patients who have received ≥1 androgen receptor pathway inhibitor treatment and were not selected based on biomarkers.

JNJ-6420 is the first radioactive ligand therapy targeting hK2, capable of emitting high-energy, short-range α-particles (225Ac) to prostate cancer cells. hK2 (encoded by the KLK2 gene) is a novel target expressed on the surface of prostate cancer cells, with limited expression in other areas.

As of January 5, 2024, 67 patients had received ≥1 dose of JNJ-6420 treatment. The treatment outcomes of 57 patients in the ≥150μCi JNJ-6420 cohort were summarized. At the interim analysis, confirmed objective responses were observed in 3 patients (12.5%), with 1 patient achieving complete response. The disease control rate at 6 months was 28.1%.

In terms of safety, 35 patients (61.4%) experienced Grade 3 or higher treatment-emergent adverse events (TEAEs), and 21 patients (36.8%) experienced serious TEAEs. Notable TEAEs included thrombocytopenia (63.2%) and interstitial lung disease (ILD, 9%), both of which were associated with repeated dosing. Nine patients (15.8%) discontinued treatment due to treatment-related adverse events (TRAEs); four patients died due to TRAEs.

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