ASCO24: J&J's radioligand bet overshadowed by patient deaths in early trial
24 May 2024
ASCOPhase 1Clinical Result
Johnson & Johnson's targeted alpha therapy JNJ-6420 demonstrated potentially encouraging anti-tumour effects in heavily pretreated men with metastatic castration-resistant prostate cancer, according to new early-stage trial data to be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting.
However, while the company's foray into the radiopharmaceutical space was marked by promising efficacy, the first-in-human Phase I study of JNJ-6420 – which targets human kallikrein 2 with an actinium-225 (225Ac)-labeled antibody – was also marred by four patient deaths considered related to treatment.
Among 57 patients treated at dose levels of ≥150 µCi of JNJ-6420, 45.6% saw their prostate-specific antigen levels decline by at least half (PSA50), while 14% achieved PSA90. Researchers also noted that JNJ-6420 elicited "profound and durable biochemical and radiographic responses" after one or two doses of the experimental therapy. The confirmed objective response rate was 12.5% among the 24 patients with measurable disease at baseline, including one complete reponse and two partial responses.
ILD, thrombocytopenia key adverse events
However, the flip side of the JNJ-6420 data revealed treatment-related toxicities, including thrombocytopenia and interstitial lung disease (ILD), which researchers said were both associated with repeated dosing. Rates of thrombocytopenia and ILD were 63.2% and 9%, respectively. Investigators noted that all five ILD cases occurred at cumulative doses of ≥500 µCi and prior to implementation of pulmonary function surveillance.
Overall, 61.4% of patients treated with 150 µCi of JNJ-6420 or more experienced Grade ≥3 treatment-emergent adverse events, which aside from thrombocytopenia and ILD also included anaemia, lymphopenia and leukopenia. In addition, nine out of 57 patients (15.8%) discontinued treatment due to toxicities related to JNJ-6420.
Johnson & Johnson is the latest company jumping into the increasingly busy radiopharmaceutical space, which has seen a spate of recent deals, including Eli Lilly inking one just this week for Aktis Oncology to the tune of up to $1.1 billion. For related analysis, see Vital Signs: Mapping the slim pickings in radiopharmaceuticals.
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