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Originally posted by ttppxx: ↑

Actinium-225 alpha therapyfrom J&J? (what we know so far - per info gleaned from an abstract due to be reported next week)

SOME BACKGROUND

Clinical Trial Title: A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Link for full details: https://clinicaltrials.gov/study/NCT04644770

[Note: JNJ-69086420 (also referred to as JNJ-6420) is an alpha-particle emitter (as opposed to Cu67 which is a beta emitter)]

Study Objectives
To determine the recommended Phase 2 dose(s) (RP2D) of JNJ-69086420 in Part 1 (Dose Escalation), and,
To determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion)

Other Trial Details
An open-label clinical trial
Targetting men 'aged ≥18 years with advanced metastatic castration-resistant prostate cancer who have previously received at least one prior androgen receptor pathway inhibitor'.

THE REPORTS - (so far)

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REPORT 1: ASCO: J&J's radioligand spurs responses, but 4 deaths mar early results

Link to this report: https://www.fiercebiotech.com/biotech/asco-jjs-radioligand-spurs-responses-4-deaths-mar-early-result

Findings (summary) - almost verbatim
64 patients received at least one dose of JNJ-6420, with safety data being recorded for 57 who had received 150 μCi.
35(61%) experienced grade 3 or higher treatment-emergent adverse events (TEAEs), and 21(37%) had a serious TEAE. Almost all patients experienced some sort of TEAE.
Four patient deaths occurred, linked to repeated dosing of JNJ-6420. Two deaths were associated with interstitial lung disease (ILD), one with COVID-19-related respiratory failure, and one with decreased appetite/hypotension.
ILD occurred in patients receiving cumulative doses of 750 μCi or higher.
Thrombocytopenia (low platelet count) was reported in 63% of treatment-emergent adverse events (TEAEs), and ILD in 9%.
Common TEAEs included anemia, lymphopenia, and leukopenia.
Nine patients discontinued treatment.
JNJ-6420 demonstrated a reported PSA50 rate of 45.6%, indicating a positive prostate-specific antigen response associated with prolonged survival.
The drug produced one complete response, two partial responses, and three confirmed objective responses.
Notable clinical, biochemical, and radiographic responses were observed in patients receiving doses of 150 μCi and higher, with durable responses noted up to 112 weeks.

TO MITIGATE RISK: the study recommends a "cumulative dose cap and adaptive dosing schedule'. Evaluation of adaptive dosing is ongoing.

-----
REPORT 2: Ahead of ASCO, J&J reports mixed data on next-generation radiopharmaceutical

Link to this report: https://www.statnews.com/2024/05/23/johnson-and-johnson-radiopharmaceuticals-prostate-cancer/

Highlights:
"... An early-stage clinical trial of a radiopharmaceutical drug developed by Johnson & Johnson showed some signs of efficacy in prostate cancer patients, newly released data show, but four participants in the trial died.
"... 18% of participants on a mid-level dose of JnJ’s treatment had a complete or partial response. For comparison, approx. 29.8% of subjects in a Phase 3 trial of Pluvicto responded to the treatment..."

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I hope I have accurately represented the information that I found - and I hope this is useful to the Cu6 community.

Expand

Thanks for sharing and interpreting it for us. Unfortunate for the patients who died or had adverse impacts (one patient who died had Covid which would likely be not treatment related). Despite such a poor response why would J&J be presenting/ accepted by ASCO to present at such a prestigious event?

Despite the poor results their HREC is continuing the trials for patients who want to continue treatment despite knowing the interim results - should we interpret it as a serious lack of alternatives?

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