JNJ-6420 / J&J - LARVOL DELTA

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=257 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2027 ➔ May 2028 | Trial primary completion date: Sep 2027 ➔ May 2028

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=232 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2028 ➔ Sep 2027

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=231 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=111 ➔ 231 | Trial primary completion date: Feb 2028 ➔ Sep 2027

Enrollment change • Metastases • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Dec 2025 ➔ Feb 2028

Metastases • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2026 ➔ Aug 2028

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 1 study of JNJ-69086420 (JNJ-6420), an actinium-225 ( 225 Ac) -labeled antibody targeting human kallikrein 2 (hK2), for metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2024) - P1 | "In this first-in-human study, key TEAEs of JNJ-6420 were thrombocytopenia and ILD, both associated with repeated dosing. At ≥150 μCi, 1-2 doses of JNJ-6420 elicited profound and durable biochemical and radiographic responses. Evaluation of the RP2D is ongoing."

Metastases • P1 data • Anemia • Genito-urinary Cancer • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • KLK2

ASCO: J&J's radioligand spurs responses, but 4 deaths mar early results (FierceBiotech) - P1 | N=111 | NCT04644770 | Sponsor: Janssen Research & Development, LLC | "Johnson & Johnson’s radiopharmaceutical spurred 'profound and durable' responses, however, four patient deaths in the early-stage trial marred the results....There were four deaths due to TEAEs, which were associated with repeated dosing of JNJ-6420....The abstract noted cases of thrombocytopenia (low platelet count) in 63% of the reported TEAEs and ILD in 9%. The cases of ILD all occurred in patients who had received cumulative doses of greater than or equal to 500 μCi prior to the implementation of pulmonary function surveillance....As for the responses, the data showed a reported PSA50 rate of 45.6%."

P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=76 ➔ 111 | Trial completion date: Jul 2025 ➔ Oct 2025

Enrollment change • Metastases • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=134 ➔ 76

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=134 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=100 ➔ 134

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2025 ➔ Jul 2025 | Trial primary completion date: Mar 2023 ➔ Mar 2025

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=70 ➔ 100

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 1 study of JNJ-69086420, an actinium-225-labeled antibody targeting human kallikrein-2, for advanced prostate cancer. (ASCO-GU 2022) - P1 | "Secondary endpoints include prostate specific antigen response rate, overall response rate (PCWG3 modified RECIST 1.1 criteria), PK, PD, immunogenicity, and biomarker analyses. Enrollment began in Dec 2020; as of Sep 2021, 4 sites have been initiated and 14 pts enrolled; currently, dose escalation is ongoing."

IO biomarker • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • KLK2

Phase 1 study of JNJ-69086420, an actinium-225-labeled antibody targeting human kallikrein-2, for advanced prostate cancer. (ASCO 2022) - P1 | "Secondary endpoints include prostate specific antigen response rate, overall response rate (PCWG3 modified RECIST 1.1 criteria), PK, PD, immunogenicity, and biomarker analyses. Enrollment began in Dec 2020; as of 10 Feb 2022, 4 sites have been initiated and 23 patients enrolled; currently, dose escalation is ongoing."

IO biomarker • P1 data • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • AR • KLK2

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=50 ➔ 70

Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2023 ➔ Aug 2024

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor