cetrelimab (JNJ-63723283) / J&J, Xoma - LARVOL DELTA

Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results (ESMO 2025) - P2 | "Conclusions At primary analysis, TAR-200 + CET showed high pCR, pOR and 1-y RFS, supporting a role for the combination in MIBC. Exploratory ut/ctDNA data support further investigation as predictive biomarkers for residual disease after neoadjuvant therapy in MIBC."

Biomarker • Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology

C3NIRA: Randomized phase II study of carboplatin-cabazitaxel-cetrelimab (anti-PD-1) induction followed by niraparib +/- cetrelimab maintenance in men with aggressive variant prostate cancers (AVPC). (ASCO 2025) - P2 | "Most were White/non-Hispanic (78%) and had not received prior docetaxel (58%). A subset of men with AVPC derive meaningful benefit from the addition of anti-PD-1 to PARP inhibitor maintenance following platinum-taxane-anti-PD-1 induction. Ongoing correlates aim to identify biomarkers to select patients for this treatment strategy and reveal candidate mechanisms of resistance to guide future therapeutic combinations."

Clinical • IO biomarker • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • FOXP3

Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. (ASCO-GU 2026) - P3 | "Gem-iDRS (previously TAR-200), approved for BCG-unresponsive non-MIBC with carcinoma in situ, is an intravesical drug-releasing system designed for sustained delivery of gemcitabine in bladder... Patients (pts; ≥18 yrs with cT2-T4a, N0, M0 MIBC, declined/ineligible for RC) were randomized 1:1 to Gem-iDRS + intravenous CET (arm 1) or concurrent CRT (cisplatin or gemcitabine plus RT, 64 or 55 Gy; arm 2)... In SunRISe-2, Gem-iDRS + CET did not show superior BI-EFS over CRT in pts with MIBC not receiving RC. 24-mo BI-EFS rates in pts with CR at W18, and MFS and OS rates in all pts were similar in both arms. There were no unexpected safety findings in either arm."

Clinical • Combination therapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. (PubMed, Lancet Oncol) - P2 | "Neoadjuvant TAR-200 plus cetrelimab showed a high pathological complete response rate with a manageable safety profile. These results support continued investigation of TAR-200 in patients with muscle-invasive bladder cancer planned for radical cystectomy."

Journal • Monotherapy • P2 data • Bladder Cancer • Diabetes • Genito-urinary Cancer • Oncology • Solid Tumor

TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. (PubMed, J Clin Oncol) - P2 | "TAR-200 monotherapy was well tolerated, with a high CR rate, durable responses, and prolonged DFS in patients with BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS."

Journal • P2b data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SunRISe-4: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov) - P2 | N=163 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2027 ➔ Mar 2026

Trial completion date • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer

QUEST: A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=136 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2025 ➔ Dec 2026

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

BASELINE URINARY TUMOR DNA, MINIMAL RESIDUAL DISEASE AND GENOMIC DISEASE BURDEN IN RELATION TO CLINICAL RESPONSE TO TAR-200 IN THE PHASE 2B SUNRISE-1 TRIAL (SUO 2025) - "SunRISe-1 is an ongoing Phase 2b study assessing the safety and efficacy of TAR-200 ± cetrelimab (CET, an anti-PD-1 antibody) and CET alone in Bacillus Calmette-Guérin -unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. While residual disease assessed by utDNA is a known prognostic factor, these results show TAR-200 treatment is associated with a high CR rate and durable responses in patients, independent of utDNA MRD status. This corroborates broad clinical activity observed with TAR-200 monotherapy in BCG-unresponsive high-risk-NMIBC with CIS with or without papillary disease."

Clinical • Minimal residual disease • P2b data • Residual disease • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease (ESMO 2025) - P2 | "SunRISe-1 (NCT04640623) is an ongoing Phase 2b study assessing the safety and efficacy of TAR-200 ± cetrelimab (CET, antiPD-1) and CET alone in Bacillus Calmette-Guérin -unresponsive high-risk NMIBC with CIS, with/without papillary disease. CR rate (78.2% [95% CI 56.3%, 92,5%] vs 88.9% [95% CI 65.3%, 98.6%]) and median DOR (26.5 mo [8.31 mo, NE] vs NE [7.06 mo, NE]) were similar between MRD+ and MRD− pts. Conclusions TAR-200 monotherapy showed broad clinical activity in BCG unresponsive HR-NMIBC with CIS independent of baseline somatic alterations, PD-L1, and utDNA MRD status."

Biomarker • Clinical • IO biomarker • P2b data • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Microsatellite Instability • Oncology • Solid Tumor • HER-2 • MSI • PD-L1 • PIK3CA • TMB • TP53

PolyDamas: A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=71 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

Association of genomic disease burden markers and programmed death-ligand 1 with clinical outcomes in patients with muscle-invasive bladder cancer treated with gemcitabine intravesical system + cetrelimab (CET) or CET alone in the Phase 2 SunRISe (AUA 2026) - No abstract available

Clinical • Clinical data • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1b | N=125 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2024 ➔ May 2024

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

Neoadjuvant (Neoadj) gemcitabine intravesical system (Gem-iDRS) plus cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC) ineligible for/refusing neoadj cisplatin-based chemotherapy (NAC): Updated perioperative outcomes from SunRISe-4. (ASCO-GU 2026) - P2 | "Gem-iDRS, previously TAR-200, is a novel intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder. In pts with MIBC ineligible for or refused NAC, neoadj Gem-iDRS plus CET and CET alone were not associated with declines in overall health, delays to RC, or significant increase in 30- and 90-d post-RC morbidity or mortality. Addition of Gem-iDRS to the checkpoint inhibitor CET did not worsen safety and post-RC morbidity compared with CET alone. Safety outcomes within 30 and 90 d post RC."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=413 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=600 ➔ 413

Enrollment change • Enrollment closed • First-in-human • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=368 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2019 ➔ Nov 2020

First-in-human • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1b | N=126 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2023 ➔ Sep 2023

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

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1b | N=102 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2020 ➔ Jun 2023

IO biomarker • Trial completion date

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Apr 2019 ➔ Jul 2019

First-in-human • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=169 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1b | N=126 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2023 ➔ Jun 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

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

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1b | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=102 ➔ 150

Enrollment change • IO biomarker • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Recruiting | N=368 ➔ 250

Enrollment change • Enrollment open • First-in-human • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1b | N=102 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=413 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Oct 2024 ➔ Oct 2023

First-in-human • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jan 2022 ➔ Feb 2023

First-in-human • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer