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

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

SOGUG-NEOWIN: A phase 2, open-label, multicenter, multinational interventional trial evaluating the efficacy and safety of erdafitinib (ERDA) monotherapy and the combination of ERDA and cetrelimab (CET) as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) harboring FGFR gene alterations. (ASCO 2025) - "As of January 21, 2025, 68 patients were pre-screened, 6 were FGFR2/3-positive, and 4 were enrolled. (EU CT Number 2024-512573-27-01)."

Clinical • IO biomarker • Monotherapy • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Otorhinolaryngology • Pain • Retinal Disorders • Solid Tumor • Urothelial Cancer • FGFR • FGFR2

TALQUETAMAB + CETRELIMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: INITIAL SAFETY AND EFFICACY RESULTS FROM THE PHASE 1B TRIMM-3 STUDY (EHA 2025) - P1 | "Background: Talquetamab (Tal) is the first approved GPRC5D-targeting bispecific antibody (BsAb) for relapsed/refractory multiple myeloma (RRMM). Tal + Cet showed deep and durable responses in pts with RRMM and prior CD3 redirecting Ab therapy, contrary to results with Tal monotherapy (shortened durability) but similar to results with Tal + daratumumab. These proof-of-concept data are encouraging for PD-1 inhibition in RRMM and further support Tal as a versatile combination partner to overcome intrinsic resistance mechanisms due to its unique mechanism of action."

Clinical • IO biomarker • P1 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • CD8 • GPRC5D • PD-L1

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: Rahul Aggarwal | Active, not recruiting ➔ Terminated; Funding

Trial termination • Castration-Resistant Prostate Cancer • Endocrine Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • RB1 • SYP

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=213 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2025 ➔ Jun 2026

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

PolyDamas: A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Initial results from a phase 1 study of an A2a receptor antagonist, administered as monotherapy and in combination with anti-PD1 therapy in patients with advanced non-small cell lung cancer (AACR 2025) - P1 | "JNJ-86974680 demonstrated a favorable safety and tolerability profile as monotherapy and in combination with cetrelimab, with dose-proportional PK and near-complete A2aR inhibition in peripheral lymphocytes at clinically relevant doses (15-30 mg). Ongoing dose escalation aims to optimize intratumoral drug concentrations and maximize A2aR inhibition."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ADORA2A

CD8 PET Imaging in Metastatic Solid Tumours (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University Medical Center Groningen | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=126 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | N=76 ➔ 126 | Trial completion date: Aug 2028 ➔ Jun 2029

Enrollment change • Monotherapy • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • ROS1

Association of Urine Tumor DNA (utDNA) with Pathologic Complete Response to Neoadjuvant TAR-200 + Cetrelimab in the Phase 2b SunRise-4 Trial in Patients with Localized Muscle-Invasive Bladder Cancer (MIBC) Scheduled for Radical Cystectomy (RC) (EAU 2025) - No abstract available

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

QUEST: A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=136 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2024 ➔ Dec 2025

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

NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov) - P1/2 | N=125 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2025 ➔ Dec 2025

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

Development of TAR-200: A novel targeted releasing system designed to provide sustained delivery of gemcitabine for patients with bladder cancer. (PubMed, Urol Oncol) - "This includes 3 phase I studies evaluating the safety and initial tumor activity of TAR-200 and 5 phase II/III studies assessing the efficacy and safety of TAR-200, with or without systemic cetrelimab, as a treatment option for patients with HR NMIBC (bacillus Calmette-Guérin naive [papillary and carcinoma in situ] and MIBC (neoadjuvant and patients ineligible for or refusing radical cystectomy). Preliminary data from the phase IIb SunRISe-1 study demonstrate that TAR-200 monotherapy is safe and effective in patients with bacillus Calmette-Guérin-unresponsive high-risk NMIBC. TAR-200 represents an innovative approach to the local treatment of bladder cancer."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

PolyDamas: A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2026 ➔ Jun 2026

Trial completion date • Lung Cancer • Non Small Cell Lung 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 | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer

SAFETY AND TOLERABILITY OF TAR-200 MONOTHERAPY IN PATIENTS WITH BACILLUS CALMETTE–GUÉRIN (BCG)-UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (HR NMIBC) IN SUNRISE-1 (SUO 2024) - P2 | "SunRISe-1 (SR-1; NCT04640623) is an ongoing, phase 2b study assessing the efficacy and safety of TAR-200 + cetrelimab (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or cetrelimab alone (C3) in patients with BCG-unresponsive HR NMIBC ineligible for or refusing radical cystectomy. TAR-200 monotherapy was well tolerated in SR-1, with a high rate of insertion success and a median indwelling duration of 22 days. Commonly reported lower urinary tract related TRAEs were manageable and resolved after a short duration. TAR-200 has a promising safety and efficacy profile as a local, bladder-sparing treatment in HR NMIBC unresponsive to BCG."

Clinical • Monotherapy • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

TAR-200 +/- cetrelimab and cetrelimab alone in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer: updated results from SunRISe-1 (EMUC 2024) - P2 | "Cetrelimab alone provided a modest CR rate comparable to other anti-PD-(L)1 agents. Results from Cohort 1, Cohort 2, and Cohort 3 support the continued development of TAR-200 monotherapy in patients with BCG-unresponsive HR NMIBC."

Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy: interim analysis of SunRISe-4 (EMUC 2024) - P2 | "Table. Efficacy results TAR-200 + cetrelimab (Cohort 1) Cetrelimab alone (Cohort 2) Efficacy evaluable: overall n=53 n=31 pCR rate, % (95% CI) 42 (28-56) 23 (10-41) pOR rate, % (95% CI) 60 (46-74) 35 (19-55) Efficacy evaluable: cT2 subgroup n=40 n=26 pCR rate, % (95% CI) 48 (32-64) 23 (9-44) pOR rate, % (95% CI) 68 (51-81) 31 (14-52)"

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

SunRISe-3: A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) (clinicaltrials.gov) - P3 | N=1135 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | N=66 ➔ 96

Enrollment change • Metastases • Monotherapy • Oncolytic virus • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Quality of Primary TURBTs for Non-Muscle Invasive Bladder Cancer Patients (SIU 2024) - P2 | "In middle grade lists, Mitomycin C was given in 40% of cases and detrusor muscle was only found in 37% of specimens...SunRISe-1 (NCT04640623) is a randomized phase 2b study assessing efficacy and safety of TAR-200 + cetrelimab (Cohort 1 [C1]), TAR-200 (C2), or cetrelimab (C3) in patients with BCG-unresponsive HR NMIBC with carcinoma in situ (CIS) ineligible for or refusing radical cystectomy... In SunRISe-1, TAR-200 monotherapy is associated with a clinically meaningful, high, centrally confirmed CR rate, durable responses, and a favorable benefit-risk profile in patients with BCG-unresponsive CIS."

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

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=345 ➔ 200

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • 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=160 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Dec 2026 ➔ Feb 2025

Combination therapy • Trial primary completion date • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer

SunRISe-2: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder (clinicaltrials.gov) - P3 | N=518 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

TAR-200 plus cetrelimab (CET) or CET alone as neoadjuvant therapy in patients (pts) with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy (NAC): Interim analysis of SunRISe-4 (SR-4) (ESMO 2024) - P2 | "TAR-200 + CET neoadjuvant therapy revealed compelling pCR and pOR rates, with a manageable safety profile, supporting the addition of TAR-200 to anti-PD-1 tx in pts with MIBC. In the cT2 subgroup, >2/3 pts who received TAR-200 + CET tx were downstaged to ≤ T1 at RC and ∼1/2 pts achieved pCR. SR-4 interim results support further investigation of TAR-200 + CET in pts with MIBC."

Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor