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

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=67 | Active, not recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | Trial completion date: Jun 2029 ➔ Nov 2027

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

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

Early chemo-induced TME alterations as a predictor of response to PD-1 blockade in AVPC: Single-cell data from C3NIRA. (ASCO 2026) - P2 | "The C-COLA study (NCT03263650) showed that Cabazitaxel/Carboplatin (CabCarb) elicited inflammatory signaling in responsive patients with AVPC...Sixty patients completed induction and were subsequently randomized to Niraparib maintenance with or without Cetrelimab... One cycle of CabCarb induction altered the TME in a subset of AVPC tumors, with reduction of suppressive myeloid and T cell populations and expansion of anti-tumor effector cells associated with clinical responses. These early TME changes may predict benefit from the addition of PD-1 blockade and help refine patient selection for immune checkpoint inhibition. Ongoing analyses are identifying additional therapeutic vulnerabilities in the TME that can be targeted to further improve outcomes in men with AVPC."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • FOXP3 • GZMK • LAG3 • SPP1 • TIGIT

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

Results from SunRISe-1 in patients (Pts) with bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) receiving TAR-200 monotherapy (ESMO 2023) - P2b | "SunRISe-1 (NCT04640623) is an ongoing, randomized, ph 2b study assessing efficacy and safety of TAR-200 + cetrelimab (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or cetrelimab alone (C3) in pts with BCG-unresponsive HR NMIBC ineligible for or refusing radical cystectomy. No deaths were reported. Conclusions In SunRISe-1, TAR-200 monotherapy is associated with an unprecedented CR rate, durable responses, and a favorable tolerability profile in pts with BCG-unresponsive CIS, supporting its continued investigation in HR NMIBC."

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

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

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) - P2 | "Source of Funding: Johnson & Johnson INTRODUCTION AND OBJECTIVES: Previous SunRISe-4 analyses (NCT04919512) demonstrated that Gemcitabine Intravesical System (Gem-iDRS; formerly TAR-200) + CET achieved high pathologic complete response (pCR), pathologic overall response (pOR), and 1-year recurrence free survival (RFS). High TMB, GDB and PD-L1 were all associated with higher pOR rates in muscle invasive bladder cancer (MIBC) pts in the overall cohort or with GEM iDRS+CET in the SunRISe-4 study. These findings warrant further investigation in a larger study to assess the potential utility of these biomarkers."

Clinical • Clinical data • IO biomarker • P2 data • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • MLH1 • MSH2 • MSH6 • PD-L1 • PMS2 • TMB

TAR-200 +/- cetrelimab (CET) and CET alone in patients (pts) with bacillus Calmette-Guérin-unresponsive (BCG UR) high-risk non-muscle-invasive bladder cancer (HR NMIBC): Updated results from SunRISe-1 (SR-1) (ESMO 2024) - P2 | "TAR-200 monotherapy is highly effective, with the highest single agent CR rate based on published data to date in pts with BCG UR HR NMIBC, durable responses and low d/c rate from TRAEs. CET alone provided modest CR rate comparable to other anti-PD-(L)1 agents. Results from C1, C2, and C3 support the continued development of TAR-200 monotherapy in pts with BCG UR HR NMIBC."

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

SOGUG-NEOWIN: A phase II, open-label, multi-centre trial evaluating the efficacy and safety of erdafitinib (ERDA) monotherapy and ERDA and cetrelimab (CET) as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) and FGFR gene alterations (ESMO 2024) - P2 | "First patient screened on 31-Jan-2024. This trial would be the first to systematically address whether ERDA ± CET improves pCR in patients with FGFR+ MIBC."

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

Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study. (PubMed, J Clin Oncol) - "First-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC."

IO biomarker • Journal • P2 data • Dental Disorders • Genito-urinary Cancer • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Stomatitis • Urothelial Cancer • Xerostomia • FGFR • PD-L1

Association of PD-L1 expression with clinical response to TAR-200 in the phase IIb SunRISe-1 trial (ESMO 2024) - P2 | "SunRISe-1 (NCT04640623) is an ongoing randomized, phase 2b study assessing efficacy and safety of TAR-200 + cetrelimab (CET) (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or CET alone (C3) in pts with BCG-unresponsive high-risk (HR) NMIBC with carcinoma in situ (CIS), with or without papillary disease, who are ineligible for or refusing radical cystectomy. In this study of SunRISe-1 PD-L1 expression limited by small sample size and number of clinical events, we observed high clinical response to TAR-200 monotherapy in HR NMIBC pts with BCG-unresponsive CIS irrespective of PD-L1 status."

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

First Results From SunRISe-1 in Patients With BCG Unresponsive High-Risk Non–muscle-Invasive Bladder Cancer Receiving TAR-200 in Combination With Cetrelimab, TAR-200, or Cetrelimab Alone (AUA 2023) - "First results from SunRISe-1 show promising CR rate and safety profile with TAR-200 monotherapy, and CET results are consistent with other anti-PD(L)1 tx in this setting. Preliminary efficacy and safety data support the continued study in NMIBC."

Clinical • Combination therapy • Late-breaking abstract • Bladder Cancer • Cardiovascular • Fatigue • 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

Erdafitinib (ERDA) vs ERDA plus cetrelimab (ERDA+CET) for patients (pts) with metastatic urothelial carcinoma (mUC) and fibroblast growth factor receptor alterations (FGFRa): Final results from the phase 2 Norse study. (ASCO 2023) - P1b | "Background: First-line (1L) therapy for cisplatin (cis)-ineligible pts with mUC remains an unmet need and includes alternative chemotherapy or anti-PD-(L)1 monotherapy for PD-L1 positive tumors. Combination ERDA+CET demonstrated clinically meaningful activity and was well tolerated. These results, in 1L cis-ineligible pts, support previously described activity of ERDA monotherapy in FGFRa mUC. The safety profile was consistent with the known profile for ERDA and CET with no additive toxicity for the combination."

Clinical • Metastases • P2 data • Dental Disorders • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Urothelial Cancer • FGFR

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

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

TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or refuse neoadjuvant platinum-based chemotherapy: interim analysis of SunRISe-4 (IBCN 2024) - No abstract available

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

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

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 • First-in-human • IO biomarker • Metastases • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ADORA2A

TAR-200 IN PATIENTS WITH BACILLUS CALMETTE-GUERIN-UNRESPONSIVE HIGH-RISKNONeMUSCLE-INVASIVE BLADDER CANCER: RESULTS FROM SUNRISE-1 STUDY (AUA 2024) - P2 | "SunRISe-1(NCT04640623) is an ongoing, randomized, phase 2b study assessing efficacy and safety of TAR-200þcetrelimab (anti-PD1) (Cohort 1 [C1]),TAR-200 alone (C2), or cetrelimab alone (C3) in pts with BCG-unresponsive HR NMIBC with carcinoma in situ (CIS), with or without papillary disease, who are ineligible for or refusing radical cystectomy. In SunRISe-1, TAR-200 monotherapy is associated with a clinically meaningful, high, centrally confirmed CRrate, durable responses, and a favorable benefit-risk profile in pts withBCG-unresponsive CIS."

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

SunRISe-3: TAR-200 plus cetrelimab or TAR-200 versus intravesical Bacillus Calmette–Guérin in patients with BCG-naive high-risk non–muscle-invasive bladder cancer (EAU 2024) - No abstract available

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

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

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 • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • CD8 • GPRC5D • PD-L1

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