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

Therapeutic Intensification Based on Immune Checkpoint Inhibitors in Non-Muscle Invasive Bladder Cancer: State of the Art and Future Perspectives. (PubMed, Cancers (Basel)) - "Therapeutic intensification using systemic immunotherapy applies to both BCG-unresponsive NMIBC, with a new target pathway (HLA-E/NKG2A), and BCG-naïve HR NMIBC, where the combination of BCG instillations and immunotherapy represents a major breakthrough."

Checkpoint inhibition • IO biomarker • Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HLA-E • KLRC1

SunRISe-1: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (clinicaltrials.gov) - P2 | N=220 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2027 ➔ Sep 2027 | Trial primary completion date: Sep 2024 ➔ Jul 2025

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

Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with MIBC: primary analysis and biomarker results of SunRISe-4. (PubMed, J Clin Oncol) - P2 | "TAR-200 plus cetrelimab provided higher pCR, pOR, and 1-year RFS rates compared with cetrelimab monotherapy, supporting further investigation of the neoadjuvant combination in MIBC. utDNA and ctDNA MRD results support further investigation as biomarkers for residual local and non-local disease, respectively."

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

Ankyra Therapeutics Announces First Patient Dosed in Phase 1b Trial Evaluating First-in-Class Anchored Immunotherapy in Combination with Immune Checkpoint Blockade in Patients with Lung Cancer (Businesswire) - "This study will evaluate the combination of Ankyra’s tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate with the anti-PD1 agent, cetrelimab, in patients who have progressed after initial treatment of metastatic, non-mutated non-small cell lung cancer (NSCLC). In addition, the study will evaluate tolododekin alfa in combination with standard of care immune checkpoint blockade in first-line treatment of patients with metastatic, non-mutated NSCLC and a tumor proportion score (TPS) of ≥ 50%."

Trial status • Non Small Cell Lung Cancer

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" (DGHO 2025) - P1 | "Introduction: 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 Tal monotherapy but similar to Tal + daratumumab results. These proof-of-concept data further support Tal as a versatile combination partner to overcome intrinsic resistance mechanisms."

Clinical • IO biomarker • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Pneumonia • Respiratory Diseases • CD8 • GPRC5D • PD-1 • PD-L1

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

Phase I study of intratumoral administration of JNJ-87704916, an oncolytic virus, as monotherapy and in combination with cetrelimab in advanced solid tumors (ESMO 2025) - "Two pts with IO refractory advanced melanoma experienced Partial Responses at 6 weeks that are still ongoing at 20 and 25 weeks, including evidence of response in uninjected lesions and deepening of response with time. Conclusions IT injection of JNJ-4916 demonstrated acceptable safety when combined with CET, with evidence of systemic disease control in 2 pts with anti-PD1 refractory metastatic melanoma."

Combination therapy • IO biomarker • Metastases • Monotherapy • Oncolytic virus • P1 data • Melanoma • Oncology • Solid Tumor • CD40 • IFNG • IL12A

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 completion date: Sep 2026 ➔ Mar 2027

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

ANK-101-004: A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Ankyra Therapeutics, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The Evolving Landscape of Systemic Immunotherapy for Bacillus Calmette-Guérin-naïve High-risk Non-muscle-invasive Bladder Cancer: At the Edge of a Tsunami? (PubMed, Eur Urol Oncol) - P3 | "The combination of systemic immunotherapy with intravesical BCG instillations is being investigated and may become a new therapeutic strategy for BCG-naïve HR NMIBC."

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

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=245 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=176 ➔ 245

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • 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 | Trial completion date: Oct 2025 ➔ Dec 2026

First-in-human • Trial 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) - P1/2 | N=125 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2025 ➔ Oct 2026

Trial completion date • Genito-urinary 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 | Phase classification: P1/2 ➔ P2

Phase classification • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

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. | Trial completion date: Nov 2033 ➔ Aug 2032

Monotherapy • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • 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 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 (Lancet Oncol) - "In the efficacy-evaluable set (TAR-200 plus cetrelimab n=53, cetrelimab monotherapy n=31), at a median follow up of 23·5 weeks (IQR 8·6–42·0), pathological complete response rates were 42% (22 of 53 patients; 95% CI 28–56) in the TAR-200 plus cetrelimab cohort and 23% (seven of 31 patients; 10–41) in the cetrelimab monotherapy cohort."

P2 data • Bladder Cancer

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

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 | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2025 ➔ Jan 2026

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

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 | Trial completion date: Dec 2029 ➔ Dec 2028

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

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

A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Ankyra Therapeutics, Inc

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Talquetamab/Cetrelimab Leads to Deep, Durable Responses in R/R Multiple Myeloma (OncLive) - P1b | N=74 | TRIMM-3 (NCT05338775) | Sponsor: Janssen Research & Development, LLC | "The combination of talquetamab-tgvs (Talvey) and cetrelimab was safe and elicited deep and durable responses in patients with relapsed/refractory multiple myeloma, including those who previously received treatment with a bispecific antibody, according to proof-of-concept results of the phase 1b TRIMM-3 trial (NCT05338775) presented during the 2025 EHA Congress. Findings showed that, at a medium follow-up of 11.5 months (range, 1.5-32.3), the objective response rate (ORR) with the combination in the overall population (n = 44) was 70.5%, with a very good partial response (VGPR) or higher rate of in 65.9%; the complete response (CR) rate was 6.8%, the VGPR rate was 25.0%, and the partial response (PR) rate was 4.5%....The 9-month duration of response (DOR) and 6-month progression-free survival (PFS) rates were 72.6% and 69.9%, respectively."

P1 data • Multiple Myeloma