sasanlimab (PF-06801591) / Pfizer - 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

Sasanlimab in combination with Bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (HR NMIBC): Asian subgroup analysis from CREST [WITHDRAWN] (ESMO Asia 2025) - No abstract available

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

Sasanlimab in combination with Bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non-muscle-invasive bladder cancer (HR NMIBC): Exploratory analysis of patients with very HR (VHR) disease from the phase 3 CREST trial (EMUC 2025) - P3 | "Conclusions Sasanlimab with BCG-I+M outperformed BCG-I+M in the overall population and in subgroups of pts with CIS, T1, or VHR disease at randomization. Combined with a manageable safety profile, these data support the use of sasanlimab in combination with BCG as a potential practice-changing tx for pts with BCG-naive, HR NMIBC, including those with VHR disease."

Clinical • Combination therapy • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SASANLIMAB IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) IN BCG-NAIVE, HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (NMIBC): EXPLORATORY ANALYSIS EVALUATING BCG-UNRESPONSIVE DISEASE (SUO 2025) - P3 | "This exploratory analysis shows that the addition of sasanlimab to BCG-I+M delays the development of BCG-unresponsive disease compared with BCG-I+M. These data suggest that this combined treatment can address a relevant unmet need for patients with BCG-naive high-risk NMIBC by delaying the administration of follow-up anticancer drug therapy for BCG-unresponsive disease, thereby reducing the treatment burden on these patients compared with BCG monotherapy."

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

A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines. (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; Study terminated as part of strategic considerations and not based on safety concerns.

First-in-human • Trial termination • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Combination Approaches With Systemic Immunotherapy Enhance Medical Oncologists’ Role in NMIBC (Targeted Oncology) - "'However, overall survival was not improved, and in the prespecified subgroup analysis, it appears that patients who had CIS benefited more,' Gupta said."

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CREST Physician Experience Survey: Evaluating the Impact of Time and Effort of Treatment Administration in Non-Muscle Invasive Bladder Cancer (NMIBC) (ISPOR-EU 2025) - P3 | "Despite small sample, findings suggest that among specialists, urologists lead diagnosis and treatment selection in HR-NIMBC. Pending approval, SC sasanlimab may offer a quicker, more convenient treatment option, potentially saving time, effort, and resource costs for healthcare systems."

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

NKT2152-202: Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov) - P2 | N=18 | Terminated | Sponsor: NiKang Therapeutics, Inc. | N=172 ➔ 18 | Trial completion date: Jun 2026 ➔ Sep 2025 | Active, not recruiting ➔ Terminated; This study was terminated as a result of Sponsor portfolio reprioritization.

Enrollment change • Trial completion date • Trial termination • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Nephrology • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor • Urethral Cancer • Urology

Re: Sasanlimab plus BCG in BCG-naive, High-risk Non-muscle Invasive Bladder Cancer: The Randomized Phase 3 CREST Trial. (PubMed, Eur Urol) - No abstract available

Journal • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (clinicaltrials.gov) - P1 | N=294 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Immune-mediated adverse events (imAEs) associated with sasanlimab in combination with Bacillus Calmette-Guérin (BCG): Phase III study (CREST) (ESMO 2025) - P3 | "Conclusions imAEs seen with sasanlimab in combination with BCG were aligned with the known safety profile of ICIs. imAEs were manageable with treatment interruption/discontinuation and administration of corticosteroids and/or hormonal replacement therapy."

Adverse events • Combination therapy • P3 data • Oncology

RAD-VACCINE: Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: The Methodist Hospital Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Apr 2027

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

A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (clinicaltrials.gov) - P1 | N=294 | Not yet recruiting | Sponsor: Pfizer

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=220 ➔ 6 | Trial completion date: Apr 2029 ➔ Feb 2026 | Trial primary completion date: Jan 2029 ➔ Feb 2026

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • B Cell Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma

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

Advancements in bladder cancer immunotherapy: a focus on intravesical approaches. (PubMed, Front Pharmacol) - "Novel combinations, such as sasanlimab (a PD-1 monoclonal antibody) with BCG, have improved event-free survival in high-risk non-muscle-invasive bladder cancer (NMIBC). Intravesical anti-PD-1/PD-L1 agents like pembrolizumab and nadofaragene firadenovec have demonstrated efficacy and safety in BCG-unresponsive NMIBC, leading to regulatory approval. Additionally, BCG combined with immunostimulatory protein complexes (e.g., N-803) achieved high complete response rates while preserving quality of life...Promising results have also been observed with intravesical oncolytic immunotherapy combined with systemic anti-PD-1 therapy in cisplatin-ineligible MIBC. These advancements underscore the potential of intravesical and systemic immunotherapies to improve bladder cancer outcomes and warrant further investigation."

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

SPARCC: A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Stephanie Berg

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns

Trial termination • Bladder Cancer • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. (BASCO-MN 2025) - No abstract available

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

Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=155 | Active, not recruiting | Sponsor: Pfizer | Phase classification: P2 ➔ P1/2 | Trial completion date: Apr 2025 ➔ Jun 2026

Phase classification • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • PD-L1 • ROS1

Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC) (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Papillary Renal Cell Carcinoma • Renal Cell Carcinoma • Solid Tumor • CD4

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1 | N=399 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2029 ➔ Jul 2029 | Trial primary completion date: Feb 2028 ➔ Jul 2028

Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Association of deep learning CT response assessment and interpretable components with overall survival in advanced NSCLC: Validation in a trial of sasanlimab and a real-world dataset. (ASCO 2025) - "SerialCTRS outperformed RECIST 1.1 in predicting OS in independent clinical trial and RWD datasets. Interpretable submodels highlighted the prognostic value of tumor burden, body composition, and vasculature changes. SerialCTRS offers a promising tool for personalizing therapy and accelerating drug development in aNSCLC, with a fully automated pipeline for robust and scalable clinical use."

Clinical • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. (ASCO 2025) - P3 | "Sasanlimab in combination with BCG (IND and MNT) improved EFS outcomes in the overall population and in the subgroups of pts with BCG-naive, high-risk NMIBC who had CIS or T1 tumors at randomization. This post hoc analysis further supports the potential of sasanlimab in combination with BCG as a practice-changing treatment in pts with aggressive disease."

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

Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Patient-reported outcomes (PROs) from CREST. (ASCO 2025) - P3 | "PROs from CREST showed QOL was maintained when combining sasanlimab with BCG vs BCG (both IND + MNT). These results can help inform the benefit-risk assessment of CREST."

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