sasanlimab (PF-06801591) / Pfizer - LARVOL DELTA

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

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

Immune-mediated adverse events (imAEs) associated with sasanlimab in combination with Bacillus Calmette-Guérin (BCG): Phase 3 study (CREST) (ESMO 2025) - No abstract available

Adverse events • Combination therapy • P3 data • Oncology

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

Sasanlimab as bladder-sparing maintenance treatment after neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (MIBC): The phase 2, SASAN-SPARING trial. (ASCO 2025) - P2 | "Patients are ≥ 18 years, ECOG 0-1 and treatment-naïve for MIBC candidates to receive neoadjuvant cisplatin/gemcitabine followed by RC. Study of biomarkers will provide a useful tool to corroborate achievement of a clinical complete response, contributing to personalized treatments. The study is approved and started with recruitment of patients in December 2024."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A phase II prospective, open-label, multi-center, single-arm study of sasanlimab plus sacituzumab govitecan in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) pts: SSANTROP (APRO07-2022). (ASCO 2025) - "Pembrolizumab (Pem) was approved by the FDA based on Keynote-057 (41% complete response rate (CRR)) and offers a non-surgical option for pts who decline or are ineligible for RC. Nadofaregene firadenovec and Nogapendekin alfa inbakicept have been recently approved in this setting... This trial is the first to evaluate the combination of Sa and SG in BCG-unresponsive HR-NMIBC. With preliminary 3 mo CRR of 68%, the safety analysis identified no unexpected concerns, with severe AEs mainly involving neutropenia and febrile neutropenia. No treatment related toxic deaths occurred."

Clinical • P2 data • Alopecia • Anemia • Bladder Cancer • Dental Disorders • Fatigue • Febrile Neutropenia • Genito-urinary Cancer • Immunology • Neutropenia • Oncology • Solid Tumor • Stomatitis • Urothelial Cancer

ASCO 2025: Trials-in-Progress – Sasanlimab as Bladder-Sparing Maintenance Treatment After Neoadjuvant Chemotherapy in Patients with Muscle Invasive Bladder Cancer (MIBC): The Phase 2, SASAN-SPARING Trial (UroToday) - "The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, IL between May 30th and June 3rd, 2025, was host to a kidney and bladder cancers poster session. Dr. Elena Sevillano presented the ongoing SASAN-SPARING trial, a phase II study of sasanlimab as bladder-sparing maintenance treatment after neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (MIBC)...The SASAN-SPARING trial (NCT06623162) is a phase Il, single-arm, multicenter study evaluating the efficacy and safety of maintenance treatment with sasanlimab in MIBC patients planned for a bladder-sparing strategy with neoadjuvant cisplatin-based chemotherapy...Dr. Sevillano highlighted that this study introduces an innovative approach to bladder cancer management by integrating urinary tumor DNA (utDNA) and blood-based circulating tumor DNA (ctDNA) monitoring as an additional tool to confirm the presence of a clinical complete response."

Trial status • Bladder Cancer

Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial. (PubMed, Nat Med) - P3 | "Sasanlimab combined with BCG-I+M has the potential to redefine the treatment paradigm and clinical decision-making for patients with BCG-naive high-risk NMIBC. ClinicalTrials.gov identifier: NCT04165317 ."

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

Sasanlimab Plus BCG Displays EFS Benefit Across Key Subgroups in High-Risk Non–Muscle Invasive Bladder Cancer (OncLive) - P3 | N=1,070 | CREST (NCT04165317) | Sponsor: Pfizer | "Sasanlimab in combination with BCG significantly prolonged event-free survival (EFS) vs BCG monotherapy in patients with high-risk non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and T1 tumors, according to data from the phase 3 CREST trial (NCT04165317) presented during the 2025 ASCO Annual Meeting. Findings from exploratory subgroup analyses of CREST demonstrated that patients with CIS at baseline who received the combination (n = 88) achieved a 36-month EFS rate of 83.0% vs 71.8% in the BCG alone arm (n = 88); the stratified HR for EFS was 0.53 (95% CI, 0.285-0.982). Patients with T1 tumors in the combination arm (n = 204) experienced a 36-month EFS rate of 81.3% vs 72.2% in the BCG alone arm (n = 194); the stratified HR for EFS was 0.63 (95% CI, 0.406-0.963)."

P3 data • Bladder Cancer

Study of PF-07265807 in Participants With Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=88 | Terminated | Sponsor: Pfizer | N=67 ➔ 88 | Trial completion date: Jun 2024 ➔ Nov 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Nov 2024; Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers. (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • 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

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1 | N=399 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P1 trial • 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

Pfizer’s Sasanlimab Combination Significantly Improves Event-Free Survival in BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer (Businesswire) - P3 | N=1,070 | CREST (NCT04165317) | Sponsor: Pfizer | "Pfizer Inc...announced results from the pivotal Phase 3 CREST trial of sasanlimab..in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The trial met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance): Hazard Ratio (HR) of 0.68; 95% Confidence Interval (CI), 0.49-0.94; 2-sided p=0.019; median EFS not yet reached. These findings show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. Pre-specified subgroup analyses for patients harboring higher risk disease showed consistent benefit with EFS HR of 0.63 (0.41, 0.96) for T1 disease..."

P3 data • Bladder Cancer

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): SASANLIMAB IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN IMPROVES EVENT-FREE SURVIVAL VERSUS BACILLUS CALMETTE-GUÉRIN AS STANDARD OF CARE IN HIGH-RISK NON- MUSCLE-INVASIVE BLADDER CANCER: PHASE 3 CREST STUDY RESULTS (AUA 2025) - P3 | "Sasanlimab in combination with BCG-I+M outperformed the current SOC of BCG-I+M with a manageable safety profile and has the potential to change the treatment paradigm for BCG-naive, HR NMIBC."

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

A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=190 ➔ 4 | Trial completion date: Jan 2029 ➔ Oct 2025 | Trial primary completion date: Jan 2028 ➔ Oct 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • 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

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=5 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=190 ➔ 5 | Trial completion date: Feb 2030 ➔ Oct 2025 | Trial primary completion date: Feb 2029 ➔ Oct 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • 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

A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.

Monotherapy • Trial termination • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer