sasanlimab (PF-06801591) / Pfizer - LARVOL DELTA

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) - "Clinical Trial Registration Number: 2022-002998-28 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

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) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • 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 | "Clinical Trial Registration Number: NCT04165317 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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 | "Clinical Trial Registration Number: NCT04165317 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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 | "Clinical Trial Registration Number: NCT06623162 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

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

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

Monotherapy • New P1 trial • 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

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

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

A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene (clinicaltrials.gov) - P1 | N=190 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Colorectal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium (Pfizer Press Release) - "From the pipeline, the first randomized progression-free survival (PFS) data from the ongoing Phase 1 dose-escalation study for mevrometostat plus XTANDI reinforce the potential of this investigational combination for patients with mCRPC. Additional pipeline presentations include updated data and real-world evidence for different types of bladder cancer, supporting the development of two potential transformative treatments, disitamab vedotin, an investigational antibody-drug conjugate (ADC), and sasanlimab, an investigational subcutaneous PD-1 blocker."

P1 data • Real-world evidence • Bladder Cancer • Castration-Resistant Prostate Cancer

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=85 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.

Trial termination • Biliary Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-L1

Pfizer’s Sasanlimab in Combination with BCG Improves Event-Free Survival in Patients with BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer (Businesswire) - P3 | N=1,070 | CREST (NCT04165317) | Sponsor: Pfizer | "The study 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)....The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors. Results will be submitted for presentation at an upcoming medical congress. Pfizer plans to discuss these data with global health authorities to support potential regulatory filings."

P3 data: top line • Bladder Cancer

A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene (clinicaltrials.gov) - P1 | N=190 | Not yet recruiting | Sponsor: Pfizer

Combination therapy • IO biomarker • Metastases • New P1 trial • Colorectal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Real-World and Clinical Trial Validation of a Deep Learning Radiomic Biomarker for PD-(L)1 Immune Checkpoint Inhibitor Response in Advanced Non-Small Cell Lung Cancer. (PubMed, JCO Clin Cancer Inform) - P1 | "The study developed and validated a deep learning radiomic biomarker using pretreatment routine CT/PET-CT scans to identify ICI benefit in advanced NSCLC."

Biomarker • Checkpoint inhibition • IO biomarker • Journal • Metastases • Real-world • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov) - P1/2 | N=34 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions

Combination therapy • Metastases • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

LTbR: A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: Pfizer | Trial completion date: Aug 2025 ➔ Aug 2024 | Active, not recruiting ➔ Terminated; Strategic business decision

Metastases • Trial completion date • Trial termination • Colorectal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

IMPRINT: Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor (clinicaltrials.gov) - P2/3 | N=20 | Not yet recruiting | Sponsor: Radboud University Medical Center | Initiation date: Aug 2024 ➔ Feb 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Checkpoint inhibition • Trial initiation date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=140 ➔ 5 | Trial completion date: Feb 2028 ➔ Mar 2025 | Trial primary completion date: Feb 2027 ➔ Mar 2025

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

A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer (clinicaltrials.gov) - P1 | N=190 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • 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

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=85 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-L1

NKT2152-202: Ph2 Study NKT2152 with Palbociclib & Sasanlimab in Subjects with Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov) - P2 | N=172 | Active, not recruiting | Sponsor: NiKang Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2026 ➔ Jun 2026 | Trial primary completion date: Jun 2026 ➔ Jun 2025

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Nephrology • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor • Urethral Cancer • Urology