sasanlimab (PF-06801591) / Pfizer - LARVOL DELTA

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

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=190 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal 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 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=190 | Not yet recruiting | Sponsor: Pfizer | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Colorectal Cancer • Gastrointestinal 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

SASAN-SPARING: Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Fundación de investigación HM

New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. (PubMed, Ther Adv Med Oncol) - P1/2 | "Administration of sasanlimab at a dose of 600 mg-Q6W subcutaneously may serve as a convenient alternative to 300 mg-Q4W administration. NCT04181788 (ClinicalTrials.gov); 2019-003818-14 (EudraCT)."

Journal • Metastases • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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

New P1 trial • Bladder Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

LTbR: A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination (clinicaltrials.gov) - P1 | N=1 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=220 ➔ 1 | Trial completion date: Feb 2029 ➔ Aug 2025 | Trial primary completion date: Feb 2028 ➔ Aug 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

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) - P1/2 | N=190 | Not yet recruiting | Sponsor: Pfizer

Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal 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

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 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Jun 2024 ➔ Oct 2024

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

CREST: A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=1070 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Jun 2024 ➔ Dec 2024

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

Phase I/II Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC) (KCRS 2024) - P1/2 | "Background This is an open-label, phase I/II study evaluating Palbociclib and Sasanlimab in adult patients with advanced clear cell RCC or papillary RCC. NCT05665361 Trial Schema"

Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

LTbR: A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Pfizer

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

Onc.AI to Present Collaboration Results Demonstrating Immunotherapy Response Prediction Using a Radiomic Signature in Late-Stage Lung Cancer (Businesswire) - P1 | N=147 | NCT02573259 | Sponsor: Pfizer | "Onc.AI...today announced that new data will be presented at the 2024 Annual Society of Clinical Oncology (ASCO) resulting from its collaboration with Pfizer. The collaboration evaluated the ability of Onc.AI’s radiomics-based multimodal signature to predict immunotherapy response in metastatic lung cancer patients....1L Real-World Holdout Cohort: PFS HR 0.18 (0.05-0.61) in patients receiving single agent immunotherapy....2L+ Clinical Trial Cohort (NCT02573259): NSCLC patients who received Sasanlimab (Pfizer). PFS HR of 0.30 (0.14-0.68) and an Overall Survival Hazard Ratio (OS HR) of 0.29 (0.10-0.83)."

Clinical data • P1 data • Lung Cancer • Non Small Cell Lung Cancer

Real-world and clinical trial validation of a deep learning radiomic biomarker for PD-(L)1 immune checkpoint inhibitor response in stage IV NSCLC. (ASCO 2024) - P1 | "To test generalizability, we validated our biomarker in a prospective clinical trial dataset evaluating Sasanlimab in PD-(L)1 therapy-naïve, advanced NSCLC patients (NCT02573259, Dataset C, N=54)... In our validations in RWD and clinical trial cohorts, a deep-learning radiomic biomarker based on routine pre-treatment CT scans predicted response to ICI and stratified patients independently from PD-L1 status. This tool may inform clinical decision-making, such as to help guide whether concomitant chemotherapy may not be needed. In future work, we plan to further validate our approach in larger prospective datasets and expand its use to new indications."

Biomarker • Checkpoint inhibition • Clinical • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

A PHASE II PROSPECTIVE, OPEN-LABEL, MULTI-CENTER, SINGLEARM STUDY OF SASANLIMAB PLUS SACITUZUMAB GOVITECANIN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS. SSANTROP (APRO07-2022) (AUA 2024) - "Based on Keynote-057 (complete response (CR)rate 41%), pembrolizumab has been recently approved by the FDAfor the treatment of NMIBC BCG-unresponsive patients who areineligible for or decline cystectomy. No safety concerns have been initially reported. This trial would be the first to systematically address whethercombining sasanlimab plus SG improves CR rates in patients withBCG-unresponsive NMIBC."

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

A Phase II prospective, open-label, multi-center, single arm study of Sasanlimab plus Sacituzumab Govitecan in BCG-unresponsive non-muscle invasive bladder cancer patients. SSANTROP (APRO07-2022) (AUA 2024) - No abstract available

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