fetrastobart vedotin (PF-08046054) / Pfizer - LARVOL DELTA

Prospective validation of artificial intelligence (AI)–assisted RECIST 1.1 in a phase 1 study of fetrastobart vedotin in patients with non–small cell lung cancer (NSCLC) (ESMO 2026) - No abstract available

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Interim results of a phase I study of SGN-PDL1V (PF-08046054) in patients with PDL1-expressing solid tumors (ESMO 2024) - P1 | "Single agent SGN-PDL1V was generally well tolerated with a manageable safety profile. Encouraging preliminary antitumor activity was observed. Enrollment in the phase 1 study continues."

Clinical • IO biomarker • P1 data • Breast Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial. (ASCO 2025) - P1 | "PDL1V monotherapy at the recommended expansion dose was generally well tolerated with a manageable safety profile. Encouraging preliminary efficacy in NSCLC was observed, independent of histology. Based on these results, further development of PDL1V in NSCLC is ongoing."

Clinical • P1 data • Anemia • Fatigue • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor

SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=438 | Recruiting | Sponsor: Seagen Inc. | Trial completion date: Dec 2026 ➔ Dec 2027

Metastases • Trial completion date • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

SGNPDL1V-001: A Study of SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=315 | Recruiting | Sponsor: Seagen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=438 | Recruiting | Sponsor: Seagen Inc. | N=322 ➔ 438

Enrollment change • Metastases • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

Reduction in circulating tumor DNA (ctDNA) in relation to radiographic response and tumor PD-L1 expression in a phase 1 study of PDL1V (PF-08046054) in patients with non-small cell lung cancer (NSCLC). (ASCO 2026) - P1, P3 | "PDL1V monotherapy showed promising antitumor activity with a manageable safety profile in pts with 2L+ TPS ≥1% NSCLC. Most pts had ctDNA reduction with PDL1V treatment, with greater ctDNA reduction in pts with radiographic response and TPS ≥1% NSCLC. These data further support evaluation of PDL1V in the ongoing phase 3 trial in 2L+ PD-L1+ NSCLC, SQ and NSQ (NCT07144280/PADL1NK-005) and the continued use of ctDNA for response monitoring and potential early prediction of clinical benefit."

Circulating tumor DNA • Clinical • IO biomarker • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Nonclinical characterization of the secondary mechanisms of action of PF-08046054 (PDL1V), a novel vedotin ADC directed to PD-L1 that selectively depletes tumor cells without depleting healthy immune cells (AACR 2025) - P1 | "PDL1V is a novel vedotin antibody drug-conjugate (ADC) currently in Phase I clinical development for advanced solid tumors as a monotherapy or in combination with pembrolizumab (NCT05208762). Since T cell-driven antitumor immunity is a key driver for the efficacy of PD-(L)1 blockade, these data suggest PDL1V is a promising combination partner with anti-PD-1 immunotherapies such as pembrolizumab. Future studies will evaluate the effects of PDL1V on immunosuppressive cells, including regulatory T cells and myeloid derived suppressor cells, and the pharmacodynamic effects of PDL1V in syngeneic mouse xenograft models.Ethics Approval: All procedures performed on animals were in accordance with regulations and established guidelines and were reviewed and approved by an Institutional Animal Care and Use Committee or through an ethical review process."

ADC • Clinical • Immune cell • IO biomarker • Tumor cell • Oncology • Solid Tumor • CALR • CD4 • CD8 • HMGB1 • PD-L1

A novel multi-modal PD-L1-ADC could be a potential BIC candidate treatment for pan-solid tumors with enhanced tumor-specificity (AACR 2026) - "The ADC showed poor cytotoxicity induction in these cells as compared to FIC SGN-PDL1V that internalized efficiently...PLoS One, 2023. 18(1): p. e0279821."

ADC • IO biomarker • Oncology • Solid Tumor • PD-1 • PD-L1

A novel multi-modal PD-L1xVEGF-ADC, HX116, could be a new potent candidate treatment for pan-solid tumors (AACR 2026) - "As a result, HX116 showed poor cytotoxicity in these cells as compared to SGN-PDL1V, a PD-L1-MMAE-ADC that is internalized efficiently. The high safety and tolerability of HX116 will also be confirmed in NHP model. If all are confirmed, HX116 would become a powerful new candidate for future cancer treatment."

ADC • Oncology • Solid Tumor • PD-L1

PADL1NK-005: A randomized phase III trial of PDL1V (PF-08046054) monotherapy vs docetaxel in patients with previously treated PD-L1-positive non-small cell lung cancer (ELCC 2026) - P1, P3 | "Other secondary endpoints are efficacy by investigator assessment, safety and tolerability, quality of life, and pharmacokinetics. Enrollment has begun."

Clinical • IO biomarker • Monotherapy • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

C5851005: A Study to Learn About the Study Medicine Called PF-08046054/SGNPDL1V Versus Docetaxel in Adult Participants with Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-small-cell Lung Cancer (NSCLC) (clinicaltrialsregister.eu) - P2/3 | N=246 | Recruiting | Sponsor: Pfizer Inc.

New P2/3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=714 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | N=315 ➔ 714 | Trial completion date: Apr 2028 ➔ Jan 2029 | Trial primary completion date: Apr 2027 ➔ Jan 2028

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

Encouraging antitumor activity of PDL1V (PF-08046054) monotherapy, an ADC targeting PD-L1, correlates with antigen expression in patients with NSCLC (ESMO 2025) - P1 | "Encouraging antitumor activity in 2L+ PD-L1 positive NSCLC was observed across a range of PDL1 expression and histology. These data support the design of the planned Ph 3 trial."

Clinical • IO biomarker • Monotherapy • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=680 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=680 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC. (ASCO 2025) - P1 | "The combination of PDL1V and pembrolizumab was generally well tolerated with no DLTs. Early encouraging objective responses were observed in half of the patients treated, including 21.4% with a CR. Enrollment in multiple combination expansion cohorts in PD-L1 expressing tumors is ongoing."

Clinical • Combination therapy • Metastases • Anemia • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hematological Disorders • Neutropenia • Pain • Pneumonia • Squamous Cell Carcinoma of Head and Neck

SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=315 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Sep 2027 ➔ Apr 2028 | Trial primary completion date: Sep 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=315 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Nov 2028 ➔ Sep 2027 | Trial primary completion date: Nov 2027 ➔ Sep 2026

Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

PDL1V (PF-08046054): A Firstin- Class PD-L1-Directed ADC with Promising Activity in 2L+ NSCLC (ADC London 2025) - "• PDL1V was engineered for enhanced potency through increased internalization and payload delivery • PDL1V is efficacious across a broad range of PD-L1 expression & induces MMAE-mediated immune activation in vivo • Interim results of a phase 1 Study of PDL1V in patients with PDL1-expressing solid tumours demonstrate promising activity in 2L+ NSCLC"

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

SGNPDL1V-001: A Study of SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=315 | Recruiting | Sponsor: Seagen Inc. | Trial completion date: Dec 2027 ➔ Nov 2028 | Trial primary completion date: Jul 2025 ➔ Nov 2027

Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

Pfizer Highlights Diverse Oncology Portfolio and Combination Approaches at ESMO 2024 (Pfizer Press Release) - "Pfizer will also present early clinical-stage research for a number of priority pipeline areas, including encouraging Phase 1 results of the potential first-in-class antibody-drug conjugate (ADC) candidate SGN-PDL1V (PF-08046054) in NSCLC and head and neck squamous cell carcinoma (HNSCC); initial data for the investigational ADC disitamab vedotin in combination with KEYTRUDA (pembrolizumab) in human epidermal growth factor receptor 2 (HER2)-expressing locally advanced or metastatic urothelial cancer (la/mUC); and the first data combining atirmociclib, our highly-selective cyclin-dependent kinase 4 (CDK4) inhibitor (CDK4i), with a novel CDK2 inhibitor (CDK2i) in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC) from a Phase 1 dose-escalation study."

P1 data • P2 data • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Phase 1 study of SGN-PDL1V, a novel, investigational vedotin antibody–drug conjugate directed to PD-L1, in patients with advanced solid tumors (SGNPDL1V-001, trial in progress). (ASCO 2022) - P1 | "Objective response rate will be analyzed by tumor type, dose levels, and schedules. Enrollment for Part A is ongoing at sites in North America and is planned in Europe."

Clinical • IO biomarker • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

SGNPDL1V-001: A Study of SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=305 | Not yet recruiting | Sponsor: Seagen Inc. | Initiation date: Aug 2022 ➔ Nov 2022

Trial initiation date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=305 | Recruiting | Sponsor: Seagen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck