SEA-TGT / Pfizer - LARVOL DELTA

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

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

SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov) - P1 | N=132 | Terminated | Sponsor: Seagen Inc. | Trial completion date: Apr 2025 ➔ Dec 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Dec 2023; Study closed due to portfolio prioritization

Metastases • Trial completion date • Trial primary completion date • Trial termination • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • TIGIT

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 | Phase classification: P1b/2 ➔ P1/2 | Trial primary completion date: Jun 2024 ➔ May 2023

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

SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov) - P1 | N=132 | Active, not recruiting | Sponsor: Seagen Inc. | Recruiting ➔ Active, not recruiting | N=417 ➔ 132

Enrollment change • Enrollment closed • Metastases • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • TIGIT

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov) - P1b/2 | N=34 | Active, not recruiting | Sponsor: Pfizer | N=24 ➔ 34

Combination therapy • Enrollment change • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRP • PD-L1

A preclinical model of acquired anti-PD-1 resistance is responsive to SEA-TGT, an effector-function enhanced anti-TIGIT monoclonal antibody (AACR 2023) - P1 | "Thus, investigational agents such as SEA-TGT may have the potential to be efficacious in tumors that are primary or secondarily resistant to anti-PD-1 therapy. We have initiated a phase 1 study (NCT04254107) evaluating the safety, tolerability, and activity of SEA-TGT monotherapy and in combination with anti-PD-1 therapy in patients with advanced malignancies."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • TIGIT

Phase 1 dose-escalation study of SGN-TGT monotherapy in patients with advanced malignancies (AACR 2023) - P1 | "Overall, clinical data for SEA-TGT from the SGNTGT-001 trial suggest a manageable and tolerable safety profile. Preliminary antitumor activity warrants further clinical evaluation of SEA-TGT. SGNTGT-001 is ongoing and evaluating monotherapy and combination therapies."

Clinical • Metastases • Monotherapy • P1 data • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • NECTIN2 • PVR • TIGIT

Using clinical utility index (CUI) to determine the optimal biological dose of a nonfucosylated anti-TIGIT antibody: A proposed alternative to maximum tolerated dose (MTD) (AACR 2023) - P1 | "Dose selection for SEA-TGT was based on biological activity as assessed via PK/PD endpoints and integrated into a CUI model. Based on the totality of clinical data and the CUI results from monotherapy dose escalation from SGNTGT-001, the SEA-TGT dose of 1 mg/kg was determined to be the lowest biologically active dose with acceptable safety and tolerability."

Clinical • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD8 • NECTIN2 • PVR • TIGIT

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov) - P1b/2 | N=24 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Dec 2025 ➔ Jun 2024 | Trial primary completion date: Jul 2023 ➔ Jun 2024

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

Seagen to Present New Clinical and Preclinical Data From Broad Portfolio of Targeted Cancer Therapeutics at the 2023 AACR Annual Meeting (Seagen Press Release) - "Seagen Inc...announced the presentation of 17 abstracts featuring new clinical and preclinical data at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place in Orlando from April 14-19, 2023....Highlights include an interim analysis from the innovaTV 207 Phase 2 study of tisotumab vedotin (TV) given every 2 weeks in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have progressed after prior platinum combination, immunotherapy, and targeted therapy, if eligible....Other notable clinical data include initial results from a Phase 1 dose-escalation study of SEA-TGT monotherapy in patients with advanced malignancies."

P1 data • P2 data • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov) - P1b/2 | N=23 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Jun 2027 ➔ Dec 2025 | Trial primary completion date: Jan 2025 ➔ Jul 2023

Combination therapy • IO biomarker • Metastases • Trial completion date • Trial primary completion date • 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) - P1b/2 | N=23 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=375 ➔ 23

Combination therapy • Enrollment change • Enrollment closed • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov) - P1 | N=397 | Recruiting | Sponsor: Seagen Inc. | Trial completion date: Mar 2023 ➔ Apr 2025 | Trial primary completion date: Dec 2022 ➔ Jan 2025

Metastases • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • Urothelial Cancer • TIGIT

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov) - P1b/2 | N=375 | Recruiting | Sponsor: Pfizer | Trial completion date: Dec 2025 ➔ Jun 2027

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

Phase 1 study of SEA-TGT, a human, nonfucosylated anti-TIGIT monoclonal antibody with enhanced immune-effector function, in patients with advanced malignancies (SGNTGT-001, trial in progress) (SITC 2021) - P1 | "Part C will assess SEA-TGT plus sasanlimab in dose-expansion cohorts after an initial safety run-in. This trial is recruiting in Europe and North America. Trial Registration NCT04254107"

Clinical • IO biomarker • P1 data • Bladder Cancer • Breast Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD8 • NECTIN2 • TIGIT

[VIRTUAL] Phase I study of effector-function enhanced monoclonal antibody (mAb), SEA-TGT, in advanced malignancies (ESMO 2021) - P1 | "Part C will assess SEA-TGT in combination with pembrolizumab. Exploratory analysis will include pharmacodynamics (PD), PK/PD relationships, biomarkers, and resistance to SEA-TGT. This trial is recruiting in Europe and North America."

IO biomarker • P1 data • Bladder Cancer • Breast Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • NECTIN2 • TIGIT

A phase 1b/2 umbrella study of anti-PD-1 sasanlimab in combination with other therapies for patients with Stage IIIB/IV non-small cell lung cancer (NSCLC): The LANDSCAPE 1011 trial in progress (SITC 2021) - P1b/2 | "Sub-Study A will investigate sasanlimab, encorafenib (a BRAF inhibitor), and binimetinib (a MEK inhibitor) in patients with BRAF^V600E mutations (only including treatment-naïve patients in phase 2). Sub-Study B will investigate sasanlimab, axitinib (a vascular endothelial growth factor receptor inhibitor), and SEA-TGT (an anti-TIGIT antibody)...The first patient was enrolled in November 2020. Trial Registration ClinicalTrials.gov NCT04585815"

Clinical • Combination therapy • IO biomarker • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov) - P1; N=377; Recruiting; Sponsor: Seagen Inc.; N=231 ➔ 377

Enrollment change • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • Urothelial Cancer

LANDSCAPE 1011: A Study of Sasanlimab With Other Therapies in People With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1b/2 | N=375 | Recruiting | Sponsor: Pfizer | Trial primary completion date: Dec 2025 ➔ Nov 2024

IO biomarker • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

SEA-TGT: a novel drug for patients with solid tumors and lymphomas (YouTube) - "Diwakar Davar...explains the mechanism of action of SEA-TGT, a human, non-fucosylated anti-T-cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT) monoclonal antibody with enhanced immune-effector function currently under investigation for the treatment of solid tumors and lymphomas. SGNTGT-001 is a Phase I study (NCT04254107) evaluating the safety of SEA-TGT in patients with advanced malignancies. This interview took place during the 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting in Washington, D.C."

Interview • Video

Seagen to Highlight Two Novel Antibody-Drug Conjugates (ADCs) at the SITC 36th Annual Meeting - (Businesswire) - "Seagen Inc...announced the presentation of two new vedotin-based antibody-drug conjugate (ADC) programs at the Society for Immunotherapy of Cancer (SITC) 36th Anniversary Annual Meeting, taking place in Washington, D.C. and virtually, November 10-14, 2021. Each program combines antibodies targeted to an immune checkpoint [PD-(L)1 or B7-H4] with the cytotoxic properties of the vedotin payload. Preclinical data demonstrate promising antitumor activity. Both ADCs are set to enter first-in-human phase 1 studies in 2022."

Clinical data • New P1 trial • Preclinical • Oncology • Solid Tumor

[VIRTUAL] SGNTGT-001: A phase I study of SGN-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (ESMO 2020) - P1 | "Funding: Seattle Genetics. Clinical trial identification: NCT04254107."

IO Biomarker • P1 data • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD8

[VIRTUAL] SGNTGT-001: A phase 1 study of SEA‑TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress). (ASCO 2021) - P1 | "Exploratory biomarkers of SEA-TGT-mediated pharmacodynamic (PD) effects, PK-PD correlations, and correlative analyses of predictive and PD measurements with response, toxicity, and resistance will be explored . The study was opened April 2020 and is enrolling across sites in North America and Europe."

IO biomarker • P1 data • Bladder Cancer • Breast Cancer • Cutaneous Melanoma • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Immune Modulation • Inflammation • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • Urothelial Cancer • CD8 • NECTIN2

Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2; N=375; Recruiting; Sponsor: Pfizer; Trial primary completion date: Nov 2024 ➔ Dec 2025

Clinical • IO biomarker • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1