PF-08046044 / Pfizer - LARVOL DELTA

First-in-human, open-label, Phase 1 study of a novel CD30-directed antibody-drug conjugate with a topoisomerase 1 inhibitor payload, PF-08046044 (35C), in patients with Relapsed/Refractory lymphomas: Updated safety, PK, preliminary efficacy and ctdna analysis from dose escalation (ASH 2025) - P1 | "35C was well tolerated at the evaluated dose levels, with a manageable safety profile andPK with a linear disposition, in pts with R/R lymphomas. 35C demonstrated promising antitumor activityin heavily pretreated pts with R/R cHL that progressed after prior BV and PD-1 inhibitors, and in pts withR/R PTCL and DLBCL. These data suggest 35C as a potential treatment option for pts with R/Rlymphomas, both as a monotherapy and in combination."

Circulating tumor DNA • Clinical • First-in-human • IO biomarker • P1 data • Alopecia • B Cell Lymphoma • Classical Hodgkin Lymphoma • Constipation • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

ASH 2025 tip sheet: Sylvester researchers contribute to more than 35 oral presentations at ASH Annual Meeting (Eurekalert)

Clinical data • Diffuse Large B Cell Lymphoma • Large B Cell Lymphoma • Myelodysplastic Syndrome

SGN-35C: A Novel CD30-Directed Antibody-Drug Conjugate for the Treatment of Lymphomas (ASH 2023) - "SGN-35C was designed to leverage the antibody backbone from brentuximab vedotin (BV) and the novel mechanism of action of camptothecin-derived ADCs. SGN-35C demonstrates a tolerability profile in non-human primates that is consistent with camptothecins. A Phase 1, first-in-human study is planned to evaluate the safety and anti-tumor activity of SGN-35C in lymphoid malignancies."

Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Systemic Anaplastic Large Cell Lymphoma • TOP1

Trial in Progress: Open-Label Phase 1 Study to Evaluate Safety of SGN-35C in Adults with Select Relapsed/Refractory Lymphomas (SGN35C-001) (ASH 2024) - P1 | "Clinical benefit with brentuximab vedotin (BV), a CD30-directed antibody-drug conjugate (ADC) with a monomethyl auristatin payload, has been observed in lymphoma studies. Secondary endpoints include PK parameters, incidence of antidrug antibodies, objective response rate, duration of response, and complete response rate. Enrollment is ongoing in the US and planned globally."

Clinical • P1 data • Acute Graft versus Host Disease • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Graft versus Host Disease • Classical Hodgkin Lymphoma • Cytomegalovirus Infection • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Infectious Disease • Interstitial Lung Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Pulmonary Disease • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma

SGN35C-001: A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Recruiting ➔ Active, not recruiting | N=210 ➔ 46

Enrollment change • Enrollment closed • B Cell Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

First-in-Human, Open-Label, Phase 1 Study of CD30-Directed Antibody-Drug Conjugate (ADC) With a Topoisomerase 1 Inhibitor Payload, PF-08046044 (35C) in Patients With Relapsed/ Refractory Lymphomas: Safety and Preliminary Efficacy From Dose Escalation (SOHO 2025) - P1 | "35C shares its antibody backbone with brentuximab vedotin (BV). 35C demonstrated promising antitumor activity in heavily pretreated R/R cHL patients who progressed after prior BV and PD-1 inhibitors, as well as in R/R PTCL patients. Safety and tolerability were encouraging, and dose-escalation is ongoing."

Clinical • P1 data • B Cell Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

OPEN-LABEL, PHASE 1 STUDY OF CD30-DIRECTED ANTIBODY DRUG CONJUGATE, PF-08046044 (35C), IN PATIENTS WITH RELAPSED/REFRACTORY LYMPHOMAS: SAFETY AND PRELIMINARY EFFICACY (ICML 2025) - P1 | "35C shares its antibody backbone with brentuximab vedotin (BV). 35C demonstrated promising antitumor activity in heavily pretreated R/R cHL pts who progressed after prior BV and PD-1 inhibitors, as well as in R/R PTCL pts. Safety and tolerability were encouraging and dose escalation is ongoing. These data suggest 35C could be a valuable option for R/R disease when current SOC is ineffective, both as a monotherapy and potentially in combination therapies."

Clinical • P1 data • B Cell Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Systemic Anaplastic Large Cell Lymphoma • T Cell Non-Hodgkin Lymphoma

FIRST-IN-HUMAN, OPEN-LABEL, PHASE 1 STUDY OF CD30-DIRECTED ANTIBODY DRUG CONJUGATE, PF-08046044 (35C), IN PATIENTS WITH RELAPSED/REFRACTORY LYMPHOMAS: DOSE ESCALATION SAFETY AND PRELIMINARY EFFICACY (EHA 2025) - P1 | "35C shares its antibody backbone with brentuximab vedotin (BV). 35C demonstrated promising antitumor activity in heavily pretreated R/R cHL pts who progressed after prior BV and PD-1 inhibitors, as well as in R/R PTCL pts. Safety and tolerability were encouraging and dose escalation is ongoing. These data suggest 35C could be a valuable option for R/R disease when current SOC is ineffective, both as a monotherapy and potentially in combination therapies."

Clinical • P1 data • Anemia • B Cell Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • Peripheral T-cell Lymphoma • Systemic Anaplastic Large Cell Lymphoma • T Cell Non-Hodgkin Lymphoma

SGN35C-001: A Safety Study of SGN-35C in Adults With Advanced Cancers (clinicaltrials.gov) - P1 | N=170 | Recruiting | Sponsor: Seagen Inc. | Trial completion date: Aug 2028 ➔ Apr 2029

Trial completion date • B Cell Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

OPEN-LABEL PHASE 1 STUDY TO EVALUATE SAFETY OF SGN-35C IN ADULTS WITH SELECT RELAPSED/REFRACTORY LYMPHOMAS (SGN35C-001; TRIAL IN PROGRESS) (EHA 2024) - P1 | "Clinical benefit with brentuximab vedotin (BV), aCD30-directed antibody-drug conjugate (ADC) with a monomethyl auristatin payload, has been observed inlymphoma studies. N/A"

Clinical • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

SGN35C-001: A Safety Study of SGN-35C in Adults With Advanced Cancers (clinicaltrials.gov) - P1 | N=170 | Recruiting | Sponsor: Seagen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Safety Study of SGN-35C in Adults With Advanced Cancers (clinicaltrials.gov) - P1 | N=170 | Not yet recruiting | Sponsor: Seagen Inc.

New P1 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

New Data for ADCETRIS (brentuximab vedotin) with Immunotherapy Combination in Hodgkin Lymphoma to be Featured at 2023 ASH Annual Meeting, and Seagen to Unveil Novel CD30-Directed Antibody-Drug Conjugate (Businesswire) - "Seagen...today announced that 12- and 24-month progression free survival data will be presented for an ADCETRIS^® (brentuximab vedotin) and immunotherapy combination in early and advanced stage classical Hodgkin lymphoma (cHL), respectively. The data will be featured in two oral presentations at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, taking place December 9-12, 2023 in San Diego...In addition, pre-clinical data will be presented for a next-generation novel CD30-directed antibody-drug conjugate (ADC), SGN-35C, that uses a topoisomerase I inhibitor payload."

Clinical data • Preclinical • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology