SEA-BCMA / Pfizer - LARVOL DELTA

SGNBCMA-001: A Safety Study of SEA-BCMA in Patients With Multiple Myeloma (clinicaltrials.gov) - P1 | N=83 | Terminated | Sponsor: Seagen Inc. | Trial completion date: Feb 2026 ➔ Nov 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Nov 2023; Study closed due to portfolio prioritization

Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Sea-BCMA Mono- and Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma: Updated Results of a Phase 1 Study (SGNBCMA-001) (ASH 2022) - P1 | "Here, we evaluated intensive SEA-BCMA dosing (Part B) and the addition of dexamethasone (DEX; Part C) to further assess the safety, tolerability, and clinical activity. Part C2 and Part D (testing the combination of SEA-BCMA with pomalidomide and DEX in pts who have received ≥3 prior lines of therapy), are enrolling. Part C2 has been amended to allow pts with prior exposure to BCMA-directed therapy to enroll."

Clinical • Combination therapy • P1 data • Anemia • Back Pain • Cough • Fatigue • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Musculoskeletal Pain • Pain • Pneumonia • Respiratory Diseases

Updated Phase I Results From SGNBCMA-001 Study of SEA-BCMA in Patients With R/R Multiple Myeloma (YouTube) - "Al-Ola Abdallah, MD...describes updated results from the Phase I SGNBCMA-001 study (NCT03582033) of SEA-BCMA monotherapy and in combination with dexamethasone or pomalidomide in patients with relapsed/refractory (R/R) multiple myeloma....This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA."

Interview • Video

SGNBCMA-001: A Safety Study of SEA-BCMA in Patients With Multiple Myeloma (clinicaltrials.gov) - P1 | N=83 | Active, not recruiting | Sponsor: Seagen Inc. | Recruiting ➔ Active, not recruiting | N=131 ➔ 83

Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

Seagen to Highlight ADCETRIS (brentuximab vedotin) Clinical Progress at the 2022 American Society of Hematology (ASH) Annual Meeting (Businesswire) - "Seagen Inc...announced new data for ADCETRIS^® (brentuximab vedotin) will be featured at the upcoming 64th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 10-13, 2022. The abstracts, including five oral presentations, highlight updated and interim efficacy and safety clinical trial results for ADCETRIS in both early- and advanced stage settings of classical Hodgkin lymphoma (cHL), and in patients with other CD30-expressing lymphomas and other rare cancers....Updated results will also be presented from a phase 1 study of the investigational agent SEA-BCMA in patients with relapsed/refractory multiple myeloma."

P1 data • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Multiple Myeloma • Oncology

SEA-BCMA, an Investigational Nonfucosylated Monoclonal Antibody: Ongoing Results of a Phase 1 Study in Patients with Relapsed/Refractory Multiple Myeloma (SGNBCMA-001) (ASH 2021) - P1 | "Parts B and C aim to optimize efficacy by testing intensified dosing (Part B; weekly [Q1W] induction dosing of SEA BCMA for 8 weeks is followed by Q2W maintenance dosing) and dexamethasone (DEX) combination therapy (Part C) in pts who have received ≥3 prior lines of therapy for MM and are triple‑class refractory...Following a safety monitoring review, premedication with acetaminophen + antihistamine was introduced to mitigate IRRs in expansion cohorts...Expansion cohorts testing intensified SEA-BCMA dosing and the addition of DEX are underway to further assess the safety, tolerability, and estimate of SEA-BCMA activity in the context of these treatment approaches. An additional expansion cohort (Part D), testing the combination of SEA-BCMA with pomalidomide and DEX in pts who have received ≥2 prior lines of therapy, is now enrolling."

Clinical • P1 data • Anemia • Fatigue • Hematological Malignancies • Hypertension • Immune Modulation • Inflammation • Multiple Myeloma

Pharmacodynamics of SEA-BCMA, a Nonfucosylated Antibody Targeting BCMA, in Patients with Relapsed/Refractory Multiple Myeloma (ASH 2021) - P1 | "Overall, these PD results provide insight into the saturation potential of plasma cell membrane BCMA by SEA-BCMA and informed the dose selection and schedule in expansion cohorts. Further evaluation of these relationships to patient response is ongoing as the Phase 1 study continues to enroll."

Clinical • IO biomarker • PK/PD data • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology

SGNBCMA-001: A Safety Study of SEA-BCMA in Patients With Multiple Myeloma (clinicaltrials.gov) - P1 | N=131 | Recruiting | Sponsor: Seagen Inc. | N=305 ➔ 131 | Trial completion date: Jul 2023 ➔ Feb 2026 | Trial primary completion date: Jan 2023 ➔ Feb 2025

Enrollment change • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Seagen to Highlight Multiple ADCETRIS (brentuximab vedotin) Data Presentations at the Upcoming 2021 American Society of Hematology (ASH) Annual Meeting (Businesswire) - “Seagen Inc....announced that new data for ADCETRIS® (brentuximab vedotin), including five oral presentations, will be featured at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 11-14, 2021. Data presentations will include updated safety and efficacy results from clinical trials examining the potential of ADCETRIS with novel combinations in patients with advanced stage classical Hodgkin lymphoma (HL), in patients with newly diagnosed CD30-expressing peripheral T-cell lymphoma (PTCL) and in patients with other histologies.”

Clinical data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Multiple Myeloma • Oncology • Peripheral T-cell Lymphoma

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma (clinicaltrials.gov) - P1; N=305; Recruiting; Sponsor: Seagen Inc.; N=225 ➔ 305; Trial completion date: Nov 2022 ➔ Jul 2023; Trial primary completion date: Jan 2022 ➔ Jan 2023

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase 1 Study of Two Investigational Agents, ACTR087, an Autologous T Cell Product Expressing an Antibody-Coupled T Cell Receptor, in Combination with SEA-BCMA, a Novel Non-Fucosylated Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma (ASH 2018) - P1; "...ACTR087 expresses a 4-1BB-containing receptor and has been evaluated in combination with rituximab in subjects with relapsed or refractory (R/R) CD20+ B cell lymphoma as previously reported (Akard et al., Blood 2017)...After the third dose of SEA-BCMA and lymphodepleting chemotherapy (cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2, each daily for 3 days), subjects receive a single dose of ACTR087...Enrollment in Cohort 3 is ongoing. Updated data, including SEA-BCMA PK, biomarkers, and preliminary Cohort 3 data, will be presented."

Clinical • Combination therapy • P1 data • Biosimilar • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pain

SGNBCMA-001: A Phase 1 study of SEABCMA, a non-fucosylated monoclonal antibody, in subjects with relapsed or refractory multiple myeloma. (ASCO 2019) - P1; "Biomarker and pharmacokinetic evaluations will be performed on peripheral blood and bone marrow. Clinical trial information: NCT03582033"

Clinical • IO Biomarker • P1 data

SpringWorks Therapeutics Announces Clinical Collaboration with Seagen to Evaluate Nirogacestat in Combination with SEA-BCMA in Patients with Relapsed or Refractory Multiple Myeloma (GlobeNewswire) - "SpringWorks Therapeutics...announced that the company has entered into a clinical trial collaboration agreement with Seagen Inc. to evaluate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with SEA-BCMA, Seagen’s investigational monoclonal antibody targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma."

Licensing / partnership • Hematological Malignancies • Multiple Myeloma • Oncology

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma (clinicaltrials.gov) - P1; N=185; Recruiting; Sponsor: Seattle Genetics, Inc.; N=65 ➔ 185

Enrollment change

ATTCK-17-01t: Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=15; Terminated; Sponsor: Unum Therapeutics Inc.; N=30 ➔ 15; Trial completion date: Mar 2021 ➔ Oct 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Mar 2020 ➔ Oct 2019; Business reasons

Clinical • Combination therapy • Enrollment change • IO Biomarker • Trial completion date • Trial primary completion date • Trial termination

ATTCK-17-01t: Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Unum Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • IO Biomarker