Belrapzo (bendamustine RTD) / Eagle Pharma, SymBio Pharma - LARVOL DELTA

CALGB-50904: Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2026 ➔ Sep 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD4

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • High-grade B-cell lymphoma • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

CALGB-50904: Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD4

ALLIANCE A041202: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P3 | N=547 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD20 • CD4 • CD5 • FCER2

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • B Cell Lymphoma • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • High-grade B-cell lymphoma • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Fox Chase Cancer Center | Trial completion date: Sep 2027 ➔ Mar 2028 | Initiation date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Mar 2027 ➔ Sep 2027

Trial completion date • Trial initiation date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

waveLINE-003: A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (clinicaltrials.gov) - P2/3 | N=290 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 ➔ Sep 2027 | Trial primary completion date: Jun 2027 ➔ Sep 2027

Combination therapy • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Fox Chase Cancer Center | Initiation date: Sep 2024 ➔ Dec 2024

Trial initiation date • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Fox Chase Cancer Center

New P2 trial • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - P2 | N=95 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD4

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (clinicaltrials.gov) - P2/3 | N=260 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=420 ➔ 260 | Trial completion date: Dec 2025 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Jun 2027

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - P2 | N=95 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD4

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=200 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: National Cancer Institute (NCI)

Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD4

ALLIANCE A041202: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P3 | N=547 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2024 ➔ Jan 2025

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD20 • CD4 • CD5 • FCER2

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

New P3 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

FDA-Approved Drugs: New Drug Application (NDA): 205580 (FDA) - Labeling-Package Insert for Eagle Pharms' Belrapzo approved on 11th January 2024

sNDA • Chronic Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Immune Modulation • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) (clinicaltrials.gov) - P3 | N=82 | Terminated | Sponsor: MEI Pharma, Inc. | N=534 ➔ 82 | Trial completion date: Sep 2031 ➔ Mar 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Mar 2023; Discontinuation of zandelisib program

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

"#EaglePharmaceuticals World-Wide Sales for #BELRAPZO was 11m USD in Q4 2022 (Up 29%) https://t.co/3SbYFaR7fz" (@1stOncology)

SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - P2 | N=95 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting

Enrollment open • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD4

Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Results (GlobeNewswire) - "Q4 2022 BELRAPZO net product sales were $11.0 million, compared to $5.5 million in the fourth quarter of 2021....Q4 2022 PEMFEXY^® net product sales were $12.1 million..."

Sales • Lung Cancer • Non Small Cell Lung Cancer • Oncology

ALLIANCE A041202: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P3 | N=547 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2023 ➔ Jan 2024

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD19 • CD20 • CD4 • CD5 • FCER2

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) (clinicaltrials.gov) - P3 | N=534 | Active, not recruiting | Sponsor: MEI Pharma, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20