Vegzelma (bevacizumab-adcd) / Celltrion - LARVOL DELTA

Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy (clinicaltrials.gov) - P2 | N=87 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2026 ➔ Jun 2027

Enrollment open • Platinum sensitive • Trial initiation date • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial (clinicaltrials.gov) - P3 | N=226 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Mar 2029 ➔ Mar 2034

Trial completion date • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • IL2

Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial (clinicaltrials.gov) - P3 | N=129 | Not yet recruiting | Sponsor: City of Hope Medical Center | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • Appendix Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Celltrion said Friday that an integrated population pharmacokinetic analysis of phase 1 and 3 clinical data for Vegzelma (CT-P16), its biosimilar of Avastin (bevacizumab), has been published in BioDrugs, providing further evidence of the product's pharmacokinetic comparability with the reference drug. (Korea Biomedical Review) - "The study pooled data from two global phase 1 trials conducted in healthy subjects and one global phase 3 trial involving patients with non-squamous non-small cell lung cancer (NSCLC), all of which were conducted to support regulatory approval....The results showed that Vegzelma had pharmacokinetic characteristics comparable to those of the U.S.- and EU-sourced reference products, with no clinically meaningful differences in key parameters, including clearance and central volume of distribution."

Retrospective data • Lung Non-Squamous Non-Small Cell Cancer

A092001: Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Mesothelioma • Oncology • Peritoneal Mesothelioma • Psoriatic Arthritis • Solid Tumor

A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial (clinicaltrials.gov) - P=N/A | N=202 | Recruiting | Sponsor: Mayo Clinic | N=120 ➔ 202

Enrollment change • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=88 ➔ 4 | Trial completion date: Sep 2026 ➔ Aug 2027 | Trial primary completion date: Sep 2026 ➔ Jan 2026

Enrollment change • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • IL2

Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin® and US-Avastin® in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. (PubMed, BioDrugs) - P1, P3 | "Within a unified population pharmacokinetic framework, CT-P16 demonstrated comparable pharmacokinetics to both EU-Avastin® and US-Avastin®, with no clinically meaningful drug-product effect on clearance or central volume of distribution. Covariate effects mirrored those reported for reference bevacizumab, and simulated steady-state exposures were generally consistent with a published progression-free-survival-based exposure benchmark at the median level across covariate-defined patient subgroups. These findings extend the totality of evidence supporting CT-P16 biosimilarity and illustrate how population pharmacokinetic modelling can quantitatively inform a streamlined biosimilar assessment in the era of reduced reliance on comparative clinical efficacy trials."

Journal • PK/PD data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer (clinicaltrials.gov) - P1/2 | N=85 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Aug 2029 ➔ Feb 2031 | Trial primary completion date: Aug 2029 ➔ May 2030

Checkpoint inhibition • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • IL2

Celltrion’s anti-cancer biosimilar Vegzelma has successively been listed on the formularies of large U.S. pharmacy benefit managers (PBMs) (Business Korea) - "Celltrion announced on July 7 that Vegzelma (ingredient name bevacizumab), a treatment for metastatic colorectal cancer and breast cancer, was listed as a preferred drug on the public and private insurance formularies of Express Scripts (ESI) and the public insurance formulary of Optum, two of the top three PBMs in the United States. Optum and ESI’s public insurance began applying reimbursements on July 1, while full-scale reimbursements for ESI’s private insurance will take place starting in January next year."

Reimbursement • Breast Cancer • Colorectal Cancer

South Korean biosimilar developer Celltrion Inc. announced on Monday that it has launched Truxima (rituximab), a treatment for blood cancer, and Vegzelma (bevacizumab), a treatment for metastatic colorectal and breast cancer, in Vietnam (Pulse by Maeil Business News Korea) - "Celltrion plans to expand the supply of Truxima and Vegzelma by leveraging the network it has established through the commercialization of Herzuma."

Biosimilar launch • Breast Cancer • Chronic Lymphocytic Leukemia • Colorectal Cancer • Non-Hodgkin’s Lymphoma

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) (clinicaltrials.gov) - P1/2 | N=460 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=280 ➔ 460

Enrollment change • Platinum resistant • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

ECOG-ACRIN 5103: Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer (clinicaltrials.gov) - P3 | N=4994 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

NRG-GY009: Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3 | N=444 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2026 ➔ Apr 2027

Platinum resistant • Trial completion date • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • PD-L1

Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer (clinicaltrials.gov) - P2 | N=349 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Carcinosarcoma • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • AKT1

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=403 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Head and Neck Cancer • Hypopharyngeal Cancer • Lung Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Carcinoma of Unknown Primary • Tongue Carcinoma

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer (clinicaltrials.gov) - P3 | N=50 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

S0533: Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Large Cell Carcinoma • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer (clinicaltrials.gov) - P1/2 | N=85 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Feb 2028 ➔ Aug 2029 | Trial primary completion date: Aug 2027 ➔ Aug 2029

Checkpoint inhibition • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial (clinicaltrials.gov) - P2 | N=535 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2026 ➔ Apr 2026

Biomarker • Enrollment open • IO biomarker • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Celltrion grows Europe share as cancer…drugs win tenders, scripts (Chosun Biz) - "The cancer drug 'Vegzelma' (bevacizumab) has expanded supply by winning a series of major public tenders in France. Supply is being carried out through public hospital group purchasing organizations such as UniHA, HACOM, and GRAPS, and it has recorded a majority market share in the local bevacizumab market. In the same market, 'Herzuma' (trastuzumab) and 'Truxima' (rituximab) are also continuing with tenders and supply."

Commercial • Cervical Cancer • Chronic Lymphocytic Leukemia • Colorectal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial (clinicaltrials.gov) - P3 | N=226 | Recruiting | Sponsor: NRG Oncology | Initiation date: Oct 2025 ➔ Feb 2026

Trial initiation date • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • IL2