Vegzelma (bevacizumab-adcd) / Celltrion - LARVOL DELTA

Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=169 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jan 2025

Trial completion • Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

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

New P3 trial • Appendix Cancer • Colorectal Cancer • Oncology • Solid Tumor

TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Brain Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Fallopian Tube Cancer • Glioblastoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Uterine Cancer • BRAF

Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer (clinicaltrials.gov) - P3 | N=255 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P3 trial • pMMR • Endometrial Cancer • Oncology • Solid Tumor

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=78 ➔ 280

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

Celltrion’s Vegzelma tops Japan’s bevacizumab prescriptions (Pulse by Maeil Business News Korea) - "According to market tracker IQVIA and local data, Vegzelma achieved a 50 percent market share as of last month, marking a more than threefold increase from 15 percent a year earlier. Celltrion’s Herzuma (trastuzumab), used to treat breast and gastric cancers, also continues to dominate with a 74 percent market share, maintaining a wide lead over competing products."

Commercial • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Glioblastoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jan 2026 ➔ Jun 2025

Trial initiation date • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor

A092001: Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

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

NCI-2018-01503: Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=96 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

Platinum resistant • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor • MSLN

ZIABC011078: Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma (clinicaltrials.gov) - P2 | N=63 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

IO biomarker • Trial completion date • Trial primary completion date • Alveolar Soft Tissue Sarcoma • Oncology • Sarcoma • Solid Tumor

A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jun 2029 ➔ May 2030 | Trial primary completion date: Jul 2028 ➔ May 2030

Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

CALGB 40603: Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery (clinicaltrials.gov) - P2 | N=454 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ Sep 2025

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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 | N=54 ➔ 85

Checkpoint inhibition • Enrollment change • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Adenocarcinoma • Cervical Cancer • Cervical Squamous Cell Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3 | N=120 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Active, not recruiting

dMMR • Enrollment closed • Mismatch repair • MSI-H • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Rectal Cancer • Solid Tumor • MLH1 • MSH2 • MSH6 • MSI

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: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

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

Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial (clinicaltrials.gov) - P3 | N=252 | Not yet recruiting | Sponsor: NRG Oncology

New P3 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer. (PubMed, Cancer Treat Res Commun) - P3 | "Long-term results of the CT-P16 3.1 study confirm equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC."

Clinical • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Celltrion expands footprint in Italy with continued wins for...oncology drugs (Korea Biomedical Review) - "These contracts have helped Truxima reach a 29 percent market share, Vegzelma 30 percent, and trastuzumab biosimilar Herzuma 29 percent, placing all three oncology products among Italy’s top-prescribed treatments in their classes...Additional tenders for these products are scheduled in the second half of the year."

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

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 2025 ➔ Jul 2026

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

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (clinicaltrials.gov) - P3 | N=692 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jul 2026

Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

Celltrion's operating profit hits record high in Q2 on strong sales of new high-margin drugs (Korea Biomedical Review) - "The company said its second quarter revenue reached 961.5 billion won ($690.5 million), up 9.9 percent year-on-year, while operating profit jumped 234.5 percent to 242.5 billion won -- both all-time highs for the second quarter...The strong performance was driven by robust demand for Remsima SC (marketed as Zymfentra in the U.S.), a subcutaneous infliximab biosimilar for autoimmune diseases, Yuflyma, an adalimumab biosimilar for rheumatoid arthritis and inflammatory conditions, Vegzelma, a bevacizumab biosimilar used in cancer treatment, and Steqeyma, a ustekinumab biosimilar targeting psoriasis and Crohn’s disease."

Commercial • Breast Cancer • Crohn's disease • Glioblastoma • Immunology • Inflammatory Bowel Disease • Non Small Cell Lung Cancer • Ovarian Cancer • Psoriasis • Rheumatoid Arthritis

Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases (clinicaltrials.gov) - P2 | N=7 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=112 ➔ 7 | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Feb 2025

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

Physicochemical Stability of a Bevacizumab Biosimilar in Vials and Diluted Preparations: Implications for Hospital Practice and Inventory Management. (PubMed, Ann Pharm Fr) - "These findings demonstrate the biosimilar's resilience against a 72-hour temperature spike. Pharmacies could use this data for flexible treatment scheduling, advanced preparation for weekends, and holidays, resulting in cost-efficiencies with biosimilars."

Journal

Celltrion’s Cancer Drug Herzuma Achieves 75% Market Share in Japan (Business Korea) - "Celltrion announced on June 13 that its breast and gastric cancer treatment Herzuma recorded a 75% market share in Japan as of April. According to pharmaceutical market research firm IQVIA and local market data, Herzuma has maintained the top position in prescriptions for four consecutive years since surpassing the market share of the original product for the first time in the second quarter of 2021....During the same period, Vegzelma, a treatment for metastatic colorectal and breast cancer, captured a 29% market share."

Commercial • Breast Cancer • Colorectal Cancer • Gastric Cancer