Avegra (bevacizumab biosimilar) / Biocad - LARVOL DELTA

Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (clinicaltrials.gov) - P3 | N=408 | Recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial completion date: Jun 2034 ➔ Jun 2029

Trial completion date • Colorectal Cancer • Oncology • Solid Tumor

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

Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer (clinicaltrials.gov) - P3 | N=2431 | Completed | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2027 ➔ May 2026 | Active, not recruiting ➔ Completed

Biomarker • Trial completion • Trial completion date • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • MSH2 • MSI

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

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) (clinicaltrials.gov) - P2 | N=160 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=353 | Completed | Sponsor: Biocad | N=138 ➔ 353

Enrollment change • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Oct 2024 ➔ Dec 2023

Trial primary completion date • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Final results of APOLLON-11 and SOYUZ-APOLLON study: Multicentre prospective observational post-authorization study of bevacizumab biosimilar in patients with metastatic colorectal cancer in real-world practice (ESMO Asia 2023) - "Background Bevacizumab biosimilar (Avegra®) became available for patients in Russia since 2015...Conclusions Our findings are consistent with previously known bevacizumab safety and efficacy profile. Numerically low incidence of ARs is most likely due to reduced reporting of adverse events in real-world clinical practice settings."

Clinical • Metastases • Observational data • Real-world • Real-world evidence • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Dec 2024

Enrollment closed • Trial completion date • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab. (PubMed, BMC Cancer) - P3 | "Thus, the results of this study demonstrated therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug."

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

[VIRTUAL] A phase III study comparing BCD-021, a bevacizumab biosimilar, and reference bevacizumab in patients with stage IIIB or IV non-squamous NSCLC (ESMO 2021) - P3 | "This study compared the efficacy, safety, pharmacokinetics (PK), and immunogenicity of BCD-021 to BEV in patients with stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC). In this randomised, double-blind, multicentre study, patients were randomised in a ratio 1:1 (for Russia, Belarus and Ukraine) and 2:1 (for India) to receive BCD-021 or BEV with paclitaxel and carboplatin Q3W for 6 cycles. This study demonstrated equivalence between BCD-021 and BEV in terms of ORR risk difference and risk ratio. Safety, PK, and immunogenicity parameters were comparable between BCD-021 and BEV."

Clinical • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Biocad's BCD-021 Bevacizumab Biosimilar Demonstrates Equivalence in NSCLC (Center for Biosimilars) - P3, N=357; NCT01763645; Sponsor: Biocad; "Confirmed ORRs were observed in 34.6% of the biosimilar cohort (n = 71) and 33.8% of the reference population (n = 46). The respective confirmed percentages for CR were 1.5% and 0.7%; and PR, 33.2% and 33.1%...Patients experiencing stable disease in the biosimilar and reference groups were 31.7% and 33.8%, respectively. The proportions experiencing progressive disease were 13.2% and 11.0%, respectively."

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

"Thanks for spreading the word about World Blood Cancer Day. #WBCD2021" (,@DKMS_us)

Hematological Malignancies • Oncology

"#FBCD2021 @ISEHSociety @CellPressNews @ASH_hematology @ISSCR @AACR @MDSFoundation @FASEBorg @STARProtocols" (,@Amitmadrid)

Clinical • Hematological Disorders

"#FBCD2021 @IndiaBioscience @CellReports @BloodJournal @BCD_AACR" (,@Amitmadrid)

Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: Results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC (ASCO 2015) - Presentation time: Monday June 1, 8:00 AM to 11:30 AM; Abstract #8057; P3, N=138; NCT01763645; Sponsor: Biocad; "ORR (primary endpoint) in both groups had no statistically significant differences: 42.59 % (95% CI 30.33 – 55.83) in BCD-021 group and 39.29% (95% CI 27.58 – 52.27%) in Avastin group. The lower limit of 95% CI for ORR difference between the groups (-14.96%) did not exceed the non-inferiority margin, hence BCD-021 is non-inferior to Avastin."

P3 data • Biosimilar • Non Small Cell Lung Cancer • Oncology

A safety and efficacy study of BCD-021 with paclitaxel and carboplatin compared to avastin with paclitaxel and carboplatin in non-small cell lung cancer (clinicaltrials.gov) - P3, N=110; Sponsor: Biocad; Recruiting; New P3 trial.

New P3 trial • Biosimilar