Avegra (bevacizumab biosimilar) / Biocad - LARVOL DELTA

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