Versavo (bevacizumab biosimilar) / Dr. Reddy’s - LARVOL DELTA

A prospective, multi-center, phase IV study to evaluate safety and efficacy of Dr. Reddy's bevacizumab (DRL_BZ) in patients with solid tumors (AACR 2025) - "The safety profile of DRL_BZ, in terms of reported adverse events, in patients with solid tumors is comparable and consistent with the known safety profile of bevacizumab in literature. Overall, findings from this Phase IV study indicate that the safety and efficacy of DRL_BZ in patients with solid tumors is as per the approved prescribing information."

Clinical • P4 data • Cervical Cancer • Colorectal Cancer • Epithelial Ovarian Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

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

Comparison of Efficacy and Safety of a Bevacizumab Biosimilar, in Combination with Chemotherapies, in Nonresectable Metastatic Colorectal Cancer and in Advanced Nonsquamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study. (PubMed, South Asian J Cancer) - "In part A, a total of 117 mCRC patients were intended to receive 5 mg/kg of bevacizumab every 2 weeks along with mFOLFOX6 chemotherapy for a maximum of 18 cycles. In part B, 60 NSCLC patients were to receive 15 mg/kg of bevacizumab every 3 weeks along with pemetrexed and carboplatin for the initial four cycles, followed by pemetrexed for another four cycles...Overall, the efficacy, safety, immunogenicity, and pharmacokinetic parameters of DRL_BZ and RMP were found to be comparable. Clinical Trial Registration For BZ-01-002: CTRI/2016/01/006481."

Clinical • Combination therapy • Journal • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Dr. Reddy's Laboratories launches Versavo (bevacizumab) in the UK (Businesswire) - "Dr. Reddy’s Laboratories Ltd...announced the launch of Versavo (bevacizumab) in the United Kingdom (UK). Dr. Reddy’s Versavo is a (bevacizumab) biosimilar of Avastin and indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer. Versavo is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK. It is available in strengths of 100mg and 400mg single use vials."

Launch Europe • Brain Cancer • Breast Cancer • Cervical Cancer • CNS Tumor • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Gynecologic Cancers • Kidney Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • 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

Bevacizumab plus erlotinib maintenance versus observation in advanced biliary tract cancers: Results from the phase II component of a prospective integrated phase II-phase III parallel design superiority clinical trial (BEER-BTC study) (ESMO 2023) - "Eligible patients with advanced BTC who had responsive or stable disease status post 6 months of gemcitabine – based chemotherapy were randomly assigned (1:1) to either observation arm (O) or intervention arm (BEER), which was a combination of Bevacizumab 5 mg/m2 IV every 21 days plus erlotinib 100 mg once daily,...Conclusions The combination of bevacizumab and erlotinib improves progression free survival in patients with chemotherapy responsive advanced BTC in this phase 2 clinical trial. The ongoing phase III component of the study will evaluate whether the significant benefit in PFS translates to improvement in overall survival."

Clinical • Head-to-Head • Metastases • P2 data • P3 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal 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 | 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

"Bevacizumab similar biologic Versavo launched in India: Indiabased generics manufacturer Dr Reddys Laboratories Dr Reddys announced on 19 August 2019 that it had launched its bevacizumab similar biologic Versavo DRZBZ in India. https://t.co/oYWns96OZn" (@AntibodyNews)

Generic launch

"Dr. Reddy's Laboratories announces the launch of Versavo® (bevacizumab biosimilar) in India https://t.co/sMUZN6P5l7" (@NewsFromBW)

Biosimilar launch

Dr. Reddy's Laboratories announces the launch of Versavo (bevacizumab biosimilar) in India (Businesswire) - "Dr. Reddy’s Laboratories Ltd...announced...that it has launched Versavo® (bevacizumab), a biosimilar of Roche’s Avastin® in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer)."

Biosimilar launch