BI 695502 (bevacizumab biosimilar) / Boehringer Ingelheim - LARVOL DELTA

A phase I/II study of nintedanib and capecitabine in refractory metastatic colorectal cancer. (ASCO-GI 2017) - P1/2; " Key eligibility criteria included histologically proven mCRC, ECOG PS of 0 or 1, progression/intolerance to a fluoropyrimidine, oxaliplatin, irinotecan, and anti-EGFR therapy for RAS wt patients. Nintedanib is a TKI which inhibits VEGFR, PDGFR, and FGFR with preclinical efficacy in bevacizumab resistant CRC. Prior regorafenib, uncontrolled hypertension ( ≥ 160/90), recent clinically significant thrombosis/hemorrhage, or prior intolerance to capecitabine were exclusionary. Treatment was well tolerated. Most of the observed AEs were grade 1 or 2, without a marked difference between DLs. PPE was readily managed with dose adjustments."

P1/2 data • Biosimilar • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Immunology • Oncology • Venous Thromboembolism

Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC. (PubMed, JTO Clin Res Rep) - "In this phase 3, multicenter, randomized, double-blind trial of adult patients with recurrent or metastatic NSCLC received up to 18 weeks of induction treatment with BI 695502 or bevacizumab RP 15 mg/kg plus paclitaxel and carboplatin. Adverse events were class-related and similar between the two treatment arms. This study revealed equivalent ORR after 18 weeks of treatment with BI 695502 or bevacizumab RP, with similar adverse event profiles."

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

Safety and efficacy of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma (YouTube) - "Prof Richard Finn speaks to ecancer in an online interview for the virtual AACR 2021 meeting about the updated safety and efficacy results of IMbrave150. The IMbrave150 study looked at atezolizumab plus bevacizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma and included patients with high-risk features. Prof Finn explains that the trial led to atezolizumab plus bevacizumab being approved globally as the standard of care for these patients."

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Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer (clinicaltrials.gov) - P1/2; N=66; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial primary completion date: Feb 2017 ➔ Feb 2018

Trial primary completion date • Biosimilar • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma

First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU (clinicaltrials.gov) - P3; N=489; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Sep 2014 ->Jul 2015 ; N=96 -> 489

Trial primary completion date • Biosimilar • Breast Cancer • Oncology • Triple Negative Breast Cancer

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Mayo Clinic; Trial primary completion date: Jan 2016 ➔ Jan 2017

Trial primary completion date • Biosimilar • Melanoma • Oncology

Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme (clinicaltrials.gov) - P2; N=128; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting

Enrollment closed

Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov) - P2; N=88; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Sep 2016 ➔ Mar 2017

Trial primary completion date