aprutumab (BAY 1179470) / Bayer - LARVOL DELTA

Phase I study of fibroblast growth factor receptor 2 antibody-drug conjugate (FGFR2-ADC) BAY 1187982 in patients with advanced cancer (AACR 2017) - "Background: FGFR2-ADC (BAY 1187982) consists of an anti-FGFR2 antibody (BAY 1179470) and a stably linked, highly potent and non-cell permeable microtubule-binding auristatin toxophore. While this drug was tolerated well at lower dose levels, dose-limiting toxicities occurred below the expected therapeutic dose level. As the predicted human efficacious dose level based on the majority of animal models was above 0.4 mg/kg (Wittemer-Rump et al. AACR; Cancer Res 2015;75, 15 Suppl: Abstract nr 1683) a Phase II dose cannot be recommended and a successful clinical development of the compound was regarded as unlikely."

P1 data • Biliary Cancer • Biosimilar • Breast Cancer • Gastrointestinal Cancer • Oncology • Ophthalmology • Renal Disease • Venous Thromboembolism

Roundtable Discussion: Abou-Alfa Evaluates Choice of Therapy for HCC Based on Patient Factors (Targeted Oncology) - "During a Targeted Oncology case-based roundtable event, Ghassan K. Abou-Alfa, MD, MBA, discussed the case of a patient with hepatocellular carcinoma whose comorbidities impacted the choice of treatment....ABOU-ALFA: That is a great point that you bring up. [There are] a few points [to consider] about the biopsy. [Concerning] LI-RADS...I spoke with the radiologist who wrote the final LI-RADS radiologic assessments....ABOU-ALFA: [The patient] had Crohn disease, and she [also] bled from varices and she had banding 2 months ago. My question is, with varices, what's your comfort zone? [At what point do] you think you can give bevacizumab [Avastin]? [Do you not wait] at all, wait 2 months, 4 months, 6 months, or 1 year?"

Media quote

First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors (clinicaltrials.gov) - P1; N=35; Completed; Sponsor: Bayer; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Oncology

Bayer to present data on advancing oncology portfolio - Quick facts (First Word Pharma) - "Bayer HealthCare (Bayer) will present latest preclinical and clinical data on promising early-stage compounds with new mechanism of action at the American Association for Cancer Research (AACR) 105th Annual Meeting, April 5-9, 2014, in San Diego, CA....The agents include...BAY 1163877...BAY 1179470, as well as an FGFR2 antibody-drug conjugate (ADC)."

Anticipated conference • Oncology