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Poster display session

3308 - Phase 1b multi-indication study of the antibody drug conjugate anetumab ravtansine in patients with mesothelin-expressing advanced or recurrent malignancies


11 Sep 2017


Poster display session


Clinical Research


Alex A. Adjei


Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367


A.A.A. Adjei1, A. Walter2, L. Cupit3, J. Siegel4, A. Holynskyj3, B.H. Childs3, C. Elbi3

Author affiliations

  • 1 Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 2 Biomarker Strategy, Bayer AG, Berlin/DE
  • 3 Clinical Development, Bayer HealthCare Pharmaceuticals Inc., 07981 - Whippany/US
  • 4 Clinical Statistics, Bayer HealthCare Pharmaceuticals Inc., 07981 - Whippany/US


Abstract 3308


Mesothelin is expressed in a wide variety of tumours, including mesothelioma, ovarian, pancreatic, gastric/GEJ, NSCLC, triple-negative breast cancer, cholangiocarcinoma, and thymic carcinomas. Anetumab ravtansine (BAY 94-9343), is a novel fully human anti-mesothelin IgG1 antibody conjugated to the maytansinoid tubulin inhibitor DM4 and has shown encouraging anti-tumor activity in mesothelioma and ovarian cancer patients in a phase I study. We will therefore conduct a signal generating study with anetumab ravtansine in six additional high unmet medical need malignancies with mesothelin expression (NCT03102320).

Trial design

Eligibility criteria include: ≥18 years, unresectable locally advanced or metastatic recurrent or relapsing disease, one or more prior lines of therapy, and availability of tumour tissue for mesothelin expression testing. Mesothelin-positive patients with selected adenocarcinomas (NSCLC, triple negative breast, gastric including gastroesophageal junction) and thymic carcinoma will receive anetumab ravtansine as monotherapy at 6.5 mg/kg IV on a 21-day cycle. Patients with cholangiocarcinoma will receive anetumab ravtansine in combination with cisplatin (25 mg/m2 IV day 1 and 8 on a 21-day cycle for up to 6 cycles) and patients with pancreatic adenocarcinoma will receive anetumab ravtansine in combination with gemcitabine (1000 mg/m2 IV day 1 and 8 on a 21-day cycle). A safety run-in phase (18-24 patients each) will be conducted for the combination regimens prior to enrolling patients in the main study phase. The primary objective of the main phase of the study is objective response rate (ORR) of anetumab ravtansine as monotherapy or combination therapy in patients with either of two mesothelin expression levels: high (≥30% positive tumor cells with moderate and stronger membrane staining intensity) and low-mid (≥5% all intensities and

Clinical trial identification


Legal entity responsible for the study

Bayer AG


Bayer AG


A. Walter: Employee of Bayer AG. L. Cupit, J. Siegel, A. Holynskyj, B.H. Childs, C. Elbi: Employee of Bayer HealthCare Pharmaceuticals Inc. All other authors have declared no conflicts of interest.

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