Bayer’s Phase II trial for MPM drug fails to meet primary endpoint


Bayer’s Phase II clinical trial of its oncology product candidate anetumab ravtansine (BAY 949343) did not meet the primary endpoint of progression-free survival in recurrent malignant pleural mesothelioma (MPM) patients.

Anetumab ravtansine is an antibody-drug conjugate (ADC) designed to specifically target mesothelin and cause cell cycle arrest, as well as apoptosis in dividing cells.

During the randomised, open-label, active-controlled, multi-centre superiority trial, the safety and tolerability of the investigational candidate were found to be consistent with data from the previous studies.

The trial evaluated anetumab ravtansine as a second line treatment in 248 patients with advanced or metastatic mesothelin-positive MPM that has progressed following first-line platinum / pemetrexed-based chemotherapy.

The trial compared 6.5mg/kg of intravenous anetumab ravtansine every three weeks with 30mg/m² of intravenous vinorelbine every week.

"Based on the available data, we remain committed to further evaluating the utility and safety of anetumab ravtansine across multiple tumour types with significant unmet medical need."

In addition to overall survival, the trial’s secondary endpoints included measure of efficacy indicators such as patient-reported outcomes, objective tumour response rate, duration of response, disease control rate and durable response rate.

Bayer oncology strategic business unit executive vice-president and head Robert LaCaze said: “Malignant pleural mesothelioma is a very difficult-to-treat tumour, and we had hoped for a better outcome for patients.

“Based on the available data, we remain committed to further evaluating the utility and safety of anetumab ravtansine across multiple tumour types with significant unmet medical need.”

Anetumab ravtansine is being further studied as a monotherapy and combination therapy in various oncology trials such as a Phase Ib multi-indication trial for six different advanced solid tumours, and another Phase Ib combination trial to treat recurrent platinum-resistant ovarian cancer patients.


Image: CT of Pleuramesothelioma. Photo: courtesy of Hellerhoff.