Merck KGaA MKGAF and Pfizer Inc. PFE announced that the companies have started an open-label, multi-center, randomized phase III study (EMR 100070-004) to evaluate the efficacy and safety of avelumab (MSB0010718C) in comparison with Taxotere for the treatment of stage IIIb/IV non-small cell lung cancer (NSCLC) in patients who experienced disease progression after receiving a prior platinum-containing doublet therapy.
In this study, patients will be administered either avelumab or Taxotere in a 1:1 ratio irrespective of their programmed death-ligand 1 (PD-L1) status. The primary endpoint of the study is overall survival in treatment-experienced patients with PD-L1 positive stage IIIb/IV NSCLC and suffering from disease progression.
The study will be conducted as part of the JAVELIN development program for avelumab. Apart from the EMR 100070-004 study, the JAVELIN program includes a number of other studies on avelumab – a phase II study for metastatic Merkel cell carcinoma, a phase I study for metastatic or locally-advanced solid tumors and another phase I study for Japanese patients suffering from metastatic or locally-advanced solid tumors with an expansion part in Asian patients with gastric cancer.
The phase I program for avelumab includes multiple types of tumor including breast, gastric, ovarian and bladder cancers, melanoma, mesothelioma and NSCLC.
We remind investors that in Nov 2014 Merck KGaA entered into a global agreement with Pfizer to co-develop and co-commercialize avelumab for multiple types of tumor. The companies will join forces on up to 20 high-priority immuno-oncology clinical development programs many of which are expected to begin in 2015. The phase III avelumab study is the first of several registration studies that the companies are planning to initiate jointly in 2015.
According to the American Cancer Society, NSCLC is the most common type of lung cancer, comprising for 85% – 90% of all types of lung cancers. Merck KGaA believes that new therapies are urgently needed to improve the overall survival of NSCLC patients. The Merck KGaA-Pfizer partnership should create the opportunity to combine avelumab with a range of approved oncology therapies and investigational candidates in Pfizer’s portfolio, thereby enhancing the prospect of developing cancer immunotherapy for broader use.
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