On September 11, 2015 Merck KGaA, Darmstadt, Germany and Pfizer reported that six abstracts on studies evaluating the potential role of programmed death-ligand 1 (PD-L1) inhibition and the safety and efficacy of the investigational cancer immunotherapy avelumab* will be presented at this year’s ECC in Vienna, Austria, September 25–29, 2015 (Press release, Pfizer, SEP 11, 2015, View Source [SID:1234507453]).

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New data will be presented in urothelial (e.g. bladder), mesothelioma and gastric/gastroesophageal cancers. Additional NSCLC and ovarian cancer data from Phase Ib trials build on those previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1–10 As the promise of immuno-oncology continues to grow, these new data help to further the understanding of the potential role of avelumab for patients suffering from cancers with high unmet need.

Despite continued progress in bringing new treatments to patients, there remains a significant unmet need across many types of cancer. For example, the incidence of gastric cancer remains a major public issue in Western and Asian countries, and there is a continued need to better understand the disease biology to provide patients with the most appropriate and effective treatment.11 For some cancer types, such as mesothelioma, the incidence rates are rising worldwide,12 with limited treatment options currently available for patients.

"Our clinical program for avelumab continues to accelerate, and we remain on-target to initiate up to six pivotal trials this year," said Dr Luciano Rossetti, Global Head of Research & Development of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "As we investigate avelumab across a broad range of tumor types, Merck KGaA, Darmstadt, Germany and Pfizer are working together diligently to analyze and present data at important congresses like ECC, to share the latest knowledge and understanding of this immune-checkpoint inhibitor with the medical community."

Currently, more than 1,000 cancer patients have been treated with avelumab in the Phase I/Ib clinical program (JAVELIN Solid Tumor), and more than 15 tumor types are under investigation.

"This is an exciting time for the Merck KGaA, Darmstadt, Germany and Pfizer alliance. Working together, we have made substantial progress in advancing the clinical evaluation of avelumab as both a single agent and as part of combination therapy in patients with difficult-to-treat cancers," said Dr Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "We believe that the talent, resources, pipeline products, and commitment that each partner brings to this collaboration position us well to become potential leaders in the field of immuno-oncology."

Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Data to be presented at ECC are part of the JAVELIN clinical trial program, an extensive international program exploring the use of PD-L1 inhibition with avelumab to treat multiple types of cancer.

The JAVELIN clinical trial program includes a Phase III open-label, multicenter trial to investigate avelumab versus docetaxel in patients with Stage IIIb/IV or recurrent NSCLC that has progressed after platinum-based chemotherapy (JAVELIN Lung 200); an international Phase II trial to investigate avelumab in patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200); a Phase Ib, open-label, multicenter, multiple-dose trial designed to estimate the maximum tolerated dose and select the recommended Phase II dose of avelumab in combination with axitinib in patients with previously untreated advanced renal cell carcinoma (JAVELIN Renal 100); an international Phase I trial to investigate avelumab in patients with metastatic or locally advanced solid tumors (JAVELIN Solid Tumor); and a Phase I trial to investigate avelumab in Japanese patients with metastatic or locally advanced solid tumors, with an expansion cohort in Asian patients with gastric cancer (JAVELIN Solid Tumor Japan). The clinical development program for avelumab now includes more than 1,000 patients treated across more than 15 tumor types, including NSCLC, breast cancer, gastric cancer, ovarian cancer, urothelial cancer, esophageal cancer, head and neck cancer, renal cell carcinoma, Merkel cell carcinoma, melanoma and mesothelioma.

In the United States and Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, operates as EMD Serono.

*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C)