Merck KgaA, and Pfizer announced that avelumab presentations across seven different tumour types, including two oral presentations, will be featured at the 52nd American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3–7, 2016, in Chicago, Illinois.
The avelumab presentations, from the rapidly accelerating JAVELIN clinical development programme, include new study results from a number of difficult-to-treat cancers, including data from the pivotal phase II trial of avelumab being investigated as second-line treatment for metastatic Merkel cell carcinoma (MCC). Additional data include highlights from mesothelioma, adrenocortical carcinoma, non-small cell lung cancer, and urothelial bladder, gastric and ovarian cancers, as well as updated safety data.
“One of our key highlights for ASCO will be the new avelumab data in second-line metastatic Merkel cell carcinoma,” said Luciano Rossetti, executive vice president, global head of research & development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. “As there are currently no approved treatments for this rare and aggressive cancer, these clinically meaningful data represent a breakthrough for this difficult-to-treat tumour type.”
Since ASCO 2015, the collaboration between Merck KGaA, Darmstadt, Germany, and Pfizer has made significant progress. The JAVELIN development program for avelumab now includes 30 ongoing clinical programs and nine pivotal studies. As of May 2016, JAVELIN now includes approximately 2,200 patients, being treated across more than 15 tumour types.
"These data add to the growing body of evidence for avelumab, indicating efficacy and a favorable safety profile in multiple cancers, which supports ongoing development,” said Chris Boshoff, M.D., PhD., vice president and head of early development, translational and immuno-oncology at Pfizer Oncology. “Through our comprehensive JAVELIN clinical development programme for avelumab, we are making meaningful advances for a broad range of patients with cancer.”
Avelumab is an investigational, fully human antibody specific for a protein found on tumour cells called PD-L1, or programmed death ligand. As a checkpoint inhibitor, avelumab is thought to have a dual mechanism of action which is believed to enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumour cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumour responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumours in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity.
Avelumab (also known as MSB0010718C) is an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US, enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.