June 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Amgen , headquartered in Thousand Oaks, Calif., announced today a collaboration with Roche on a Phase Ib clinical trial to evaluate talimogene laherparepvec combined with atezolizumab, also known as MPDL3280A for the treatment of triple-negative breast cancer and colorectal cancer with liver metastases.
Amgen did not respond to a request for comment by deadline.
Talimogene laherparepvec is Amgen’s cancer immunotherapy. MPDL3280A is Roche’s investigational anti-PDL1 therapy. Talimogene is designed to selectively replicate in tumors and cause an immune response to the cancer cells, while not stimulating immune response to normal cells. The company said the theory behind combining the two drugs is to both active an anti-tumor immune response while blocking inhibitory T-cell checkpoints. In other words, they hope to stimulate the body’s immune reaction to the cancer cells while blocking certain activity that puts the brakes on T cells.
“Atezolizumab is our most advanced cancer immunotherapy with 10 ongoing Phase III pivotal trials across lung, bladder, breast and kidney cancers,” said Sandra Horning, chief medical officer and head of Roche’s Global Product Development in a statement. “We are looking forward to working with Amgen on this trial, which can inform potential future treatment options for patients affected by very difficult-to-treat tumor types.”
This is not the first collaboration between Amgen and Roche. In October 2013 Amgen entered into a definitive agreement with Roche to buy Roche’s rights to filgrastim and pegfilgrastim in about 100 markets. Roche held the rights to the two compounds under a license from Kirin-Amgen, Inc., a joint venture between Amgen and Kirin Holdings Co. Limited, of Japan, for Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. The two compounds are white blood cell boosting therapeutics. Amgen markets them in the U.S. and Europe under the names Neupogen and Neulasta.
Only last week Amgen announced an expanded collaboration agreement with Merck & Co. to evaluate the safety and efficacy of talimogene laherparepvec in combination with Merck’s Keytruda, an anti-PD-1 therapy, in a Phase I trial. The companies also announced a global, randomized Phase III trial to evaluate the combination in patients with regionally or distantly metastatic melanoma.
“We believe that talimogene laherparepvec has potential in several cancer types based on its proposed mechanism of action to initiate tumor antigen release and presentation, important steps in activating a systemic anti-tumor immune response,” said Sean Harper, executive vice president of research and development at Amgen in a statement.
“Talimogene laherparepvec and Keytruda are designed to result in anti-tumor immune responses through different and potentially complementary mechanisms of action.”
It was noted by analysts in a report published by Moody’s titled “Biosimilars: Parsing the Industry’s Pipelines,” that Roche, Amgen and AbbVie are three companies most vulnerable to competition from biosimilars. Specifically, Amgen’s Neulasta, Roche’s Rituxan and AbbVie ’s Humira. Biosimilars are a drug that are very similar to known drugs, but which have the same therapeutic action and can be marketed competitively.
Perhaps ironically, Amgen’s pipeline for biosimilars is one of the most ambitious in the field. “There’s already lots of competition, and we’re used to having to compete on value,” said Geoff Eich, executive director of Amgen’s biosimilars division in a statement. “This is the natural evolution.”
Although a collaboration between Amgen and Roche is probably not directly related to biosimilar competition, if Amgen’s combination treatment studies with Roche and Merck are successful, testing for talimogene laherparepvec in combination with other anti-PDL1 therapies may be down the road. In November 2014, Merck announced it was working with Pfizer Inc. to jointly develop and commercialize MSB0010718C, an investigational anti-PD-L1 antibody for multiple types of cancer.
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?
