September 29, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Now that Pfizer has decided not to split into two separate companies analysts and investors are eager to speculate on what the company’s strategy going forward will be. Certainly many are thinking modest-sized mergers and acquisitions are likely. George Budwell, writing for The Motley Fool, notes that the company’s recent Medivation acquisition isn’t Pfizer’s only bold step in oncology.
About two years ago, Pfizer struck a global strategic alliance with Merck KgaA to develop avelumab for a variety of cancers. Budwell writes, “If avelumab can perform as expected in the clinic, Pfizer should subsequently sport three mega-blockbuster oncology products. Peak sales are in the neighborhood of $4 billion to $6 billion, and even though Merck KGaA has claim to the majority of sales, this experimental cancer drug could eventually help to propel Pfizer into the upper echelons of revenue growth within its peer group.”
The two companies are exploring avelumab as a monotherapy or as part of a combination treatment for more than 15 tumor types in a grouping of clinical trials dubbed JAVELIN. Data is expected in non-small cell lung cancer in the fourth quarter of next year. If all goes well, it would hit the market in 2018. Budwell writes, “If so, avelumab could serve as an important buffer against the looming generic threat to Lyrica, which is one of Pfizer’s most important revenue drivers but is set to lose its main U.S. patent protection in 2018.”
Avelumab, falling cleanly into the immune-oncology arena, is a fully human anti-PD-L1 IgG1 monoclonal antibody. It inhibits PD-L1 interactions, which allows the activation of T-cells and the immune system. In addition to non-small cell lung cancer, it is being studied in solid tumors, gastric cancer, Merkel Cell Carcinoma, bladder cancer, head & neck cancer, mesothelioma, ovarian cancer and renal cancer.
Of concern is that although immune-oncology drugs are very impressive, they have tended to underperform somewhat across clinical trials. Still, in June, Pfizer and Merck KGaA announced results from its Phase II study of avelumab, which showed a 31.8 percent objective response rate (ORR) in patients with metastatic Merkel cell carcinoma. It was also a rapid response, with 78.6 percent of patients responding in 7 weeks.
“To see a tumor response in almost a third of patients in this trial, and for the majority to keep responding after six months, represents a potential breakthrough for this challenging disease,” said Howard Kaufman, lead investigator, and physician at the Rutgers Cancer Institute of New Jersey, in a statement. “Currently, the only treatment option available for advanced stages of this aggressive type of skin cancer is chemotherapy, where the response rates are not adequate or durable.”
Budwell writes, “So while the idea of Pfizer sporting three mega-blockbuster cancer drugs is certainly intriguing from a top-line perspective, investors shouldn’t count their chickens before they hatch. Pfizer’s strong dividend program, healthy cash flows, and maturing late-stage clinical pipeline as a whole, by contrast, are perhaps better reasons to buy or hold this pharma stock right now.”
Those three drugs are Ibrance, for breast cancer, will is projected to have peak sales of $5 billion. Medivation’s Xtandi is believed to be able to draw $4.8 billion by 2020.
