Amgen's ($AMGN) cancer vaccine candidate may be awaiting FDA and EMA approval as a melanoma monotherapy, but the company isn't stopping there. Like many of its peers, it's looking to explore its prospect's potential as part of an immunotherapy duo, and now it's kicked off a trial combining its treatment with Merck's ($MRK) anti-PD-1 therapy that should help it do just that.
On Monday, the California company announced it had initiated a study of its oncolytic immunotherapy talimogene laherparepvec--T-Vec for short--in combination with Merck's newly approved checkpoint inhibitor Keytruda in metastatic melanoma patients. After enrolling its first participant, the safety and efficacy study will recruit about 109 more across 35 sites in the U.S., Australia and Europe, the biotech announced.
Amgen is hoping trial data will show that the two treatments complement one another, and as Amgen's VP of translational sciences, David Reese, told FierceVaccines earlier this year, there's good reason to believe they will. Where T-Vec is designed to stimulate the immune system, Keytruda is meant to take off the immune system's brakes, he said.
|F. Stephen Hodi--Courtesy of Dana-Farber Cancer Institute|
Antigen release and presentation--which T-Vec promotes--"is a fundamental step required for mounting a systemic effect against melanoma, and we think there is a strong rationale for combining" the two, F. Stephen Hodi, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute, said in a statement.
Plenty of companies have turned to immunotherapy combos to test their cancer vaccine candidates in the wake of large-scale monotherapy failures from companies like GlaxoSmithKline ($GSK) and Merck KGaA. Like Amgen, New Jersey biotech Advaxis ($ADXS), for one, has plans to test its vaccine alongside Keytruda.
And it won't be T-Vec's first immunotherapy pairing, either. In June, Amgen announced results from a Phase Ib study that showed that T-Vec administered prior to or in combination with Bristol-Myers Squibb's ($BMY) Yervoy either shrank or eliminated tumors in 56% of the 19 participating patients. And importantly, researchers didn't find that use of the pair enhanced toxicity--one of the key challenges with immunotherapy cocktails.
- read Amgen's release
Special Reports: Top 10 experimental cancer drugs - 2013 - T-Vec | ASCO preview: What's the outlook for cancer vaccines? | Top 10 Phase III disasters of 2014 - Tecemotide - MAGE-A3