The FDA is deliberating whether to approve Amgen's melanoma-fighting vaccine, T-Vec, after an advisory committee recommended it 22-1 for approval in April. In the meantime, the California biotech is looking at possibilities beyond melanoma.
Amgen ($AMGN) is partnering with Merck ($MRK) to test T-Vec in combination with the PD-1 drug, Keytruda, in patients with head and neck cancer, PharmaTimes reported Sunday. Merck announced the collaboration at the American Society of Clinical Oncology (ASCO) meeting Friday.
The Phase I open-label trial will recruit patients with recurrent or metastatic squamous cell carcinoma of the head and neck, the news outlet reported. It will investigate whether the therapies used in tandem will provide a new treatment option for this particular cancer.
This isn't the first time that the pharmas are testing T-Vec and Keytruda together: In December 2014, they launched a Phase I, open-label trial to test the combo in patients with advanced melanoma. At ASCO, the companies also announced a global, randomized Phase III trial to follow.
Amgen is also testing T-Vec with Bristol-Myers Squibb's ($BMY) Yervoy, reporting Phase Ib results in June 2014. The pairing didn't increase toxicity, and shrank or eliminated tumors in more than half of the 19 study patients. Other combination treatments for cancer in clinical trials include Bavarian Nordic's Prostvac with BMS' Yervoy as well as the latter's Opdivo with Aduro's pancreatic cancer vaccine, GVAX.
- here's the PharmaTimes story
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