Amgen presents positive data from late-stage trial of T-Vec in advanced melanoma

Amgen presented additional data at the ASCO meeting from a late-stage trial suggesting that more patients with late-stage melanoma achieved a complete or partial response lasting for at least six months when given talimogene laherparepvec (T-Vec) compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). "These are the first data from a controlled trial of oncolytic immunotherapy to demonstrate activity in melanoma," remarked Sean E. Harper, executive vice president of R&D at Amgen, adding that "we look forward to the mature overall survival data later this year."

The study randomised more than 400 patients with unresected stage IIIB, IIIC or IV melanoma to receive T-Vec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28 day cycle. The study design allows for treatment to last for up to 18 months and, where appropriate, stable or responding patients could receive additional treatment as part of an extension protocol. As previously announced, the study met its primary endpoint of durable response rate (DRR), with 16 percent of patients given Amgen’s investigational oncolytic immunotherapy experiencing a complete or partial response lasting continuously for at least six months, compared to 2 percent of patients given the GM-CSF comparator. Specifically, the DRR for T-Vec was 33 percent in stage IIIB/IIlC, 16 percent in stage IVM1a, 3 percent in stage IVM1b and 8 percent in stage IVM1c. The DRR with GM-CSF was not higher than four percent in any of the stage subsets.

Amgen added that the overall response rate was 26 percent with T-Vec as compared to 6 percent for GM-CSF and a trend toward overall survival with Amgen’s drug was also observed at a predefined interim analysis. Serious adverse events included disease progression, cellulitis and pyrexia and occurred in 26 percent of patients given T-Vec and 13 percent of patients given GM-CSF.

Commenting on the future of the drug, which the drugmaker gained as part of its acquisition of BioVex in 2011, Amgen’s vice president of oncology development David Chang noted that "scientifically, it's a compelling idea to combine T-Vec with a PD-1," which prime a patient's immune system to identify and kill cancer cells and are currently under development by several drugmakers. "We're doing early safety studies, it's too early to comment but the interest in pursuing this approach is much higher today," he added.

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