Amgen announced additional results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Talimogene laherparepvec is oncolytic immunotherapy derived from the herpes simplex virus type-1, designed to selectively replicate within tumors and to produce GM-CSF, which enhances systemic antitumor immune responses.
The trial was a global, randomized, open-label trial evaluating the safety and efficacy of talimogene laherparepvec compared to a control therapy with GM-CSF in over 400 patients with unresected stage IIIB, IIIC or IV melanoma. Patients were randomized 2:1 to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28 day cycle. Treatment could last for up to 18 months. Where appropriate, stable or responding patients could receive additional treatment on an extension protocol.
New data presented included:
- The durable response rate (DRR) was 19% with talimogene laherparepvec vs. 1% for the GM-CSF arm.
- The objective response rate was 31% vs. 6% in the talimogene laherparepvec and GM-CSF arm, respectively.
- Overall there was a high degree of correlation between the independent and investigator assessments.
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