Amgen today announced the publication of primary results from the Phase 3 OPTiM study in the Journal of Clinical Oncology (JCO). The data published in JCO, which were previously presented at the Annual Meetings of the American Society of Clinical Oncology (ASCO) in 2013 and 2014, demonstrated a significantly higher durable response rate (DRR) in patients with unresected stage IIIB, IIIC or IV metastatic melanoma receiving the investigational oncolytic immunotherapy talimogene laherparepvec compared to those who received granulocyte-macrophage colony-stimulating factor (GM-CSF). Results showed that the primary endpoint of DRR was met, however the secondary endpoint of overall survival (OS) was not met, although there was a strong trend in favor of talimogene laherparepvec
MRV Research
As FDA Considers Approval, Weber Discusses Adjuvant Ipilimumab in Melanoma
In the EORTC 18071 study, patients with melanoma who received ipilimumab (Yervoy; n = 475) had an average recurrence-free survival of 26.1 months versus 17.1 months in placebo-treated patients (n = 476). Additionally, 46.5% of ipilimumab-treated patients survived 3 years without experiencing recurrence compared to 34.8% of patients in the control arm.
‘NONO’ says yes for repairing DNA damage induced by UV radiation
Major risk for skin cancer is ultraviolet (UV) exposure. In scientific terms, when cells respond to UV radiation, they induce DNA damage by activating different ‘checkpoints’ of the cell cycle, which in turn halts and activates DNA repair pathways.
Combining Surgery and Ipilimumab Increases Melanoma Patients Survival
In a new study entitled “Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial” researchers show that advanced stage melanoma patients submitted to surgery and treated afterwards with ipilimumab improved recurrence-free survival. The study was published in the journal The Lancet.