Phase III study 309 results for Halaven (eribulin) in soft tissue sarcoma published in The Lancet- Eisai

Full results from the phase III study 309 have been published for the first time in The Lancet, and show Halaven (eribulin), from Eisai, improved median overall survival compared to dacarbazine for people with unresectable locally advanced liposarcomas and leiomyosarcomas, two of the most common forms of soft-tissue sarcoma. In addition to the full results, The Lancet has also published an editorial in which the results of the study are discussed.

Overall, 452 patients were randomized (228 eribulin; 224 dacarbazine). Median OS for eribulin and dacarbazine was 13.5 and 11.5 months, respectively. PFS was 2.6 months in both arms. PFS rate at week 12 was 33% and 29% for eribulin and dacarbazine, respectively. Eribulin had a toxicity profile consistent with prior experience, with no unexpected or new safety findings. In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of eribulin.

Comment: In July a Type II variation application to extend the indication of eribulin was submitted in the European Union for the treatment of patients with unresectable soft tissue sarcoma who have received prior chemotherapy for locally advanced disease. In the US, FDA approval was granted on January 28 2016 for eribulin in the treatment of patients with unresectable liposarcoma who have received a prior anthracycline containing regimen. A similar application was submitted in Japan.