Metastatic melanoma has been an “incredibly frustrating disease,” with only one treatment – high dose interleukin-2 – approved since dacarbazine was approved in 1975, Dr. Sosman noted. The approval of interleukin-2 in 1998 was not based on overall survival benefit or high response rate, but the “incredible durability” among the subset of responders, about 5%-10% of those treated. “We used to consider melanoma the graveyard for phase III studies,” with every study of regimens and drugs turning out negative, he said.
Dr. Sosman emphasized there is still a lot to learn, and that studies of treatment combinations are crucial, as these “may change the whole nature of the disease.” He foresaw combining a drug that does not have a high response rate but has “incredible durability” with a drug such as a BRAF inhibitor, with “an extremely high response rate that causes a lot of tumor death rapidly and can even make a sick patient well.”
He predicted that dacarbazine will fall by the wayside and will not be used in studies. It has a response rate of 5%-10% has never been shown to improve survival, and does not have a history of durability, he said.
Dr. Sosman disclosed that his institution received a grant from study sponsors BMS and Medarex for participating in the phase III trial.
* UPDATE: This article was updated on 3/28/2011.