Stemline wraps positive pivotal trial for its controversial lead cancer drug, clearing a path to the FDA
Back in February, Stemline Therapeutics $STML managed to put itself in the middle of a controversy when it rolled out a $45 million offering, while failing to tip investors off to another patient death in its pivotal study of SL-401 for blastic plasmacytoid dendritic cell neoplasm due to capillary leak syndrome.
Shares dropped, investors cried foul and accusations flew on Twitter.
But Stemline’s pivotal trial was never held up by regulators, and today the biotech says their drug came through in the study, hitting the primary endpoint and touting top-line data on Stage 3, where a small group of 13 first-line patients registered a complete response rate of 54% and an overall response rate of 77%.
The data update — with details due to arrive at ASH — leaves the biotech in a position to follow through on plans to file for an approval within five months.
Stemline shares shot up 19% pre-market on the news, as investors proved willing to forgive — if not forget.
A total of three of all 148 patients treated with SL-401 have died from CLS, and it’s important to note that the biotech had no new deaths to report today.
Stemline CEO Ivan Bergstein says in their statement that the company is ramping up a commercial team in preparation of a launch. And Dana-Farber’s Andrew Lane says the drug is ready to go.
SL-401 has demonstrated efficacy with meaningful clinical benefit in BPDCN while maintaining a manageable safety profile, particularly notable in this predominantly older population, representing a major advance in the management of BPDCN. Also, given the presence of CD123 on additional aggressive hematologic cancers, we are also exploring SL-401 in combination with other agents in clinical trials of high risk MDS and AML.