Maybe this is why volume spiked today.
The LI-1 Trial has a “pick a winner” design that evaluates several candidates in front-line (FL) AML and could significantly de-risk vosaroxin potential in this setting. The trial is designed to identify promising FL AML candidates that may at least double complete remission (CR) or 12-month survival vs. low dose Ara- C (LDAC) SOC. Baseline expectations for LDAC should be ~15-20% for CRs and 18-20% for 12-
month survival. Advancing from Stage-1 to Stage-2 of this trial would imply a candidate can demonstrate 30-40% CR rate and +30% 12-month survival. The DMC reviews Stage-1 data after 50 experimental arm patients can be compared to 50 in the LDAC SOC comparator arm and will look at both CR rate and 12-month survival rate. Vosaroxin's LI-1 updates in early 3Q13 Arm-3 (monotherapy) and 4Q13 Arm-4 (combo with LDAC) could be major catalysts driving us to include meaningful FL revenues in our model. While it is risky to predict Phase III results based on Phase II data, we are at least encouraged that the previous FL Phase II REVEAL-1 Vosaroxin monotherapy trial (non-randomized) demonstrated a 31% CR rate (combined CR+CRp rate 35%) and a 38% 12-month survival rate. Interim data from MD Anderson's IST in MDS is important to Sunesis as it will provide the first look at combining vosaroxin with a hypomethylating agent such as Decitabine. While the primary end point of this trial will evaluate maximum tolerated doses (MTD) of the combination, it should also provide emerging efficacy details characterizing vosaroxin's potential as an MDS therapeutic option. Given that we
currently do not include any MDS revenues in our model, this trial could begin to de-risk MDS as a potential future growth opportunity for vosaroxin.
The Arm-3 monotherapy news will be the next piece of data that we get (most likely) and perhaps one of the tougher hurdles given the required data to move forward. Let's hope for the best - would be great news to hear that Vosaroxin is moving ahead into Stage-2.