Citi "MM-020 Data Delayed Likely Due To Better Efficacy" Positive
Citi "MM-020 Data Delayed Likely Due To Better Efficacy"
Celgene Corp (CELG)
Alert: Citi Healthcare Conference - MM-020 Data Delayed Likely Due To Better Efficacy
What's New Today?— At our conf, we hosted a fireside chat with Mark Alles, Head of Global Heme/Onc commercial operations. The big news is that based on a slowdown in PFS event accrual in late '12/Jan '13, Celgene now expects MM-020 data in late Q2/mid-'13 to reach the 70% of PFS events required to trigger the interim analysis. This is a 3 months delay on top of the previous 3 months delay. While many investors will worry that this could be a negative, we believe that the chance that the MPT arm is doing much better than expected is low given the historical experience with the regimen. Based on our analysis, most patients have likely stopped therapy on that arm so the longer PFS is likely due to Rd.
PFS Events Taking Longer-Likely a Positive Sign— It has been 55 mos since the MM-020 study began enrolling and pts have been on the study ~26 mos since enrollment completion. Based on historical data, the PFS should likely be ≥30-36 mos on Rd. Celgene continues to believe that the 24 mos projected PFS for MPT is likely still a reasonable expectation. If that is the case, then a longer PFS on Rd must be the explanation for the slower PFS progression rate in the study. Recall that the PFS in the MM-015 study (similar population) on MPT (tested Revlimid alone from 9-32 mos) was 32 mos. In MM-020, Rd is tested continuously and so this also provides evidence that the PFS should be 30 mos predicted when the study was designed. So while many will be worried that this is negative sign, we believe that it is actually a positive.
Celgene Comments on NDMM EU Market Opportunity— Celgene stated that the front-line myeloma EU market opportunity could add incremental revenue of $800M- $1B by ~2019/20. Current market share is mid-single digits on average. Our model projects 1st-line EU approval adding $344M in Revlimid sales in 2015 going up to $812M by 2020. We model 10% front-line market share in EU in 2013 doubling to 20% by 2015 with front-line approval and then increasing to 35% by 2020.
Expect Mature MM-015 Data In Next Few Weeks— MM-015, which is also being conducted in 1st line new transplant ineligible pts, will have mature data based on 50% of survival events in the next few wks. We believe the data could show evidence of a positive overall survival trend in 65-75 yrs old that will support EU regulatory submission in H2:13. We also expect the study to show SPM rates beginning to plateau, which will help address the benefit/safety question for Revlimid.
Updates on CALGB and IFM Studies This Year— Data from CALGB-100104 and IFM 2005-02 trials of Revlimid in the post-stem cell transplant maintenance setting will be updated this year and should help further support the benefit/risk profile of Revlimid. At the IMW meeting in April, the more mature OS data incl crossover will be presented from the CALGB study. While at ASH in December more mature IFM data will be presented.