March 11, 2013
A Key Endorsement
Impact on our views: Addition of Kyprolis to National Comprehensive Cancer Network or NCCN treatment
guidelines for newly diagnosed myeloma patients undergoing stem cell transplant is an expected positive.
Front line use is largely upside to MSe/consensus and should allay concerns about competitive pressures from
Celgene’s Pomalyst. Moreover, guideline inclusion will ease front line reimbursement and create an additional
source of growth in the coming quarters.
NCCN treatment guideline details as expected. Kyprolis is listed as an “other regimen” (versus a preferred regimen) for primary therapy in patients undergoing stem cell transplant for use in combination with Revlimid and dexamethasone. Kyprolis received a Category 2A recommendation meaning that “based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.”
How much bigger? We estimate roughly 40-50% of the ~15,000 treated front line patients receive a stem
cell transplant in the US. Moreover, Kyprolis should fit in with the roughly 25% of patients currently receiving the combination of the other marketed proteasome inhibitor Velcade + Revlimid and dex. The magnitude of the near term front line opportunity for Kyprolis is difficult to call. However, given broad off-label use in myeloma, (front line use of Celgene’s Revlimid for example) we expect uptake of Kyprolis to grow over time as physicians gain comfort with the regimen.
In other news. Recently published dose escalation data from the 006 trial provide early insights in the key
ASPIRE trial (1-3 prior lines of therapy comparing CRd to Rd). While only 8 patients, at the ASPIRE regimen of
20/27 mg/m2 of Kyprolis and 25 mg of Revlimid, the response rate was 87.5% and the median PFS was 14.6
months. This compares favorably to a 60% response rate and ~11 months of PFS for Revlimid and dex in the
line 2+ MM-009/MM-010 trials. CRd looked superior despite 70% of patients being previously treated with
Revlimid or Velcade (~55% both). We look forward to
data from the 44 patient 006 expansion cohort at ASCO.