SUMMARY
Positive data reported today and yesterday at ASCO have expanded the market potential of Revlimid and Rituxan to include first-line maintenance settings in multiple myeloma (MM) and follicular lymphoma (FL) respectively.  Use of Revlimid is currently limited to the second-line MM setting whilst Rituxan is used in the first-, second- and second-line maintenance FL settings.  Approval of both compounds for first-line maintenance therapy will expand the respective drug's sales bases, as well as the whole market due to a lack of current treatment options.

ANALYSIS

  • Revlimid and Velcade currently dominate the treatment of multiple myeloma (MM).  While we believe that these two drugs will continue to be the standard of care in the medium term, we believe emerging data could change treatment patterns and sales of the respective drugs.
  • Today at ASCO, positive data from two studies were reported demonstrating Revlimid is a beneficial treatment option for the 45% of newly diagnosed patients in the US and 30% in Europe that receive stem-cell therapy.  The first study, CALGB 100104, reported results from a second interim analysis, which showed that Revlimid significantly increased time to progression compared to placebo by 58% (13.8% of Revlimid-treated patients progressed at 12 months compared to 27.9% of placebo-treated patients).  The second trial, IFM 2005-02, was unblinded 24 months after randomization due to superiority of the Revlimid arm during an interim analysis.  In the treatment arm, patients received Revlimid consolidation post transplant followed by Revlimid maintenance whilst the control arm received placebo.  The results demonstrated that the Revlimid arm had a 54% reduction in risk of disease progression: The 3-year PFS improved from 38% with placebo to 68% with Revlimid.
  • Celgene had already presented positive results of the MM-015 trial investigating Revlimid as a first-line and maintenance therapy in transplant ineligible patients at ASH in December 2009. The results supported the use of Revlimid as induction and maintenance therapy in newly diagnosed patients that do not receive stem-cell transplants.
  • Although optimal maintenance duration of Revlimid is not yet known for either setting, it is likely to continue until progression.  Clearly this significantly increases the sales potential for Revlimid, but also expands the market as there is no current standard for maintenance therapy; Celgene's Thalomid has given mixed results and Johnson & Johnson's Velcade is less attractive in the maintenance setting as it cannot be given orally.  Furthermore, there is no evidence to support Revlimid maintenance following Velcade induction; therefore, if Revlimid is approved, we believe Velcade could lose market share to Celgene's drug in the first-line setting. 
  • Yesterday at ASCO, positive data of the PRIMA study investigating Rituxan as a maintenance therapy in follicular lymphoma was also reported.  The data showed that Rituxan reduced the risk of disease recurrence by 50% in newly diagnosed follicular lymphoma when given for 2 years in the maintenance setting. Although Rituxan is already indicated for the first-, second- and second-line maintenance settings, approval for first-line maintenance would provide further upside and completes Rituxan's dominance of the FL arena.

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