SUMMIT, N.J. (
) --Research abstracts for next month's annual meeting of the
American Society of Hematology
, or ASH, will be posted online Tuesday at 10 a.m. EST. Investors will be particularly focused on details of a phase III study of
cancer drug Revlimid in newly diagnosed, or front-line, multiple myeloma patients.
The key question from this study -- known as MM-015 -- is how much Revlimid does a newly diagnosed multiple myeloma patient need?
Last July, Celgene announced positive top-line results from MM-015, telling investors that treatment with Revlimid plus chemotherapy followed by Revlimid "maintenance" demonstrated a statistically significant improvement in progression-free survival over treatment with chemotherapy alone.
But MM-015 also included a third arm that treated multiple myeloma patients with a fixed, nine-month course of Revlimid plus chemotherapy. To date, Celgene has released no information about the magnitude of the benefit from this so-called Revlimid "induction only" arm.
Celgene shares have been volatile of late because of worries that the benefit of Revlimid maintenance (i.e., more Revlimid) won't outweigh Revlimid induction (i.e., less Revlimid).
Revlimid turned in a strong third quarter, with sales of nearly $450 million, prompting Celgene to raise 2009 sales guidance. Investors expect Revlimid sales to grow from around $1.7 billion this year to well over $3 billion in 2013-2014. To meet these expectations for high growth, however, the treatment duration of Revlimid therapy needs to grow longer, particularly for front-line multiple myeloma patients.
The release of the MM-015 abstract for the upcoming ASH meeting in early December should start to provide answers to this important, "how much Revlimid?" question. Unfortunately, data from the Revlimid induction arm (nine months of Revlimid only) isn't likely to be ready until sometime later this year or next year.
Still, investors are likely to take comfort in Celgene by a strong progression-free survival benefit demonstrated by Revlimid maintenance, especially if that benefit stacks up well against similar data already compiled by Velcade, a competing multiple myeloma drug marketed by
More Biotechs in the ASH spotlight
brings to ASH this year its second-generation protease inhibitor carfilzomib, which the company acquired after
Investors will be scrutinizing a response rate data from a phase II study of carfilzomib in relapsed or refractory multiple myeloma patients. Particularly important will be data on the benefit of carfilzomib treatment in a subset of patients progressing after prior Revlimid and Velcade treatment.
, in part, because of expectations for strong data at the ASH meeting from a phase I proof-of-concept study for its drug AP-24534 in chronic myeloid leukemia.
The ASH focus for
( CEPH) this year will be on its cancer drug Treanda, specifically additional data from an investigator-led study testing a combination of Treanda plus Rituxan against Rituxan plus chemotherapy in patients with non-Hodgkin's lymphoma. Rituxan is a mainstay treatment for NHL marketed by
-- Reported by Adam Feuerstein in Boston.
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