) presented multiple data at the 53rd Annual Meeting of the
American Society of Hematology (
) in the US. The biotechnology firm presented encouraging interim
data from a study (CLL-009), which evaluated Revlimid at three
doses (5 mg, 10 mg or 15 mg) in patients suffering from chronic
lymphocytic leukemia (CLL) who have received at least one prior
therapy for the disease.
The study is evaluating the safety and efficacy of Revlimid in
patients suffering from relapsed or refractory CLL. The study
allowed for the dosage strength to be increased every 4 weeks by 5
mg/day depending on tolerability. The interim results revealed that
Revlimid was generally well tolerated and Revlimid therapy resulted
in a 38% overall response rate.
We note that Revlimid is already approved (in approximately 70
nations) in combination with dexamethasone for treating patients
suffering from multiple myeloma (MM) who have been treated at least
once for the disease. Though Celgene is a key player in the global
MM market, competition in the MM space is fast catching up with the
potential approval of
Onyx Pharmaceuticals Inc.
Moreover, Revlimid is also approved for treating patients
suffering from transfusion-dependent anemia due to low- or
intermediate-1-risk myelodysplastic syndrome (
) associated with a deletion 5q cytogenetic abnormality (with or
without additional cytogenetic irregularities). Revlimid is not
currently approved for the CLL indication. If the drug is cleared
for the indication then it would further boost the sales potential
of the drug.
Celgene also presented positive data from two multicenter
studies, (MDS-003 and MDS-004), which evaluated MDS patients
treated with Revlimid versus those who had not received Revlimid
therapy. They were treated with only the best supportive care.
Results revealed that there was a significant decline in the
risk of death for patients in the Revlimid arm. Moreover, patients
treated with Revlimid did not demonstrate any increased risk of
being affected by acute myeloid leukemia (AML). Results also
revealed a median overall survival rate of 5.2 years for patients
treated with Revlimid as opposed to 3.8 years for patients who had
not received Revlimid therapy.
Celgene also presented data from an early-stage study of its
pipeline candidate, azacitidine, in patients suffering from AML,
myelodysplastic syndromes or chronic myelomonocytic leukemia. The
patients were either not eligible or had responded unfavorably to
other therapies. The candidate was well tolerated in the study.
We continue to have an Outperform recommendation on Celgene. We
believe that Celgene, driven by its impressive oncology portfolio,
expansion efforts, strong balance sheet and robust pipeline, will
continue to outperform the broader market in the coming
Our optimism is justified by the Zacks #1 Rank (Strong Buy
rating) carried by the stock in the short run.
CELGENE CORP (
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