Recently, Celgene Corporation ( CELG">CELG ) presented multiple data at the 53rd Annual Meeting of the American Society of Hematology ( ASH ) 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. 's ( ONXX">ONXX ) carfilzomib.
Moreover, Revlimid is also approved for treating patients suffering from transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome ( MDS ) 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 quarters.
Our optimism is justified by the Zacks #1 Rank (Strong Buy rating) carried by the stock in the short run.