Celgene called a halt to a phase III trial of Revlimid in elderly patients with a rare form of leukaemia after seeing a high mortality rate with drug treatment.
The ORIGIN study was looking at the role of Revlimid (lenalidomide) in B-cell chronic lymphocytic leukaemia (CLL), a hard-to-treat cancer generally affecting older people that had been seen as a major new market for the product.
“An imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil,” said Celgene in a statement.
The mortality rate was almost double among patients on the company’s treatment, with 34 deaths out of 210 patients in the lenalidomide arm compared to 18 deaths out of 211 patients in the chlorambucil arm. That finding prompted the US Food and Drug Administration (FDA) to place the trial on a clinical hold earlier this month.
Revlimid is already sold to treat haematological cancers such as multiple myeloma and mantle cell lymphoma, and has been a major success for Celgene with sales of $3.76bn in 2012 and a 55 per cent share of the multiple myeloma market.
The failure of CLL is potentially a blow to the ultimate prospects for Revlimid, as the leukaemia affects around 16,000 new people in the US every year and is predicted to grow into a $10bn-plus market on the back of new product launches.
BioPharm Insight had previously predicted that Revlimid could achieve annual sales of $7.7bn in 2017, although this estimate included a CLL indication. However, some analysts have suggested expectations for the drug in CLL were not huge because of the number of competitors coming through the pipeline, notably Pharmacyclics/J&J’s ibrutinib, Roche/Genentech’s obinutuzumab, Gilead Sciences idelalisib (CAL-101) and AbbVie/Roche’s ABT-199.
Nevertheless, there seems to be plenty of upside for Revlimid yet. It reported positive data as a first-line multiple myeloma therapy in the US a few days ago, and the company believes this opens up another $500m market for the product if it can wrest market share from Takeda/Millennium and Johnson & Johnson’s Velcade (bortezomib).
Meanwhile, a maintenance therapy label claim is also being sought and could add another $500m to the tally.