Celgene’s Follicular Lymphoma Regimen Fails Phase III
Celgene Crashed After Follicular Lymphoma Regimen Failed Phase III
By Alex Keown
Shares of Celgene plunged more than five points per share after the company announced Revlimid combined with Biogen’s Rituxan failed in a late-stage study of previously untreated patients with follicular lymphoma.
Celgene announced the Phase III results late Thursday and share prices dropped about 4 percent to $102.69 as of 9:30 this morning.
The RELEVANCE study pitted the combination therapy of Revlimid (lenalidomide) and Rituxan (rituximab) against the standard of care treatment of rituximab plus chemotherapy. In the study, patients were given the investigational combination that was then followed by a maintenance treatment of Rituxan. Trial data showed the combination treatment did not achieve superiority over the standard of care in the co-primary endpoints of complete response or unconfirmed complete response at 120 weeks, as well as progression free survival, Celgene said. The company noted that additional analysis of the data are ongoing and will be presented at a future medical conference.
The RELEVANCE trial was the first late-stage study to evaluate a chemotherapy-free regimen to the established standard of care in patients with previously untreated follicular lymphoma, Gilles Salles, president of the Lymphoma Study Association (LYSA), said in a statement. Being a first-of-its-kind study Salles called it a landmark event.
Jay Backstrom, Celgene’s chief medical officer said the company remains committed to advancing its “broad pipeline of novel therapies to establish new standards of care for patients with lymphoma.” However, Backstrom did not indicate if the company planned to continue development of the combination treatment for this particular indication.
Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin’s lymphoma (NHL), is incurable and becomes harder to treat each time it returns. It accounts for about a third of all cases of NHL. Celgene’s blockbuster blood cancer drug Revlimid has not been approved for the treatment of follicular lymphoma. The drug was approved in 2013 for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
In November, the U.S. Food and Drug Administration approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma. The label expansion is for patients with stage II bulky, III or IV disease, the FDA said in announcing the label expansion. The new FDA approval has Gazyva being used in combination with chemotherapy followed by Gazyva alone for the common blood cancer.
Celgene is studying Revlimid in a number of lymphoma trials. In the ongoing Phase IIIb MAGNIFY trial, Celgene has been paired with Rituxan in the treatment of patients with relapsed or refractory marginal zone lymphoma (MZL). The combination treatment is also being evaluated in the AUGMENT trial of patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma.
BMO Capital analyst Ian Somaiya noted that although the RELEVANCE trial failed, that should not have any bearing on the AUGMENT trial, StreetInsider posted.