Not looking good for Celldex this morning
Celldex Advised to Discontinue Phase III Study on Rintega
5:05 pm ET March 8, 2016 (Zacks) Print
Celldex Therapeutics, Inc.’s CLDX shares plunged 53.7% to a new 52-week low after the company announced that it has been recommended by an independent Data Safety and Monitoring Board (DSMB) to discontinue the evaluation of Rintega in the phase III ACT IV study for the treatment of patients with newly diagnosed EGFRvIII-positive glioblastoma.
The company said that the DSMB completed a pre-planned interim analysis and determined that the study will fail to reach the primary endpoint of overall survival in patients with minimal residual disease, as both the Rintega and control arms showed on par performance. Moreover, the control arm demonstrated median overall survival of 21.1 months, compared to 20.4 months in the Rintega arm.
Meanwhile, Celldex is focusing on other candidates in its pipeline. Currently, the company is evaluating glembatumumab vedotin in a phase IIb study (METRIC) for the treatment of triple negative breast cancer, and a phase II study for the treatment of metastatic melanoma. Enrollment in the breast cancer study is expected to be complete in the second half of 2016, while that in the metastatic melanoma study is expected to close in the first half of the year and data expected in the second half.
Another candidate in the company’s pipeline is varlilumab, which is being evaluated in several phase I/II combination studies across multiple types of cancer.
Our Take
The DSMB’s recommendation to discontinue evaluating the company’s most advanced candidate, Rintega, in the ACT IV study was a major set back. Moreover, unfavorable data from the interim analysis was disappointing. This would delay the company from filing for approval and getting it to the market, if approved
