The pipeline has to perform better for AbbVie to overcome the revenues as sales erosion of Humira is increasing. However, Depatux-M troubled AbbVie’s pipeline. Depatux-M is late-stage product indicated for glioblastoma showed no efficacy.
Abbvie has released a press statement confirming that its product Depatuxizumab Mafodotin has not reached the primary endpoint in Phase 3 clinical trial. The drug is indicated for the patients suffering from glioblastoma which has EGFR (epidermal growth factor receptor) amplification. Phase 3 is INTELLANCE-1, conducted in collaboration with RTOG Foundation. Independent data monitoring committee has confirmed that the primary endpoint has not reached in the trial and suggested to end the trial as there was no survival benefit. The enrolment in the trial was halted.
Phase 3 study which compared the Depatux-M versus placebo, which is administered along with radiation and temozolomide in patients who are newly diagnosed EGFR-amplified GBM. The main efficacy endpoint was overall survival. The safety and efficacy were not approved by the regulators for the approval.