Depatux-M fails to meet objectives in INTELLANCE-1 study
The biopharma company arrived at the decision after finding that the late-stage INTELLANCE-1 study did not meet primary endpoint of overall survival at the interim analysis. Furthermore, the trial could not show any survival benefit for patients subjected to treatment with Depatux-M.
The phase 3 featured 639 patients with newly diagnosed GBM, whose tumours have epidermal growth factor receptor (EGFR) amplification. The randomized, placebo-controlled trial pitted Depatux-M against placebo when administered with concurrent radiation and temozolomide and temozolomide as an adjuvant therapy.
AbbVie said that the INTELLANCE-1 trial was recommended to be stopped by an independent data monitoring committee (IDMC) and enrolment in all ongoing studies pertaining to the antibody drug conjugate has been stopped.
The biopharma company said that no new safety findings were recorded about Depatux-M, which was formerly known as ABT-414.
AbbVie vice chairman and president Michael Severino said: “Glioblastoma patients and their caregivers face a devastating disease for which there are few therapeutic options. While we are disappointed that Depatux-M did not demonstrate a survival benefit in the INTELLANCE-1 study, we remain committed to discovering and developing therapies to address some of the most debilitating cancers.”
In 2014, ABT-414 was granted orphan drug designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of glioblastoma and glioma in adult patients, respectively.
In 2016, the FDA granted rare disease designation to the investigational ADC for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG).
Last week, AbbVie and Roche secured approval from the FDA for their oral B-cell lymphoma-2 (BCL-2) inhibitor VENCLEXTA (venetoclax) in combination with obinutuzumab (GAZYVA) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).