^
Association details:
| Biomarker: | EGFR amplification |
|---|---|
| Cancer: | Glioma |
| Drug: | depatuxizumab mafodotin (ABT-414) (Microtubule inhibitor, EGFR-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Excerpt:
...- Participants must have confirmed EGFR amplification by central lab in Phase 2 portion...
Trial ID:
Source:
Title:
Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
Excerpt:
...- Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of Epithelial Growth Factor Receptor (EGFR) amplification...
Trial ID:
Less C2 evidence
Source:
Title:
Safety and Efficacy of Depatuxizumab Mafodotin in Japanese Patients With Malignant Glioma: A Non-randomized, Phase 1/2 Trial
Published date:
10/05/2021
Excerpt:
In second-line arms, patients with EGFR-amplified recurrent WHO grade III/IV glioma received Depatux-M plus chemotherapy (temozolomide)...The primary endpoint was 6-month progression-free survival (PFS) in patients with EGFR-amplified tumors receiving second-line Depatux-M plus chemotherapy....The 6-month PFS estimate was 25.6% (95% confidence interval [CI] 11.4-42.6) and median PFS was 2.1 months (95% CI 1.9-3.9) with second-line Depatux-M plus chemotherapy in the EGFR-amplified subgroup.
DOI:
10.1111/cas.15153
Trial ID:
