depatuxizumab mafodotin (ABT-414) / AbbVie 
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  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Preclinical, Journal:  Efficacy of Depatuxizumab Mafodotin (ABT-414) in preclinical models of head and neck cancer. (Pubmed Central) -  Feb 20, 2024   
    ABT-414 treatment yielded antitumor activity in FaDu tumors, but not in UMSCC47, highlighting the potential for ABT-414 efficacy in high EGFR-expressing tumors. While ABT-414-IRDye800 localized tumors in both cell lines, the differing antitumor responses highlight the need for further investigation into the role of the tumor microenvironment in drug delivery.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie, losatuxizumab vedotin (ABBV-221) / AbbVie
    Efficacy and pharmacokinetics of EGFR-targeted antibody-drug conjugates following convection-enhanced delivery in mice with glioblastoma xenografts (Exhibition Hall) -  Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_391;    
    However, high concentrations of ABBV-221 are associated with increased neuronal cell loss and toxicity as compared to Depatux-M, suggesting a broader therapeutic window for the latter ADC. Median survival, daysTreatmentGBM6GBM39GBM108AB095 – CED 4920NRAB095-MMAF – CED >80 58 18.5 Depatux-M – IP 57 68 NR Depatux-M – CED >80 >100 NR AB095-MMAE – CED 57 19 NR ABBV-221 – IP 53 >100 NR ABBV-221 – CED >80 >100 NR No
  • ||||||||||  depatuxizumab (ABT-806) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie
    Clinical, Journal:  Ocular surface toxicity of depatuxizumab mafoditin (ABT-414): case reports. (Pubmed Central) -  Aug 6, 2022   
    The initiation of artificial tears and lubricant ointment was enough to control the ocular surface signs and symptoms. A multidisciplinary approach, complete ophthalmologic monitorization, and elaboration of protocols are required to adequately manage these patients.
  • ||||||||||  depatuxizumab (ABT-806) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie
    Preclinical, Journal:  Biodistribution Analysis of an Anti-EGFR Antibody in the Rat Brain: Validation of CSF Microcirculation as a Viable Pathway to Circumvent the Blood-Brain Barrier for Drug Delivery. (Pubmed Central) -  Jul 29, 2022   
    To pave the way for future efficacy studies for the treatment of GBM with an intra-CSF administered ADC consisting of a conjugate of ABT-806 (or of one of its close analogs), we verified in vivo the binding of ABT-414 to GBM tumor cells implanted in the cisterna magna and collected toxicity data from both the central nervous system (CNS) and peripheral tissues. The current study supports further exploration of harnessing CSF microcirculation as an alternative to systemic delivery to achieve higher brain tissue exposure, while reducing previously reported ocular toxicity with ABT-414.
  • ||||||||||  Review, Journal:  Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (Pubmed Central) -  Mar 18, 2022   
    In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.
  • ||||||||||  serclutamab talirine (ABBV-321) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie
    Convection enhanced delivery of EGFR-targeting antibody drug conjugates ABBV-321 and Depatux-M (Section 22) -  Mar 9, 2022 - Abstract #AACR2022AACR_2719;    
    Depatux-M is well tolerated when infused into normal brain and results in extended survival in orthotopic GBM PDXs. In contrast, ABBV-321, with a distinct PBD toxin, had a much narrower therapeutic window when delivered by CED.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Clinical, P1/2 data, Clinical Trial,Phase II, Journal:  Safety and Efficacy of Depatuxizumab Mafodotin in Japanese Patients With Malignant Glioma: A Non-randomized, Phase 1/2 Trial. (Pubmed Central) -  Dec 16, 2021   
    P1/2
    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. This study showed acceptable safety profile of Depatux-M alone or plus chemotherapy/chemoradiotherapy in Japanese patients with WHO grade III/IV glioma.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    ABT-414 resistant GBM tumors harbor the TEK S466I mutation and exhibit increased stemness (Exhibit Hall D) -  Nov 16, 2021 - Abstract #SNO2021SNO_298;    
    ABT-414-treated tumors also demonstrate increased expression of inhibitor of differentiation (ID)1 and ID3, associated with stem-like phenotype in glioblastoma. Taken together, our data indicate that resistance to ABT-414 is mediated by both de novo mutations not detected in the parent tumor and adaptive dysregulation of pathways which may lead to dedifferentiation and therapeutic resistance.
  • ||||||||||  serclutamab talirine (ABBV-321) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie, losatuxizumab vedotin (ABBV-221) / AbbVie
    Journal:  Targeting Multiple EGFR Expressing Tumors with a Highly Potent Tumor-Selective Antibody Drug Conjugate. (Pubmed Central) -  Aug 8, 2021   
    Collectively, these data suggest that ABBV-321 may offer an extended breadth of efficacy relative to other EGFR ADCs while extending utility to multiple EGFR-expressing tumor indications. Despite its highly potent PBD dimer payload, the tumor selectivity of ABBV-321 - coupled with its pharmacology, toxicology and pharmacokinetic profiles - support continuation of ongoing Phase 1 clinical trials in patients with advanced EGFR-expressing malignancies.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Trial primary completion date:  Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) -  May 24, 2021   
    P2/3,  N=640, Active, not recruiting, 
    The dramatic tumor regressions achieved using combined agents in pre-clinical TNBC models underscore the abilities of BCL-2/X antagonists to enhance the effectiveness of EGFR-targeted ADCs and highlight the clinical potential for usage of such targeted ADCs to alleviate toxicities associated with combinations of BCL-2/X inhibitors and systemic chemotherapies. Trial primary completion date: Jun 2021 --> Dec 2021
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Clinical, Journal, Adverse events:  Ocular Side Effects of EGFR-Inhibitor ABT-414 in Recurrent Glioblastoma: A Long-Term Safety Study. (Pubmed Central) -  Nov 11, 2020   
    ABT-414 corneal side effects are detectable in all treated patients. Related symptoms are gradually experienced by all patients during treatment and although reversible, they are characterized by a relative prolonged persistence after treatment discontinuation.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    [VIRTUAL] Neurocognitive function (NCF) outcomes of RTOG Foundation 3508: A Phase 3 trial of ABT-414 with concurrent chemoradiation and adjuvant temozolomide in patients with EGFR-amplified newly diagnosed GBM () -  Oct 24, 2020 - Abstract #SNO2020SNO_10;    
    The depatux-m arm, in comparison to the placebo arm, showed greater decline from baseline on the HVLT-R at the following time points: cycle 3 (Total Recall: mean= -1.8, SD=5.7 vs mean= -0.5, SD=5.5, respectively, p=0.046; Delayed Recall: mean= -1.1, SD=3.0 vs. mean= -0.2, SD=2.7, respectively, p=0.01), cycle 7 (Total Recall: mean= -0.6, SD=5.1 vs mean= 1.4, SD=5.0, respectively, p=0.009; Delayed Recall: mean -0.6, SD=3.0 vs. mean= 0.5, SD=2.7, respectively, p=0.01), and cycle 9 (Delayed Recall: mean=-0.4, SD=2.7 vs. mean= 0.8, SD=2.4, respectively, p=0.003). Depatux-m added to concurrent chemoradiation and adjuvant temozolomide was associated with faster time to deterioration and worse episodic learning and memory over time than placebo.
  • ||||||||||  depatuxizumab (ABT-806) / AbbVie, Life Science Pharma
    Clinical, Journal:  Targeting and Efficacy of Novel mAb806-Antibody-Drug Conjugates in Malignant Mesothelioma. (Pubmed Central) -  Oct 8, 2020   
    We demonstrated the specific targeting of the mAb806 epitope expressing MM tumors using Zr-based PET imaging. Our data suggest that targeting EGFR in MM using specific ADCs is a valid therapeutic strategy and supports further investigation of the mAb806 epitope expression as a predictive biomarker.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Clinical, Review, Journal:  Anti-epidermal growth factor receptor therapy for glioblastoma in adults. (Pubmed Central) -  Sep 13, 2020   
    Newer drugs that are specially designed for glioblastoma targets may raise the possibility of success in this population, but data are lacking at present. Future studies should be more selective in pursuing people displaying specific EGFR targets.
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Trial completion:  Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) -  Sep 3, 2020   
    P1/2,  N=53, Completed, 
    Future studies should be more selective in pursuing people displaying specific EGFR targets. Active, not recruiting --> Completed
  • ||||||||||  temozolomide / Generic mfg., depatuxizumab mafodotin (ABT-414) / AbbVie
    Journal:  Depatux-M and temozolomide in advanced high-grade glioma. (Pubmed Central) -  Jul 29, 2020   
    The analysis showed that both an integrated complex ADC model and the individual models that have shorter computational time would result in similar outcomes. No abstract available
  • ||||||||||  depatuxizumab mafodotin (ABT-414) / AbbVie
    Trial completion date, Trial primary completion date:  Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) -  Jul 23, 2020   
    P1/2,  N=53, Active, not recruiting, 
    Funding: Has not received any funding. Trial completion date: Dec 2020 --> Aug 2020 | Trial primary completion date: Dec 2020 --> Aug 2020