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- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical, Journal, Adverse events: Corneal side effects induced by EGFR-inhibitor antibody-drug conjugate ABT-414 in patients with recurrent glioblastoma: a prospective clinical and confocal microscopy study. (Pubmed Central) - Jun 23, 2020
Side effects are detectable in all treated patients and CCM documents early corneal epithelium and subbasal nerve plexus toxicity, with subsequent progressive restoration after treatment discontinuation. Ocular side effects due to ABT-414 can be manageable.
- || temozolomide / Generic mfg., Avastin (bevacizumab) / Roche, depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical, P1 data, Journal: Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. (Pubmed Central) - May 2, 2020
P1, P2, P2
Antitumor activity in this TMZ-refractory population was encouraging. Continued study of depatux-m in patients with EGFR-amplified, newly diagnosed, or recurrent GBM is ongoing in 2 global, randomized trials (NCT02573324, NCT02343406).
- |||| depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion date, 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) - Apr 20, 2020
P2/3, N=691, Active, not recruiting, Sponsor: AbbVie
Continued study of depatux-m in patients with EGFR-amplified, newly diagnosed, or recurrent GBM is ongoing in 2 global, randomized trials (NCT02573324, NCT02343406). Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion, Trial completion date, Trial primary completion date, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Apr 3, 2020
P3b, N=40, Completed, Sponsor: AbbVie
Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020 Active, not recruiting --> Completed | Trial completion date: Jul 2020 --> Mar 2020 | Trial primary completion date: Feb 2020 --> Sep 2019
- temozolomide / Generic mfg., depatuxizumab mafodotin (ABT-414) / AbbVie
[VIRTUAL] Depatuxizumab mafodotin (Depatux-M) plus temozolomide (TMZ) in recurrent glioblastoma patients: Real-world experience from a multicenter study of Italian Association of Neuro-Oncology (AINO). (Poster Board 35) - Feb 27, 2020 - Abstract #ASCO2020ASCO_198;
We showed encouraging clinical benefit, despite most patients were treated beyond the second-line of therapy. Overall the results are closed to those reported in previous phase II trial.
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical, Journal: Epidermal growth factor receptor (EGFR) amplification rates observed in screening patients for randomized trials in glioblastoma. (Pubmed Central) - Jan 8, 2020
EGFR amplification occurs less frequently in patients from Asia than elsewhere. Further study is required to understand biological differences to optimize treatment in glioblastoma.
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie, Rintega (rindopepimut) / Celldex
Clinical: make the vaccine. I believe that with the failures of RIndopepimut, ABT-414, Toca, and more that special consideration has to be given to something that has shown to have clinical success in the form of survival. (Twitter) - Nov 13, 2019
- depatuxizumab mafodotin (ABT-414) / AbbVie
Depatuxizumab mafodotin (ABT-414)-induced glioblastoma cell death requires EGFR overexpression, but not phosphorylation (Grand Canyon 7) - Oct 29, 2019 - Abstract #SNO2019SNO_1400;
- Avastin (bevacizumab) / Roche, depatuxizumab mafodotin (ABT-414) / AbbVie
A series of patients (pts) with recurrent GBM (rGBM) treated with ABT-414, bevacizumab (Bev) and CCNU (Ballroom Lawn) - Oct 29, 2019 - Abstract #SNO2019SNO_937;
Despite the outcome of Intellance 1, there may be a subgroup of relapsed pts who benefit from this combination. Further studies are warranted to identify and analyse this group.
- depatuxizumab mafodotin (ABT-414) / AbbVie
Quantifying individualized ABT-414 sensitivity and blood-brain barrier penetrance from serial imaging of patient-derived xenografts models of glioblastoma (Ballroom Lawn) - Oct 29, 2019 - Abstract #SNO2019SNO_417;
Further studies are warranted to identify and analyse this group. Although more cell lines are needed to validate our approach, parameterizing this model for PDXs gives valuable insight into the extent of BBB breakdown in patient GBMs and may aid in determining optimal therapies for individual patients.
- Pre-clinical assessment of combined ABT-263/Navitoclax and ABT-414 or ABBV-321 treatment for EGFR-expressingTNBC (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1374;
Notably, this strategy avoids the toxicities associated with systemic chemotherapy and BCL-2/XL-inhibitors. These results also highlight the translational relevance of 321+263, within the context of EGFR-expressing TNBC.
- depatuxizumab mafodotin (ABT-414) / AbbVie
A randomized, double-blind, placebo-controlled phase 3 trial of depatuxizumab mafodotin (ABT-414) in Epidermal Growth Factor Receptor (EGFR) amplified (amp) newly diagnosed glioblastoma (nGBM) (Grand Canyon Ballroom) - Sep 20, 2019 - Abstract #SNO2019SNO_20;
P2/3
- | depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical, Journal: Efficacy and safety results of depatuxizumab mafodotin (ABT-414) in patients with advanced solid tumors likely to overexpress epidermal growth factor receptor. (Pubmed Central) - Sep 14, 2019
A partial response in 1 patient with EGFR-amplified disease provides the opportunity to study depatux-m in diseases with a high incidence of EGFR amplification. Cancer 2018.
- | depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion date, Trial primary completion date, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Sep 11, 2019
P3b, N=40, Active, not recruiting, Sponsor: AbbVie
Cancer 2018. Trial completion date: Feb 2020 --> Jul 2020 | Trial primary completion date: Sep 2019 --> Feb 2020
- | depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion, Trial completion date, Trial primary completion date: RTOG Foundation 3508: 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 (clinicaltrials.gov) - Aug 20, 2019
P2, N=255, Completed, Sponsor: AbbVie
Trial completion date: Feb 2020 --> Jul 2020 | Trial primary completion date: Sep 2019 --> Feb 2020 Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Aug 2019 | Trial primary completion date: Dec 2019 --> Aug 2019
- | Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Antibodies to watch in 2019. (Pubmed Central) - Aug 1, 2019
In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
- | depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification, Trial completion date, 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) - Jul 11, 2019
P2/3, N=691, Active, not recruiting, Sponsor: AbbVie
We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series. Phase classification: P3 --> P2/3 | Trial completion date: Jul 2021 --> Jul 2020 | Trial primary completion date: Mar 2020 --> Jul 2020
- | losatuxizumab vedotin (ABBV-221) / AbbVie
Journal: Characterization of ABBV-221, a Tumor-Selective EGFR Targeting Antibody Drug Conjugate. (Pubmed Central) - Jun 22, 2019
ABBV-221 has similar activity as depatux-m against an EGFR amplified GBM PDX model and is highly effective alone and in combination with standard of care (SOC) temozolomide in an EGFRvIII positive GBM xenograft model. Based on these results, ABBV-221 has advanced to a phase 1 clinical trial in patients with advanced solid tumors associated with elevated levels of EGFR.
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment closed: RTOG Foundation 3508: 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 (clinicaltrials.gov) - May 28, 2019
P2, N=251, Active, not recruiting, Sponsor: AbbVie
Based on these results, ABBV-221 has advanced to a phase 1 clinical trial in patients with advanced solid tumors associated with elevated levels of EGFR. Recruiting --> Active, not recruiting
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment closed, Enrollment change: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) - May 28, 2019
P1/2, N=53, Active, not recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=105 --> 53
- ||||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment closed: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - May 28, 2019
P3, N=691, Active, not recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting | N=105 --> 53 Recruiting --> Active, not recruiting
- ||||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment closed, Enrollment change, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - May 28, 2019
P3b, N=40, Active, not recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=90 --> 40
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - May 16, 2019
P3, N=640, Recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting | N=90 --> 40 Phase classification: P2/3 --> P3
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification, Trial completion date: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - Mar 5, 2019
P2/3, N=640, Recruiting, Sponsor: AbbVie
Phase classification: P2/3 --> P3 Phase classification: P3 --> P2/3 | Trial completion date: Jan 2021 --> Jul 2021
- | depatuxizumab (ABT-806) / AbbVie, Life Science Pharma, depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical, PK/PD data, Journal, Combination therapy, Monotherapy: Safety, Pharmacokinetics and Antitumor Response of Depatuxizumab Mafodotin as Monotherapy or in Combination with Temozolomide in Patients with Glioblastoma. (Pubmed Central) - Jan 19, 2019
P2, P2/3
Depatux-m alone or in combination with temozolomide demonstrated an acceptable safety and pharmacokinetic profile in glioblastoma. Further studies are currently underway to evaluate its efficacy in newly diagnosed (NCT02573324) and recurrent glioblastoma (NCT02343406).
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification, Trial completion date: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - Jan 10, 2019
P3, N=640, Recruiting, Sponsor: AbbVie
Further studies are currently underway to evaluate its efficacy in newly diagnosed (NCT02573324) and recurrent glioblastoma (NCT02343406). Trial completion date: Jul 2021 --> Jan 2021 | Phase classification: P2b --> P3
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification, Trial completion date: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - Dec 17, 2018
P2b, N=640, Recruiting, Sponsor: AbbVie
Trial completion date: Jul 2021 --> Jan 2021 | Phase classification: P2b --> P3 Phase classification: P3 --> P2b | Trial completion date: Feb 2021 --> Jul 2021
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion date, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Dec 13, 2018
P3b, N=90, Recruiting, Sponsor: AbbVie
Phase classification: P3 --> P2b | Trial completion date: Feb 2021 --> Jul 2021 Trial completion date: Nov 2019 --> Mar 2020
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion date: RTOG Foundation 3508: 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 (clinicaltrials.gov) - Nov 5, 2018
P2, N=260, Recruiting, Sponsor: AbbVie
Trial completion date: Nov 2019 --> Mar 2020 Trial completion date: Jun 2020 --> Dec 2020
- |||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment open, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Aug 6, 2018
P3b, N=90, Recruiting, Sponsor: AbbVie
Trial completion date: Jun 2020 --> Dec 2020 Not yet recruiting --> Recruiting
- |||| depatuxizumab mafodotin (ABT-414) / AbbVie
Trial initiation date, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Jun 7, 2018
P3b, N=90, Not yet recruiting, Sponsor: AbbVie
Not yet recruiting --> Recruiting Initiation date: Mar 2018 --> Jun 2018
- | depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical, Journal, Combination therapy: Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. (Pubmed Central) - May 10, 2018
P2, P2/3
ABT-414 plus chemoradiation demonstrated an acceptable safety and pharmacokinetic profile in newly diagnosed glioblastoma. Randomized studies are ongoing to determine efficacy in newly diagnosed (NCT02573324) and recurrent glioblastoma (NCT02343406).
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Trial primary completion date: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) - Apr 17, 2018
P1/2, N=105, Recruiting, Sponsor: AbbVie
Randomized studies are ongoing to determine efficacy in newly diagnosed (NCT02573324) and recurrent glioblastoma (NCT02343406). Trial primary completion date: Jul 2018 --> Dec 2020
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Mar 3, 2018
P3b, N=90, Not yet recruiting, Sponsor: AbbVie
Trial primary completion date: Jul 2018 --> Dec 2020 Phase classification: P3 --> P3b
- |||||||||| depatuxizumab mafodotin (ABT-414) / AbbVie
New P3 trial, Adverse events: UNITE Study: Understanding New Interventions With GBM ThErapy (clinicaltrials.gov) - Feb 5, 2018
P3, N=90, Not yet recruiting, Sponsor: AbbVie
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - Jan 17, 2018
P3, N=640, Recruiting, Sponsor: AbbVie
Phase classification: P3 --> P3b Phase classification: P2b --> P3
- | depatuxizumab (ABT-806) / AbbVie, Life Science Pharma, depatuxizumab mafodotin (ABT-414) / AbbVie
Clinical Trial,Phase I, Journal: Efficacy of depatuxizumab mafodotin (ABT-414) monotherapy in patients with EGFR-amplified, recurrent glioblastoma: results from a multi-center, international study. (Pubmed Central) - Dec 3, 2017
P1
Depatux-m monotherapy displayed frequent but mostly Grade 1/2 ocular toxicities. A PFS6 of 28.8% was observed in this rGBM population, warranting further study.
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment change: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) - Oct 30, 2017
P1/2, N=105, Recruiting, Sponsor: AbbVie
A PFS6 of 28.8% was observed in this rGBM population, warranting further study. N=50 --> 105
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion: Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme (clinicaltrials.gov) - Jul 7, 2017
P1, N=202, Completed, Sponsor: AbbVie
N=50 --> 105 Active, not recruiting --> Completed
- depatuxizumab mafodotin (ABT-414) / AbbVie
Trial primary completion date: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) - May 2, 2017
P1/2, N=46, Recruiting, Sponsor: AbbVie
Active, not recruiting --> Completed Trial primary completion date: Nov 2018 --> Jul 2018
- depatuxizumab mafodotin (ABT-414) / AbbVie
New trial: Expanded Access to ABT-414 (clinicaltrials.gov) - Apr 20, 2017
P=N/A, N=0, Available, Sponsor: AbbVie
- |||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment open, Trial primary completion date: RTOG Foundation 3508: 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 (clinicaltrials.gov) - Nov 2, 2016
P2, N=260, Recruiting, Sponsor: AbbVie
Trial primary completion date: Nov 2018 --> Jul 2018 Active, not recruiting --> Recruiting | Trial primary completion date: Jun 2017 --> Dec 2019
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Trial primary completion date: Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme (clinicaltrials.gov) - Oct 26, 2016
P1, N=196, Active, not recruiting, Sponsor: AbbVie
Active, not recruiting --> Recruiting | Trial primary completion date: Jun 2017 --> Dec 2019 Trial primary completion date: Jan 2017 --> May 2017
- |||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment open: RTOG Foundation 3508: 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 (clinicaltrials.gov) - Aug 16, 2016
P2, N=240, Recruiting, Sponsor: AbbVie
Trial primary completion date: Jan 2017 --> May 2017 Active, not recruiting --> Recruiting
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Trial primary completion date: Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme (clinicaltrials.gov) - Jul 28, 2016
P1, N=196, Active, not recruiting, Sponsor: AbbVie
Active, not recruiting --> Recruiting Trial primary completion date: Jun 2016 --> Jan 2017
- ||| depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment closed: RTOG Foundation 3508: 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 (clinicaltrials.gov) - Jul 27, 2016
P2, N=240, Active, not recruiting, Sponsor: AbbVie
Trial primary completion date: Jun 2016 --> Jan 2017 Recruiting --> Active, not recruiting
- | depatuxizumab mafodotin (ABT-414) / AbbVie
Phase classification: Intellance1: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (clinicaltrials.gov) - Jul 11, 2016
P2b, N=720, Recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting Phase classification: P2 --> P2b
- || depatuxizumab mafodotin (ABT-414) / AbbVie
Enrollment closed: Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme (clinicaltrials.gov) - Apr 14, 2016
P1, N=196, Active, not recruiting, Sponsor: AbbVie
Phase classification: P2 --> P2b Recruiting --> Active, not recruiting
- |||| depatuxizumab mafodotin (ABT-414) / AbbVie
Trial completion, Enrollment change, Metastases: A Study of ABT-414 in Subjects With Solid Tumors (clinicaltrials.gov) - Jan 11, 2016
P1/2, N=57, Completed, Sponsor: AbbVie (prior sponsor, Abbott)
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=90 --> 57
- | depatuxizumab mafodotin (ABT-414) / AbbVie
New P1/2 trial: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (clinicaltrials.gov) - Oct 29, 2015
P1/2, N=45, Recruiting, Sponsor: AbbVie