Delving into the Latest Updates on Parsatuzumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

ANTI-EGFL7

+ [7]

Target

EGFL7

Mechanism

EGFL7 inhibitors(Epidermal growth factor-like protein 7 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases

Active Indication-

Inactive Indication

Advanced cancerAdvanced Malignant Solid NeoplasmLocally Advanced Malignant Solid Neoplasm+ [2]

Originator Organization

Genentech, Inc.

Active Organization-

Inactive Organization

Genentech, Inc.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 319372686L

Source: *****

Sequence Code 9975906H

Source: *****

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to estimate the efficacy of MEGF0444A treatment to disease progression, combined with oxaliplatin + folinic acid + 5-Fluorouracil (mFOLFOX-6) + bevacizumab therapy in participants with metastatic colorectal cancer (CRC).

Start Date01 Nov 2011

Sponsor / Collaborator

Genentech, Inc.

EUCTR2011-000711-85-CZ

/ Not yet recruitingNot Applicable

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF MEGF0444A IN COMBINATION WITH CARBOPLATIN, PACLITAXEL ANDBEVACIZUMAB IN PATIENTS WITH ADVANCED OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED DISEASE

Start Date17 Oct 2011

Sponsor / Collaborator

Genentech, Inc.

100 Clinical Results associated with Parsatuzumab

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100 Translational Medicine associated with Parsatuzumab

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100 Patents (Medical) associated with Parsatuzumab

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2

Literatures (Medical) associated with Parsatuzumab

01 Jun 2018·The OncologistQ2 · MEDICINE

Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer

Q2 · MEDICINE

Article

Author: Losonczy, György ; Juhász, Erzsébet ; Ye, Weilan ; McCall, Bruce ; Chang, Ilsung ; Anderson, Maria ; von Pawel, Joachim ; Ervin, Thomas ; Wakshull, Eric ; Hegde, Priti ; Chen, Daniel ; Spigel, David R. ; Rhee, Ina ; Reck, Martin ; Barlesi, Fabrice

AbstractLessons LearnedThe lack of efficacy associated with anti-EGFL7 combined with standard bevacizumab and chemotherapy in this phase II trial in non-small cell lung carcinoma is consistent with the lack of benefit observed in colorectal carcinoma, highlighting the challenge of enhancing the efficacy of VEGF inhibition in unselected populations. Future efforts with agents like anti-EGFL7 should be guided by advances in pharmacodynamic and predictive biomarker development for antiangiogenic agents.BackgroundEpidermal growth factor-like domain 7 (EGFL7) is an extracellular matrix-associated protein that is upregulated during angiogenesis and supports endothelial cell survival. This phase II trial evaluated the efficacy of the anti-EGFL7 antibody, parsatuzumab, in combination with bevacizumab plus platinum-based therapy for advanced or recurrent nonsquamous non-small cell lung cancer (NS-NSCLC).MethodsPatients (n = 104) were randomized to either placebo or parsatuzumab (600 mg) in combination with bevacizumab (15 mg/kg) and carboplatin/paclitaxel, administered on day 1 of each 21-day cycle. Carboplatin and paclitaxel were administered for up to six cycles. Bevacizumab and parsatuzumab/placebo were administered for a maximum of 24 months.ResultsThe progression-free survival (PFS) hazard ratio (HR) was 1.7 (95% confidence interval [CI], 1.0–2.8; p = .047). The median PFS was 6.7 months for the parsatuzumab arm versus 8.1 months for the placebo arm. The hazard ratio for overall survival (OS) was 1.1 (95% CI, 0.5–2.2; p = .847). The objective response rate (ORR) was 29% in the parsatuzumab arm and 56% in the placebo arm. Overall safety and tolerability were consistent with the established toxicity profile of bevacizumab.ConclusionThere was no evidence of efficacy for the addition of parsatuzumab to the combination of bevacizumab and chemotherapy for first-line NS-NSCLC.

01 Apr 2017·The OncologistQ2 · MEDICINE

Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with FOLFOX and Bevacizumab for First-Line Metastatic Colorectal Cancer

Q2 · MEDICINE

Article

Author: Tebbutt, Niall ; Jassem, Jacek ; Funke, Roel ; Braiteh, Fadi ; Hurwitz, Herbert ; McCall, Bruce ; Wainberg, Zev A. ; Rhee, Ina ; Ye, Weilan ; Chang, Ilsung ; Wakshull, Eric ; Chen, Daniel ; García-Carbonero, Rocío ; Stroh, Mark ; Argiles, Guillem ; Rivera, Fernando ; Gore, Ira ; Anderson, Maria ; van Cutsem, Eric ; Hegde, Priti

AbstractLessons LearnedThese negative phase II results for parsatuzumab highlight the challenges of developing an agent intended to enhance the efficacy of vascular endothelial growth factor inhibition without the benefit of validated pharmacodynamic biomarkers or strong predictive biomarker hypotheses. Any further clinical development of anti-EGFL7 is likely to require new mechanistic insights and biomarker development for antiangiogenic agents.BackgroundEGFL7 (epidermal growth factor-like domain 7) is a tumor-enriched vascular extracellular matrix protein that supports endothelial cell survival. This phase II trial evaluated the efficacy of parsatuzumab (also known as MEGF0444A), a humanized anti-EGFL7 IgG1 monoclonal antibody, in combination with modified FOLFOX6 (mFOLFOX6) (folinic acid, 5-fluorouracil, and oxaliplatin) bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC).MethodsOne-hundred twenty-seven patients were randomly assigned to parsatuzumab, 400 mg, or placebo, in combination with mFOLFOX6 plus bevacizumab, 5 mg/kg. Treatment cycles were repeated every 2 weeks until disease progression or unacceptable toxicity for a maximum of 24 months, with the exception of oxaliplatin, which was administered for up to 8 cycles.ResultsThe progression-free survival (PFS) hazard ratio was 1.17 (95% confidence interval [CI], 0.71–1.93; p = .548). The median PFS was 12 months for the experimental arm versus 11.9 months for the control arm. The hazard ratio for overall survival was 0.97 (95% CI, 0.46–2.1; p = .943). The overall response rate was 59% in the parsatuzumab arm and 64% in the placebo arm. The adverse event profile was similar in both arms.ConclusionsThere was no evidence of efficacy for the addition of parsatuzumab to the combination of bevacizumab and chemotherapy for first-line mCRC.

100 Deals associated with Parsatuzumab

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Parsatuzumab	-	DB14897

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 2	US	Genentech, Inc.	01 Jun 2011
Advanced cancer	Phase 2	FR	Genentech, Inc.	01 Jun 2011
Advanced cancer	Phase 2	DE	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	HU	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	AU	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	FR	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	US	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	DE	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	PL	Genentech, Inc.	01 Jun 2011
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	CZ	Genentech, Inc.	01 Jun 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01366131 (Pubmed \| Oncologist) Manual	Phase 2	Non-squamous non-small cell lung cancer First line	104	Carboplatin+Paclitaxel+Bevacizumab+Parsatuzumab	(yphfiwarlc) = uqsxinikoy qdcxeojljs (yrxhlzdogl ) View more	Negative	01 Jun 2018
				Carboplatin+Paclitaxel+Bevacizumab+Placebo	(yphfiwarlc) = enfpbcjqxw qdcxeojljs (yrxhlzdogl ) View more
NCT01399684 (Pubmed \| Oncologist) Manual	Phase 2	Colorectal Cancer First line	127	Bevacizumab+mFOLFOX6+Parsatuzumab	(gnyqruyoho): HR = 0.97 (95% CI, 0.46 - 2.1), P-Value = 0.943 View more	Negative	01 Apr 2017
				Bevacizumab+mFOLFOX6，bevacizumab, 5 mg/kg+Placebo