Phase Ib Study to Test the Safety and Potential Synergy of Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor

This research study is studying an investigational combination of drugs as a possible treatment for advanced solid tumors: melanoma, ovarian, renal, or colorectal cancer.
The drugs involved in this study are:
* Pembrolizumab
* AMG386

Start Date31 Aug 2017

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT01907308

/ WithdrawnPhase 2IIT

A Phase II Single-arm Study of AMG 386 in Combination With Docetaxel for Advanced Urothelial Carcinoma After Failure of a Platinum-containing Regimen

This study plans to learn more about the combination of AMG 386 and docetaxel for the treatment of advanced urothelial cancer. Subjects are being asked to be in this research study because they have advanced urothelial cancer which has progressed after treatment with a platinum-based therapy.
The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a single agent.

Start Date01 Feb 2014

Sponsor / Collaborator

University of Colorado Denver

[+1]

NCT01666977

/ CompletedPhase 1/2

A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.

Start Date01 Aug 2012

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Trebananib

100 Translational Medicine associated with Trebananib

100 Patents (Medical) associated with Trebananib

Literatures (Medical) associated with Trebananib

09 Jan 2025·Cancer Immunology Research

A Phase I Trial of Trebananib, an Angiopoietin 1 and 2 Neutralizing Peptibody, Combined with Pembrolizumab in Patients with Advanced Ovarian and Colorectal Cancer

Article

Author: Ferro, Allison ; Kao, Katrina Z. ; Rodig, Scott J. ; Giannakis, Marios ; Tyan, Kevin ; Singh, Harshabad ; Cleary, James M. ; Ng, Kimmie ; Li, Yvonne Y. ; Bockorny, Bruno ; Rahma, Osama E. ; Baginska, Joanna ; Kelland, Sarah ; Maloney, Anna K. ; Mariño-Enríquez, Adrián ; Huffman, Brandon M. ; Manos, Michael P. ; Schlechter, Benjamin L. ; Pfaff, Kathleen L. ; Giobbie-Hurder, Anita ; Hodi, F. Stephen ; Welsh, Emma L. ; Cherniack, Andrew D.

Abstract:

Ovarian cancers and microsatellite stable (MSS) colorectal cancers are insensitive to anti–programmed cell death 1 (PD-1) immunotherapy, and new immunotherapeutic approaches are needed. Preclinical data suggest a relationship between immunotherapy resistance and elevated angiopoietin 2 levels. We performed a phase I dose escalation study of pembrolizumab and the angiopoietin 1/2 inhibitor trebananib (NCT03239145). This multicenter trial enrolled patients with metastatic ovarian cancer or MSS colorectal cancer. Trebananib was administered intravenously weekly for 12 weeks with 200 mg intravenous pembrolizumab every 3 weeks. The toxicity profile of this combination was manageable, and the protocol-defined highest dose level (trebananib 30 mg/kg weekly plus pembrolizumab 200 mg every 3 weeks) was declared the maximum tolerated dose. The objective response rate for all patients was 7.3% (90% confidence interval, 2.5%–15.9%). Three patients with MSS colorectal cancer had durable responses for ≥3 years. One responding patient’s colorectal cancer harbored a POLE mutation. The other two responding patients had left-sided colorectal cancers, with no baseline liver metastases, and genomic analysis revealed that they both had KRAS wild-type, ERBB2-amplified tumors. After development of acquired resistance, biopsy of one patient’s KRAS wild-type ERBB2-amplified tumor showed a substantial decline in tumor-associated T cells and an increase in immunosuppressive intratumoral macrophages. Future studies are needed to carefully assess whether clinicogenomic features, such as lack of liver metastases, ERBB2 amplification, and left-sided tumors, can predict increased sensitivity to PD-1 immunotherapy combinations.

01 Sep 2024·Expert Review of Anticancer Therapy

Evaluating the efficacy and safety of trebananib in treating ovarian cancer and non-ovarian cancer patients: a meta-analysis and systematic review

Review

Author: Su, Jingyang ; Zhou, Yeyue ; Zhang, Jialin ; Lu, Jinhua

OBJECTIVES:

Due to its anti-angiogenic properties, trebananib is frequently employed in the treatment of cancer patients, particularly those with ovarian cancer. We conducted a meta-analysis to assess the efficacy and safety profile of trebananib in combination with other drugs for treating both ovarian and non-ovarian cancer patients.

METHODS:

Our search encompassed PubMed, Medline, Cochrane, and Embase databases, with a focus on evaluating study quality. Data extraction was conducted from randomized controlled trials (RCTs), and RevMan 5.3 facilitated result analysis.

RESULTS:

Combining trebananib with other drugs extended progression-free survival (PFS) [HR 0.81, (95%CI: 0.65, 0.99), p = 0.04] and overall survival (OS) [HR 0.88, (95%CI: 0.79, 1.00), p = 0.04] in ovarian cancer patients. Ovarian cancer patients exhibited a higher objective response rate (ORR) with trebananib compared to non-ovarian cancer cohorts. Moreover, the incorporation of trebananib into the standard treatment regimen for malignant tumors did not significantly elevate drug-related adverse events [RR 1.05, (95% CI: 1.00, 1.11), p = 0.05].

CONCLUSION:

Trebananib plus other drugs can improve the PFS, OS and ORR in patients with cancer, especially ovarian cancer. Our recommendation is to use trebananib plus other drugs to treat advanced cancer, and to continuously monitor and manage drug-related adverse events.

REGISTRATION:

PROSPERO (No. CRD42023466988).

16 Feb 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery

Article

Author: Berry, Donald A ; Wilson, Amy ; Haddad, Tufia ; Blair, Sarah ; Esserman, Laura J ; Stringer-Reasor, Erica ; Euhus, David ; Symmans, W Fraser ; Lu, Janice ; Petricoin, Emanuel F ; Tripathy, Debu ; Boughey, Judy C ; Yau, Christina ; Wallace, Anne M ; Rugo, Hope S ; Forero-Torres, Andres ; Buxton, Meredith ; Pusztai, Lajos ; Gallagher, Rosa I ; Perlmutter, Jane ; Melisko, Michelle ; Hirst, Gillian L ; Wulfkuhle, Julia D ; DeMichele, Angela M ; Chen, Yunn Yi ; Wolf, Denise M ; Yee, Douglas ; Lang, Julie E ; Asare, Adam L ; Brown-Swigart, Lamorna ; Chien, A Jo ; Hylton, Nola M ; Elias, Anthony D ; Krings, Gregor ; Asare, Smita M ; Nanda, Rita ; Van't Veer, Laura J ; Potter, David A ; Albain, Kathy S ; Berry, Scott ; Yung, Rachel L ; Matthews, Jeffrey B ; Godellas, Constantine ; Singhrao, Ruby ; Sanil, Ashish ; Clennell, Julia L ; Kaplan, Henry ; Isaacs, Claudine ; Clark, Amy S

Abstract:

Purpose::

The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast cancer trial.

Patients and Methods::

I-SPY2, a phase II neoadjuvant trial, adaptively randomizes patients with high-risk, early-stage breast cancer to one of several experimental therapies or control based on receptor subtypes as defined by hormone receptor (HR) and HER2 status and MammaPrint risk (MP1, MP2). The primary endpoint is pathologic complete response (pCR). A therapy “graduates” if/when it achieves 85% Bayesian probability of success in a phase III trial within a given subtype. Patients received weekly paclitaxel (plus trastuzumab if HER2-positive) without (control) or with weekly intravenous trebananib, followed by doxorubicin/cyclophosphamide and surgery. Pathway-specific biomarkers were assessed for response prediction.

Results::

There were 134 participants randomized to trebananib and 133 to control. Although trebananib did not graduate in any signature [phase III probabilities: Hazard ratio (HR)-negative (78%), HR-negative/HER2-positive (74%), HR-negative/HER2-negative (77%), and MP2 (79%)], it demonstrated high probability of superior pCR rates over control (92%–99%) among these subtypes. Trebananib improved 3-year event-free survival (HR 0.67), with no significant increase in adverse events. Activation levels of the Tie2 receptor and downstream signaling partners predicted trebananib response in HER2-positive disease; high expression of a CD8 T-cell gene signature predicted response in HR-negative/HER2-negative disease.

Conclusions::

The angiopoietin (Ang)/Tie2 axis inhibitor trebananib combined with standard neoadjuvant therapy increased estimated pCR rates across HR-negative and MP2 subtypes, with probabilities of superiority >90%. Further study of Ang/Tie2 receptor axis inhibitors in validated, biomarker-predicted sensitive subtypes is warranted.

News (Medical) associated with Trebananib

13 Jun 2022

·www.prnewswire.com

Fallopian Tube Cancer Therapeutics Market Size to Grow by USD 628.28 million | 39% of Market Growth to Originate from North America | Technavio

NEW YORK, June 13, 2022 /PRNewswire/ -- Fallopian tube cancer, also known as tubal cancer, is a type of cancer that is caused by an abnormal cell division in the fallopian tubes that connect to the ovaries and the uterus. It is a less common type of gynecologic cancer. The fallopian tube cancer therapeutics market size is expected to grow by USD 628.28 mn from 2021 to 2026. Moreover, the growth momentum of the market will accelerate at a CAGR of 9.06% during the forecast period. Technavio has announced its latest market research report titled Fallopian Tube Cancer Therapeutics Market by Product and Geography - Forecast and Analysis 2022-2026 Download an Exclusive Sample Report to learn more about market growth Top Key players in Fallopian Tube Cancer Therapeutics Market Amgen Inc. - The company offers fallopian tube cancer therapeutics, namely Trebananib. Baxter International Inc. - The company offers fallopian tube cancer therapeutics, namely Doxil. Bristol Myers Squibb Co. - The company offers fallopian tube cancer therapeutics, namely Opdivo. Clovis Oncology Inc. - The company offers fallopian tube cancer therapeutics, namely Rucaparib. Eli Lilly and Co. - The company offers fallopian tube cancer therapeutics, namely Gemzar. View an Exclusive Sample Report for a list of other key vendors operating in the market Market Trend and Challenge The growing research on regenerative therapies is driving the market growth. Various institutes and vendors are conducting research on developing novel regenerative therapies, including gene therapy, for the treatment of fallopian tube cancer. This, in turn, will fuel the fallopian tube cancer therapeutics market growth during the forecast period. Difficulty in diagnosis is challenging the fallopian tube cancer therapeutics market growth. The use of therapeutics may be carried out for long durations, which is a disadvantage for patients with late-stage fallopian tube cancer. This delay in diagnosis is resulting in an increased preference for alternative treatment options, such as surgeries. Market Segmentation Fallopian Tube Cancer Therapeutics Market Split by Product Targeted therapy: This segment will have the highest market share growth during the forecast period. The benefits of targeted therapy will drive the growth of the segment during the forecast period. Chemotherapy Fallopian Tube Cancer Therapeutics Market Split by Geography North America: The region will have the highest market share growth during the forecast period. This growth will be driven by factors such as the increasing adoption of therapeutics for the treatment of the indication. Moreover, market growth in this region will be faster than the growth of the market in other regions. Europe Asia Rest of World (ROW) Imperative Insights on the following aspects: What was the size of the global fallopian tube cancer therapeutics industry by value in 2020? What will be the size of the global fallopian tube cancer therapeutics industry in 2026? What factors are affecting the strength of competition in the global fallopian tube cancer therapeutics industry? How has the industry performed over the last five years? What are the main segments that make up the global fallopian tube cancer therapeutics market? Get lifetime access to our Technavio Insights! Subscribe to our "Basic Plan" billed annually at USD 5000 Why buy? Identify growth Strategies across markets Analyze your competitor market Know the financial performance of competitors with better insight Related Reports Payment Gateways Market by End-user and Geographic Landscape - Forecast and Analysis 2021-2025 Payment Gateways Market by End-user and Geographic Landscape - Forecast and Analysis 2021-2025 Table of Content: 1 Executive Summary 1.1 Market overview Exhibit 01: Executive Summary – Chart on Market Overview Exhibit 02: Executive Summary – Data Table on Market Overview Exhibit 03: Executive Summary – Chart on Global Market Characteristics Exhibit 04: Executive Summary – Chart on Market by Geography Exhibit 05: Executive Summary – Chart on Market Segmentation by Product Exhibit 06: Executive Summary – Chart on Incremental Growth Exhibit 07: Executive Summary – Data Table on Incremental Growth Exhibit 08: Executive Summary – Chart on Vendor Market Positioning 2 Market Landscape 2.1 Market ecosystem Exhibit 09: Parent market Exhibit 10: Market Characteristics 3 Market Sizing 3.1 Market definition Exhibit 11: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 12: Market segments 3.3 Market size 2021 3.4 Market outlook: Forecast for 2021-2026 Exhibit 13: Chart on Global - Market size and forecast 2021-2026 ($ million) Exhibit 14: Data Table on Global - Market size and forecast 2021-2026 ($ million) Exhibit 15: Chart on Global Market: Year-over-year growth 2021-2026 (%) Exhibit 16: Data Table on Global Market: Year-over-year growth 2021-2026 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 17: Five forces analysis - Comparison between 2021 and 2026 4.2 Bargaining power of buyers Exhibit 18: Chart on Bargaining power of buyers – Impact of key factors 2021 and 2026 4.3 Bargaining power of suppliers Exhibit 19: Bargaining power of suppliers – Impact of key factors in 2021 and 2026 4.4 Threat of new entrants Exhibit 20: Threat of new entrants – Impact of key factors in 2021 and 2026 4.5 Threat of substitutes Exhibit 21: Threat of substitutes – Impact of key factors in 2021 and 2026 4.6 Threat of rivalry Exhibit 22: Threat of rivalry – Impact of key factors in 2021 and 2026 4.7 Market condition Exhibit 23: Chart on Market condition - Five forces 2021 and 2026 5 Market Segmentation by Product 5.1 Market segments Exhibit 24: Chart on Product - Market share 2021-2026 (%) Exhibit 25: Data Table on Product - Market share 2021-2026 (%) 5.2 Comparison by Product Exhibit 26: Chart on Comparison by Product Exhibit 27: Data Table on Comparison by Product 5.3 Targeted therapy - Market size and forecast 2021-2026 Exhibit 28: Chart on Targeted therapy - Market size and forecast 2021-2026 ($ million) Exhibit 29: Data Table on Targeted therapy - Market size and forecast 2021-2026 ($ million) Exhibit 30: Chart on Targeted therapy - Year-over-year growth 2021-2026 (%) Exhibit 31: Data Table on Targeted therapy - Year-over-year growth 2021-2026 (%) 5.4 Chemotherapy - Market size and forecast 2021-2026 Exhibit 32: Chart on Chemotherapy - Market size and forecast 2021-2026 ($ million) Exhibit 33: Data Table on Chemotherapy - Market size and forecast 2021-2026 ($ million) Exhibit 34: Chart on Chemotherapy - Year-over-year growth 2021-2026 (%) Exhibit 35: Data Table on Chemotherapy - Year-over-year growth 2021-2026 (%) 5.5 Market opportunity by Product Exhibit 36: Market opportunity by Product ($ million) 6 Customer Landscape 6.1 Customer landscape overview Exhibit 37: Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 38: Chart on Market share by geography 2021-2026 (%) Exhibit 39: Data Table on Market share by geography 2021-2026 (%) 7.2 Geographic comparison Exhibit 40: Chart on Geographic comparison Exhibit 41: Data Table on Geographic comparison 7.3 North America - Market size and forecast 2021-2026 Exhibit 42: Chart on North America - Market size and forecast 2021-2026 ($ million) Exhibit 43: Data Table on North America - Market size and forecast 2021-2026 ($ million) Exhibit 44: Chart on North America - Year-over-year growth 2021-2026 (%) Exhibit 45: Data Table on North America - Year-over-year growth 2021-2026 (%) 7.4 Europe - Market size and forecast 2021-2026 Exhibit 46: Chart on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 47: Data Table on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 48: Chart on Europe - Year-over-year growth 2021-2026 (%) Exhibit 49: Data Table on Europe - Year-over-year growth 2021-2026 (%) 7.5 Asia - Market size and forecast 2021-2026 Exhibit 50: Chart on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 51: Data Table on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 52: Chart on Asia - Year-over-year growth 2021-2026 (%) Exhibit 53: Data Table on Asia - Year-over-year growth 2021-2026 (%) 7.6 Rest of World (ROW) - Market size and forecast 2021-2026 Exhibit 54: Chart on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 55: Data Table on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 56: Chart on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) Exhibit 57: Data Table on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) 7.7 US - Market size and forecast 2021-2026 Exhibit 58: Chart on US - Market size and forecast 2021-2026 ($ million) Exhibit 59: Data Table on US - Market size and forecast 2021-2026 ($ million) Exhibit 60: Chart on US - Year-over-year growth 2021-2026 (%) Exhibit 61: Data Table on US - Year-over-year growth 2021-2026 (%) 7.8 Austria - Market size and forecast 2021-2026 Exhibit 62: Chart on Austria - Market size and forecast 2021-2026 ($ million) Exhibit 63: Data Table on Austria - Market size and forecast 2021-2026 ($ million) Exhibit 64: Chart on Austria - Year-over-year growth 2021-2026 (%) Exhibit 65: Data Table on Austria - Year-over-year growth 2021-2026 (%) 7.9 China - Market size and forecast 2021-2026 Exhibit 66: Chart on China - Market size and forecast 2021-2026 ($ million) Exhibit 67: Data Table on China - Market size and forecast 2021-2026 ($ million) Exhibit 68: Chart on China - Year-over-year growth 2021-2026 (%) Exhibit 69: Data Table on China - Year-over-year growth 2021-2026 (%) 7.10 Switzerland - Market size and forecast 2021-2026 Exhibit 70: Chart on Switzerland - Market size and forecast 2021-2026 ($ million) Exhibit 71: Data Table on Switzerland - Market size and forecast 2021-2026 ($ million) Exhibit 72: Chart on Switzerland - Year-over-year growth 2021-2026 (%) Exhibit 73: Data Table on Switzerland - Year-over-year growth 2021-2026 (%) 7.11 India - Market size and forecast 2021-2026 Exhibit 74: Chart on India - Market size and forecast 2021-2026 ($ million) Exhibit 75: Data Table on India - Market size and forecast 2021-2026 ($ million) Exhibit 76: Chart on India - Year-over-year growth 2021-2026 (%) Exhibit 77: Data Table on India - Year-over-year growth 2021-2026 (%) 7.12 Market opportunity by geography Exhibit 78: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges 8.3 Impact of drivers and challenges Exhibit 79: Impact of drivers and challenges in 2021 and 2026 8.4 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 80: Overview on Criticality of inputs and Factors of differentiation 9.3 Landscape disruption Exhibit 81: Overview on factors of disruption 9.4 Industry risks Exhibit 82: Impact of key risks on business 10 Vendor Analysis 10.1 Vendors covered Exhibit 83: Vendors covered 10.2 Market positioning of vendors Exhibit 84: Matrix on vendor position and classification 10.3 Amgen Inc. Exhibit 85: Amgen Inc. - Overview Exhibit 86: Amgen Inc. - Product / Service Exhibit 87: Amgen Inc. - Key offerings 10.4 Baxter International Inc. Exhibit 88: Baxter International Inc. - Overview Exhibit 89: Baxter International Inc. - Business segments Exhibit 90: Baxter International Inc. - Key news Exhibit 91: Baxter International Inc. - Key offerings Exhibit 92: Baxter International Inc. - Segment focus 10.5 Bristol Myers Squibb Co. Exhibit 93: Bristol Myers Squibb Co. - Overview Exhibit 94: Bristol Myers Squibb Co. - Product / Service Exhibit 95: Bristol Myers Squibb Co. - Key offerings 10.6 Clovis Oncology Inc. Exhibit 96: Clovis Oncology Inc. - Overview Exhibit 97: Clovis Oncology Inc. - Business segments Exhibit 98: Clovis Oncology Inc. - Key offerings Exhibit 99: Clovis Oncology Inc. - Segment focus 10.7 Eli Lilly and Co. Exhibit 100: Eli Lilly and Co. - Overview Exhibit 101: Eli Lilly and Co. - Product / Service Exhibit 102: Eli Lilly and Co. - Key offerings 10.8 F. Hoffmann La Roche Ltd. Exhibit 103: F. Hoffmann La Roche Ltd. - Overview Exhibit 104: F. Hoffmann La Roche Ltd. - Business segments Exhibit 105: F. Hoffmann La Roche Ltd. - Key news Exhibit 106: F. Hoffmann La Roche Ltd. - Key offerings Exhibit 107: F. Hoffmann La Roche Ltd. - Segment focus 10.9 GlaxoSmithKline Plc Exhibit 108: GlaxoSmithKline Plc - Overview Exhibit 109: GlaxoSmithKline Plc - Business segments Exhibit 110: GlaxoSmithKline Plc - Key news Exhibit 111: GlaxoSmithKline Plc - Key offerings Exhibit 112: GlaxoSmithKline Plc - Segment focus 10.10 ImmunoGen Inc. Exhibit 113: ImmunoGen Inc. - Overview Exhibit 114: ImmunoGen Inc. - Product / Service Exhibit 115: ImmunoGen Inc. - Key offerings 10.11 Johnson and Johnson Exhibit 116: Johnson and Johnson - Overview Exhibit 117: Johnson and Johnson - Business segments Exhibit 118: Johnson and Johnson - Key news Exhibit 119: Johnson and Johnson - Key offerings Exhibit 120: Johnson and Johnson - Segment focus 10.12 Merck and Co. Inc. Exhibit 121: Merck and Co. Inc. - Overview Exhibit 122: Merck and Co. Inc. - Business segments Exhibit 123: Merck and Co. Inc. - Key news Exhibit 124: Merck and Co. Inc. - Key offerings Exhibit 125: Merck and Co. Inc. - Segment focus 11 Appendix 11.1 Scope of the report 11.2 Inclusions and exclusions checklist Exhibit 126: Inclusions checklist Exhibit 127: Exclusions checklist 11.3 Currency conversion rates for US$ Exhibit 128: Currency conversion rates for US$ 11.4 Research methodology Exhibit 129: Research methodology Exhibit 130: Validation techniques employed for market sizing Exhibit 131: Information sources 11.5 List of abbreviations Exhibit 132: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Us: Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

Gene Therapy

24 Jun 2016

·www.biospace.com

Takeda Returns Certain Molecules, Products to Amgen

June 24, 2016 By Alex Keown , BioSpace.com Breaking News Staff OSAKA, Japan – Takeda Pharmaceutical Company announced this morning that it was returning some molecules and products to Amgen it had access to through a collaboration agreement that yielded a cancer treatment for the Japanese market. Takeda and Amgen struck a deal to develop and commercialize multiple molecules and products that belong to Amgen’s pipeline for commercialization in Japan. Among the molecules being returned to Amgen are AMG403, for the treatment of pain related to cancer, and AMG386, an anti-angiopoietin peptibody for the treatment of solid tumors in various types of cancer. The company did not specify why it was returning the molecules to Amgen, only saying it looked forward to future collaboration on other molecules that remained within its keeping. Those molecules being returned will be done immediately, Takeda said. Amgen and Takeda struck its struck its collaboration deal in 2008 for 13 molecules from Amgen’s pipeline. At the time the deal was struck, the pipeline included early to mid-stage clinical-stage candidates across a range of therapeutic areas, including oncology, inflammation and pain. The Amgen / Takeda deal included the colorectal cancer drug Vectibix, which Takeda was able to bring to the Japanese market in 2010. “Through our work with Amgen, we have successfully delivered Vectibix to the Japanese patients facing a challenging diagnosis while continuing to build our scientific understanding of novel treatment pathways,” Phil Rowlands , interim head of Takeda’s oncology therapeutic unit. “We look forward to continuing our scientific discovery and to building a portfolio of innovative medicines through our ongoing collaboration with Amgen.” Takeda said it will work with Amgen to ensure a smooth transition of the return of the molecules and will cooperate with Amgen to ensure patients will receive appropriate therapies in Japan. This is not the first time this year that Takeda has returned some experimental products in its pipeline to the parent companies. Earlier this year, Takeda returned the U.S. rights to the anti-obesity drug Contrave to its partner Orexigen . Takeda said the move will allow the company to focus on its inflammatory bowel disease drugs, gout, diabetes and its products for major depressive disorder. In addition to recently returning those drug molecules, Takeda also recently created two new business units to support its pipeline. A dedicated Specialty Business Unit will enable Takeda to develop best-in-class capabilities in areas such as patient support and evidence generation. Takeda’s new General Medicine Business Unit will support marketing operations for the company pipeline. Shares of Takeda, which trades on the Tokyo Stock Exchange , are down more than 7 percent this morning.

License out/in

100 Deals associated with Trebananib

External Link

KEGG	Wiki	ATC	Drug Bank
D10177	-	-	DB12056

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube Carcinoma	Phase 3	Japan	Amgen, Inc.	01 Jan 2012
Fallopian Tube Carcinoma	Phase 3	Greece	Amgen, Inc.	01 Jan 2012
Fallopian Tube Carcinoma	Phase 3	Netherlands	Amgen, Inc.	01 Jan 2012
Fallopian Tube Carcinoma	Phase 3	Russia	Amgen, Inc.	01 Jan 2012
Fallopian Tube Carcinoma	Phase 3	Spain	Amgen, Inc.	01 Jan 2012
Ovarian Epithelial Carcinoma	Phase 3	United States	Amgen, Inc.	01 Jan 2012
Ovarian Epithelial Carcinoma	Phase 3	Japan	Amgen, Inc.	01 Jan 2012
Ovarian Epithelial Carcinoma	Phase 3	Austria	Amgen, Inc.	01 Jan 2012
Ovarian Epithelial Carcinoma	Phase 3	Belgium	Amgen, Inc.	01 Jan 2012
Ovarian Epithelial Carcinoma	Phase 3	Canada	Amgen, Inc.	01 Jan 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00853372 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma \| Advanced Renal Cell Carcinoma	85	Trebananib+Sunitinib (Trebananib 10 mg/kg + Sunitinib)	wehinloueh = zrchbmqgis cihufxgalj (ogyxvnounp, lcmfcuckux - ghnenngqrf) View more	-	01 Jul 2020
				Trebananib+Sunitinib (Trebananib 15 mg/kg + Sunitinib)	wehinloueh = opzhqxynbo cihufxgalj (ogyxvnounp, veaingpbvw - manjcszvqs) View more
NCT01493505 (TRINOVA-3, Pubmed \| Lancet Oncol) Manual	Phase 3	Ovarian Cancer First line	1,015	carboplatin+paclitaxel+Trebananib	rwbancrsre(kauevypjui) = ybhrwtgcia inxadwsxaz (wpdktpwhjo ) View more	Negative	01 Jun 2019
				carboplatin+paclitaxel+Placebo	rwbancrsre(kauevypjui) = dtvwkelidi inxadwsxaz (wpdktpwhjo ) View more
NCT03239145 (ASCO 12019 \| ASCO 22019) Manual	Phase 1	Colorectal Cancer	18	trebananib+pembrolizumab	bgzuullxyq(znnahcaodi) = None sazfuqhprq (cuncwuizas ) View more	Positive	31 May 2019
NCT01553188 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer \| Advanced Prostate Carcinoma	36	prednisone+Abiraterone+AMG 386 (Abiraterone, Prednisone and AMG)	atlieifrlh(papklwqefd) = jnyniwixce estoazajou (igtnpxubmk, eafjthvicx - rwkoxeawhf) View more	-	16 Oct 2018
				prednisone+Abiraterone (Abiraterone and Prednisone Only)	atlieifrlh(papklwqefd) = gdeksvpajc estoazajou (igtnpxubmk, ypokavwkqy - twucqfeujx) View more
NCT00872014 (Pubmed)	Phase 2	Advanced Hepatocellular Carcinoma First line	60	Trebananib 10 mg/kg	zrtfckmctu(dhgqbpqwpg) = goregtanne uiumtmyezo (pwlgjwgxwn ) View more	Negative	01 Jul 2017
				Trebananib 15 mg/kg	zrtfckmctu(dhgqbpqwpg) = feurwqlkou uiumtmyezo (pwlgjwgxwn ) View more
NCT01290263 (CTgov)	Phase 1/2	Glioblastoma Multiforme \| Recurrent Glioblastoma	48	Bevacizumab+AMG 386 (All Cohort B Participants: AMG 386 + Bevacizumab)	ufaopksnhr = swoycimaqz lwembadjhz (abakxskqge, gcuvowsexd - iqfgnhvyia) View more	-	25 May 2017
				AMG 386 (Cohort A: AMG 386 30 mg/kg)	ufaopksnhr = cooscguqce lwembadjhz (abakxskqge, lvieuunvsp - sdeyppxrjz) View more
NCT01281254 (ENGOT-ov-6 \| TRINOVA-2, Pubmed \| Eur J Cancer Care (Engl) \| Eur J Cancer) Manual	Phase 3	Ovarian Cancer	223	pegylated liposomal doxorubicin+trebananib	gjmglxmvog(ldidqqpsdd) = yxivbaajlr kqtfpvkfaa (jkmrsazznk, 7.2 - 9.0) View more	Negative	01 Jan 2017
				pegylated liposomal doxorubicin+Placebo	gjmglxmvog(ldidqqpsdd) = vgzhglxveo kqtfpvkfaa (jkmrsazznk, 4.8 - 8.2) View more
NCT01204749 (TRINOVA-1, Pubmed \| Obstet Gynecol Surv) Manual	Phase 3	Recurrent ovarian cancer	919	paclitaxel+trebananib	piytbsykha(kyzqofhoxz) = pkxqmbdefx ypzobwzyjw (uhmserrzgn ) View more	Negative	01 Oct 2016
				paclitaxel+Placebo	piytbsykha(kyzqofhoxz) = zvrwoeoqif ypzobwzyjw (uhmserrzgn ) View more
SNO2015	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	114	Bevacizumab + AMG 386	gybpmkgvqf(tjxfdjujnh) = ltjjoehfgw pwmmblznmd (awfehmkqna )	Positive	09 Nov 2015
				Bevacizumab + Placebo	gybpmkgvqf(tjxfdjujnh) = xihnalonhb pwmmblznmd (awfehmkqna )
NCT00853372 (Pubmed \| J Urol \| J Clin Oncol) Manual	Phase 2	Metastatic Renal Cell Carcinoma	85	Trebananib+Sunitinib (sunitinib 50 mg and trebananib 10 mg/kg)	oxzjdxyvdg(xbjkcyxkrm) = gwsirdzjbt rjapmateih (qnjaxmxeon ) View more	Positive	20 Oct 2015
				Trebananib+Sunitinib (sunitinib 50 mg and trebananib 15 mg/kg)	oxzjdxyvdg(xbjkcyxkrm) = tahanlwhyh rjapmateih (qnjaxmxeon ) View more

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