Delving into the Latest Updates on 90Y Clivatuzumab Tetraxetan with Synapse

Overview

Basic Info

Drug Type

Radiolabeled antibody, Therapeutic radiopharmaceuticals

Synonyms

90Y-HPAM4, 90Y-clivatuzumab tetraxetan, Clivatucyn

+ [16]

Target

MUC1 x MUC5AC

Mechanism

MUC1 inhibitors(Mucin-1 inhibitors), MUC5AC inhibitors(Mucin-5AC inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Pancreatic Cancer

Inactive Indication

Locally Advanced Pancreatic AdenocarcinomaPancreatic adenocarcinoma metastaticSecondary malignant neoplasm of pancreas

Originator Organization

Immunomedics, Inc.

Active Organization

New Jersey Medical SchoolGoshen Community Care & Hospice, Inc.

The Fox Chase Cancer Center

+ [1]

Inactive Organization

Gilead Sciences, Inc.

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure

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Gene Sequence

Sequence Code 9723471L

Source: *****

Sequence Code 9723466H

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An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1) - PANCRIT-1 (PANcreatic Cancer RadioImmunoTherapy Trial 1)

Start Date16 Jun 2015

Sponsor / Collaborator

Immunomedics, Inc.

EUCTR2013-004516-21-BE / Not yet recruitingPhase 3

An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1) - PANCRIT-1 (PANcreatic Cancer RadioImmunoTherapy Trial 1)

Start Date02 Jun 2015

Sponsor / Collaborator

Immunomedics, Inc.

NCT01956812 / TerminatedPhase 3

An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

Start Date01 Dec 2013

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with 90Y Clivatuzumab Tetraxetan

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100 Translational Medicine associated with 90Y Clivatuzumab Tetraxetan

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100 Patents (Medical) associated with 90Y Clivatuzumab Tetraxetan

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9

Literatures (Medical) associated with 90Y Clivatuzumab Tetraxetan

01 Sep 2015·European Journal of CancerQ1 · MEDICINE

90 Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies

Q1 · MEDICINE

Article

Author: Frank, Richard C ; Wegener, William A ; Horne, Heather ; Ocean, Allyson J ; Sharkey, Robert M ; Manzone, Timothy C ; Goldsmith, Stanley J ; Ramanathan, Ramesh K ; Goldenberg, David M ; Richards, Donald A ; Dragovich, Tomislav ; Sheikh, Arif ; Intenzo, Charles M ; Korn, Ronald L ; Picozzi, Vincent J ; Lowery, Maeve A ; Braiteh, Fadi S ; Mitchel, Edith P ; Cohen, Steven J ; Gribbin, Thomas E ; Lee, Marie ; O'Neil, Bert H ; Starodub, Alexander N ; O'Reilly, Eileen M ; Conkling, Paul R ; Pandit-Taskar, Neeta ; Bahary, Nathan ; Bridges, Benjamin B ; Von Hoff, Daniel D ; Guarino, Michael J ; Lee, Fa-Chyi

BACKGROUNDFor patients with metastatic pancreatic adenocarcinoma, there are no approved or established treatments beyond the 2nd line. A Phase Ib study of fractionated radioimmunotherapy was undertaken in this setting, administering (90)Y-clivatuzumab tetraxetan (yttrium-90-radiolabelled humanised antibody targeting pancreatic adenocarcinoma mucin) with or without low radiosensitising doses of gemcitabine.METHODSFifty-eight patients with three (2-7) median prior treatments were treated on Arm A (N=29, (90)Y-clivatuzumab tetraxetan, weekly 6.5 mCi/m(2)doses×3, plus gemcitabine, weekly 200 mg/m(2) doses×4 starting 1 week earlier) or Arm B (N=29, (90)Y-clivatuzumab tetraxetan alone, weekly 6.5 mCi/m(2)doses×3), repeating cycles after 4-week delays. Safety was the primary endpoint; efficacy was also evaluated.RESULTSCytopaenias (predominantly transient thrombocytopenia) were the only significant toxicities. Fifty-three patients (27 Arm A, 26 Arm B, 91% overall) completed ⩾1 full treatment cycles, with 23 (12 Arm A, 11 Arm B; 40%) receiving multiple cycles, including seven (6 Arm A, 1 Arm B; 12%) given 3-9 cycles. Two patients in Arm A had partial responses by RECIST criteria. Kaplan-Meier overall survival (OS) appeared improved in Arm A versus B (hazard ratio [HR] 0.55, 95% CI: 0.29-0.86; P=0.017, log-rank) and the median OS for Arm A versus Arm B increased to 7.9 versus 3.4 months with multiple cycles (HR 0.32, P=0.004), including three patients in Arm A surviving >1 year.CONCLUSIONSClinical studies of (90)Y-clivatuzumab tetraxetan combined with low-dose gemcitabine appear feasible in metastatic pancreatic cancer patients beyond 2nd line and a Phase III trial of this combination is now underway in this setting.

02 Jan 2015·mAbsQ2 · MEDICINE

Antibodies to watch in 2015

Q2 · MEDICINE

Review

Author: Reichert, Janice M

The commercial pipeline of recombinant antibody therapeutics is robust and dynamic. As of early December 2014, a total of 6 such products (vedolizumab, siltuximab, ramucirumab, pembrolizumab, nivolumab, blinatumomab) were granted first marketing approvals in 2014. As discussed in this perspective on antibodies in late-stage development, the outlook for additional approvals, potentially still in 2014 and certainly in 2015, is excellent as marketing applications for 7 antibody therapeutics (secukinumab, evolocumab, mepolizumab, dinutuximab, nivolumab, blinatumomab, necitumumab) are undergoing a first regulatory review in the EU or US. Of the 39 novel mAbs currently in Phase 3 studies, a marketing application for one (alirocumab) may be submitted in late 2014, and marketing application submissions for at least 4 (reslizumab, ixekizumab, ocrelizumab, obiltoxaximab) are expected in 2015. Other 'antibodies to watch' are those in Phase 3 studies with estimated primary completion dates in late 2014 or 2015, which includes 13 for non-cancer indications (brodalumab, bimagrumab, bococizumab, MABp1, gevokizumab, dupilumab, sirukumab, sarilumab, tildrakizumab, guselkumab, epratuzumab, combination of actoxumab + bezlotoxumab, romosozumab) and 2 (racotumomab and clivatuzumab tetraxetan) undergoing evaluation as treatments for cancer. In addition to the novel antibody therapeutics mentioned, biosimilar infliximab and biosimilar trastuzumab are 'antibodies to watch' in 2015 because of their potential for entry into the US market and regulatory review, respectively.

01 Jul 2014·mAbs

Antibodies to watch in 2014

Author: Reichert, Janice M

The commercial pipeline of monoclonal antibodies is highly dynamic, with a multitude of transitions occurring during the year as product candidates advance through the clinical phases and onto the market. The data presented here add to that provided in the extensive "Antibodies to watch in 2014" report published in the January/February 2014 issue of mAbs. Recent phase transition data suggest that 2014 may be a banner year for first approvals of antibody therapeutics. As of May 2014, three products, ramucirumab (Cyramza®), siltuximab (Sylvant®) and vedolizumab (Entyvio™), had been granted first approvals in the United States, and four additional antibody therapeutics (secukinumab, dinutuximab, nivolumab, pembrolizumab) are undergoing regulatory review in either the US or the European Union. Other notable events include the start of first Phase 3 studies for seven antibody therapeutics (dupilumab, SA237, etrolizumab, MPDL3280A, bavituximab, clivatuzumab tetraxetan, blinatumomab). Relevant data for these product candidates are summarized, and metrics for antibody therapeutics development are discussed.

100 Deals associated with 90Y Clivatuzumab Tetraxetan

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External Link

KEGG	Wiki	ATC	Drug Bank
-	90Y Clivatuzumab Tetraxetan	-	DB15368

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	Phase 2	US	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	IL	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	FR	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	BE	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	ES	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	CA	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	AT	Gilead Sciences, Inc.	01 Dec 2013
Pancreatic adenocarcinoma metastatic	Phase 2	PL	Gilead Sciences, Inc.	01 Dec 2013
Secondary malignant neoplasm of pancreas	Phase 2	BE	Gilead Sciences, Inc.	01 Dec 2013
Secondary malignant neoplasm of pancreas	Phase 2	AT	Gilead Sciences, Inc.	01 Dec 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01956812 (GlobeNewswire) Manual	Phase 3	Pancreatic Cancer	-	Gemcitabine+yttrium-90-labeled (90Y) clivatuzumab tetraxetan	(sswesxvnoi) = the treatment arm of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care did not demonstrate a sufficient improvement in OS as compared to placebo plus low-dose gemcitabine and best supportive care. eihcrzhbsy (xfbqvjjqmr )	Negative	14 Mar 2016
				Gemcitabine+Placebo
NCT01510561 (Pubmed \| Eur J Cancer Care (Engl))	Phase 1	Secondary malignant neoplasm of pancreas	53	(90)Y-clivatuzumab tetraxetan + gemcitabine	(hgizzlvtmp) = vazsuosvxu fagqwwnlgm (gumhpcclqm )	-	01 Sep 2015
				(90)Y-clivatuzumab tetraxetan alone	(hgizzlvtmp) = tzmqheshsd fagqwwnlgm (gumhpcclqm )
ASCO_GI2012	Phase 1/2	Pancreatic Cancer First line	100	90Y-hPAM4	(oksspatkxg) = olnbcqnsnv kvobgqsbsr (afwdxcicyx )	-	01 Feb 2012
ASCO_GI2011	Phase 1/2	Pancreatic Cancer	42	Clivatuzumab tetraxetan	lrygevtwff(rjugwntjbe) = improved aeyjxepvze (mngyahleib )	-	01 Feb 2011
				Gemcitabine
ASCO2010	Phase 1/2	Pancreatic Cancer	-	Clivatuzumab tetraxetan	fyfzxsxydm(qcqvadqrce) = lmmsdenvfu gwanboymrz (alwmvujpsf ) View more	-	20 May 2010
AACR2010	Not Applicable	Pancreatic Carcinoma	68	PAM4-antigen (PAM4-based EIA)	berntftzku(uxciwikujp) = oplusccfoa sywugcqxgk (fapyezsgkq ) View more	-	15 Apr 2010
				90Y-hPAM4 + Gem	(apgytjxqax) = mdutivhqcn cmmqgbhdzz (ujfxnqqnna )