A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.

Start Date01 Aug 2007

Sponsor / Collaborator

Abbott Biotherapeutics Corp.

[+1]

NCT00425347 / CompletedPhase 1

Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Subjects With Advanced Multiple Myeloma

To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the safety of HuLuc63 IV given every other week for 4 doses.

Start Date01 Dec 2006

Sponsor / Collaborator

Abbott Biotherapeutics Corp.

100 Clinical Results associated with Abbott Biotherapeutics Corp.

0 Patents (Medical) associated with Abbott Biotherapeutics Corp.

Literatures (Medical) associated with Abbott Biotherapeutics Corp.

20 May 2015·Journal of Clinical Oncology

Enzalutamide (ENZA) in men with chemotherapy-Naïve metastatic castration-resistant prostate cancer (mCRPC): Final analysis of the phase 3 PREVAIL study.

Author: Saad, Fred ; De Bono, Johann Sebastian ; Carles, Joan ; Bhattacharya, Suman ; Venner, Peter M. ; Van Os, Steve ; TOMBAL, Bertrand F. ; Mansbach, Harry H. ; Higano, Celestia S. ; Sternberg, Cora N. ; Mainwaring, Paul N. ; Phung, De ; Armstrong, Andrew J. ; Loriot, Yohann ; Joshua, Anthony M. ; Parli, Teresa ; Rathkopf, Dana E. ; Evans, Christopher P. ; Beer, Tomasz M.

5036 Background: PREVAIL (NCT01212991) was a phase 3 trial that investigated the impact of ENZA vs placebo (PBO) on overall survival (OS) and radiographic progression-free survival (rPFS) in asympt...

16 Nov 2012·Blood

A Phase 2 Study of Elotuzumab (Elo) in Combination with Lenalidomide and Low-Dose Dexamethasone (Ld) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results

Author: Deng, Wei ; Moreau, Philippe ; Kroog, Glenn ; Vij, Ravi ; Lonial, Sagar ; Raab, Marc S ; White, Darrell J. ; Benboubker, Lotfi ; Singhal, Anil K ; Richardson, Paul G. ; Facon, Thierry ; Zonder, Jeffrey A. ; Reece, Donna ; Jakubowiak, Andrzej ; Jagannath, Sundar

AbstractAbstract 202Background:Elotuzumab (Elo) is a humanized monoclonal IgG1 antibody targeting CS1, a cell surface glycoprotein highly expressed on >95% of MM cells, with lower expression on natural killer (NK) cells and little to no expression on normal tissues. The mechanism of action of Elo is primarily NK cell-mediated antibody-dependent cellular cytotoxicity against MM cells. In the Phase 1 portion of this 1703 study, Elo escalated from 5 to 20 mg/kg intravenously (IV) plus Ld resulted in an 82% objective response rate (ORR) in pts with R/R MM (Lonial, J Clin Oncol 2012). Historically, lenalidomide plus high dose dexamethasone provided a 61% ORR and a median 11.1 months (mos) progression free survival (PFS) in a similar pt population (Dimopoulos, Weber, N Engl J Med 2007). At the time of previous presentation (Moreau, ASCO 2012), median PFS in the Phase 2 portion the 1703 study of Elo + Ld was not reached (NR) with 10 mg/kg after a median follow-up of 17.2 mo and was 18.6 mo with 20 mg/kg.Methods:Pts with R/R MM previously treated with 1–3 prior therapies were randomized to Elo 10 or 20 mg/kg IV (days 1, 8, 15, 22 every 28 days in cycles 1–2 and days 1, 15 in cycles ≥3) plus lenalidomide 25 mg (PO) (days 1–21) and dexamethasone 40 mg PO weekly or 28 mg PO plus 8 mg IV on Elo dosing days. All pts received a premedication regimen of methylprednisolone or dexamethasone, diphenhydramine, ranitidine, and acetaminophen prior to elo dosing to minimize infusion reactions. Treatment continued until disease progression, unacceptable toxicity, or death. Pts were monitored for PFS until 60 days post-treatment follow-up. The primary objective was efficacy (ORR ≥partial response) according to the International Myeloma Working Group criteria.Results:73 pts were treated (10 mg/kg, n=36; 20 mg/kg, n=37). Median age was 63 (range, 39–82) years, 55% received ≥2 prior therapies, 60% prior bortezomib, and 62% prior thalidomide. Median (range) duration of treatment was 20.5 (3.0–31.0) and 16.0 (1.0–32.0) cycles with 10 and 20 mg/kg, respectively. At the data cutoff (July 10 2012), 27 pts (10 mg/kg, n=15; 20 mg/kg, n=12) were ongoing and 46 pts discontinued (disease progression, n=26; adverse events, n=11; investigator/pt decision, n=9). ORR was 84% overall; 92% with 10 mg/kg (chosen as the Phase 3 dose) and 76% with 20 mg/kg (see Table). Overall median time to objective response was 1 month (range, 0.7–19.2). After a median follow-up of 18.1 mos, median PFS in the 10 mg/kg cohort was 26.9 mos (95% confidence interval [CI]: 14.9–NR); however, 15 pts are still ongoing with a median follow-up of 23.9 mos, and the PFS data will likely mature further with longer follow up. Median PFS in the 20 mg/kg cohort was 18.6 mos (95% CI: 12.9–NR). In subgroup analyses combining 10 and 20 mg/kg cohorts, ORRs for pts with 1 (n=33) or ≥2 prior therapies (n=40) were 91% and 78%, respectively, and overall median PFS were 25.0 (95% CI: 15.7–NR) and 21.3 mos (95% CI: 14.0–NR), respectively. Pts with prior thalidomide (n=45) had an ORR of 82% and median PFS of 26.9 mos (95% CI: 14.9–NR). Fifty-six (78%) pts experienced ≥1 treatment emergent grade ≥3 event. Most common were lymphopenia (19%), neutropenia (18%), thrombocytopenia (16%), anemia (12%), leukopenia (10%), hyperglycemia (10%), pneumonia (7%), diarrhea (7%), fatigue (7%), and hypokalemia (6%). Two deaths occurred on study (multiple adverse events [n=1; pneumonia, multiple organ failure and sepsis]; disease progression [n=1]). Investigator-designated (any grade) infusion reactions were reported in 12% of pts; 1 pt had a grade 3 event (rash). There were 4 cases of second primary malignancies (prostate; bladder; myelodysplastic syndrome; nasal squamous cell); all were deemed unrelated to Elo.Conclusions:In pts with R/R MM, Elo + Ld was generally well tolerated. Elo at 10mg/kg (the phase 3 dose) + Ld resulted in a high ORR and an encouraging median PFS of 26.9 mos after 18.1 mos of median follow-up. Phase 3 trials of Elo 10 mg/kg ± Ld are ongoing in newly diagnosed MM (ELOQUENT-1; CA204-006; NCT01335399) and R/R MM (ELOQUENT-2; CA204-004; NCT01239797).Disclosures:Richardson: Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees. Off Label Use: Elotuzumab in combination with lenalidomide and dexamethasone for the treatment of relapsed/refractory multiple myeloma. Elotuzumab is not currently approved for any indication. Jagannath:Onyx Pharm: Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck Sharp & Dohme: Honoraria, Membership on an entity's Board of Directors or advisory committees; Millennium Pharm: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Jakubowiak:Onyx: Honoraria, Speakers Bureau; BMS: Honoraria, Speakers Bureau; Celgene: Honoraria, Speakers Bureau; Millennium: Honoraria, Speakers Bureau. Facon:BMS: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Vij:Celgene: Honoraria, Research Funding; BMS: Honoraria, Research Funding. White:Celgene: Honoraria, Research Funding. Reece:Johnson & Johnson: Research Funding; Merck: Honoraria, Research Funding; Otsuka: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Millennium: Research Funding. Zonder:Millenium: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Deng:Abbott Biotherapeutics Corp: Employment. Kroog:BMS: Employment. Singhal:Abbott Biotherapeutics: Employment, Equity Ownership. Lonial:Onyx: Consultancy; BMS: Consultancy; Novartis: Consultancy; Celgene: Consultancy; Millennium: Consultancy; Merck: Consultancy.

15 Apr 2012·Cancer Research

Abstract 2722: Active recruitment of immune effector cells mediates in vivo tumor growth inhibition by enavatuzumab, an antibody to human TWEAK receptor

Author: Culp, Patricia A. ; Belmar, Nicole ; Fang, Yuni ; Chao, Debra T. ; Sho, Mien ; Fox, Melvin ; Keller, Stephen ; Zhao, Vivian ; Starling, Gary C. ; Choi, Donghee ; Ye, Shiming

AbstractEnavatuzumab (PDL192) is a humanized anti-TWEAK receptor antibody currently under clinical evaluation for the treatment of solid malignancies. Enavatuzumab is postulated to exert its potent anti-tumor activity in xenograft models through two distinct mechanisms of action: direct inhibition of tumor cell growth and Fc-mediated function. The goal of this study was to elucidate the role of immune effector cells in Fc-mediated function. The initial evidence for a role of effector cells was obtained in a subset of tumor xenograft mouse models which responded to enavatuzumab but did not respond to a version of enavatuzumab containing a mutation in the FcαRIII binding region. Subsequent analysis of circulating effector cells showed increased expression of activation markers DX5 and CD27 on monocyte-like cells (CD45+CD11bHigh) and DX5 on NK-like cells (CD45+CD11bLow) after enavatuzumab treatment in xenograft models dependent on Fc-FcR interactions for enavatuzumab efficacy. The involvement of effector cells was further confirmed by immunohistochemistry, which revealed strong infiltration of CD45+ effector cells into tumor xenografts in responding models, but minimal infiltration in non-responders. Consistent with the in vivo xenograft studies, human effector cells migrated towards enavatuzumab-treated tumor cells in vitro. Effector cells preferentially migrated toward in vivo responsive tumor cells, and the majority of migratory cells were monocytes and NK cells. Conditioned media from enavatuzumab-treated tumor cells also induced migration, and contained elevated levels of cytokines/chemokines, including IL8 and MCP-1. The presence of an anti-MCP-1 neutralizing antibody in enavatuzumab-treated tumor cell conditioned medium significantly blocked effector cell migration, suggesting that MCP-1 might be responsible for effector cell migration triggered by enavatuzumab. We also observed elevated levels of human MCP-1 in the serum of both enavatuzumab-treated xenograft mouse models and in a subset of patients from the enavatuzumab Phase I clinical study. In summary, in vivo and in vitro studies suggest that enavatuzumab exerts its potent anti-tumor activity, in part, by actively recruiting effector cells and activating effectors to kill tumor cells. In addition, enavatuzumab-induced chemokines may be potential pharmacodynamic biomarkers and warrant further evaluation in clinical studies.Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 2722. doi:1538-7445.AM2012-2722

News (Medical) associated with Abbott Biotherapeutics Corp.

07 Jan 2009

·www.biospace.com

Facet Biotech Chief Business Officer "Terminated"

January 6, 2009 - San Francisco Business Times - Redwood City’s Facet Biotech Corp. — recently spun off from PDL BioPharma Inc. — will part with its chief business officer Friday.

100 Deals associated with Abbott Biotherapeutics Corp.

100 Translational Medicine associated with Abbott Biotherapeutics Corp.

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