tbuckley/cabot-search huggingface dataset:
Post-hoc analysis of the nintedanib exposure-response relationships in the CHIVA trial in advanced ovarian cancer: A GINECO study
Authors: S. Haviari, B. Blanchet, O. Colomban, L. Venat-Bouvet, N. Dohollou, A. Floquet, C. Louvet, J.-P. Lotz, S Abadie Lacourtoisie, L. Favier, M. Fabbro, N. Bonichon-Lamichhane, J.E. Kurtz, P. Follana, M. Leheurteur, F. Del Piano, C.R. Alliot, J. Alexandre, B. You, M. Tod
Journal: Annals of Oncology (2019)
Treatment-related adverse events and tolerability in patients with advanced renal cell carcinoma treated with first-line combination therapy with checkpoint inhibitors
Authors: T Win Htut, S. Swarup, A. Sultan, F. Mogollon-Duffo, S. Meda, M. Arevalo, N. Adhikari, P.T. Naing, P.P. Hlaing, Y Mon Myat, F. Hardwicke, N. D’Cunha, L. Tijani, K.Z. Thein
Journal: Annals of Oncology (2019)
Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study
Authors: A.M.M. Eggermont, M.S. Carlino, A. Hauschild, P.A. Ascierto, A. Arance, A. Daud, S.J. O’Day, M.H. Taylor, A. Smith, A. Rodgers, B Homet Moreno, S.J. Diede, H. Kluger
Journal: Annals of Oncology (2019)
Prognostic Relevance of CD49d Expression On B Leukemic Cells in Chronic Lymphocytic Leukemia. Meta-Analysis of Published and unpublished Individual Data From 3146 Patients
Authors: Pietro Bulian, Tait D. Shanafelt, Chris Pepper, Chris Fegan, Giovanni Del Poeta, Gianluca Gaidano, Davide Rossi, Luca Baldini, Lilla Cro, Holger Nuckel, Jan A. Burger, Valter Gattei
Journal: Blood (2012)
Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): Challenges in assessing effectiveness of treatment sequencing in the real world (RW)
Authors: T. Sanglier, A. Fabi, C. Flores, E. Flahavan, N. Lindegger, F. Montemurro
Journal: Annals of Oncology (2019)
Patient characteristics associated with poor performance status, ECOG 2-3, and effect on survival in 1086 Finnish metastatic colorectal cancers (mCRC) nationwide (prospective RAXO study)
Authors: P.J. Österlund, T. Salminen, A. Algars, L.-M. Soveri, R. Ristamäki, R.S. Kallio, A. Lamminmäki, P.M. Halonen, T. Poussa, E. Lantto, A. Ovissi, A. Nordin, P. Nyandoto, J.T. Kononen, L.J. Aroviita, A. Jekunen, I.H. Kellokumpu, M. Murashev, R. Lindvall-Andersson, H. Isoniemi
Journal: Annals of Oncology (2019)
Monalizumab in combination with cetuximab in patients (pts) with recurrent or metastatic (R/M) head and neck cancer (SCCHN) previously treated or not with PD-(L)1 inhibitors (IO): 1-year survival data
Authors: R.B. Cohen, G. Lefebvre, M.R. Posner, J.R. Bauman, S. Salas, C. Even, E. Saada-Bouzid, T. Seiwert, D. Colevas, F. Calmels, R. Zerbib, P. André, A. Boyer-Chammard, J. Fayette
Journal: Annals of Oncology (2019)
Abstract 19627: Can Heart Failure Be Caused by Coronary Microvascular Dysfunction
Authors: Vahagn Ohanyan, Liya Yin, Molly Enrick, Tatevik Hakobyan, Christopher L Kolz, William M Chilian
Journal: Circulation (2016)

Recently, we reported that Kv1.5 channels in smooth muscle connect myocardial blood flow to cardiac work. When this connection is uncoupled (Kv1.5-/- mice), during an acute metabolic stress induced...
Analysis of immunosuppressive factors produced by tumorspheres in NSCLC: Prognostic value of galectin-3 in adenocarcinoma
Authors: S. Torres Martinez, A. Herreros Pomares, F. Zhang, S. Calabuig-Fariñas, Á González, R. Sirera, A. Moreno-Manuel, M. Mosqueda, E. Escorihuela, E. Duréndez, S. Gallach, J. Garde, R. Guijarro, E. Jantus-Lewintre, C. Camps
Journal: Annals of Oncology (2019)
Upfront atezolizumab chemoimmunotherapy-associated immune-related adverse events in patients with advanced non-small cell lung cancer
Authors: F. Mogollon-Duffo, K.Z. Thein, A.M. Tun, S. Swarup, N. Jahan, N. Adhikari, T Win Htut, T.W. Naing, P.P. Hlaing, Y Mon Myat, P.T. Naing, F. Hardwicke, L. Tijani, N. D’Cunha, S. Awasthi
Journal: Annals of Oncology (2019)
Abstract 11489: Respiratory Quotient Correlates With Blood Lactate During Hemorrhage
Authors: Joshua W Lampe, Ralph Wijshoff, Jens Muehlsteff, Marek Bartula, Marc Fuller, Dawn Jorgenson, Lance B Becker
Journal: Circulation (2015)

Background: Cellular energy productions shifts from oxidative phosphorylation to glycolysis during periods of hypoxia, a symptom common to both shock and rigorous exercise. In critical care, serum excess lactate is measured as a marker of increased anaerobic metabolism. In exercise physiology, the respiratory quotient (RQ), defined as the ratio of the number of carbon dioxide molecules produced to the number of oxygen molecules consumed in a single breath, is used to track shifts between aerobic and anaerobic metabolism. We hypothesized that the respiratory quotient could be used to track the metabolic status of animals in shock. Methods: To compare lactate and RQ during two states of shock, 5 swine (~30kg) were subjected to 2 minutes of untreated VF followed by ACLS (2 minutes of CPR followed by defibrillation). After successful resuscitation and hemodynamic stabilization, 1 L of blood volume was removed through a femoral introducer sheath. In addition to standard physiological monitoring, we measured airway flow, oxygraphy, and capnography. Blood chemistry was measured at baseline, 1.5 minutes into arrest and at 3 time points after resuscitation. Serum lactate values were aggregated across all animals and fit with a least squares linear regression. The respiratory quotient was calculated using breath by breath values of oxygen consumption and carbon dioxide production. Results: All animals were successfully resuscitated. Blood pressures and heart rates normalized within 30 minutes of resuscitation for all animals. All animals died within 100 minutes of the initiation of hemorrhage. During and after hemorrhage, the serum lactate model increased 60% and the respiratory quotient increased 7%. The Pearson correlation coefficient between the serum lactate model and the mean respiratory quotient was R = 0.69 with p = 0.02. Conclusions: We have developed a stable model of altered hemodynamics and metabolic injury. Both serum lactate and the respiratory quotient increased monotonically with time, and were strongly correlated. These data suggest that the combination of volumetric capnography and volumetric oxygraphy can be used to track patient metabolic status in real time during shock.
Patient data to monitor clinical patterns in early and advanced breast cancer in Europe
Authors: F. Giusti, C. Martos, E. Crocetti, N. Dimitrova, G. Randi, L. Neamtiu, R.N. Carvalho, T. Dyba, M. Flego, N. Nicholson, M. Bettio
Journal: Annals of Oncology (2019)
Development and Scale-up of a Novel GMP Method for Enrichment and Expansion of Terminally Differentiated Adaptive Natural Killer Cells (FATE-NK100) with Enhanced Anti-Tumor Function
Authors: Frank Cichocki, Bahram Valamehr, Dhifaf Sarhan, Bin Zhang, Sarah Cooley, Michael R. Verneris, Bruce R. Blazar, Ryan Bjordahl, Betsy Rezner, Paul Rogers, Chad Green, David H McKenna, Daniel Shoemaker, Scott Wolchko, Jeffrey S. Miller
Journal: Blood (2016)
Regulation of Mother-to-Offspring Transmission of mtDNA Heteroplasmy
Authors: Ana Latorre-Pellicer, Ana Victoria Lechuga-Vieco, Iain G. Johnston, Riikka H. Hämäläinen, Juan Pellico, Raquel Justo-Méndez, Jose María Fernández-Toro, Cristina Clavería, Adela Guaras, Rocío Sierra, Jordi Llop, Miguel Torres, Luis Miguel Criado, Anu Suomalainen, Nick S. Jones, Jesús Ruíz-Cabello, José Antonio Enríquez
Journal: Cell Metabolism (2019)

mtDNA is present in multiple copies in each cell derived from the expansions of those in the oocyte. Heteroplasmy, more than one mtDNA variant, may be generated by mutagenesis, paternal mtDNA leakage, and novel medical technologies aiming to prevent inheritance of mtDNA-linked diseases. Heteroplasmy phenotypic impact remains poorly understood. Mouse studies led to contradictory models of random drift or haplotype selection for mother-to-offspring transmission of mtDNA heteroplasmy. Here, we show that mtDNA heteroplasmy affects embryo metabolism, cell fitness, and induced pluripotent stem cell (iPSC) generation. Thus, genetic and pharmacological interventions affecting oxidative phosphorylation (OXPHOS) modify competition among mtDNA haplotypes during oocyte development and/or at early embryonic stages. We show that heteroplasmy behavior can fall on a spectrum from random drift to strong selection, depending on mito-nuclear interactions and metabolic factors. Understanding heteroplasmy dynamics and its mechanisms provide novel knowledge of a fundamental biological process and enhance our ability to mitigate risks in clinical applications affecting mtDNA transmission.
Modalities of biosimilar filgrastim use in clinical practice in &gt; 1000 patients receiving chemotherapy regimens with a rest period of ≤ 14 days: The TOPAZE study
Authors: J.M. Phelip, P.-J. Souquet, S. Bordenave, M. Declerck, E. Nabirotchkina, O. Tredan
Journal: Annals of Oncology (2019)
Treatment of relapsed/refractory (R/R) B-cell malignancies by chimeric antigen receptor T cells cultured from 50-100 mL peripheral blood in 7-10 days.
Authors: Lu Han, Jian Zhou, Ke-Shu Zhou, Ling-Di Zhao, Xing-Hu Zhu, Qing-Song Yin, Quan-Li Gao, Yong-Ping Song
Journal: Journal of Clinical Oncology (2018)

7034 Background: Anti-CD19 chimeric antigen receptor (CAR) T cells for R/R B-cell malignancies has been remarkably effective in recent clinical trials. However, the training process is complex and long. We try to seek a method, which the preparation process is simple and short. Methods: We extracted 50-100 mL peripheral blood from patients (pts), and the CAR-T cells cultured 7-10 days to back to pts. All pts received a chemotherapy of cyclophosphamide and fludarabine followed by 1- 3x 106 CAR- T cells/kg, and were monitored for response. Results: CAR-T cells were capable of large numerical expansion in 7-10 days, up to about 5x108 magnitudes, and the culture success rate reached to 100%. We treated 29 pts with R/R B-cell malignancies (17 ALL and 12 B-cell lymphoma). Complete remissions (CRs) was achieved in 16 ALL pts (100%) 1 month after CAR-T cells infusion and CRs in 15 pts were MRD- negative, except 1 pt died in cytokine release syndrome (CRS). The CRs were 71.4% at 3 months and 56.0% at 6 months, respectively. 12 pts experienced CRS and severe CRS had 11.76% in ALL.Of 12 B-cell lymphoma, 4 achieved CR, 5 achieved PR, and 3 had progress disease (PD) when evaluated in 2 months. The CRs and overall response were 37.5% and 50.0% at 6 months, respectively. 2 pts were observed with CRS in lymphoma. Conclusions: Treatment of R/R B-cell malignancies with a high CRs by CAR-T cells, which cultured from 50-100 mL peripheral blood and achieved larger amount of amplification in short time. These results could be benefit for more high-risk pts. Clinical trial information: NCT02924753 NCT0310709.
Abstract 2692: Strain Rate Analysis Using Velocity Vector Imaging technique Identifies Global and Regional Right Ventricular Diastolic Function in patients with pulmonary hypertension
Authors: Hong Meng, Hector R Villarraga, Aijaz A Shah, Pui W Lee, Maytinee Kittipovanonth, James B Seward, Krishnaswamy Chandrasekaran
Journal: Circulation (2007)
Patients with metastatic non-small cell lung cancer and targetable molecular alterations in Germany. Treatment and first outcome data from the prospective German Registry Platform CRISP (AIO-TRK-0315)
Authors: F. Griesinger, W.E.E. Eberhardt, A. Nusch, M. Reiser, M.-O. Zahn, N.W. Marschner, M. Jänicke, A. Fleitz, L. Spring, J. Sahlmann, A. Karatas, A. Hipper, W. Weichert, C. Waller, M. Reck, P. Christopoulos, M. Sebastian, M. Thomas
Journal: Annals of Oncology (2019)
Cancer patient participation and compliance in microbiome sample collection: An oncology research nurse’s experience
Authors: J. Malo, M. Messaoudene, F. Cauchois, W. Belkaid, D. Frizon-Peresa, S. Ikene, L. Rousseau, J.-B. Lattouf, A. Elkrief, L. Mezquita, L. Derosa, B. Besse, N. Blais, R. Alameddine, M. Tehfe, M. Florescu, B. Routy
Journal: Annals of Oncology (2019)
Abstract 5685: The First Human Experience With An Irrigated-tip Magnetic Catheter In Patients Undergoing Remote Ablation Of Atrial Fibrillation
Authors: Vincenzo Santinelli, Andrea Radinovic, Gabriele Vicedomini, Gabriele Paglino, Giuseppe Augello, Simone Gulletta, Patrizio Mazzone, Giuseppe Ciconte, Stefania Sacchi, Carlo Pappone
Journal: Circulation (2008)
Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D
Authors: R. Kim, J. Chaves, P. Kavan, M. Fakih, J. Kortmansky, K. Spencer, L. Wong, M. Tehfe, J.J. Li, M. Lee, C. Mayo, P. Marinello, E. Chiorean
Journal: Annals of Oncology (2019)
CD33 - but Not Myeloid Antigens in General - Heralds Poor Prognosis in Childhood B Precursor ALL. Czech Pediatric Hematology Working Group (CPH) Population-Based Study.
Authors: Ester Mejstrikova, Martina Vaskova, Tomas Kalina, Jan Trka, Jan Stary, Ondrej Hrusak
Journal: Blood (2004)
ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups
Authors: A. Stenzl, R.Z. Szmulewitz, D.P. Petrylak, J. Holzbeierlein, A. Villers, A.A. Azad, A. Alcaraz, B.Y. Alekseev, T. Iguchi, N.D. Shore, B. Rosbrook, B. Baron, G.P. Haas, R. Morlock, K. Ramaswamy, A.J. Armstrong
Journal: Annals of Oncology (2019)
Outcome of high-grade gliomas (HGGs) treated into immunotherapeutic early-phase clinical trials (ieCTs): A single-center experience
Authors: M. Simonelli, P. Persico, A. Dipasquale, E. Lorenzi, L. Giordano, F. Pessina, P. Navarria, M. Scorsetti, L. Bello, A. Santoro
Journal: Annals of Oncology (2019)
Qualitative study of patients’ experiences of living with and beyond a soft tissue sarcoma diagnosis: The impact of sarcoma specialist services
Authors: A. Martins, L. Storey, M. Wells, L.A. Fern, C. Gerrand, L. Bennister, J. Woodford, M. Onasanya, R. Windsor, J. Whelan, R.M. Taylor
Journal: Annals of Oncology (2019)
iSCORE: Immunotherapy sequencing in colon and rectal cancer
Authors: F.S. Turkes, R. Crux, D. Cunningham, A. Athauda, E. Kalaitzaki, A. Musallam, R. Begum, K. De Paepe, N. Fotiadis, A. Riddell, K Von Loga, J. Kinross, J.R. Marchesi, J. Teare, D. Morganstein, S. Rao, D. Watkins, I. Chau, M. Gerlinger, N. Starling
Journal: Annals of Oncology (2019)
Effect of CCR2 antagonism on the metastatic capacity of non-small cell lung cancer cells.
Authors: Jun An, Meijun Long, Yong Huang, Yun Li, Hang Su, Junhang Zhang
Journal: Journal of Clinical Oncology (2016)

e20637 Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, which is the leading cancer killer in the world. Despite recent advance in diagnosis and therapy, the prognosis for NSCLC patients remains very poor, mainly due to the development of drug resistance and metastasis. The disruption of CCL2/CCR2 chemokine signaling has been shown to suppress cancer cell growth, migration and metastasis. CCL2 neutralizing antibodies, which have shown promising therapeutic efficacy in several cancer models, nevertheless, are not widely in use due to technical issues. CCR2 antagonism hence becomes an alternative way for cancer treatment. However, the efficacy of CCR2 antagonists on NSCLC progression remains poorly understood. Methods: The expression levels of CCL2 and CCR2 were examined using RT-PCR and Western Blotting among five NSCLC cell lines including A549, NCI-H460, RERF-LC-A1, LC99A and LC11-18. The effects of CCR2 antagonist, CAS 445479-97-0, on cell growth, migration and invasion were evaluated using WST-1 cell viability assay, transwell migration assay and Matrigel invasion assay respectively. A mouse metastatic model was deployed to compare the metastatic capacity of A549 cells between CAS 445479-97-0 treated and untreated groups. Results: We found A549 cell line had the highest levels of CCL2 secretion and CCR2 expression among all examined cell lines. CCL2 treatment promoted cell migration and invasion activity by 2.35-fold and 4.20-fold respectively in A549 cells, and this induction was significantly suppressed by CAS 445479-97-0 treatment. Interestingly, in cells with undetectable CCR2 expression, there is no difference in migration and invasion activity between experimental groups. Moreover, CCR2 antagonist completely reversed CCL2-induced A549 cell proliferation. Of great importance is that CCR2 antagonist suppressed the metastatic capacity by 35.42% in a mouse metastasis model. Conclusions: We demonstrated that CCR2 expression is a key factor in CCL2-mediated cell growth, migration and invasion, and that CAS 445479-97-0 effectively suppresses metastasis. Our data suggest that CCR2 antagonists are potential drugs for the treatment of CCR2-positive metastatic NSCLC patients.
PTEN loss as predictor of tumour heterogeneity (TH) and poor prognosis in EGFR-mutant advanced non-small cell lung cancer (ANSCLC) patients (pts) receiving tyrosine-kinase inhibitors (TKIs)
Authors: M.G. Ferrara, E. Vita, E. D’Argento, M. Martini, V P Di Noia, I. Sperduti, M. Bilotta, A. Virtuoso, M. Ribelli, P. Damiano, M.A. Cannella, S. Pilotto, M. Milella, G. Tortora, E. Bria
Journal: Annals of Oncology (2019)
A phase Ia/Ib trial of the anti-programmed death-ligand 1 (PD-L1) human monoclonal antibody (mAb), CS1001, in patients (pts) with advanced solid tumours or lymphomas
Authors: L. Shen, J. Li, N. Xu, B. Xing, Q. Zhang, Y. Zhao, J. Cao, J. Ding, J. Wang, Y. Wang, H. Dai
Journal: Annals of Oncology (2019)
Artificial intelligence combining radiomics and clinical data for predicting response to immunotherapy
Authors: M. Ligero, A. Garcia-Ruiz, C. Viaplana, M.V. Raciti, I. Matos, J Martín Liberal, C. Hierro, M. Gonzalez, R Morales Barrera, C. Suárez, E. Elez, I. Brana, E. Muñoz-Couselo, A. Oaknin, E. Felip, J. Tabernero, J. Carles, R. Dienstmann, E. Garralda, R Perez Lopez
Journal: Annals of Oncology (2019)
Unsorted single-cell RNA sequencing profiles of metastatic melanoma patients reveal the heterogeneity of melanoma-associated fibroblasts
Authors: K. Homicsko, D. Barras, V Aedo Lopez, B Gautron Moura, G. Berthod, M. Matter, O. Gaide, G. Coukos, D. Hanahan, O.A. Michielin
Journal: Annals of Oncology (2019)
Abstract 1846: Catalytic topoisomerase II inhibitors suppress the androgen receptor signaling and prostate cancer progression
Authors: Haolong Li, Ning Xie, Martin Gleave, Xuesen Dong
Journal: Cancer Research (2015)

Abstract Background: Although the new generation of anti-androgens (e.g. MDV) improves survival of metastatic prostate cancer patients, tumors eventually recur indicating that additional therapeutic means is required to fully block the functions of the androgen receptor (AR). Since DNA topoisomerase II (Topo II) was demonstrated to be essential for AR to initiate gene transcription, this study tested whether catalytic inhibitors of Topo II can suppress the AR signaling and block prostate tumor growth. Methods and Results: Androgen-dependent and MDV-resistant prostate cancer cells were treated with increasing doses of catalytic Topo II inhibitors, ICRF187 and ICRF193. Luciferase reporter assays showed that both inhibitors suppressed the transcriptional activities of wild-type AR, mutant AR (F876L and W741C), and AR-V7 splice variant. ICRF187 and ICRF193 decreased AR recruitment to its target promoters and reduced AR nuclear localization. Both ICRF187 and ICRF193 inhibited androgen-dependent and MDV-resistant cancer cell proliferation and delayed cell cycling at the G2/M stages. In castration-resistant LNCaP tumors, ICRF187 inhibited tumor growth, PSA secretion and expressions of several other AR regulated genes. These repressive effects became stronger when tumors were co-treated with MDV. Additionally, ICRF187 effectively inhibited tumor growth of MDV-resistant MR49F as well as castration-resistant 22RV1 xenografts. Conclusions: Catalytic Topo II inhibitors can block the AR signaling and inhibit tumor growth of castration-resistant xenografts, suggesting their potential applications in treating castration-resistant cancers in patients. Citation Format: Haolong Li, Ning Xie, Martin Gleave, Xuesen Dong. Catalytic topoisomerase II inhibitors suppress the androgen receptor signaling and prostate cancer progression. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 1846. doi:10.1158/1538-7445.AM2015-1846
Ligelizumab for Chronic Spontaneous Urticaria
Authors: Marcus Maurer, Ana M. Giménez-Arnau, Gordon Sussman, Martin Metz, Diane R. Baker, Andrea Bauer, Jonathan A. Bernstein, Randolf Brehler, Chia-Yu Chu, Wen-Hung Chung, Inna Danilycheva, Clive Grattan, Jacques Hébert, Constance Katelaris, Michael Makris, Raisa Meshkova, Sinisa Savic, Rodney Sinclair, Karl Sitz, Petra Staubach, Bettina Wedi, Jürgen Löffler, Avantika Barve, Kenneth Kobayashi, Eva Hua, Thomas Severin, Reinhold Janocha
Journal: New England Journal of Medicine (2019)

In the majority of patients with chronic spontaneous urticaria, most currently available therapies do not result in complete symptom control. Ligelizumab is a next-generation high-affinity humanized monoclonal anti-IgE antibody. Data are limited regarding the dose-response relationship of ligelizumab and the efficacy and safety of ligelizumab as compared with omalizumab and placebo in patients who have moderate-to-severe chronic spontaneous urticaria that is inadequately controlled with H1-antihistamines at approved or increased doses, alone or in combination with H2-antihistamines or leukotriene-receptor antagonists.In a phase 2b dose-finding trial, we randomly assigned patients to receive ligelizumab at a dose of 24 mg, 72 mg, or 240 mg, omalizumab at a dose of 300 mg, or placebo, administered subcutaneously every 4 weeks for a period of 20 weeks, or a single 120-mg dose of ligelizumab. Disease symptoms of hives, itch, and angioedema were monitored by means of weekly activity scores. The main objective was to determine a dose-response relationship for the complete control of hives (indicated by a weekly hives-severity score of 0, on a scale from 0 to 21, with higher scores indicating greater severity); the primary end point of this response was assessed at week 12. Complete symptom control was indicated by a weekly urticaria activity score of 0 (on a scale from 0 to 42, with higher scores indicating greater severity). Safety was analyzed throughout the trial.A total of 382 patients underwent randomization. At week 12, a total of 30%, 51%, and 42% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of hives, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. A dose-response relationship was established. At week 12, a total of 30%, 44%, and 40% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of symptoms, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. In this small and short trial, no safety concerns regarding ligelizumab or omalizumab emerged.A higher percentage of patients had complete control of symptoms of chronic spontaneous urticaria with ligelizumab therapy of 72 mg or 240 mg than with omalizumab or placebo. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT02477332.).
Phase 1 Dose-Escalation Study of Multiple Dosing Schedules of the Investigational Drug MLN4924, a Nedd8-Activating Enzyme Inhibitor, In Patients with Relapsed and/or Refractory Multiple Myeloma or Lymphoma.
Authors: Jatin J Shah, R. Donald Harvey, Owen A O'Connor, Andrzej J Jakubowiak, Mitchell R Smith, Robert Z. Orlowski, George J Mulligan, Peter G Smith, Michael D Pickard, Bruce J. Dezube, Sagar Lonial
Journal: Blood (2010)