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Proffered Paper - Developmental therapeutics

527O - CC-90010, a reversible, oral bromodomain and extra-terminal (BET) inhibitor in patients (Pts) with advanced solid tumours (STs) and relapsed/refractory (R/R) non-Hodgkin lymphoma: Updated results of a phase I study


20 Sep 2020


Proffered Paper - Developmental therapeutics


Clinical Research

Tumour Site



Victor Moreno Garcia


Annals of Oncology (2020) 31 (suppl_4): S462-S504. 10.1016/annonc/annonc271


V. Moreno Garcia1, I. Braña2, J.M. Sepulveda Sanchez3, M. Vieito2, T. Hernández-Guerrero1, B. Doger1, O. Saavedra2, C. Carlo-Stella4, J. Michot5, A. Italiano6, G. Musuraca7, R. Sarmiento8, B. Amoroso8, S. Mora8, T. Sánchez-Pérez8, I. Aronchik9, E. Filvaroff9, B. Hanna9, Z. Nikolova8, A. Pinto10

Author affiliations

  • 1 Start Madrid-fjd, Hospital Universitario Fundación Jimenez Diaz, 28040 - Madrid/ES
  • 2 Vall D'hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), 8035 - Barcelona/ES
  • 3 Neuro-oncology Multidisciplinary Unit, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 4 Humanitas Cancer Center, Humanitas Clinical and Research Center, 20089 - Milan/IT
  • 5 Department Of Hematology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 6 Early Phase Trials Unit, Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, 33076 - Bordeaux/FR
  • 7 Hematology Unit, Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (IRST), 47014 - Meldola/IT
  • 8 Early Clinical Development, Celgene Institute for Translational Research Europe, A Bristol Myers Squibb Company, 41092 - Sevilla/ES
  • 9 Epigenetics, Bristol Myers Squibb, 08648 - Princeton/US
  • 10 Istituto Nazionale Tumori Ircss Fondazione Pascale, IRCCS, 80131 - Naples/IT


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Abstract 527O


BET proteins are epigenetic readers implicated in cancer pathogenesis. CC-90010 is a potent BET inhibitor that showed promising clinical activity in pts with advanced malignancies.


CC-90010-ST-001 is a phase I dose-escalation (part A) and -expansion (part B) study of CC-90010 in pts with advanced STs and R/R diffuse large B-cell lymphoma (DLBCL). Eleven dose levels (DLs) and 4 dosing schedules (2 weekly [2 d on/5 d off; 3 d on/4 d off], 1 biweekly [3 d on/11 d off], and 1 monthly [4 d on/24 d off]) were evaluated. Primary objectives were to determine safety, maximum tolerated dose (MTD), and recommended phase II dose (RP2D). Secondary and exploratory objectives were to assess antitumor activity, pharmacokinetics, and pharmacodynamics (PD).


As of 7 Feb 2020, 84 pts were enrolled. In part A, 67 pts had advanced STs and 2 had R/R DLBCL. In part B, 13 pts had R/R DLBCL (1 pt was not treated until after the data cutoff), and 2 had advanced STs. MTDs were identified for 3 of the 4 dosing schedules. The RP2Ds were 30 mg 3 d on/11 d off and 45 mg 4 d on/24 d off. Six pts from part A had dose-limiting toxicities, in all dosing schedules. The most common grade 3/4 treatment-related adverse event (TRAE) was thrombocytopenia (part A=16%, part B=64%). Eight pts (12%) in part A and 4 pts (29%) in part B had serious TRAEs. In part A, 1 pt with progressive grade 2 astrocytoma had a complete response (CR; ongoing in cycle 19), and 1 pt with advanced endometrial carcinoma had a partial response (PR); 10 pts had stable disease (SD) ≥4 cycles, 3 had prolonged SD (19, 20, and 24 mo). In part B, 2 pts with R/R DLBCL had responses (CR and PR). Plasma exposures increased in an ∼ dose-proportional manner across DLs. The terminal half-life (t1/2) of CC-90010 was ∼60 h. CC-90010 induced ≥50% decrease of the PD biomarker CCR1 at doses ≥25 mg 4 h post last dose.


CC-90010 was well tolerated and showed antitumor activity in heavily pretreated pts with advanced malignancies. The long t1/2 and favorable PD profile improved tolerability and enabled less frequent dosing. These results support further evaluation of CC-90010 in STs and R/R DLBCL.

Clinical trial identification

Study ID: CC-90010-ST-001 NCT03220347; 2015-004371-79 (EudraCT Number).

Editorial acknowledgement

Tisheeka Graham-Steed, PhD BioConnections, LLC.

Legal entity responsible for the study

Celgene Corporation.


Celgene Corporation.


V. Moreno: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Bayer; Advisory/Consultancy: Pieris; Advisory/Consultancy: Janssen. I. Braña: Research grant/Funding (self): Celgene, A Bristol-Myers Squibb Company. J.M. Sepulveda Sanchez: Advisory/Consultancy, Research grant/Funding (self): Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: AbbVie; Advisory/Consultancy: Celgene, A Bristol-Myers Squibb Company; Advisory/Consultancy: GW Pharma; Speaker Bureau/Expert testimony: Astellas; Travel/Accommodation/Expenses: Ipsen. M. Vieito: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Debio; Advisory/Consultancy: TFS; Travel/Accommodation/Expenses: Merck-Serono. O. Saavedra: Travel/Accommodation/Expenses: MSD; Travel/Accommodation/Expenses: Kyowakirin. C. Carlo-Stella: Honoraria (self): Bristol Myers Squibb; Honoraria (self), Speaker Bureau/Expert testimony: MSD; Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): ADCT; Honoraria (self), Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy: Sanofi; Research grant/Funding (self): Novartis; Speaker Bureau/Expert testimony: AstraZeneca; Travel/Accommodation/Expenses: Takeda. J-M. Michot: Honoraria (self): Celgene, A Bristol-Myers Squibb Company; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): AstraZeneca; Honoraria (self): Janssen. A. Italiano: Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy: Springworks; Advisory/Consultancy: Epizyme; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Merck; Research grant/Funding (self): MSD; Research grant/Funding (self): Pharmamar. G. Musuraca: Advisory/Consultancy: Servier. R. Sarmiento: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Celgene, A Bristol-Myers Squibb Company. B. Amoroso: Advisory/Consultancy, Shareholder/Stockholder/Stock options, Full/Part-time employment: Celgene, A Bristol-Myers Squibb Company; Advisory/Consultancy: NordicNanovector; Advisory/Consultancy: ArgenX. T. Sánchez-Pérez: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Celgene, A Bristol-Myers Squibb Company. I. Aronchik: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. E. Filvaroff: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment: Bristol-Myers Squibb; Shareholder/Stockholder/Stock options: Amgen; Shareholder/Stockholder/Stock options: Gilead; Shareholder/Stockholder/Stock options: Genentech/Roche. B. Hanna: Research grant/Funding (self), Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. Z. Nikolova: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Celgene, A Bristol-Myers Squibb Company. A. Pinto: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self): Celgene, A Bristol Myers Squibb Company; Honoraria (self): Servier; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MSD; Advisory/Consultancy: Novartis; Travel/Accommodation/Expenses: Takeda. All other authors have declared no conflicts of interest.

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