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Mini Oral session

8MO - CC-90010, a reversible, potent oral bromodomain and extraterminal inhibitor (BETi) in patients (pts) with advanced solid tumours (aSTs) and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Longer follow-up from parts A & B and first reporting of part C of a phase I study

Date

02 Mar 2021

Session

Mini Oral session

Presenters

Victor Moreno

Citation

Annals of Oncology (2021) 32 (suppl_1): S4-S8. 10.1016/annonc/annonc457

Authors

V. Moreno1, M. Vieito Villar2, J.M. Sepulveda Sanchez3, V. Galvao2, T. Hernández Guerrero1, B. Doger1, O. Saavedra4, C. Carlo Stella5, J. Michot6, A. Italiano7, M. Magagnoli5, C. Carpio4, R. Sarmiento8, B. Amoroso8, I. Aronchik9, E. Filvaroff9, B. Hanna9, A. Pinto10, Z. Nikolova11, I. Braña2

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), Vall d’Hebron University Hospital (HUVH), 08035 - Barcelona/ES
  • 3 Neuro-oncology Multidisciplinary Unit, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 4 Vall D’hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital (HUVH), Barcelona/ES
  • 5 Humanitas Cancer Center, Humanitas Clinical and Research Center, Milan/IT
  • 6 Institut Gustave Roussy, Department of Hematology, 94800 - Villejuif/FR
  • 7 Early Phase Trials Unit, Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, 33076 - Bordeaux/FR
  • 8 Centre For Innovation And Translational Research Europe, A Bristol Myers Squibb Company, 41092 - Seville/ES
  • 9 Epigenetics, Bristol Myers Squibb, Princeton/US
  • 10 Istituto Nazionale Tumori Ircss Fondazione Pascale, IRCCS, Naples/IT
  • 11 Centre For Innovation And Translational Research Europe, A Bristol Myers Squibb Company, 2017 - Seville/ES
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Resources

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Abstract 8MO

Background

CC-90010, a potent oral BETi, was well-tolerated with promising activity in pts with advanced malignancies. We present longer follow-up results of parts A (A) and B (B) from CC-90010-ST-001 and, for the first time, results from part C (C) describing food effect on CC-90010 pharmacokinetics (PK).

Methods

CC-90010-ST-001 is a phase I dose-escalation (A) and -expansion (B) study of CC-90010 in pts with aSTs and R/R DLBCL also evaluating high-calorie/-fat meal effects on CC-90010 PK in pts with aSTs (C); 11 dose levels (DLs) and 4 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 tested. Primary objectives were safety, tolerability, maximum tolerated dose and recommended phase II dose (RP2D). Secondary and exploratory objectives were antitumor activity, PK, pharmacodynamics and food effect.

Results

As of 3 Nov 2020, 133 pts were enrolled. In A and B, 67 and 2 pts had aSTs; 2 and 21 pts had R/R DLBCL. In C, 41 pts had aSTs. In A, 6 pts (11%) had dose-limiting toxicities across dosing schedules. The most common grade 3/4 treatment-related adverse event (TRAE) was thrombocytopenia (A, 16%; B, 76%; C, 10%); 8 pts (12%) in A, 6 (29%) in B, and 2 (5%) in C had serious TRAEs. In A, 1 pt (progressing grade 2 astrocytoma) had a complete response (CR) before progression (19 cycles); 1 pt (endometrial carcinoma) had a partial response (PR; 8 cycles). In B, 2 pts with R/R DLBCL responded (CR, PR). In C, 2 pts (parotid basal cell adenocarcinoma, nasopharyngeal cancer) had durable PRs, and 23 had stable disease (≥4 mo in 9 pts); 1 pt (relapsing glioblastoma) had a minor response. Plasma exposures rose dose-proportionally across DLs. CC-90010 terminal half-life was ∼60 h and PK was similar under fasted vs fed conditions in C. CC-90010 ≥25 mg caused ≥50% decrease in CCR1 mRNA (BETi blood biomarker) 4 h after last dose. CCR1 modulation was similar in A and B after first and last dose at the RP2D.

Conclusions

Overall, CC-90010 was very well tolerated with promising antitumor activity and PK not impacted by food intake, supporting exploration in combination therapy.

Clinical trial identification

NCT03220347; EUDRACT 2015-004371-79.

Editorial acknowledgement

Writing and editorial assistance were provided by Brittany L. Phillips, PhD, of Bio Connections LLC, funded by Bristol Myers Squibb Company.

Legal entity responsible for the study

Celgene, a Bristol-Myers Squibb Company.

Funding

Celgene, a Bristol-Myers Squibb Company.

Disclosure

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

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