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Circulating tumor cell number predicts time to progression (TTP) in patients with heavily pretreated gynecological cancers treated with selinexor (SEL)

Date

08 Oct 2016

Session

Poster Display

Presenters

Marsha Crochiere

Citation

Annals of Oncology (2016) 27 (6): 296-312. 10.1093/annonc/mdw374

Authors

M. Crochiere1, I.B. Vergote2, B. Lund3, H. Havsteen4, Z. Ujmajuridze5, E. Van Nieuwenhuysen6, C. Haslund3, T. Juhler-Nøttrup5, M. Mau-Sørensen7, P. Berteloot6, A. Kranich8, J. Meade9, G. Wright9, E. Shacham1, T. Rashal9, J. Saint-Martin1, S. Shacham9, M. Kauffman9, M. Raza Mirza9, Y. Landesman9

Author affiliations

  • 1 Karyopharm, Karyopharm Therapeutics, 02459 - Newton/US
  • 2 Obstetrics & Gynaecology, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 3 Oncology, Aalborg University Hospital, Aalborg/DK
  • 4 Oncology, University Hospital Herlev, Herlev/DK
  • 5 Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK
  • 6 Obstetrics & Gynecology, Katholieke Universiteit, 3000 - Leuven/BE
  • 7 Department Of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK
  • 8 Gso, GSO, Hamburg/DE
  • 9 Karyopharm, Karyopharm Therapeutics, Newton/US
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Resources

Background

SEL, an oral, first-in-class selective inhibitor of XPO1-mediated nuclear export (SINE), induces nuclear retention and activation of tumour suppressor proteins including p53, BRCA1/2, CDKN2A and pRB. SEL has anti-cancer activity in preclinical models of cervical cancer (CC) & ovarian cancer (OC) and in a phase I clinical study. In an effort to identify markers predictive of disease control with SEL, circulating tumour cells (CTCs) were enumerated during the phase 2 trial from patients (pts) with heavily pretreated OC, CC & endometrial cancer (EC). NCT02025985.

Methods

Patients with ≥ 2 lines of prior therapy, ECOG PS 0-1, were treated with single agent SEL. At predose C1D1, 7.5 mL of blood was collected in CellSave tubes and CTCs were identified using the Janssen Diagnostics CellSearch System. Intact cells that measured at least 4 microns in size and stained positive for DAPI, EpCAM, and cytokeratin while negative for CD45 were counted as CTCs.

Results

CTC were enumerated at predose C1D1 in 47 (33 OC, 8 EC, 6 CC) of 114 patients. To date, 31 pts had 2 CTCs with a median days on study of 56 days (p = 0.01). Ten patients with

Conclusions

Detection of CTC in the peripheral blood of cancer patients has proven feasible and of prognostic value in different neoplasms, including in patients with OC. These results suggest that low CTC count (

Clinical trial identification

NCT02025985

Legal entity responsible for the study

Sharon Shacham

Funding

Karyopharm Therapeutics, Inc.

Disclosure

M. Crochiere: I am a current employee of Karyopharm Therapeutics and own stock. I.B. Vergote: PI on a Karyopharm Clinical Study. B. Lund, H. Havsteen, Z. Ujmajuridze, C. Haslund, T. Juhler-Nøttrup, M. Mau-Sørensen, P. Berteloot: PI on a Karyopharm clinical study. E. Van Nieuwenhuysen: PI on a Karyopham clinical study. A. Kranich: Director of the CRO managing Karyopharm clinical study. J. Meade, G. Wright, E. Shacham, J-R. Saint-Martin: Current Karyopharm employee and stock holder. T. Rashal: Former Karyopharm employee and stock holder. S. Shacham, M. Kauffman: Owner of Karyopharm and stock holder. M. Raza Mirza: Karyopharm board member and stock holder. Y. Landesman: Current employee of Karyopharm and stock holder.

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