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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

2590 - Phase 1/2 study of ODM-203, a selective dual FGFR/VEGFR inhibitor, in patients with advanced solid tumours

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Clinical Research

Tumour Site

Presenters

Petri Bono

Citation

Annals of Oncology (2018) 29 (suppl_8): viii133-viii148. 10.1093/annonc/mdy279

Authors

P. Bono1, C. Massard2, K. Peltola3, A. Azaro4, A. Italiano5, R. Kristeleit6, U.N. Lassen7, H. Arkenau8, P. Hakulinen9, C. Garratt9, T. Ikonen10, M. Mustonen10, J. Rodon11

Author affiliations

  • 1 Comprehensive Cancer Center  , Helsinki University Central Hospital, 00029 - Helsinki/FI
  • 2 Ditep, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR
  • 3 Trial Unit, Helsinki University Central Hospital, 00029 - Helsinki/FI
  • 4 Molecular Therapeutics Research Unit. Department Of Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 5 Early Phase Trials Unit, Institute Bergonié, 33076 - Bordeaux/FR
  • 6 Academic Department Of Oncology, University College London UCL Cancer Institute, WC1E 6DD - London/GB
  • 7 Dept. Of Oncology, Phase 1 Unit, Copenhagen University Hospital - Rigshospitalet, 2100 - Copenhagen/DK
  • 8 Scri, Sarah Cannon Research Institute SCRI UK, W1G 6AD - London/GB
  • 9 Orion Corporation, Orion Pharma, 02100 - Espoo/FI
  • 10 Orion Corporation, Orion Pharma, 02200 - Espoo/FI
  • 11 Early Drug Development, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
More

Resources

Abstract 2590

Background

ODM-203 is an orally available small molecule with balanced inhibitory effects on FGFR 1-4 and VEGFR 1-3 subtypes. We present here results of the phase 1/2 KIDES study.

Methods

The KIDES study is an open-label, non-randomized, multicentre phase 1/2 first-in-man study of ODM-203 in patients with advanced solid tumors. In the Part 1 dose escalation (3 + 3), ODM-203 was evaluated in 31 patients between 50-800mg daily with food to identify the maximum tolerated dose (MTD). Part 2 expansion included 53 patients to evaluate a new formulation, the recommended phase 2 dose and the dose schedule. Patients continued ODM-203 treatment until disease progression or dose limiting toxicity.

Results

84 patients (median 57 years, range 28-80), with the most common tumor types being cholangio, breast, colorectal, endometrium, ovarian and thyroid carcinoma, were included, with most patients in Part 2 having FGFR alterations. Six patients remain on treatment. In the dose-escalation Part 1, 800mg/day was considered the highest dose that could not be tolerated although MTD was not formally identified. This was because of a general adverse event (AE) burden and increased bilirubin in most patients. Bilirubin increase was due to UGT1A1 inhibition by ODM-203 and resolved in all cases upon dose reduction/interruption. In Part 2, the optimal dose was determined to be 400mg/day with food. Most AE’s were grade 1-2, the most common ones being increased bilirubin (76%), fatigue and asthenia (68%), diarrhoea (60%), stomatitis (41%), arthralgia (41%) and decreased apetite (41%). Most common grade >3 AE’s were bilirubin increase (45%), fatigue (6%) and diarrhoea (6%). There were 6 (9%) partial responses (PR) and additionally 24 (35%) patients achieved target lesion reduction. In total, 30 (44%) patients had disease stabilisation (SD) with median of 21 weeks on the study. The clinical benefit rate (CR + PR + SD) was 36/69 (52%).

Conclusions

Patients treated with ODM-203, especially those with FGFR-aberrant or VEGFR sensitive tumours, had preliminary promising anti-tumour response and on-target effects.

Clinical trial identification

NCT02264418.

Legal entity responsible for the study

Orion Corporation Orion Pharma.

Funding

Orion Corporation Orion Pharma.

Editorial Acknowledgement

Disclosure

P. Bono: Honoraria: Orion Pharma during the conduct of the study; Honoraria from Pfizer, MSD, BMS, Novartis, Oncorena and Ipsen outside the submitted work. K. Peltola: Personal fees: Orion Pharma, BMS, Pfizer, Roche, MSD, Ipsen, outside the submitted work; Stock holder: Faron Pharmaceuticals. P. Hakulinen, C. Garratt, T. Ikonen, M. Mustonen: Employee: Orion Corporation Orion Pharma. All other authors have declared no conflicts of interest.

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