All times are listed in CEST (Central European Summer Time)

Found 1 Presentation For Request "458P"

Poster Display session

458P - Phase (Ph) I/Ib trial of fruquintinib (fru) in patients (pts) with advanced solid tumors: Preliminary results of the dose expansion (exp) cohort in refractory metastatic colorectal cancer (mCRC)

Presentation Number
458P
Speakers
  • N. Arvind Dasari (Houston, TX, United States of America)
Date
17.09.2020

Abstract

Background

Fru is a highly selective, novel vascular endothelial growth factor receptor (VEGFR) -1, -2, and -3 tyrosine kinase inhibitor (TKI). In the ph 3 FRESCO study (NCT02314819) that led to its approval in China, Fru 5mg daily, 3 weeks (wks) on 1 wk off, improved the median overall survival in pts with mCRC in third line and beyond when compared to placebo (9.3 v 6.6 months); hazard ratio 0.65 (P < 0.001).

Methods

This is an ongoing ph 1/1b open-label, dose escalation (esc)/exp study conducted in the US. The dose esc was previously reported with confirmation of the approved dose/schedule in China. Here we present the preliminary safety and efficacy data from pts with refractory mCRC (exp) who progressed on all standard therapies including TAS-102 and/or regorafenib (rego).

Results

To date, 24 pts have been treated; age <65 years (62.5%), Caucasian (75%), female (54.2%), and ECOG PS 1 (62.5%). Median number of prior therapies was 4 (range: 1-7), and 7 pts (29.2%) received rego, 11 (45.8%) received TAS-102 and 6 (25.0%) received both rego and TAS-102. 16 pts remain on treatment. The median duration of Fru treatment was 2.8 months (range: 0.7– 10.4). The most frequently reported treatment-related (TR) treatment emergent adverse events (TEAEs) of any grade (Gr)(≥20% of pts) were hypertension (37.5%), proteinuria (29.2%), fatigue (29.2%), hand-foot syndrome (HFS)(29.2%), diarrhea (25.0%), headache (20.8%), stomatitis (20.8%), and elevated alk phos (20.8%). 8 (33.3%) pts reported Gr ≥3 TR TEAEs. Those that occurred in ≥5% of pts were hypertension (25%), proteinuria (8.3%) and fatigue (8.3%). No Gr ≥3 HFS was seen. Preliminary efficacy in pts who had a post-baseline scan and at least 3 months of follow up or discontinued treatment early (n=14) showed stable disease in 11 pts, with a disease control rate of 78.6%.

Conclusions

Fru is generally well-tolerated in heavily pretreated pts with refractory mCRC, with less HFS compared to other VEGFR TKIs. Evidence of anticancer activity was also observed in these pts. The multi-cohort dose exp is ongoing. Fru is being further investigated in refractory mCRC in a global Ph 3 study (NCT04322539).

Clinical trial identification

NCT03251378 (first posted 16 Aug 2017).

Editorial acknowledgement

Sarah Milner, PhD (Synchrogenix) provided editorial assistance.

Legal entity responsible for the study

Hutchison MediPharma Limited.

Funding

Hutchison MediPharma Limited.

Disclosure

N.A. Dasari: Advisory/Consultancy, Research grant/Funding (institution): Hutchison MediPharma Ltd. A. Wang-Gillam: Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Esai; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Bristol Myer Squibb; Honoraria (self), Advisory/Consultancy: Tyme; Honoraria (self), Advisory/Consultancy: Merrimack; Honoraria (self), Advisory/Consultancy: Jacobio; Research grant/Funding (institution): Barns Jewish Foundation; Research grant/Funding (institution): Pancreatic Cancer Action Network. J.M. Hubbard: Research grant/Funding (institution): Merck; Research grant/Funding (institution): Boston Biomedical; Research grant/Funding (institution): Treos Bio; Research grant/Funding (institution): Taiho; Research grant/Funding (institution): Senhwa Pharmaceuticals; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): TriOncology; Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution): Hutchison MediPharma. A. Fernandez: Full/Part-time employment: Hutchison MediPharma International, Inc; Shareholder/Stockholder/Stock options: Hutchison China Meditech Ltd. S. Nanda: Full/Part-time employment: Hutchison MediPharma International, Inc; Shareholder/Stockholder/Stock options: Hutchison China Meditech Ltd. M. Kania: Full/Part-time employment: Hutchison MediPharma International, Inc; Shareholder/Stockholder/Stock options: Hutchison China Meditech Ltd. W.R. Schelman: Full/Part-time employment: Hutchison MediPharma International, Inc; Shareholder/Stockholder/Stock options: Hutchison China Meditech Ltd. T.S. Bekaii-Saab: Research grant/Funding (institution): Boston Biomedical; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution): Merck; Research grant/Funding (institution): Celgene; Advisory/Consultancy, Research grant/Funding (institution), IDMC/DSMB: Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Clovis; Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy, Research grant/Funding (institution): Array Biopharma; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Abgenomics; Advisory/Consultancy, Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Bristol Myers Squibb; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Treosbio; Advisory/Consultancy: Sobi; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, IDMC/DSMB: Exelixis; Advisory/Consultancy, IDMC/DSMB: PanCan; Advisory/Consultancy, IDMC/DSMB: 1Globe; Advisory/Consultancy: Imugene; Advisory/Consultancy: Immuneering; Advisory/Consultancy: Sun Biopharma.

Collapse