Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

E-Poster Display

433P - A phase Ib/II clinical trial of tolerability, safety and efficacy of regorafenib in combination with toripalimab (a PD-1 antibody) in patients with relapsed or metastatic colorectal cancer

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Colon and Rectal Cancer

Presenters

Feng Wang

Citation

Annals of Oncology (2020) 31 (suppl_4): S409-S461. 10.1016/annonc/annonc270

Authors

F. Wang1, M. He2, Y. Yao2, Z. Wang1, Y. Jin1, F. Wang1, M. Qiu1, Z. Lv1, D. Wang1, H. Luo1, Y. Li1, D. Zhang1, R. Xu1

Author affiliations

  • 1 Department Of Medical Oncology, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2 Department Of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou/CN

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 433P

Background

This is a two-part, dose escalation and dose expansion phase Ib/II study evaluating the safety, tolerability, and preliminary efficacy of regorafenib plus toripalimab, a PD-1 mAb for patients with pMMR/MSS metastatic colorectal cancer (mCRC) who had failed ≥ 2 previous lines of chemotherapy or were intolerant to prior systemic chemotherapy.

Methods

During dose escalation, the planned dosing cohorts were 80mg, 120mg, or 160mg regorafenib [po, qd (D1-D21), q4w] plus toripalimab (3 mg/kg, iv, d1 and d15, q4w), using a mTPI design with target toxicity probability of 30%. The primary objective during dose escalation phase was MTD. During dose-expansion phase, the primary endpoint was ORR, and secondary endpoints included safety, DCR, PFS, and OS.

Results

Twelve mCRC patients were enrolled during dose escalation. Three DLTs (2 grade 3 hand-food syndrome (HFS), and 1 grade 3 transaminase elevation) occurred in 3 (100%) patients in the 120 mg regorafenib cohort. One DLT (grade 3 HFS) occurred in 9 (11.1%) patients in the 80mg regorafenib cohort. 80mg regorafenib plus 3mg/kg toripalimab was determined to be the recommended dose for the dose expansion cohort of 30 patients. As of May 12th, 2020, the ORR was 13.9% (5/36), and the DCR was 36.1% (13/36). The median PFS was 3.0 months and median OS was not reached. 95.2% patients had at least 1 TRAE and 42.9% patients had at least 1 grade 3 TRAE. The most common grade 3 TRAEs included HFS (14.3%) and impaired liver function (7.1%). No grade 4 or 5 TRAEs occurred.

Conclusions

The combination of 80mg regorafenib plus 3mg/kg toripalimab was determined to be the MTD for this study. A subset of unselected pMMR/MSS mCRC patients may benefit from this treatment. An ongoing exploratory analysis aims to provide additional insights.

Clinical trial identification

NCT03946917.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Shanghai Junshi Bioscience Co.

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.