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

Poster Display session 1

4114 - A Phase I Open-Label, Non-Randomized Study of Recombinant Super-Compound Interferon (rSIFN-co) In Patients with Advanced Solid Tumors

Date

28 Sep 2019

Session

Poster Display session 1

Presenters

Amanda Seet

Citation

Annals of Oncology (2019) 30 (suppl_5): v159-v193. 10.1093/annonc/mdz244

Authors

A. Seet1, M.C.F. Macapagal2, A. Ahmad1, G. Li1, M.L. Goh3, M.C.H. Ng4, T. Tan5, D.S.W. Tan6, S.P. Choo4, W.T.D. Lim1, D.W.M. Tai4

Author affiliations

  • 1 Division Of Medical Oncology, NCCS - National Cancer Centre Singapore, 169610 - Singapore/SG
  • 2 Cte, NCCS - National Cancer Centre Singapore, 169610 - Singapore/SG
  • 3 Cte, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 4 Division Of Medical Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 5 Medical Oncology, NCCS - National Cancer Centre Singapore, 169610 - Singapore/SG
  • 6 Division Of Medical Oncology, National Cancer Center Singapore, 169610 - Singapore/SG
More

Resources

Abstract 4114

Background

Recombinant super-compound interferon (rSIFN-co) is a new class of interferon derived from altering the spatial structure and configuration of the basic interferon protein. rSIFN-co displayed greater anti-tumor activity in solid tumors compared to interferon α-2b in pre-clinical studies.

Methods

Patients with advanced malignancies were enrolled to determine the safety, tolerability, recommended phase II dose (RP2D), pharmacodynamics (PD) and preliminary anti-tumor activities in a 3 + 3 dose escalation design. rSIFN-co was dosed 3 times a week via subcutaneous injection for 21 days followed by 7 days rest. This was preceded by a lead in phase. PD studies comprised of FDG-PET, pre and post treatment changes in plasma cytokine profile and tumor repressive/ enhancing genes as well as 2’5’-oligoadenylate synthetase levels.

Results

39 treatment refractory patients (pts) were enrolled, 18 (46%) colorectal cancer (CRC), 11 (28%) hepatocellular carcinoma (HCC), 6 (15%) non-small cell lung cancer (NSCLC), 2 (5%) melanoma, 1 (3%) renal cell carcinoma (RCC) and 1 (3%) nasopharyngeal carcinoma (NPC). Gender M/F 25/14, median age 61.0 yrs, and ECOG 0/1/2 - 18/20/1. Patients were dosed at 4 dose levels. No dose limiting toxicities were encountered even at DL4 - 30μg (1.6 × 107IU) 3x/week for 21 days followed by 7 days rest. Most common drug related adverse event (drAE) includes pyrexia (92%), chills (54%), fatigue and anorexia (each 41%) and nausea (26%). Grade 3 drAEs include fatigue (8%), WBC decrease (8%), neutropenia (5%), anorexia and pyrexia and weight loss (3%). No grade 4/5 AE were reported. 2 (5.1%) had PR (2 HCC) maintained at 15.9 and 5.9 mths, 19 (48.7%) had disease control (DCR = PR+SD) of which in 6 (31.5%) DCR was >4 mths (3 HCC, 1 NSCLC and 2 CRC), and median PFS was 2.2 mths. Detailed PD data will be presented for all cohorts.

Conclusions

The RP2D of rSIFN-co was 30ug (1.6 × 107IU) 3x/week for 21days followed by 7 days’ rest. Anti-tumour activity seen in heavily pre-treated advanced solid tumor patients. especially in HCC. Future plans involve combinations with other immunotherapies.

Clinical trial identification

NCT02387307.

Editorial acknowledgement

Legal entity responsible for the study

Sichuan Huiyang Life Science and Technology Corporation.

Funding

Sichuan Huiyang Life Science and Technology Corporation.

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