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.
Resources from the same session
2182 - Evaluating the prevalence of the expression of PD-L1 in NSCLC specimens with short-duration formalin fixation using IHC 22C3 pharmDx
Presenter: Keiichi Ota
Session: Poster Display session 1
Resources:
Abstract
5255 - [18F]-FDG PET/CT in predicting PD-L1 status in nasopharyngeal carcinoma
Presenter: Liang Zhao
Session: Poster Display session 1
Resources:
Abstract
4910 - Expression of PD-L1 in Chinese Patients with Common Cancers
Presenter: Min Zheng
Session: Poster Display session 1
Resources:
Abstract
4227 - The clearance of EGF by tumor-associated macrophages is suppressed by chemotherapeutic agent cisplatin
Presenter: Irina Larionova
Session: Poster Display session 1
Resources:
Abstract
5222 - VHIO-300 and a thousand one nights, a tale of Precision Medicine
Presenter: Ginevra Caratù
Session: Poster Display session 1
Resources:
Abstract
5668 - Matched Whole-Genome Sequencing and Whole-Exome Sequencing with Circulating Tumor DNA (ctDNA) Analysis are complementary modalities in clinical practice
Presenter: Robin Imperial
Session: Poster Display session 1
Resources:
Abstract
5772 - Exploring the role of genes associated with familial cancer syndromes on the development of multiple primary tumors
Presenter: Atanaska Mitkova
Session: Poster Display session 1
Resources:
Abstract
4784 - Doxorubicin resistance: early and advanced tumors can use two different strategies based on initial and profound abnormalities in microRNA expression signature
Presenter: Volodymyr Halytskiy
Session: Poster Display session 1
Resources:
Abstract
3456 - From tumor transcriptomes to underlying cell type proportions to better predict prognosis and response to treatments
Presenter: Yuna Blum
Session: Poster Display session 1
Resources:
Abstract
4976 - Optimization of automated germline DNA extraction from non-tumoral formalin-fixed paraffin embedded (FFPE) tissues
Presenter: Omar Youssef
Session: Poster Display session 1
Resources:
Abstract