Abstract 982P
Background
Pancreatic cancer (PC) and biliary tract cancer (BTC) are highly aggressive cancers with limited treatment options. Objective response rates (ORRs) of 2nd Line chemotherapy in PC and BTC are both <10%. SHR-1701 is a bifunctional fusion protein targeting PD-L1 and transforming growth factor β (TGF-β) receptor II. Famitinib is a tyrosine kinase inhibitor against multiple targets, including vascular endothelial growth factor receptor 2/3, platelet-derived growth factor receptor β and stem cell factor receptor. Herein, we reported the safety and efficacy of SHR-1701 in combination with famitinib in patients (pts) with previously treated advanced PC and BTC.
Methods
This is an ongoing phase II study of SHR-1701 plus famitinib in pts with PC or BTC who have failed ≥1 prior therapies. Pts received SHR-1701 (30mg/kg q3w) combined with famitinib (20mg qd) until disease progression or unacceptable toxicity. The primary endpoint was ORR as per RECIST v1.1. Secondary endpoints included disease control rate (DCR), progression-free survival, overall survival and safety.
Results
Up to 27 Apr 2021, 10 and 4 pts were enrolled in PC and BTC cohorts respectively. Of 7 evaluable pts in PC cohort, 2 pts had stable disease (SD) (one remained stable for 4.6 months), one had unconfirmed complete response. The DCR was 43%. Among 3 evaluable pts in BTC cohort, one had SD, one had partial response, which is ongoing for 3.3+ months (tumor shrinkage >45%). The ORR and DCR were 33% and 67%, respectively. 11 pts were included in safety set. The most common any-grade treatment-related adverse events (TRAEs) were proteinuria (82%), hypertension (64%), blood urine present (64%), alanine aminotransferase increased (64%), aspartate aminotransferase increased (55%) and hypoproteinaemia (55%). Most frequent grade 3 TRAE was bilirubin conjugated increased (2pts); no grade 4/5 adverse events were reported.
Conclusions
Combination of SHR-1701 and famitinib showed promising activity with well-tolerated toxicities in pts with advanced PC or BTC. Updated results will be presented.
Clinical trial identification
ChiCTR2000037927.
Editorial acknowledgement
Legal entity responsible for the study
Fudan University Shanghai Cancer Center.
Funding
Jiangsu Hengrui Medicine Co. Ltd.
Disclosure
All authors have declared no conflicts of interest.