Abstract 776P
Background
SHR-1701 is a novel bifunctional fusion protein composed of a mAb against PD-L1 fused with the extracellular domain of TGF-β receptor II. We initiated a phase I study (NCT03774979) to assess SHR-1701 in multiple cancer types. Here, the results from clinical expansion cohort 4 of cervical cancer are reported.
Methods
Pts with histologically or cytologically confirmed advanced cervical cancer who had progressed on or were intolerant to 1 or 2 lines of platinum-based regimens were enrolled to receive SHR-1701 at 30 mg/kg Q3W. Primary endpoint was ORR per RECIST v1.1.
Results
Totally, 32 eligible pts were recruited: squamous cell carcinoma, 100%; ≥2 metastasis sites, 68.8%; prior platinum-based chemotherapy, 87.5%; prior platinum-based chemotherapy plus bevacizumab, 12.5%; previous neoadjuvant or adjuvant therapy, 15.6%. As of Feb 26, 2021, median duration of SHR-1701 exposure was 12.0 weeks (range, 3.0-39.7), and 8 pts were still on treatment. Five pts achieved PR, and 11 had SD. ORR was 15.6% (95% CI, 5.3-32.8). DCR was 50.0% (95% CI, 31.9-68.1). At data cutoff date, responses were ongoing in 4 of the 5 responders (80.0%). 23 (71.9%) pts experienced disease progression or death, and median PFS was 1.8 months (95% CI, 1.4-4.1). Treatment-related adverse events (TRAEs) occurred in 26 (81.3%) pts, but majority were grade 1 or 2 in severity. Grade 3 TRAEs occurred in 8 (25.0%) pts, including anemia (6 [18.8%]), hyperglycemia (1 [3.1%]), and increased blood creatinine (1 [3.1%]). No grade 4 or 5 TRAEs were reported. Immune related adverse events (irAEs) occurred in 13 (40.6%) pts, with the most common being hypothyroidism (5 [15.6%]), hyperthyroidism (3 [9.4%]), and increased blood TSH (3 [9.4%]). Only one (3.1%) pt experienced grade 3 irAE.
Conclusions
SHR-1701 exhibits encouraging antitumor activity and controllable safety in pts with previously treated advanced cervical cancer after platinum-based regimens, might providing another treatment option for this population.
Clinical trial identification
NCT03774979; Release date: December 13, 2018.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Medicine, China.
Funding
Jiangsu Hengrui Medicine, China.
Disclosure
X. Zhang, J. Yang, P. Liu: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Medicine Co., Ltd. All other authors have declared no conflicts of interest.