In this ongoing phase 2 study, the efficacy of SHR-1316 plus IBI310 is being evaluated in patients with advanced intrahepatic cholangiocarcinoma after inadequate response to first-line therapy.
Treatment options for patients with highly invasive advanced intrahepatic cholangiocarcinoma (iCCA) are limited following inadequate response to first-line therapy. Jia Fan, PhD, presented data on the efficacy and safety of anti–PD-L1 antibody SHR-1316 in combination with anti-CTLA4 antibody IBI310 in patients with previously treated advanced iCCA at the 2023 ESMO Conference in Madrid, Spain.
In patients with iCCA refractory to standard treatment, SHR-1316 plus IBI310 was well tolerated and showed promising antitumor activity.
In this ongoing open-label, single-arm, phase 2 trial of patients with unresectable, locally advanced or metastatic iCCA who responded inadequately to first- or subsequent-line therapy, patients received a combination of intravenous SHR-1316 (20 mg/kg) and IBI310 (3 mg/kg) every 3 weeks for 4 cycles, followed by SHR-1316 monotherapy until disease progression, unacceptable toxicity, or a maximum of 2 years after enrollment. The primary end point was objective response rate (ORR). Secondary objectives included safety, overall survival, progression-free survival, and disease control rate (DCR). Response was evaluated according to RECIST version 1.1. Adverse effects (AEs) were assessed according to Common Terminology Criteria for Adverse Events version 5.0.
A total of 39 patients with pathologically confirmed advanced iCCA were enrolled by May 1, 2023. Patients had a median age of 59 years (range, 28-74). Previous treatments included systemic chemotherapy (39 patients), anti–PD-1 antibody therapy (21 patients), and tyrosine kinase inhibitors (26 patients). At the time of cut-off, the median follow-up was 6.1 months (95% confidence interval, 0.2-18.7), 28 patients were alive, and 18 patients remained on treatment. Of 25 evaluable patients, 2 patients achieved complete response and 3 had partial response. The confirmed ORR and DCR were 20% and 60%, respectively. Overall, 38 (97.4%) patients experienced ≥1 treatment-emergent AE. Grade ≥3 AEs occurred in 16 (41%) patients, most commonly jaundice (15.4%), rash (10.3%), alanine transaminase elevation (7.7%), hypersensitivity (7.7%), aspartate aminotransferase elevation (5.1%), and diarrhea (5.1%). No treatment-related deaths or unexpected safety signals were seen.
In patients with iCCA refractory to standard treatment, SHR-1316 plus IBI310 was well tolerated and showed promising antitumor activity. The identification of predictive/prognostic biomarkers is needed to improve the selection of patients who will benefit the most from this treatment strategy.
Fan J, Zhou J, Shi G, et al. A phase 2 study of SHR-1316 plus IBI310 in patients with advanced intrahepatic cholangiocarcinoma after failure of first-line therapy. Presented at: ESMO Congress 2023, October 20-24, 2023; Madrid, Spain.
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