No Response Observed With Olaparib Plus Durvalumab for IDH-Mutated Cholangiocarcinoma
According to results from a phase 2 study, the combination of olaparib and durvalumab did not induce response in any patients with IDH-mutant cholangiocarcinoma during stage 1 of the study.
These results were presented at the 2023 ASCO Annual Meeting by Erica Tsang, MD, Princess Margaret Cancer Center, Toronto, Ontario, Canada, on Monday, June 5, 2023 in Chicago, Illinois.
In stage 1 of this open-label, phase 2 study, 10 patients with advanced IDH-mutant, cholangiocarcinoma received 300 mg olaparib twice daily continuously, and 1500 mg durvalumab every 4 weeks. If ≥2 responses were observed at the interim efficacy analysis, the trial would proceed to expansion. The primary objective was overall response rate (ORR) and disease control rate (DCR). Secondary objectives included progression-free survival (PFS), overall survival (OS), and safety of this combination.
The median duration of treatment for the patients in Stage 1 was 1.95 months. There were no complete or partial responses observed. The DCR was 30%, with 3 patients achieving stable disease. The median PFS was 1.97 months. The study was discontinued after Stage 1 because of a lack of efficacy.
There were no grade 3/4 toxicities observed. Any grade toxicities included fatigue, nausea, anemia, hypothyroidism, and elevated liver enzymes.
Dr Tsang et al concluded, “IDH1/2 may not induce a BRCAness phenotype and further correlative studies are planned to evaluate this.”
Source:
Tsang ES, O’Kane GM, Knox JJ. A phase II study of olaparib and durvalumab in patients with IDH-mutated cholangiocarcinoma. Presented at 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. Abstract 4099
