Patient-reported outcomes for the Phase III TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (Abstract #4070)
Durvalumab Mechanism of Action: Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants
AstraZeneca’s Durvalumab, a PD-L1 antagonist, is currently approved for lung cancer. The drug has recently been granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on the TOPAZ-1 Phase 3 trial.
The addition of durvalumab was well tolerated, with no significant difference in Time to deterioration; the primary assessment of PROs in durvalumab + gemcitabine + cisplatin versus placebo + gemcitabine + cisplatin for patients reported symptoms or functioning using either C30 or BIL21, or Global Health Status/QoL (hazard ratio= 0.87; p=0.279).
Hence the addition of durvalumab to gemcitabine + cisplatin improved OS and was well tolerated with no difference in TTD of QoL for patients, supporting Durvalumab + GC as a new treatment option for patients with BTC.
“TOPAZ-1 is the first phase 3 trial to show that adding immunotherapy to standard chemotherapy can increase survival in [BTC], and importantly, does so without inducing any new serious [adverse] effects [AEs]” – Expert Opinion
“The current standard of care for inoperable biliary tract cancer is combined chemotherapy. That standard has not changed in over a decade. TOPAZ-1 is the first phase 3 trial to demonstrate the benefit of immunotherapy for improved [OS] in combination with chemotherapy, creating a new standard of care. Patients have a greater reason for hope given the positive results seen with the use of immunotherapy in [BTC],”– Expert Opinion
The recent data of TOPAZ-1 trial results are a tremendous advance for the patients, showing a clear survival benefit for durvalumab added to chemotherapy compared with standard of care with a remarkable safety profile. This combination will provide a desperately needed and potentially practice-changing new treatment option in a setting where the current prognosis is devastating.