The PROs Further Support Durvalumab + Chemo in Becoming The New Standard of Care in 1st Line Advanced Biliary Tract Cancer

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Durvalumab + Chemo Highlights: ASCO 2022

Patient-reported outcomes for the Durvalumab, Gemcitabine, and Cisplatin Phase III TOPAZ-1 Study in Advanced Biliary Tract Cancer

Durvalumab Mechanism of Action: Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants

The PD-L1 antagonist Durvalumab from AstraZeneca is presently accepted for the treatment of lung cancer. Based on the TOPAZ-1 Phase 3 trial, the medicine recently received priority evaluation in the US for patients with locally advanced or metastatic biliary tract cancer.

Durvalumab was added, and there was no discernible difference in the Time to deterioration; instead, patients in the durvalumab + gemcitabine + cisplatin group compared to those in the placebo + gemcitabine + cisplatin group reported their symptoms or functional status using either C30 or BIL21, or their 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.

KOL Insights

"TOPAZ-1 is the first phase 3 trial to demonstrate that combining immunotherapy to conventional chemotherapy can increase survival in [BTC], and significantly, does so without producing any new severe adverse effects [AEs]," according to the study. - Expert Advice

Combination chemotherapy is currently the gold standard of treatment for incurable biliary tract cancer. This standard has not altered in more than ten years. In order to establish a new standard of treatment, TOPAZ-1 is the first phase 3 trial to show the value of immunotherapy for better [OS] when combined with chemotherapy. The use of immunotherapy in [BTC] has shown promising outcomes, giving patients further cause for optimism. - Expert Advice

Conclusion

The most recent TOPAZ-1 study data represent a significant step forward for patients, clearly demonstrating a survival advantage for durvalumab coupled to chemotherapy over standard of care with an exceptional safety profile. In a situation where the prognosis is dire, this combination will offer a much-needed and perhaps game-changing new therapy option.

Also, read- ASCO Conference 2020 | ASCO 2020 Abstracts | ASCO 2021 Highlights