Enticing benefit, but questions remain
In her discussion of the paper, Dr. Azad pointed out that Asian patients comprised more than half of the cohort and appeared to derive more benefit from the investigational treatment compared to other groups. “So the question is if that is driving the benefit or just an increased benefit,” she said. “That is going to be an open question for our research community.”
Dr. Azad also noted that patients with nonmetastatic disease at enrollment did a little better, so more data are needed on how that affected the outcomes.
“PDL-1 just missed statistical significance, but that is something that will be further explored,” she said. “And we still have open questions about viral hepatitis, liver fluke infection, and cirrhosis, and I do hope that these will be included in the final analysis of the study.”
The GICS meeting is organized by the American Society of Clinical Oncology (ASCO), and the society highlighted these data in a press release. Cathy Eng, MD, FACP, ASCO expert in gastrointestinal cancers, commented in the statement: “TOPAZ-1 is the first phase 3 trial to demonstrate the benefit of immunotherapy for improved overall survival, in combination with chemotherapy, creating a new standard of care.”
The study received funding from AstraZeneca, marker of durvalumab. Dr. Oh and Dr. Azad reported relationships with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.