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ESMO Asia 2025 | TOURMALINE: durvalumab and gemcitabine-based chemotherapy in BTC
Stephen Lam Chan, MD, FRCP, Chinese University of Hong Kong, Hong Kong, China, comments on the interim analysis of the TOURMALINE trial (NCT05771480) of durvalumab with gemcitabine-based chemotherapy in patients with advanced biliary tract cancer (BTC) from Asia. Manageable Grade 3/4 treatment-related adverse events were reported in a majority patients, consistent with global data and prior studies. The objective response rate was also promising, supporting further evaluation. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.
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Transcript
So for the, I think it’s a 2020 oral presentation, it’s a phase 3b clinical trial that was conducted after the TOPAZ-1 study, which showed that the durvalumab could improve the outcome of gemcitabine cisplatin. But it was noted that in the real world, there have been many different regimens used in the cholangiocarcinoma because of the heterogeneity of the disease and also because of the different practices in different parts of the world...
So for the, I think it’s a 2020 oral presentation, it’s a phase 3b clinical trial that was conducted after the TOPAZ-1 study, which showed that the durvalumab could improve the outcome of gemcitabine cisplatin. But it was noted that in the real world, there have been many different regimens used in the cholangiocarcinoma because of the heterogeneity of the disease and also because of the different practices in different parts of the world. The regimen could be ranging from gemcitabine monotherapy to other gemcitabine doublet like GEMOX or GEMCAP. And also there have been some more aggressive triplet regimen like gemcitabine plus cisplatin plus the albumin-bound paclitaxel. So the TOURMALINE study is testing the combination of the durvalumab for 1,500 mg after three weeks in combination with this different chemo backbone other than the gemcitabine cisplatin. So the key result was that the primary endpoint, which is grade 3 to 4 possibly related AE, within six months of the treatment initiations was generally, I would say, expected with a wide range between the gemcitabine tocidabine triplet. Of course, we need to be cautious in the interpretation about the exact value because these regimens were mainly the investigator choice. Those with less fit status, they may be offered the less aggressive regimen, while those with more fit status, they will be offered the more aggressive chemotherapy regimen. But overall, we don’t see any alarming signal or unexpected safety signal when we combine the durvalumab with this gemcitabine-based backbone chemotherapy. Another interesting observation is that overall, the response rate was quite similar between the gemcitabine doublet to the gemcitabine triplet when they’re combining with durvalumab. The only drawback was those patients with only gemcitabine mono to get the durvalumab response rate or the disease stabilization rate is relatively low. So this study actually provides data on the use of the different chemo backbone other than the TOPAS-1 in combination of durvalumab in the treatment of cholangiocarcinoma.
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