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ASCO 2026 | NAPOLI-2: second-line fluorouracil, leucovorin & nal-IRI in biliary tract cancer
Benjamin Adam Weinberg, MD, Georgetown University, Washington, DC, presents final results from the Phase II NAPOLI-2 trial (NCT04005339) of fluorouracil, leucovorin, and nanoliposomal irinotecan (nal-IRI) as second-line treatment in pre-treated patients with advanced biliary tract cancer (BTC). The regimen met its primary endpoint, demonstrating meaningful progression-free survival at four months, though early treatment discontinuation due to adverse events was notable, supporting further correlative analyses in this setting. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
So in metastatic biliary tract cancer, for a long time we had no real second-line regimen. There have been advances in the front line of adding immunotherapy to gemcitabine cisplatin. From the second line, all we really had is FOLFOX, which is like falling off platinum with platinum. It didn’t make a lot of sense. So we’ve known for a long time that irinotecan-based chemotherapy has a role here...
So in metastatic biliary tract cancer, for a long time we had no real second-line regimen. There have been advances in the front line of adding immunotherapy to gemcitabine cisplatin. From the second line, all we really had is FOLFOX, which is like falling off platinum with platinum. It didn’t make a lot of sense. So we’ve known for a long time that irinotecan-based chemotherapy has a role here. There’s a Korean study, the NIFTY study, that initially showed benefit over 5FU Leucovorin by itself, and then it was a bit of a wash. There was a German study that showed no real benefit. So we did a single-arm study in the US to try to make a tiebreaker. And we did achieve our primary endpoint, which was that about 50% of patients were alive and progression-free four months after starting therapy. We did have to replace a number of patients who came off for early toxicity. There was a 27% grade 3 diarrhea rate, and about 20% of patients did come off before four months, not because of disease progression, but because of toxicity. And we did have a few long-term responders who were on study for more than a year. So clearly the regimen has some efficacy. There’s a very low response rate, only one responder, but there were a number of patients who had significant disease control and that can be quite durable. And it remains an open question of whether we should start at a lower dose to make this regimen more tolerable.
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