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CTX-009/Paclitaxel Yields Responses in Advanced Biliary Tract Cancer

— High toxicity, however, needs to be addressed in future trials, says Paul Oberstein, MD

MedpageToday

A phase II study presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium showed that administered as second- or third-line therapy in patients with advanced biliary tract cancer led to an objective response rate of 37.5% and a 1-year survival rate of 53%.

In this exclusive 鶹ý video, , of NYU Langone's Perlmutter Cancer Center in New York City, discusses the results of the and the impact of the drug's side effects.

Following is a transcript of his remarks:

The name of the medication is CTX-009, and it's a bispecific antibody, so it targets two specific targets. One is VEGF [vascular endothelial growth factor], which is a very familiar target to many in oncology, and the other is something in the same pathway that's downstream called DLL4 [Delta-like ligand 4], which is part of the Notch pathway. And preclinical studies and previous studies have shown that by targeting this combination, you may be able to impede growth of tumor cells.

The investigators ran a phase II study where they evaluated 24 patients with biliary tract cancers with this bispecific antibody plus a chemotherapy. And the results showed that there was significant responses, partial response in 37% of patients, which was quite encouraging, with encouraging survival and encouraging progression-free survival.

The abstract also points out that there was a lot of toxicity. So many patients had side effects -- 75% of them had grade 3 or higher side effects, and 25% of patients had to actually stop the study drug because of side effects.

So basically what they were able to show is that this combination seems to be quite effective in a very heavily pretreated cancer population, but with significant side effects. And so the next step will be to determine how to keep targeting this pathway while minimizing side effects for patients.

I think there will be good options for treatment in the future, but this needs to be fine-tuned a little bit.

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