Dear Readers,
In this issue of CCA News, we are highlighting important abstracts presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI23; January 19-21, 2023; San Francisco, CA). Each year, the number of biliary tract cancer (BTC) abstracts presented at this annual meeting has increased, and 2023 was no exception. Dr Rachna Shroff presented on the randomized, phase 3 trial of gemcitabine/cisplatin (GemCis) with or without nab-paclitaxel. Although this trial did not meet its prespecified end point of improved overall survival when compared with standard-of-care chemotherapy, there were important observations that are instructive in the field. First, such a large phase 3 trial is possible in BTC in the United States, and subtypes of these cancers can be targeted by incremental chemotherapies.
IMbrave 151 was another important study, and the findings were presented of which were presented by Dr Anthony El-Khoueiry. In this randomized, phase 2 study, researchers investigated the combination of atezolizumab with or without bevacizumab plus chemotherapy in patients with advanced BTC. Researchers demonstrated the feasibility of such a combination, although the clinical benefit of this strategy remains to be determined.
Currently, GemCis and durvalumab remain the standard of care in the first line. At ASCO GI23, we learned about the value of the addition of durvalumab in specific molecular subtypes, including KRAS mutation, which is associated with an aggressive clinical prognosis. The molecular sequencing data from TOPAZ-1 have provided key insights into the genetic profile of BTC in the first-line setting.
The ASCO GI23 presentations on novel targeted therapies included promising data on the FGFR inhibitor gunagratinib, CTX-009 (a bispecific antibody targeting delta-like ligand 4/Notch-1 and VEGF), and BI 907828, which targets MDM2-p53. It is hoped that these studies will bring novel agents for patients with specific molecular and clinical subtypes of BTC.
Exciting new updates are expected from the KEYNOTE-966 trial with pembrolizumab later this year, and a recent announcement indicated that this study of GemCis with or without pembrolizumab has met its primary end point of overall survival improvement. This is a landmark achievement, and we eagerly await further updates!
Sincerely,
Milind M. Javle, MD
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