Dr. Harding on the Management of Immune-related AEs in Advanced Biliary Tract Cancer

James Harding, MD, assistant attending physician, Memorial Sloan Kettering Cancer Center, discusses the appropriate management of immune-related adverse effects (irAEs) in patients with advanced biliary tract cancer.

Prior to the emergence of immunotherapies, the standard frontline approach for patients with unresectable biliary tract cancer was systemic, platinum-based chemotherapy. Now, several trials have released data supporting the addition of immune checkpoint inhibitors (ICIs) to standard chemotherapies in this space. Amongst these are the phase 3 TOPAZ-1 study (NCT03875235) evaluating durvalumab (Imfinzi) in combination with gemcitabine and cisplatin.

Although the utilization of chemoimmunotherapy may provide great benefit to these patients, irAEs can limit the use of ICIs in practice, Harding notes. Therefore, it is important to closely monitor patients for any associated irAEs, Harding states.

The rate of irAEs has been relatively low with the administration of single-agent PD-L1 or PD-1 inhibitors, Harding states. Moreover, complete resolution of these toxicities can often be achieved by temporarily stopping treatment and instituting immunosuppression, he adds. If an irAE is not reversible, it can still be properly managed, Harding says. 

In order to ensure rapid and effective irAE management, patients should be aware of the potential toxicities associated with immunotherapy regimens and notify clinicians of any changes in their clinical status, Harding continues.

Going forward, the development of novel therapeutics that reduce the risk of irAEs could help maximize benefit with this treatment option in advanced biliary tract cancer, Harding concludes.

Editor’s Note: Dr. Harding reports serving as a consultant or in an advisory role for Adaptimmune, AstraZeneca, Bristol Myers Squibb, Exelixis, Elevar, Eisai, Genoscience (uncompensated), Hepion, Imvax, Merck (DSMB) Medivir, QED, Tyra, Zymeworks (uncompensated); he reports receiving institutional research funding from Bristol Myers Squibb, Boehringer Ingelheim, CytomX, Debiopharm, Eli Lilly, Genoscience, Incyte, Loxo Oncology at Lilly, Novartis, Polaris, Pfizer, Zymeworks, Yiviva.