AstraZeneca’s Imfinzi Beats Standard of Care in Advanced Biliary Tract Cancer

AstraZeneca on Monday announced that a combination of Imfinzi (durvalumab) plus chemotherapy improved overall survival in patients with advanced biliary tract cancer (BTC) over chemo alone. The improvement was statistically significant and clinically meaningful, said the company.

This marks the first time the addition of immunotherapy to chemotherapy bested the standard of care in the first-line disease setting.

The positive results came from an interim analysis of the Topaz-1 Phase 3 trial. An Independent Data Monitoring Board investigating the randomized double-blinded study found that the combination has met its primary endpoint of improving overall survival for patients with advanced BTC. The combination also met two secondary endpoints for progression-free survival and overall response rate.

Imfinzi plus chemo was also well-tolerated, generating a similar safety profile versus chemo alone.

“Patients with advanced biliary tract cancer are in dire need of new treatments as progress in the first-line setting has remained largely stagnant for more than 10 years. said Do-Youn Oh, MD, Ph.D., from the Seoul National University Hospital and principal investigator in the trial.

“TOPAZ-1 is the first Phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting.”

The data will be presented in a future medical meeting and shared with health authorities.

Imfinzi Leaps Ahead of Rivals

BTC is a collection of cancers that affect the bile ducts (cholangiocarcinoma) or the gallbladder. Around 50,000 people in the US, Europe, and Japan are diagnosed with BTC every year. The disease is associated with poor patient outlook because diagnosis often occurs at later stages.

Frontline treatments for BTC typically consist of chemotherapy such as cisplatin or gemcitabine. It’s only recently that targeted therapies like Imfinzi are getting attention as potential treatments.

The first FDA approval for targeted therapy for cholangiocarcinoma was given last April, to Incyte’s Pemazyre (pemegatinib). However, only patients with an FGFR2 gene mutation and have undergone a prior line of therapy could receive the drug. Similar approval was given this June to BridgeBio’s Truseltiq (infigratinib) for the same disease setting.

Merck is also eyeing the BTC indication with Keytruda (pembrolizumab) which is being investigated in the company’s Keynote-966 study.

The latest result is the second positive trial for Imfinzi in gastrointestinal cancers. Earlier this month, AstraZeneca revealed encouraging results from its Himalaya-3 trial which demonstrated a combination of Imfinzi plus tremelimumab was superior to Bayer’s Nexavar (sorafenib) in improving overall survival in patients with liver cancer.

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Joy Lin

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