# AstraZeneca’s Imfinzi recommended for approval in EU for BTC

- Link: https://www.directorstalkinterviews.com/astrazenecas%c2%a0imfinzi-recommended-for-approval-in-eu-for-btc/4121090415
- Published: 2022-11-14T08:15:23+00:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Imfinzi_ (durvalumab) has been recommended for marketing authorisation in the European
Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic
biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency based its positive opinion on the primary results from the TOPAZ-1 Phase 
III trial published in the New England Journal of Medicine Evidence, and on the 
updated results presented at the European Society for Medical Oncology Congress 
2022.

At the interim analysis, _Imfinzi_ plus chemotherapy reduced the risk of death by
20% versus chemotherapy alone (hazard ratio [HR] 0.80; 95% confidence interval [
CI] 0.66-0.97; p=0.021).

Updated results from TOPAZ-1 after an additional 6.5 months of follow-up showed 
a 24% reduction in the risk of death versus chemotherapy alone (HR 0.76; 95% CI,
0.64-0.91), with more than two times as many patients estimated to be alive at two
years versus chemotherapy alone (23.6% versus 11.5%). Updated median overall survival(
OS) was 12.9 months versus 11.3 with chemotherapy.

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.
^(1,2) There are approximately 210,000 new patients diagnosed with gallbladder and
biliary tract cancer each year, and about 40,000 of these occur across Europe.^(
3) These patients have a poor prognosis, with approximately 5% to 15% of patients
with BTC surviving five years.^(4)

> **Juan W. Valle, MD, Professor of Medical Oncology at the University of Manchester,
> UK, and a lead investigator in the TOPAZ-1 Phase III trial, said**: “This positive
> opinion is welcome news for patients with advanced biliary tract cancer in the
> European Union who face a poor prognosis and limited treatment options. The combination
> of durvalumab and chemotherapy is a significant advance for patients after more
> than a decade of limited progress, and this regimen should become a new standard
> of care option once approved.”

> **Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said**:“
> If approved, _Imfinzi_ plus chemotherapy will provide patients with advanced biliary
> tract cancer the first opportunity for treatment with an immunotherapy-based combination.
> This innovative regimen has been shown to significantly prolong patients’ lives,
> and we look forward to bringing this option to those in the European Union as 
> soon as possible.”

_Imfinzi_ plus chemotherapy was generally well tolerated, with no new safety signals
observed, and did not increase the discontinuation rate due to adverse events (AEs)
compared to chemotherapy alone. Grade 3 or 4 treatment-related AEs were experienced
by 60.9% of patients treated with _Imfinzi_ and chemotherapy, and by 63.5% of patients
treated with chemotherapy alone.

_Imfinzi_ plus chemotherapy is approved in the US, Canada, South Korea and Brazil
for the treatment of patients with locally advanced or metastatic BTC. Regulatory
applications are also currently under review in Japan and several other countries
based on the TOPAZ-1 results.

**References**

1.  Marcano-Bonilla L, _et al._ Biliary tract cancers: epidemiology, molecular pathogenesis
and genetic risk associations. _CCO_. 2016;5(5).

2.   ESMO. What is Biliary Tract Cancer. Available at:

https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-
for-Patients.pdf. Accessed November 2022.

3.   Ouyang G, _et al._ The global, regional, and national burden of gallbladder
and biliary tract cancer and its attributable risk factors in 195 countries and 
territories, 1990 to 2017: A systematic analysis for the Global Burden of Disease
Study 2017. _Cancer_. 2021;127:2238-2250.

4.   Turkes F, _et al_. Contemporary Tailored Oncology Treatment of Biliary Tract
Cancers. _Gastroenterol Res Pract._ 2019;2019:7698786.

_AstraZeneca is leading a revolution in oncology with the ambition to provide cures
for cancer in every form, following the science to understand cancer and all its
complexities to discover, develop and deliver life-changing medicines to patients._

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