Approval based on TOPAZ-1 Phase III trial results, which showed Imfinzi
combination reduced risk of death by 20% vs. chemotherapy alone
AstraZeneca’s Imfinzi( durvalumab) has been approved in the US for the treatment of adult cases with locally advanced or metastatic biliary tract cancer( BTC) in combination with chemotherapy( gemcitabine plus cisplatin).
The blessing by the Food and Drug Administration( FDA) was grounded on the results from the TOPAZ- 1 Phase III trial. In an interim analysis of TOPAZ- 1, Imfinzi plus chemotherapy reduced the threat of death by 20 versus chemotherapy alone( hazard rate( HR)0.80; 95 confidence interval( CI)0.66-0.97; p = 0.021). An estimated one in four( 25) cases treated with Imfinzi plus chemotherapy were still alive at two times compared to one in 10( 10) treated with chemotherapy alone. Results were harmonious across all prespecified groups, anyhow of PD- L1 expression or tumour position.
BTC is a group of rare and aggressive cancers that do in the corrosiveness tubes and gallbladder.1, 2 roughly,000 people in the US are diagnosed with BTC each time.1 These cases have a poor prognostic, with roughly 5 to 15 of cases with BTC surviving five times.3
Aiwu Ruth He, MD, PhD, Associate Professor of Medicine, Leader of the GI Cancer Program, Georgetown Lombardi Comprehensive Cancer Center, Medstar Georgetown University Hospital, Washington DC, and a lead investigator in the TOPAZ- 1 Phase III trial, said “ This blessing represents a major step forward for cases with advanced biliary tract cancer, who urgently need new, well- permitted and effective treatment options after further than a decade of limited invention. The combination of durvalumab and chemotherapy should come a new standard of care in this setting, having demonstrated significantly bettered survival for these cases who have historically faced a poor prognostic. ”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said “ For the first time, cases in the US with advanced biliary tract cancer have an immunotherapy- grounded treatment option that meaningfully extends survival and is well- permitted. This blessing for Imfinzi and chemotherapy advances our ambition to challenge treatment prospects and transfigure care for cases with gastrointestinal cancers with high unmet need. ”
Stacie Lindsey, CEO, Cholangiocarcinoma Foundation, said “ Cases have been staying a long time for a new, first- line treatment option for biliary tract cancer. The Foundation congratulates AstraZeneca for engaging in rare cancer exploration, which impacts cases and families nationwide. We’re especially thankful to the cases who shared in this trial making it possible for the broader rare complaint community to profit from this treatment. ”
The TOPAZ- 1 Phase III trial results were presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers( ASCO GI) Symposium and published in the New England Journal of Medicine substantiation. Imfinzi plus chemotherapy was generally well permitted and didn’t increase the termination rate due to adverse events compared to chemotherapy alone.
In July 2022, Imfinzi plus chemotherapy was added to the NCCN Clinical Practice Guidelines in Oncology( NCCN Guidelines ®) as a order 1 preferred authority as 1st- line remedy for locally advanced or metastatic BTC grounded on the data from TOPAZ-1.4
Biliary tract cancer
BTC is a group of rare and aggressive gastrointestinal( GI) cancers that form in the cells of the corrosiveness tubes( cholangiocarcinoma), gallbladder or ampulla of Vater( where the corrosiveness conduit and pancreatic conduit connect to the small intestine).1, 2
Cholangiocarcinoma is more common in China and South- East Asia and is on the rise in Western countries.1, 3 Gallbladder cancer is more common in certain regions of South America, India and Japan.5
Early- stage BTC affecting the corrosiveness tubes and gallbladder frequently presents without clear symptoms and utmost new cases of BTC are thus diagnosed at an advanced stage, when treatment options are limited and the prognostic is poor.3,,6
Imfinzi( durvalumab) is a mortal monoclonal antibody that binds to the PD- L1 protein and blocks the commerce of PD- L1 with the PD- 1 and CD80 proteins, fighting the tumour’s vulnerable- evading tactics and releasing the inhibition of vulnerable responses.
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several drugs and a variety of tumour types and stages of complaint. In 2020, GI cancers inclusively represented roughly5.1 million new cancer cases leading to roughly3.6 million deaths.
AstraZeneca in immunotherapy
Immunotherapy is a remedial approach designed to stimulate the body’s vulnerable system to attack tumours. The Company’s Immuno- Oncology( IO) portfolio is anchored in immunotherapies that have been designed to overcome elusion of theanti-tumour vulnerable response. AstraZeneca is invested in using IO approaches that deliver long- term survival for new groups of cases across tumour types.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to give cures for cancer in every form, following the wisdom to understand cancer and all its complications to discover, develop and deliver life- changing drugs to cases.
The Company’s focus is on some of the most grueling cancers. It’s through patient invention that AstraZeneca has erected one of the most different portfolios and channels in the assiduity, with the eventuality to catalyse changes in the practice of drug and transfigure the patient experience.
AstraZeneca has the vision to review cancer care and, one day, exclude cancer as a cause of death.
AstraZeneca( LSE/ STO/ Nasdaq AZN) is a global, wisdom- led biopharmaceutical company that focuses on the discovery, development, and commercialisation of tradition drugs in Oncology, Rare conditions, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Grounded in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative drugs are used by millions of cases worldwide.