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AstraZeneca's immunotherapy Imfinzi (durvalumab) produced a mixed bag when used as an add-on to transarterial chemoembolisation (TACE) in patients with hepatocellular carcinoma (HCC). According to detailed results from the Phase III EMERALD-1 trial, unveiled Friday at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), the combination significantly improved progression-free survival (PFS), but only when Roche's Avastin (bevacizumab) was part of the mix.PFS benefit of nearly 7 monthsThe three-arm study included 616 patients with embolisation-eligible unresectable HCC who were randomised to receive TACE therapy alone, or Imfinzi plus TACE either with or without Avastin. AstraZeneca said the trio combination reduced the risk of disease progression or death by a statistically significant 23%, compared to placebo plus TACE. Median PFS for the two groups was 15 months and 8.2 months, respectively.However, without Avastin, there was no significant PFS difference between those who received Imfinzi plus TACE and the TACE-only groups. Researchers said objective response rate (ORR) and time to progression (TTP) were also superior in the Imfinzi, Avastin and TACE arm. The ORR for these patients was 43.6% and median TTP was 22 months, whereas it was 29.6% and 10 months for TACE-only.Will it be enough?Susan Galbraith, who heads oncology R&D at AstraZeneca, said "we are discussing these positive EMERALD-1 data with global regulatory authorities while awaiting the final overall survival (OS) results from the trial."At the company's earnings call last November, Galbraith said it would be "important for us to show the potential for contribution of components" in the treatment regimen. She also noted that OS data would be key given the EMERALD-1 study's focus is in the locoregional setting, although "it may well be possible to file on PFS, and then wait for OS to be supplemented during the follow-up period and during the review period."Imfinzi is currently approved in combination with Imjudo (tremelimumab) for unresectable HCC in the US, Europe, Japan, China and other countries based on the Phase III TOPAZ-1 and HIMALAYA Phase III trials. The PD-L1 inhibitor is also approved for other indications including non-small-cell lung cancer, extensive-stage small cell lung cancer and advanced biliary tract cancer.

Pictured: AstraZeneca production plant/iStock, Roland Magnusson AstraZeneca’s cancer immunotherapy treatment Imfinzi (durvalumab) has shown encouraging survival results for hepatocellular carcinoma patients eligible for embolization in combination with Genentech’s Avastin (bevacizumab) and transarterial chemoembolization. On Thursday, AstraZeneca announced that results from the Phase III Emerald-1 trial “demonstrated a statistically significant clinically meaningful improvement” in the primary endpoint of progression-free survival. The trial is ongoing as AstraZeneca continues to follow the secondary endpoint of overall survival. AstraZeneca reported that the safety pro the combination was “consistent with the known pro each medicine,” with no new safety issues identified. “These positive results for Imfinzi-based treatment in Emerald-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we aim to bring this novel treatment option to patients,” Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, said in a statement. While no detailed data was provided, AstraZeneca said that the complete dataset will be presented at an unspecified medical meeting and the company will share it with regulatory authorities. “These results for durvalumab plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to [transarterial chemoembolization (TACE)] significantly improves progression-free survival,” Riccardo Lencioni, the trial’s principal investigator and director of the cancer imaging program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Italy, said in a statement. Imfinzi is also being investigated in other gastrointestinal cancers, including a combination with bevacizumab in adjuvant hepatocellular carcinoma (HCC) and a combo with Imjudo, Lenvatinib and TACE in embolization-eligible HCC. The drug is one of the main moneymakers for AstraZeneca, bringing in over $1.1 billion in the third quarter and $3.1 billion for the first nine months of 2023. Imfinzi has also been showing its efficacy in other cancers. Last month, Imfinzi, in combination with chemotherapy, showed positive results in a Phase III trial for patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. In April 2023, a combination of the drug and Lynparza reached its primary endpoint in a Phase III trial for patients with high-grade epithelial ovarian cancer. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.