ESMO Data Show Durvalumab Improves Overall Survival, Event-Free Survival in Hepatocellular Carcinoma and Bladder Cancer

Overall survival among patients with unresectable hepatocellular carcinoma (HCC) improved with durvalumab (Imfinzi; AstraZeneca) in combination with tremelimumab-actl (Imjudo; AstraZeneca), as well as in combination with chemotherapy for patients with muscle-invasive bladder cancer (MIBC), according to data presented at the 2024 European Society for Medical Oncology (ESMO) Congress.^1,2

Image Credit: Sebastian Kaulitzki - stock.adobe.com

New Data in Hepatocelllular Carcinoma

In the updated HIMALAYA (NCT03298451) phase 3 trial, durvalumab with tremelimumab-actl showed sustained and clinically meaningful overall survival (OS) benefits at 5 years for patients without prior systemic therapy who were ineligible for localized treatment. Investigators included individuals with histopathological confirmed HCC who had received no prior systemic therapy. Patients were excluded if they had hepatic encephalopathy within the past 12 months, clinically meaningful ascites, active or prior gastrointestinal bleeding, and if they had hepatitis B and C virus co-infection, according to the clinical trial information. Treatment included durvalumab, durvalumab in combination with tremelimumab, and the active comparator, sorafenib (Nexavar; Bayer HealthCare).^1,3

Investigators found that the combination, referred to as the STRIDE regimen, reduced the risk of death by 24% compared with sorafenib. Approximately 19.6% of individuals treated with STRIDE were alive at 5 years compared with 9.4% of those treated with sorafenib. The median duration of follow up for OS was 62.5 months in the STRIDE group and 59.9 months in the sorafenib group.

For safety, the STRIDE regimen had a consistent profile with the known profile for each drug, with no new safety signals with the longer follow-up. Serious adverse events were experienced by 17.5% of those treated with STRIDE compared with 9.9% with sorafenib.¹

New Data in Bladder Cancer

In the NIAGRA (NCT03732677) study, durvalumab with chemotherapy had significant and clinically meaningful improvements in event-free survival (EFS) and OS compared with neoadjuvant chemotherapy. Investigators included patients with resectable MIBC with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology, who were undergoing a radical cystectomy and who had not received prior systemic chemotherapy or immunotherapy for treatment of their MIBC, according to the clinical trial information. Patients were excluded if they had evidence of lymph node or metastatic disease, prior pelvic radiotherapy within 2 years of randomization to the study, or current or prior use of immunosuppressive medication within 14 days before the first dose of the investigational product.^2,4

Investigators reported that the drug showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death compared with the comparator. Median EFS was not reached for durvalumab but reached 46.1 months for the comparator. Furthermore, an estimated 67.8% of those treated with durvalumab were event-free at 2 years compared with 59.8% for the comparator.²

As for OS, durvalumab reduced the risk of death by 25% compared with the neoadjuvant chemotherapy with radical cystectomy. The median survival was not reached for either arm; however, 82.2% of those treated with durvalumab were alive at 2 years compared with 75.2% in the comparator arm.²

REFERENCES

1. Imfinzi (durvalumab) plus Imjudo (tremelimumab-actl) demonstrated unprecedented overall survival in advanced liver cancer with one in five patients surviving five years in HIMALAYA Phase III trial. News release. September 16, 2024. Accessed September 17, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/imfinzi-plus-imjudo-demonstrated-unprecedented-overall-survival-alc-with-one-in-five-patients-surviving-five-years-himalaya-phase-iii-trial.html

2. Imfinzi (durvalumab) perioperative regimen reduced the risk of recurrence by 32% and the risk of death by 25% vs. neoadjuvant chemotherapy alone in muscle-invasive bladder cancer in the NIAGARA Phase III trial. News release. September 15, 2024. Accessed September 17, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/imfinzi-perioperative-regimen-reduced-risk-recurrence-by-32-risk-death-by-25-vs-neoadjuvant-chemotherapy-alone-in-mibc-niagara-phase-iii-trial.html

3. Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (HIMALAYA). ClinicalTrials.gov identification: NCT03298451. Updated August 30, 2024. Accessed September 17, 2024. https://www.clinicaltrials.gov/study/NCT03298451

4. Durvalumab+ Gemcitabine/​Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA). ClinicalTrials.gov identification: NCT03732677. Updated July 1, 2024. Accessed September 17, 2024. https://clinicaltrials.gov/study/NCT03732677