Roche's 'T+A' Regimen Demonstrates Significant Improvement in Overall Survival for Patients with Advanced Hepatocellular Carcinoma

On January 12, Roche announced that it would formally present the latest overall survival (OS) results from the Phase III IMbrave150 clinical trial at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) held later this month. The trial evaluated the “T+A” regimen—combining the PD-L1 inhibitor Tecentriq with the anti-VEGF therapy Avastin—as a first-line treatment for patients with advanced hepatocellular carcinoma. The data showed that the median OS for patients treated with the “T+A” regimen was 19.2 months, while the median OS in the Chinese subgroup reached 24.0 months.

Hepatocellular Carcinoma (HCC) is one of the leading causes of cancer-related deaths worldwide. Statistics indicate that over 750,000 people are diagnosed with hepatocellular carcinoma annually globally, with the majority of cases occurring in Asia and nearly half in China. The primary causes of HCC are chronic hepatitis resulting from hepatitis B or C virus infection, as well as cirrhosis caused by alcohol consumption or non-alcoholic steatohepatitis.

Tecentriq is a blockbuster immune checkpoint inhibitor developed by Roche, while Avastin is an anti-angiogenic agent. Anti-angiogenic agents not only cut off the nutrient supply to tumors but also modulate the tumor microenvironment, thereby enhancing the efficacy of immunotherapy. In recent years, multiple combinations of checkpoint inhibitors and anti-angiogenic agents have received FDA approval. The “T+A” combination was approved by the U.S. FDA in May last year, becoming the first treatment regimen in over a decade to improve overall survival and progression-free survival compared with previous standard therapies. In October last year, China’s National Medical Products Administration (NMPA) also approved this combination therapy for marketing.

IMbrave150 is a global, phase 3, multicenter, open-label study designed to evaluate the efficacy of the “T+A” regimen versus the previous standard of care in patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy.

After a median follow-up of 15.6 months, the latest analysis demonstrated that the “A+T” regimen reduced the risk of death by 34%, with a median overall survival (OS) of 19.2 months, superior to the 13.4 months observed with the previous standard of care (HR=0.66; 95% CI: 0.52–0.85). In the Chinese subgroup, the median OS reached 24.0 months, outperforming the 11.4 months achieved with the prior standard regimen (HR=0.53; 95% CI: 0.35–0.80).

Professor Qin Shukui, Vice Chairman of the Chinese Society of Clinical Oncology (CSCO) and Principal Investigator for China in the IMbrave150 study, stated: “In October 2020, the ‘T+A’ immunotherapy combination regimen was officially approved in China. It has since been recommended by multiple authoritative clinical guidelines, fully demonstrating the breakthrough significance of this combination therapy. Notably, despite a higher prevalence of hepatitis B infection and the presence of multiple poor prognostic factors—such as macrovascular invasion, extrahepatic metastasis, and alpha-fetoprotein levels ≥400 ng/mL—the Chinese subgroup in the IMbrave150 trial and its extension studies still achieved remarkable efficacy. In particular, the median overall survival reached 24.0 months, marking a new breakthrough in the treatment of advanced hepatocellular carcinoma and holding milestone significance for the vast number of patients in China!”

Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, stated, “The data confirm that in the Phase 3 clinical trial evaluating first-line treatments for unresectable hepatocellular carcinoma, the ‘A+T’ regimen demonstrated a longer overall survival. Currently approved in more than 60 countries and regions worldwide, ‘A+T’ offers patients dual improvements in both survival and quality of life, representing a significant advancement in the treatment of hepatocellular carcinoma.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at an accredited hospital.

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