IMbrave150 Study Reports Updated Overall Survival Data: Chinese Subgroup Achieves Median OS of 24 Months with Atezolizumab Plus Bevacizumab
Roche
Oncology Drug Research, Development, and Manufacturing
Shanghai, January 12, 2021 /PRNewswire/ -- Roche announced that the latest overall survival (OS) results from the IMbrave150 study will be formally reported at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) to be held later this month. The data showed that patients receiving Tecentriq®（Tecentriq®, generic name: atezolizumab) in combination with Avastin®（Avastin®, generic name: bevacizumab) had a median overall survival (mOS) of 19.2 months in patients treated with the immunotherapy combination regimen (hereinafter referred to as the “T+A” regimen), with the mOS in the Chinese subgroup reaching 24.0 months.
IMbrave150 is a global, Phase III, multicenter, open-label study designed to evaluate the efficacy of the “T+A” regimen versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) who have not previously received systemic therapy. In November 2019, Roche announced the primary results at the ESMO Asia Congress, demonstrating that both primary endpoints—overall survival (OS) and progression-free survival (PFS)—achieved statistically and clinically significant improvements. Furthermore, high-quality patient-reported outcomes (PROs) from the IMbrave150 trial indicated that the “T+A” regimen significantly delayed the deterioration of physical and role functioning and key symptoms, thereby substantially improving patients’ quality of life.
After a median follow-up of 15.6 months, the latest analysis results indicate that the “T+A” regimen reduces the risk of death by 34%, with a median overall survival (mOS) of 19.2 months, superior to the 13.4 months observed with the previous standard regimen (HR=0.66; 95% CI: 0.52–0.85). In the Chinese subgroup, the median overall survival reached 24.0 months, outperforming the 11.4 months seen with the prior standard regimen (HR=0.53; 95% CI: 0.35–0.80). The updated overall survival data, along with progression-free survival (PFS) and objective response rate (ORR), are consistent with the primary analysis results. Its safety profile is also consistent with the previously known safety profiles of the individual agents, with no new safety signals identified.
IMbrave150Principal Investigator in China, Chinese Society of Clinical Oncology (CSCO) Professor Qin Shukui, Vice Chairman, pointed out:“In October 2020, the ‘T+A’ immunotherapy combination regimen was officially approved in China. It has since been recommended by multiple authoritative domestic and international clinical guidelines with the highest level of evidence and the strongest recommendation, fully demonstrating the breakthrough significance of this combination therapy/drug regimen. Notably, the Chinese subgroup in the IMbrave150 trial and its extension study, despite having a higher prevalence of hepatitis B infection and presenting multiple poor prognostic factors such as macrovascular invasion/extrahepatic metastasis and alpha-fetoprotein levels ≥400 ng/mL, still achieved outstanding 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 majority of patients in China!”
Chief Medical Officer and Head of Global Product Development, Roche PharmaceuticalsLevi GarrawayThe doctor stated:“Data confirm that in Phase III clinical trials of first-line therapies for currently unresectable hepatocellular carcinoma, the ‘T+A’ regimen demonstrated the longest overall survival. Currently approved in more than 60 countries and regions worldwide, and supported by primary analysis results, ‘T+A’ provides dual improvements in both survival and quality of life for patients, representing a significant advance in the treatment of hepatocellular carcinoma.”
IMbrave150Research
Latest Overall Survival (OS), progression-free survival (PFS), response rate, duration of response (DOR) Data
Global Results
“T+A”Program Team (n=336）
Control Group (n=165）
Median OS (95% CI), unit: months
19.2
(17.0–23.7)
13.4
(11.4–16.9)
OS, HR
(95% CI)
0.66
(0.52–0.85)
“T+A”Protocol Team (n=336）
Control group (n=165）
Median PFS (95% CI), unit: months
6.9
(5.7–8.6)
4.3
(4.0–5.6)
PFS, HR
(95% CI)
0.65
(0.53–0.81)
“T+A”Protocol Group (n=326）
Control Group (n=159）
Confirmed ORR (95% CI) (%)
30%
(25–35)
11%
(7–17)
Complete response, n (%)
25 (8%)
1 (< 1%)
Partial response, n (%)
72 (22%)
17 (11%)
Stable condition, n (%)
144 (44%)
69 (43%)
Still in remission, n (%)
54 (56%)
5 (28%)
“T+A”Protocol Group (n=97）
Control group (n=18）
Median DOR (95% CI), Unit: Month
18.1
(14.6, NE)
14.9
(4.9–17.0)
IMbrave150Study of Chinese SubpopulationsOS
“T+A”Protocol Team (n=133）
Control Group (n=61）
Median OS (95% CI) - Chinese Subgroup
Unit: Month
24.0
(17.1, NE)
11.4
(6.7–16.1)
OS, HR
(95% CI)
0.53
(0.35–0.80)
Control Group: Sorafenib
PFS and all response data were reported following assessment by an independent review committee in accordance with RECIST v1.1.
Median follow-up time: 15.6 months
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