In the IMbrave050 study, the combination of adjuvant atezo (atezolizumab) and bev (bevacizumab) showed a significant and meaningful improvement in recurrence-free survival (RFS) compared to active surveillance in patients who were at high risk of hepatocellular carcinoma (HCC) recurrence after undergoing resection or ablation with curative intent. In addition, the safety profile of the atezo + bev combination was generally manageable. For a study, researchers presented additional patient-reported outcome (PRO) data from the IMbrave050 study.
The IMbrave050 clinical trial (NCT04102098) included patients with hepatocellular carcinoma (HCC) at high risk of recurrence after resection or ablation. The patients were randomly assigned to either Arm A, which received atezo (atezolizumab) plus bev (bevacizumab), or Arm B, which underwent active surveillance. In Arm A, patients received atezo at a dose of 1,200 mg and bev at 15 mg/kg intravenously every three weeks for one year (17 cycles). Patients in Arm B underwent active surveillance for one year and could switch to atezo plus bev after confirmation of recurrence by an independent review facility (IRF). The primary endpoint of the study was recurrence-free survival assessed by the IRF.
Additionally, exploratory analyses were conducted to assess changes from baseline in global health status (GHS), quality of life (QoL), physical role, and emotional and social functioning. Clinically meaningful deterioration was defined as a decrease of 10 points or more. Patients completed the IL42-EORTC QLQ-C30 (reduced) questionnaire at baseline and then at odd treatment/surveillance visits up to Cycle 17.
The analysis’s intention-to-treat (ITT) population consisted of 334 Arms A and B patients. With a median follow-up time of 17.4 months (as of the clinical cutoff date on October 21, 2022), the hazard ratio (HR) for IRF-assessed recurrence-free survival (RFS) was 0.72 (95% CI: 0.56, 0.93; P = 0.0120). Among the safety population, 41% of the 332 patients in Arm A and 13% of the 330 patients in Arm B experienced Grade 3 or 4 adverse events. In the ITT population, the completion rates for the IL42-EORTC QLQ-C30 questionnaire remained above or equal to 93% in both arms from baseline throughout the treatment/surveillance period up to Cycle 17. The mean scores at baseline for the global health status/quality of life (GHS/QoL) and physical, role, emotional, and social functioning scales were high and similar in both arms. The mean changes from baseline were insignificant through Cycle 17 and showed similar results between the arms, as indicated by overlapping 95% CIs. The GHS/QoL and functioning of the patients were maintained through Cycle 17, and no clinically meaningful deterioration was observed at any point in time.
The study showed a significant and meaningful improvement in recurrence-free survival (RFS) for patients receiving atezo (atezolizumab) plus bev (bevacizumab) compared to those on active surveillance. The safety profile of atezo + bev was manageable and consistent with the known safety profiles of both drugs and the underlying disease. Patient-reported outcome (PRO) analyses indicated a similar overall health-related quality of life (HRQoL) and functioning between atezo + bev and active surveillance. The findings suggest that administering adjuvant atezo + bev to high-risk patients with hepatocellular carcinoma (HCC) following curative procedures did not lead to a clinically meaningful deterioration in HRQoL or function.
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