Safety and efficacy of durvalumab plus bevacizumab in unresectable hepatocellular carcinoma: Results from the phase 2 study 22 (NCT02519348).

Lim, Ho Yeong; Heo, Jeong; Kim, Tae-You; Tai, Wai Meng David; Kang, Yoon‐Koo; Lau, George; Kudo, Masatoshi; Tak, Won Young; Watras, Magdalena; Ali, S.; Negro, Alejandra; Abou‐Alfa, Ghassan K.; Kelley, Robin Kate

doi:10.1200/jco.2022.40.4_suppl.436

Cited by 4 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A Phase 2 trial evaluated durvalumab and the anti-CTLA-4 monoclonal antibody tremelimumab or durvalumab in combination with tremelimumab or bevacizumab for the treatment of patients with unresectable HCC where the results indicated that combinatorial durvalumab and bevacizumab showed promising clinical safety and efficacy ( 126 ).…”

Section: Targeting Immune Checkpoints For the Treatment Of Hepatocell...mentioning

confidence: 99%

Immune checkpoint inhibitors in the treatment of hepatocellular carcinoma

Akbulut,

Aru,

Aydın

et al. 2024

Front. Immunol.

View full text Add to dashboard Cite

Despite advances in cancer treatment, hepatocellular carcinoma (HCC), the most common form of liver cancer, remains a major public health problem worldwide. The immune microenvironment plays a critical role in regulating tumor progression and resistance to therapy, and in HCC, the tumor microenvironment (TME) is characterized by an abundance of immunosuppressive cells and signals that facilitate immune evasion and metastasis. Recently, anti-cancer immunotherapies, therapeutic interventions designed to modulate the immune system to recognize and eliminate cancer, have become an important cornerstone of cancer therapy. Immunotherapy has demonstrated the ability to improve survival and provide durable cancer control in certain groups of HCC patients, while reducing adverse side effects. These findings represent a significant step toward improving cancer treatment outcomes. As demonstrated in clinical trials, the administration of immune checkpoint inhibitors (ICIs), particularly in combination with anti-angiogenic agents and tyrosine kinase inhibitors, has prolonged survival in a subset of patients with HCC, providing an alternative for patients who progress on first-line therapy. In this review, we aimed to provide an overview of HCC and the role of the immune system in its development, and to summarize the findings of clinical trials involving ICIs, either as monotherapies or in combination with other agents in the treatment of the disease. Challenges and considerations regarding the administration of ICIs in the treatment of HCC are also outlined.

show abstract

Section: Targeting Immune Checkpoints For the Treatment Of Hepatocell...mentioning

confidence: 99%

Immune checkpoint inhibitors in the treatment of hepatocellular carcinoma

Akbulut,

Aru,

Aydın

et al. 2024

Front. Immunol.

View full text Add to dashboard Cite

show abstract

“…Two studies focused on the efficacy and safety of nivolumab, and the remaining one focused on pembrolizumab. A total of seven studies used combination therapy of ICIs and angiogenesis inhibitory monoclonal antibodies (AI mAbs) as the treatment of intervention group [13,[35][36][37][38][39][40]. Three studies examined atezolizumab plus bevacizumab, followed by sintilimab plus IBI305 (n = 1), toripalimab plus bevacizumab (n = 1), ezabenlimab plus BI 836,880 (n = 1), and durvalumab plus bevacizumab (n = 1).…”

Section: Study Drugsmentioning

confidence: 99%

Efficacy and safety of monotherapy and combination therapy of immune checkpoint inhibitors as first-line treatment for unresectable hepatocellular carcinoma: a systematic review, meta-analysis and network meta-analysis

et al. 2022

View full text Add to dashboard Cite

Background Hepatocellular carcinoma (HCC) is one of the cancers with the highest morbidity and mortality. Sorafenib used to be the main treatment for unresectable HCC patients. However, regimens based on immune checkpoint inhibitors (ICIs) have attracted attention in recent years because of their reported benefits. This study aimed to evaluate the efficacy and safety of monotherapy and combination therapy of ICIs as first-line treatment for unresectable HCC patients by conducting a systematic review, meta-analysis, and network meta-analysis. Methods Studies published up to 11st August 2022 were searched from 4 commonly used databases, including PubMed, Web of Science, Embase, and Clinical trials.gov. All eligible clinical trials were included. Data about reported objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and treatment-related adverse events (TRAEs) were extracted. Results Of the 8579 studies retrieved, 24 met the inclusion criteria. In patients with unresectable HCC taking ICIs-based therapy as first-line treatment, the pooled result of median PFS and median OS was 5.76 months (95% CI 4.82–6.69) and 16.35 months (95% CI 15.19–17.51) The ORR and DCR were 25.1% (95% CI 20.8–29.5%) and 75.2% (95% CI 70.3–80.2%) measured by RECIST v1.1 or 40.2% (95% CI 31.7–48.6%) with 75.2% (95% CI 68.3–82.1%) measured by mRECIST v1.1. Compared to sorafenib, ICIs-based therapy significantly prolonged OS. The combination treatment of sintilimab plus IBI305 had the highest ORR, while atezolizumab plus bevacizumab had the highest DCR. The pooled incidence of any grade TRAEs was 82.3% (95% CI 73.9–90.7%), with highest incidence appeared in dysphonia. Conclusions This study demonstrated that first-line ICIs-based therapies could provide survival benefits for patients with unresectable HCC, with manageable TRAEs. The potential of combination treatment to become the new treatment trend in clinical practice is promising.

show abstract

Toripalimab Plus Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Trial

Chen,

Du,

Shen

et al. 2024

Clinical Cancer Research

View full text Add to dashboard Cite

Purpose: This phase II, multicenter, prospective, single-arm study aimed to evaluate the efficacy and safety of toripalimab plus bevacizumab in treating advanced hepatocellular carcinoma (HCC). Patients and methods: Treatment-naïve patients with advanced HCC received toripalimab 240 mg plus bevacizumab 15 mg/kg every 3 weeks. Primary endpoints included safety and tolerability, and objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Results: Fifty-four patients were enrolled between Apr 17, 2020 and Dec 11, 2020. As assessed by the investigator according to RECIST v1.1, the ORR was 31.5% [95% confidence interval (CI), 19.5-45.6] and the lower bound of the 95% CI was above the pre-specified boundary of 10%. The independent review committee (IRC) assessed ORR according to modified RECIST (mRECIST) was 46.3% (95% CI, 32.6-60.4). The median progression-free survival were 8.5 months (95% CI, 5.5-11.0) and 9.8 months (95% CI, 5.6-not evaluable) assessed by the investigator according to RECIST v1.1 and IRC according to mRECIST criteria, respectively. The median overall survival (OS) was not reached, and the 12- and 24-month OS rates were 77.3% and 63.5%, respectively. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 27 patients (50.0%). The most common TEAEs were proteinuria (59.3%), hypertension (38.9%), aspartate aminotransferase increased (33.3%), amylase increased (29.6%), platelet count decreased (27.8%), and bilirubin increased (27.8%). Conclusions: Toripalimab plus bevacizumab showed a favorable efficacy and safety profile, supporting further studies of this combination regimen as a first-line treatment of advanced HCC.

show abstract

Safety and efficacy of durvalumab plus bevacizumab in unresectable hepatocellular carcinoma: Results from the phase 2 study 22 (NCT02519348).

Cited by 4 publications

References 0 publications

Immune checkpoint inhibitors in the treatment of hepatocellular carcinoma

Immune checkpoint inhibitors in the treatment of hepatocellular carcinoma

Efficacy and safety of monotherapy and combination therapy of immune checkpoint inhibitors as first-line treatment for unresectable hepatocellular carcinoma: a systematic review, meta-analysis and network meta-analysis

Toripalimab Plus Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Trial

Contact Info

Product

Resources

About