O-6 The novel regimen of tremelimumab in combination with durvalumab provides a favorable safety profile and clinical activity for patients with advanced hepatocellular carcinoma

Kelley, Robin K.; Kudo, Masatoshi; Harris, William Proctor; Ikeda, Masafumi; Okusaka, Takuji; Kang, Yoon‐Koo; Qin, Shukui; Tai, David; Lim, Han Woong; Yau, Tcc; Yong, Wei Peng; Cheng, Ann‐Lii; Gasbarrini, Antonio; Braud, Filippo de; Bruix, Jordi; Borad, Mitesh J.; Standifer, Nathan; He, Peng; Negro, Alejandra; Vlahović, Gordana; Sangro, Bruno; Abou‐Alfa, Ghassan K.

doi:10.1016/j.annonc.2020.04.059

Cited by 12 publications

(13 citation statements)

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“…10). Phase 1/2 trial results suggest that this combination is promising: the response rate with the combination treatment was >2-fold higher (24%) than that with single-agent durvalumab (10.6%) [191]. In addition, OS in the combination arm was longer (18.7 months) than that in the durvalumab monotherapy arm (13.6 months).…”

Section: Clinical Trials Of Icis In Combination With Anti-vegf/tkis Fmentioning

confidence: 99%

Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update

et al. 2021

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The Clinical Practice Manual for Hepatocellular Carcinoma was published based on evidence confirmed by the Evidence-based Clinical Practice Guidelines for Hepatocellular Carcinoma along with consensus opinion among a Japan Society of Hepatology (JSH) expert panel on hepatocellular carcinoma (HCC). Since the JSH Clinical Practice Guidelines are based on original articles with extremely high levels of evidence, expert opinions on HCC management in clinical practice or consensus on newly developed treatments are not included. However, the practice manual incorporates the literature based on clinical data, expert opinion, and real-world clinical practice currently conducted in Japan to facilitate its use by clinicians. Alongside each revision of the JSH Guidelines, we issued an update to the manual, with the first edition of the manual published in 2007, the second edition in 2010, the third edition in 2015, and the fourth edition in 2020, which includes the 2017 edition of the JSH Guideline. This article is an excerpt from the fourth edition of the HCC Clinical Practice Manual focusing on pathology, diagnosis, and treatment of HCC. It is designed as a practical manual different from the latest version of the JSH Clinical Practice Guidelines. This practice manual was written by an expert panel from the JSH, with emphasis on the consensus statements and recommendations for the management of HCC proposed by the JSH expert panel. In this article, we included newly developed clinical practices that are relatively common among Japanese experts in this field, although all of their statements are not associated with a high level of evidence, but these practices are likely to be incorporated into guidelines in the future. To write this article, coauthors from different institutions drafted the content and then critically reviewed each other’s work. The revised content was then critically reviewed by the Board of Directors and the Planning and Public Relations Committee of JSH before publication to confirm the consensus statements and recommendations. The consensus statements and recommendations presented in this report represent measures actually being conducted at the highest-level HCC treatment centers in Japan. We hope this article provides insight into the actual situation of HCC practice in Japan, thereby affecting the global practice pattern in the management of HCC.

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Section: Clinical Trials Of Icis In Combination With Anti-vegf/tkis Fmentioning

confidence: 99%

Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update

et al. 2021

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“…Grade 3/4 adverse events were reported in 28.9% of patients (tremelimumab 300 + durvalumab, 35.1%; tremelimumab 75 + durvalumab, 25.6%; durvalumab, 19.8%; tremelimumab, 42%). The ORR observed were the following: 22.7% for tremelimumab 300 + durvalumab; 9.5% for tremelimumab + durvalumab; 9.6% for durvalumab, and 7.2% for tremelimumab ( 32 ).…”

Section: Immune Checkpoint Inhibitors In Advanced Hccmentioning

confidence: 99%

Immune Checkpoint Inhibitors in the Treatment of HCC

et al. 2021

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Hepatocellular carcinoma (HCC) is the typical inflammation-induced neoplasia. It often prospers where a chronic liver disease persists, thus leading a strong rationale for immune therapy. Several immune-based treatments, including immune checkpoint inhibitors (ICI), cytokines, adoptive cell transfer, and vaccines, have been tested in the treatment of HCC. In this review, we summarize the role of the ICI in HCC patients in various sets of treatment. As for advanced HCC, the anti-Programmed cell Death protein 1 (PD1) antibodies and the anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) antibodies have been examined in patients with enthusiastic results in phase I-II-III studies. Overall, this led the Food and Drug Administration (FDA) to approve pembrolizumab, nivolumab, and nivolumab + ipilimumab in the second-line setting. The anti- Programmed Death-Ligand 1 (PDL-1) antibodies have also been evaluated. Thanks to the results obtained from phase III IMbrave study, atezolizumab + bevacizumab is now the standard of care in the first-line advanced setting of HCC. As for localized HCC, the putative immunological effect of locoregional therapies led to evaluate the combination strategy with ICI. This way, chemoembolization, ablation with radiofrequency, and radioembolization combined with ICI are currently under study. Likewise, the study of adjuvant immunotherapy following surgical resection is underway. In addition, the different ICI has been studied in combination with other ICI as well as with multikinase inhibitors and anti-angiogenesis monoclonal antibody. The evidence available suggests that combining systemic therapies and locoregional treatments with ICI may represent an effective strategy in this context.

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“…Ongoing studies evaluate the efficacy of double immunecheckpoint inhibition using PD-L1 inhibition and CTLA4 inhibition. The NCT02519348 study has shown efficacy and tolerability for the combination of tremelimumab (target: CTLA-4) and durvalumab (target: PD-L1) [ 34 ].…”

Section: Immunological Based Therapies In Hccmentioning

confidence: 99%

Immunmodulatory Treatment Strategies of Hepatocellular Carcinoma: From Checkpoint Inhibitors Now to an Integrated Approach in the Future

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Mayr

Kiesslich

et al. 2021

Cancers

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Background: Hepatocellular carcinoma (HCC) still represents a human tumor entity with very limited therapeutic options, especially for advanced stages. Here, immune checkpoint modulating drugs alone or in combination with local ablative techniques could open a new and attractive therapeutic “door” to improve outcome and response rate for patients with HCC. Methods: Published data on HCC experimental to pre-(clinical) treatment strategies from standard of care to novel immunomodulatory concepts were summarized and discussed in detail. Results: Overall, our knowledge of the role of immune checkpoints in HCC is dramatically increased in the last years. Experimental and pre-clinical findings could be translated to phase 1 and 2 clinical trials and became standard of care. Local ablative techniques of HCC could improve the effectivity of immune checkpoint inhibitors in situ. Conclusions: This review demonstrates the importance of immunomodulatory treatment strategies of HCC, whereby the “best treatment code” of immune checkpoint drugs, combination with ablative techniques and of timing must be evaluated in coming clinical trials.

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O-6 The novel regimen of tremelimumab in combination with durvalumab provides a favorable safety profile and clinical activity for patients with advanced hepatocellular carcinoma

Cited by 12 publications

References 0 publications

Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update

Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update

Immune Checkpoint Inhibitors in the Treatment of HCC

Immunmodulatory Treatment Strategies of Hepatocellular Carcinoma: From Checkpoint Inhibitors Now to an Integrated Approach in the Future

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