Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: Safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial

Boilève, Alice; Hilmi, Marc; Paul, Gesine; Cohen, Romain; Rousseau, Benoît; Blanc, Jean‐Frédéric; Abdelghani, Méher Ben; Castanie, Hélène; Dahan, Laétitia; Tougeron, David; Metges, Jean-Philippe; Tournigand, Christophe; Garcia-Larnicol, Marie-Line; Vernerey, Déwi; Turpin, Anthony; Neuzillet, Cindy

doi:10.1016/j.ejca.2020.10.027

Cited by 37 publications

(22 citation statements)

References 24 publications

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“…The electronic search identified 267 articles; after exclusion of duplicates, irrelevant articles, reviews, and papers not in English or with missing data, 19 articles were finally included for revision [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]. Figure 1 depicts a flowchart describing the details of the document screening process, while Table 1 reports the principal details of the articles finally selected.…”

Section: Resultsmentioning

confidence: 99%

“…These malignancies are again characterized by extremely high mortality rates, and only a few therapeutic options are currently available for patients affected by advanced stage disease. Active research is currently ongoing to identify novel targeted therapies and immunotherapeutic agents in this setting [81][82][83][84][85][86] The IMMUNOBIL PRODIGE 57 trial was designed to evaluate the efficacy and safety of durvalumab plus tremelimumab, with or without paclitaxel, in patients with advanced BTC after failure of platinum-based chemotherapy [28]. Twenty patients in total, 10 in each arm, were enrolled.…”

Section: Durvalumab Plus Tremelimumab In Gastrointestinal Tumorsmentioning

confidence: 99%

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Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review

et al. 2021

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Introduction: Cancer immunotherapy represents one of the most important innovations in modern medicine. Durvalumab is an anti-programmed cell death ligand 1 (PDL-1) agent which is currently under investigation in several studies in combination with the anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) drug tremelimumab. The aim of this review was to systematically identify and revise the current scientific literature investigating the combination of these two drugs in solid tumors. Methods: A digital search on the Medline (PubMed interface) and Scopus databases for articles published from inception to 26 February 2021 was performed. The terms used for the search were durvalumab AND tremelimumab. Trials reported in English involving adult patients with solid cancers treated with the combination durvalumab plus tremelimumab were retrieved; the references of the articles were cross-checked to identify missing papers. Results: The electronic search produced 267 results; after exclusion of duplicates, irrelevant articles, reviews, and papers not in English or missing data, 19 articles were included for revision. The total number of patients treated with the combination of durvalumab and tremelimumab in the studies retrieved was 2052. Conclusion:The combination of durvalumab plus tremelimumab showed some oncological advantages in comparison with traditional chemotherapies in some subsets of tumors, but generally has not shown consistent advantages in comparison with the employment of durvalumab monotherapy. A number of the studies examined had intrinsic methodological limitations; therefore, future well-designed studies involving larger cohorts are warranted.

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Section: Resultsmentioning

confidence: 99%

Section: Durvalumab Plus Tremelimumab In Gastrointestinal Tumorsmentioning

confidence: 99%

Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review

et al. 2021

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“…There are a large number of ongoing prospective studies for biliary tract cancer [ 86 , 87 , 88 , 89 , 90 , 91 ]. Based on promising early-phase study results, phase III studies are underway [ 92 , 93 , 94 ]. A list of major ongoing randomized controlled studies for biliary tract cancer is provided in Table 4 .…”

Section: Ongoing Clinical Trials For Biliary Tract Cancermentioning

confidence: 99%

Chemotherapy for Biliary Tract Cancer in 2021

Sasaki

Takeda

Okamoto

et al. 2021

JCM

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Biliary tract cancer refers to a group of malignancies including cholangiocarcinoma, gallbladder cancer, and ampullary cancer. While surgical resection is considered the only curative treatment, postoperative recurrence can sometimes occur. Adjuvant chemotherapy is used to prolong prognosis in some cases. Many unresectable cases are also treated with chemotherapy. Therefore, systemic chemotherapy is widely introduced for the treatment of biliary tract cancer. Evidence on chemotherapy for biliary tract cancer is recently on the increase. Combination chemotherapy with gemcitabine and cisplatin is currently the standard of care for first-line chemotherapy in advanced cases. Recently, FOLFOX also demonstrated efficacy as a second-line treatment. In addition, efficacies of isocitrate dehydrogenase inhibitors and fibroblast growth factor receptor inhibitors have been shown. In the adjuvant setting, capecitabine monotherapy has become the standard of care in Western countries. In addition to conventional cytotoxic agents, molecular-targeted agents and immunotherapy have been evaluated in multiple clinical trials. Genetic testing is used to check for genetic alterations and molecular-targeted agents and immunotherapy are introduced based on tumor characteristics. In this article, we review the latest evidence of chemotherapy for biliary tract cancer.

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“…A phase 3 study also established atezolizumab + bevacizumab, the new standard first-line therapy in advanced HCC (11). Biliary tract cancers (BTCs) were also included in phase 2 studies investigating ICIs; however, preliminary data were unsatisfactory, with few response rates and median PFS and OS not reported (9,17,21,22). ICIs (anti-PD1 and anti-CTLA4) was associated with a median OS of 16.6 months.…”

Section: Hepatobiliary Cancersmentioning

confidence: 99%

Efficacy of Immune Checkpoint Inhibitors in Rare Tumours: A Systematic Review

et al. 2021

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BackgroundRare cancers, as defined by the European Union, occur in fewer than 15 out of 100,000 people each year. The International Rare Cancer Consortium defines rare cancer incidence as less than six per 100,000 per year. There is a growing number of reports of the efficacy of immune checkpoint inhibitor (ICI) therapy in patients with rare tumours, and hence, we conducted a comprehensive review to summarise and analyse the available literature.MethodsA literature search of PubMed was performed on January 31, 2021, using the following ICI names as keywords: ipilimumab, tremelimumab, cemiplimab, nivolumab, pembrolizumab, avelumab, atezolizumab, and durvalumab. Studies on patients with rare tumours who were being treated with ICIs were included. We plotted the overall response rate against the corresponding median survival across a variety of cancer types using linear regression.ResultsFrom 1,255 publications retrieved during the primary search, 62 publications were selected (with a total of 4,620 patients). Only four were randomised trials. A minority were first-line studies, while the remaining were studies in which ICIs were delivered as salvage therapy in pretreated patients. There was a good correlation between response rate and overall survival (Spearman R2 >0.9) in skin cancers, mesothelioma, and sarcomas.ConclusionsTreatment of advanced-stage rare tumours with ICI therapy was found to be associated with significant activity in some orphan diseases (e.g., Merkel cell carcinoma) and hepatocellular carcinoma. Several ongoing prospective clinical trials will expand the knowledge on the safety and efficacy of ICI therapy in patients with these rare cancers.

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Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: Safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial

Cited by 37 publications

References 24 publications

Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review

Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review

Chemotherapy for Biliary Tract Cancer in 2021

Efficacy of Immune Checkpoint Inhibitors in Rare Tumours: A Systematic Review

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