820TiP ENGOT-EN6/GOG-3031/NSGO-CTU-RUBY part 2: A phase III, randomized, double-blind, study of dostarlimab + carboplatin-paclitaxel followed by dostarlimab + niraparib versus placebo (PBO) + carboplatin-paclitaxel followed by PBO in recurrent or advanced endometrial cancer (EC)

Mirza, Mansoor Raza; Coleman, R.L.; Hanker, LC; Slomovitz, Brian M.; Valabrega, Giorgio; DeMars, Leslie R.; Walker, Mya; Duan, Tao; Powell, Morgan A.

doi:10.1016/j.annonc.2021.08.1262

Cited by 10 publications

(5 citation statements)

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“…A therapeutic strategy that seems to be promising in the treatment of primary advanced or recurrent EC is to combine immunotherapy with a PARP inhibitor, as demonstrated by the recent presentation of the first interim results of RUBY Part 2 [30]. This study shows significant and clinically meaningful improvement in PFS for Dostarlimab + chemotherapy followed by Dostarlimab + niraparib in the overall and MMRp/MSS populations.…”

Section: Future Perspectivesmentioning

confidence: 76%

Old Issues and New Perspectives on Endometrial Cancer Therapy: How Molecular Characteristics Are Changing the Therapeutic Pathway

Luvero,

Cundari,

Ficarola

et al. 2024

Cancers

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The Cancer Genome Atlas (TCGA) has radically changed the history of endometrial cancer by outlining a new classification, based on its molecular characteristics. In the field of oncology, we are approaching the new era of molecular biology, particularly regarding endometrial cancer, with the increasing importance of targeted therapy. This paper is a review of phase III randomized controlled trials published in English between January 2019 and December 2023, comparing drugs of interest with standard adjuvant treatment and molecular subtypes in endometrial cancer. The use of immunotherapy alone or in combination with chemotherapy as therapy in patients with recurrent or advanced primary or metastatic endometrial cancer significantly improves the prognosis of these patients. The results show greater efficacy of all proposed treatments for mismatch repair deficiency (dMMR/MSI-H) patients compared to mismatch repair proficiency (pMMR) patients. Progression-free survival (PFS) and overall survival (OS) are better in dMMR patients in all studies analysed. Immunotherapy has the potential to revolutionize the gynaecological cancer treatment landscape, offering a new pathway and new hope for endometrial cancer patients, improving their outcomes in the future. Given the exciting results obtained in dMMR/MSI-H patients, MMR status should be investigated in every patient with advanced endometrial cancer at the time of diagnosis.

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Section: Future Perspectivesmentioning

confidence: 76%

Old Issues and New Perspectives on Endometrial Cancer Therapy: How Molecular Characteristics Are Changing the Therapeutic Pathway

Luvero,

Cundari,

Ficarola

et al. 2024

Cancers

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“…The DUO-E was a 3-arm phase III trial in patients with advanced or recurrent EC, investigating the combination of carboplatin and paclitaxel alongside durvalumab, followed by maintenance treatment with durvalumab with or without olaparib in the first-line setting [57] . In the intention-to-treat analysis, both the durvalumab and the durvalumab plus olaparib arms exhibited statistically significant improvements in PFS compared to the control arm.…”

Section: Icis Plus Parp Inhibitorsmentioning

confidence: 99%

“…Finally, in RUBY part 2, the efficacy and safety of dostarlimab in combination with carboplatin-paclitaxel, followed by dostarlimab and niraparib, was assessed in 291 women diagnosed with recurrent or advanced EC [ 58 ] . With a median follow-up of 19 months, the median PFS was 14.5 months in the dostarlimab-niraparib group compared to 8.3 months in the chemotherapy-alone group (HR 0.60; 95%CI 0.43-0.82; P = 0.0007).…”

Section: Endometrial Cancermentioning

confidence: 99%

The evolving role of immune checkpoint inhibitors in cervical and endometrial cancer

Martinez-Cannon,

Colombo

2024

Cancer Drug Resist

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The introduction of immune checkpoint inhibitors (ICIs) has revolutionized the treatment landscape for numerous tumor types, including cervical and endometrial cancers. Multiple ICIs against programmed cell death-1 (PD-1), programmed death-ligand 1 (PD-L1), and cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) have demonstrated encouraging outcomes in controlled clinical studies for advanced cervical and endometrial cancers. For advanced cervical cancer, approved ICIs as second-line treatment include cemiplimab, nivolumab, and pembrolizumab as single agents. In the first-line treatment setting, options include pembrolizumab alone or in combination with bevacizumab, as well as atezolizumab combined with a backbone platinum-based chemotherapy plus bevacizumab. Additionally, for locally advanced cervical cancer, pembrolizumab is recommended alongside concurrent chemoradiotherapy. For endometrial cancer, pembrolizumab monotherapy, pembrolizumab in combination with lenvatinib, and dostarlimab are currently approved as second-line treatment options. Moreover, either dostarlimab or pembrolizumab can be added to first-line platinum-based chemotherapy for mismatch repair deficient malignancies. Although the inclusion of these agents in clinical practice has led to improved overall response rates and survival outcomes, many patients still lack benefits, possibly due to multiple intrinsic and adaptive resistance mechanisms to immunotherapy. This review aims to highlight the rationale for utilizing ICIs and their current role, while also delineating the proposed mechanisms of resistance to ICIs in cervical and endometrial cancer.

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“…The combination of PARP inhibitor and immunotherapy has also been investigated in part 2 of the RUBY trial which aimed to evaluate the efficacy and safety of dostarlimab plus carboplatin and paclitaxel followed by dostarlimab plus niraparib in around 270 women with advanced (stage III/IV) or recurrent endometrial cancer. 50,59 Of note, part 1 of RUBY demonstrated Immune Checkpoint Inhibitors in Endometrial Cancer: The New Paradigm of Treatment for Advanced and Recurrent Disease healthbook TIMES Oncology Hematology a statistically significant and clinically meaningful improvement in PFS with dostarlimab plus carboplatin and paclitaxel in the dMMR/MSI-H and the overall population versus placebo plus chemotherapy. 42…”

Section: Ongoing Clinical Trials Ruby Part 2: Dostarlimab Plus Chemot...mentioning

confidence: 99%

Immune Checkpoint Inhibitors in Endometrial Cancer: The New Paradigm of Treatment for Advanced and Recurrent Disease

2023

healthbook TIMES Onco Hema

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Endometrial cancer is one of the most prevalent malignancies in women and the prognosis of metastatic and recurrent disease is dismal, with limited treatment options. Molecular classification based on data from the Cancer Genome Atlas (TCGA) project has markedly improved our understanding of the biology of endometrial cancer and accelerated the development of immunotherapy for different disease subtypes. The introduction of immune checkpoint inhibitors (ICIs) has led to major progress in the management of advanced endometrial cancer, especially in biomarker-select populations. Multiple clinical trials have assessed the efficacy and safety of immunotherapy alone or in combination with targeted therapy or chemotherapy in advanced and recurrent endometrial cancer. In this review, we summarize data from recent clinical studies on immunotherapeutic alternatives for advanced and refractory endometrial cancer, with a focus on ICI-based regimens.

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820TiP ENGOT-EN6/GOG-3031/NSGO-CTU-RUBY part 2: A phase III, randomized, double-blind, study of dostarlimab + carboplatin-paclitaxel followed by dostarlimab + niraparib versus placebo (PBO) + carboplatin-paclitaxel followed by PBO in recurrent or advanced endometrial cancer (EC)

Cited by 10 publications

References 0 publications

Old Issues and New Perspectives on Endometrial Cancer Therapy: How Molecular Characteristics Are Changing the Therapeutic Pathway

Old Issues and New Perspectives on Endometrial Cancer Therapy: How Molecular Characteristics Are Changing the Therapeutic Pathway

The evolving role of immune checkpoint inhibitors in cervical and endometrial cancer

Immune Checkpoint Inhibitors in Endometrial Cancer: The New Paradigm of Treatment for Advanced and Recurrent Disease

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