ENGOT-EN9/LEAP-001: A phase III, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer

Marth, Christian; Vulsteke, Christof; Rubio, M.J.; Makker, Vicky; Braicu, EI; McNeish, Iain A.; Radosław, Mlak; Ayhan, Ali; Wu, Xin-ai; Dutta, Lea; Xu, Chun; Keefe, Stephen Michael; Lee, J.; Pignata, Sandro

doi:10.1093/annonc/mdz250.071

Cited by 3 publications

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“…Furthermore, the ENGOT-EN9/LEAP-001 study ( ClinicalTrials.gov identifier: NCT03884101) is a phase III, randomized, open-label, active-controlled trial comparing combination therapy with pembrolizumab and lenvatinib to carboplatin and paclitaxel in patients with newly diagnosed stage III–IV or recurrent EC ( Table 2 ). 38 Approximately 720 patients not previously treated with systemic chemotherapy (except as part of a chemoradiation regimen), antiangiogenic agents, PD-1 or PD-L1 inhibitors, or other T-cell receptor-targeted agents will be randomized 1:1 to each arm. Patients will be stratified by pMMR versus dMMR, and pMMR patients will be further stratified by Eastern Cooperative Oncology Group performance status (0 versus 1), measurable disease (yes versus no), and prior chemoradiation (yes versus no).…”

Section: Antiangiogenic Therapy and Immunotherapymentioning

confidence: 99%

“…2). 38 Approximately 720 patients not previously treated with systemic chemotherapy (except as part of a chemoradiation regimen), antiangiogenic agents, PD-1 or PD-L1 inhibitors, or other T-cell receptor-targeted agents will be randomized 1:1 to each arm. Patients will be stratified by pMMR versus dMMR, and pMMR patients will be further stratified by Eastern Cooperative Oncology Group performance status (0 versus 1), measurable disease (yes versus no), and prior chemoradiation (yes versus no).…”

Section: On Gog 229-e Received Prior Radiation Therapy)mentioning

confidence: 99%

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Immunotherapy as a treatment strategy in advanced stage and recurrent endometrial cancer: review of current phase III immunotherapy clinical trials

Eskander

Powell

2021

Ther Adv Med Oncol

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The treatment of advanced stage, metastatic or recurrent endometrial cancer remains a clinically difficult scenario. Although combination carboplatin and paclitaxel is an effective standard-of-care regimen, alternate strategies have shown promise, particularly in biomarker select populations. In an effort to improve oncologic outcomes, investigators are exploring novel immunotherapy combinations. In this review, we discuss the clinical rationale and design of current phase III immuno-oncology clinical trials in patients with advanced stage or recurrent endometrial cancer.

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Section: Antiangiogenic Therapy and Immunotherapymentioning

confidence: 99%

Section: On Gog 229-e Received Prior Radiation Therapy)mentioning

confidence: 99%

Immunotherapy as a treatment strategy in advanced stage and recurrent endometrial cancer: review of current phase III immunotherapy clinical trials

Eskander

Powell

2021

Ther Adv Med Oncol

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Endometrial and Cervical Cancers

Incorvaia

Castellana

Insalaco

et al. 2021

Practical Medical Oncology Textbook

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Expanding therapeutic opportunities for progressive uterine cancer: clinical experience

Кедрова

Красильников

Беришвили

et al. 2022

Opuholi ženskoj reproduktivnoj sistemy

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The incidence of uterine cancer in Russia increased by 28.8 % over the last 10 years. This trend is partly associated with an increasing prevalence of overweight and aging of the female population. Despite the fact that uterine cancer is limited to the uterine body in 84 % of cases, searching for new treatment regimens for patients with progressive disease is still relevant because of their poor outcomes of chemotherapy and high mortality among patients with stage III– IV cancer.The aim of this study was to present our own view on the effectiveness of lenvatinib + pembrolizumab in patients with advanced or recurrent endometrial cancer on the basis of international and own experience.The international experience with lenvatinib + pembrolizumab for advanced endometrial cancer without high microsatellite instability or impairments of DNA repair mechanisms after disease progression following previous systemic therapy showed their efficacy (38.3 %), while the effect lasting more than 6 months was observed in 69 % of cases. We report two cases of progressive uterine cancer in patients who developed complete clinical remission and demonstrated good tolerability of the therapy.

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ENGOT-EN9/LEAP-001: A phase III, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer

Cited by 3 publications

References 0 publications

Immunotherapy as a treatment strategy in advanced stage and recurrent endometrial cancer: review of current phase III immunotherapy clinical trials

Immunotherapy as a treatment strategy in advanced stage and recurrent endometrial cancer: review of current phase III immunotherapy clinical trials

Endometrial and Cervical Cancers

Expanding therapeutic opportunities for progressive uterine cancer: clinical experience

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