{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T15:19:19Z","timestamp":1759331959874},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2023,8,9]],"date-time":"2023-08-09T00:00:00Z","timestamp":1691539200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,9]],"date-time":"2023-08-09T00:00:00Z","timestamp":1691539200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Invest New Drugs"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:p>Second-line treatment of endometrial cancer is an unmet medical need. Lurbinectedin showed promising antitumor activity in a phase I study in combination with doxorubicin in advanced endometrial cancer. This phase 2 Basket trial evaluated lurbinectedin 3.2 mg\/m<jats:sup>2<\/jats:sup> 1-h intravenous infusion every 3 weeks in a cohort of 73 patients with pretreated endometrial cancer. The primary endpoint was overall response rate (ORR) according to RECIST v1.1. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and an exploratory translational study. Confirmed complete (CR) and partial response (PR) was reported in two and six patients, respectively (ORR = 11.3%; 95%CI, 5.0\u201321.0%). Median DoR was 9.2 months (95%CI, 3.4\u201318.0 months), median PFS was 2.6 months (95%CI, 1.4\u20134.0 months) and median OS was 9.3 months (95%CI, 6.1\u201312.8 months). Molecular subtypes showed differences in PFS rate at 6 months (p53abn 23.7% <jats:italic>vs.<\/jats:italic> \u201cNo Specific Molecular Profile\u201d [NSMP] 42.9%) and median OS (p53abn 6.6 months <jats:italic>vs.<\/jats:italic> NSMP 16.1 months). The most common treatment-related adverse events (mostly grade 1\/2) were fatigue (54.8% of patients), nausea (50.7%), vomiting (26.0%) decreased appetite (17.8%). and constipation, (19.2%). The most common grade 3\/4 toxicity was neutropenia (43.8%; grade 4, 19.2%; febrile neutropenia, 4.1%). In conclusion, considering the exploratory aim of this trial and the hints of antitumor activity observed together with a predictable and manageable safety profile, further biomarker-based development of lurbinectedin is recommended in this indication in combination with other agents. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/\">Clinicaltrials.gov<\/jats:ext-link> identifier: NCT02454972.<\/jats:p>","DOI":"10.1007\/s10637-023-01383-2","type":"journal-article","created":{"date-parts":[[2023,8,9]],"date-time":"2023-08-09T07:01:46Z","timestamp":1691564506000},"page":"677-687","update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study"],"prefix":"10.1007","volume":"41","author":[{"given":"Rebecca","family":"Kristeleit","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Leary","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean Pierre","family":"Delord","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Moreno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Oaknin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Castellano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geoffrey I.","family":"Shappiro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristian","family":"Fern\u00e1ndez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Kahatt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicente","family":"Alfaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariano","family":"Siguero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Rueda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali","family":"Zeaiter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmad","family":"Awada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Santaballa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khalil","family":"Zaman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jalid","family":"Sehouli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vivek","family":"Subbiah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,8,9]]},"reference":[{"key":"1383_CR1","doi-asserted-by":"publisher","first-page":"209","DOI":"10.3322\/caac.21660","volume":"71","author":"H Sung","year":"2021","unstructured":"Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F (2021) Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71:209\u2013249","journal-title":"CA Cancer J Clin"},{"key":"1383_CR2","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1038\/nature12113","volume":"497","author":"C Kandoth","year":"2013","unstructured":"Cancer Genome Atlas Research N, Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA (2013) Integrated genomic characterization of endometrial carcinoma. Nature 497:67\u201373","journal-title":"Nature"},{"key":"1383_CR3","doi-asserted-by":"publisher","first-page":"802","DOI":"10.1002\/cncr.30496","volume":"123","author":"A Talhouk","year":"2017","unstructured":"Talhouk A, McConechy MK, Leung S, Yang W, Lum A, Senz J, Boyd N, Pike J, Anglesio M, Kwon JS, Karnezis AN, Huntsman DG, Gilks CB, McAlpine JN (2017) Confirmation of ProMisE: a simple, genomics-based clinical classifier for endometrial cancer. Cancer 123:802\u2013813","journal-title":"Cancer"},{"key":"1383_CR4","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1136\/ijgc-2022-003675","volume":"33","author":"H Mahdi","year":"2023","unstructured":"Mahdi H, Chelariu-Raicu A, Slomovitz BM (2023) Immunotherapy in endometrial cancer. Int J Gynecol Cancer 33:351\u2013357","journal-title":"Int J Gynecol Cancer"},{"key":"1383_CR5","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1158\/1535-7163.MCT-16-0172","volume":"15","author":"G Santamaria Nunez","year":"2016","unstructured":"Santamaria Nunez G, Robles CM, Giraudon C, Martinez-Leal JF, Compe E, Coin F, Aviles P, Galmarini CM, Egly JM (2016) Lurbinectedin specifically triggers the degradation of phosphorylated RNA polymerase II and the formation of DNA breaks in cancer cells. Mol Cancer Ther 15:1\u201314","journal-title":"Mol Cancer Ther"},{"key":"1383_CR6","doi-asserted-by":"publisher","first-page":"1099","DOI":"10.1111\/j.1476-5381.2010.00945.x","volume":"161","author":"JF Leal","year":"2010","unstructured":"Leal JF, Martinez-Diez M, Garcia-Hernandez V, Moneo V, Domingo A, Bueren-Calabuig JA, Negri A, Gago F, Guillen-Navarro MJ, Aviles P, Cuevas C, Garcia-Fernandez LF, Galmarini CM (2010) PM01183, a new DNA minor groove covalent binder with potent in vitro and in vivo anti-tumour activity. Br J Pharmacol 161:1099\u20131110","journal-title":"Br J Pharmacol"},{"key":"1383_CR7","doi-asserted-by":"publisher","first-page":"6657","DOI":"10.1158\/0008-5472.CAN-16-0568","volume":"76","author":"ML Harlow","year":"2016","unstructured":"Harlow ML, Maloney N, Roland J, Guillen Navarro MJ, Easton MK, Kitchen-Goosen SM, Boguslawski EA, Madaj ZB, Johnson BK, Bowman MJ, D\u2019Incalci M, Winn ME, Turner L, Hostetter G, Galmarini CM, Aviles PM, Grohar PJ (2016) Lurbinectedin inactivates the ewing sarcoma oncoprotein EWS-FLI1 by redistributing it within the nucleus. Cancer Res 76:6657\u20136668","journal-title":"Cancer Res"},{"key":"1383_CR8","doi-asserted-by":"publisher","first-page":"645","DOI":"10.1016\/S1470-2045(20)30068-1","volume":"21","author":"J Trigo","year":"2020","unstructured":"Trigo J, Subbiah V, Besse B, Moreno V, L\u00f3pez R, Sala MA, Peters S, Ponce S, Fern\u00e1ndez C, Alfaro V, G\u00f3mez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Mart\u00ednez M, Delord J-P, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D\u2019Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L (2020) Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol 21:645\u2013654","journal-title":"Lancet Oncol"},{"key":"1383_CR9","doi-asserted-by":"publisher","first-page":"2378","DOI":"10.1158\/1078-0432.CCR-20-3901","volume":"27","author":"S Singh","year":"2021","unstructured":"Singh S, Jaigirdar AA, Mulkey F, Cheng J, Hamed SS, Li Y, Liu J, Zhao H, Goheer A, Helms WS, Wang X, Agarwal R, Pragani R, Korsah K, Tang S, Leighton J, Rahman A, Beaver JA, Pazdur R, Theoret MR, Singh H (2021) FDA approval summary: lurbinectedin for the treatment of metastatic small cell lung cancer. Clin Cancer Res 27:2378\u20132382","journal-title":"Clin Cancer Res"},{"key":"1383_CR10","doi-asserted-by":"publisher","first-page":"2762","DOI":"10.1158\/1078-0432.CCR-22-0696","volume":"28","author":"V Subbiah","year":"2022","unstructured":"Subbiah V, Brana I, Longhi A, Boni V, Delord JP, Awada A, Boudou-Rouquette P, Sarantopoulos J, Shapiro GI, Elias A, Ratan R, Fernandez C, Kahatt C, Cullell-Young M, Siguero M, Zeaiter A, Chawla SP (2022) Antitumor activity of lurbinectedin, a selective inhibitor of oncogene transcription, in patients with relapsed ewing sarcoma: results of a basket phase II study. Clin Cancer Res 28:2762\u20132770","journal-title":"Clin Cancer Res"},{"key":"1383_CR11","doi-asserted-by":"publisher","first-page":"1428","DOI":"10.1136\/ijgc-2021-002881","volume":"31","author":"R Kristeleit","year":"2021","unstructured":"Kristeleit R, Moreno V, Boni V, Guerra EM, Kahatt C, Romero I, Calvo E, Baste N, Lopez-Vilarino JA, Siguero M, Alfaro V, Zeaiter A, Forster M (2021) Doxorubicin plus lurbinectedin in patients with advanced endometrial cancer: results from an expanded phase I study. Int J Gynecol Cancer 31:1428\u20131436","journal-title":"Int J Gynecol Cancer"},{"key":"1383_CR12","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1016\/j.ygyno.2015.04.026","volume":"138","author":"S McMeekin","year":"2015","unstructured":"McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I (2015) Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol 138:18\u201323","journal-title":"Gynecol Oncol"},{"key":"1383_CR13","doi-asserted-by":"publisher","first-page":"5503","DOI":"10.1200\/JCO.2018.36.15_suppl.5503","volume":"36","author":"DS Miller","year":"2018","unstructured":"Miller DS, Scambia G, Bondarenko I, Westermann AM, Oaknin A, Oza AM, Lisyanskaya AS, Vergote I, Wenham RM, Temkin SM, Gabra H (2018) ZoptEC: Phase III randomized controlled study comparing zoptarelin with doxorubicin as second line therapy for locally advanced, recurrent, or metastatic endometrial cancer (NCT01767155). J Clin Oncol 36:5503\u20135503","journal-title":"J Clin Oncol"},{"key":"1383_CR14","doi-asserted-by":"publisher","first-page":"5586","DOI":"10.1200\/JCO.2017.35.15_suppl.5586","volume":"35","author":"MD Forster","year":"2017","unstructured":"Forster MD, Moreno V, Boni V, Guerra E, Poveda A, Kristeleit R, Kahatt CM, Lardelli P, Vilarino JAL, Cuevas NM, Soto-Matos A, Calvo E (2017) Activity of lurbinectedin (PM01183) as single agent and in combination in patients with endometrial cancer. J Clin Oncol 35:5586\u20135586","journal-title":"J Clin Oncol"},{"key":"1383_CR15","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/j.ejca.2008.10.026","volume":"45","author":"EA Eisenhauer","year":"2009","unstructured":"Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228\u2013247","journal-title":"Eur J Cancer"},{"key":"1383_CR16","doi-asserted-by":"publisher","first-page":"471","DOI":"10.1097\/CCO.0000000000000658","volume":"32","author":"A Oaknin","year":"2020","unstructured":"Oaknin A, Leon-Castillo A, Lorusso D (2020) Progress in the management of endometrial cancer (subtypes, immunotherapy, alterations in PIK3CA pathway): data and perspectives. Curr Opin Oncol 32:471\u2013480","journal-title":"Curr Opin Oncol"},{"key":"1383_CR17","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1136\/ijgc-2020-002230","volume":"31","author":"N Concin","year":"2021","unstructured":"Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O\u2019Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL (2021) ESGO\/ESTRO\/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer 31:12\u201339","journal-title":"Int J Gynecol Cancer"},{"key":"1383_CR18","doi-asserted-by":"publisher","first-page":"3514","DOI":"10.1200\/JCO.2020.38.15_suppl.3514","volume":"38","author":"SP Aix","year":"2020","unstructured":"Aix SP, Cote GM, Gonzalez AF, Sepulveda JM, Aguilar EJ, Sanchez-Simon I, Flor MJ, Nu\u00f1ez R, Gonzalez EM, Insa M, Siguero M, Cullell-Young M, Kahatt CM, Zeaiter AH, Paz-Ares LG (2020) Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors: updated results from a phase Ib-II trial. J Clin Oncol 38:3514\u20133514","journal-title":"J Clin Oncol"},{"issue":"Suppl 1","key":"1383_CR19","doi-asserted-by":"publisher","first-page":"S123","DOI":"10.1097\/PGP.0000000000000488","volume":"38","author":"M Kobel","year":"2019","unstructured":"Kobel M, Ronnett BM, Singh N, Soslow RA, Gilks CB, McCluggage WG (2019) Interpretation of P53 immunohistochemistry in endometrial carcinomas: toward increased reproducibility. Int J Gynecol Pathol 38(Suppl 1):S123\u2013S131","journal-title":"Int J Gynecol Pathol"},{"key":"1383_CR20","unstructured":"National Comprehensive Cancer Network (2022) NCCN clinical practice guidelines in oncology (NCCN Guidelines): uterine neoplasms. Version 1.2022 \u2013 November 4, 2021. http:\/\/www.nccn.org\/professionals\/default.aspx. Accessed 22 March 2023"},{"key":"1383_CR21","doi-asserted-by":"crossref","unstructured":"Makker V, Herraez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim Y, Guerra E, Sanli U, McCormack M, Huang J, Smith A, Keefe S, Dutta L, Orlowski R, Lorusso D (2021) A multicenter, open-label, randomized, phase 3 study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab vs treatment of physician\u2019s choice in patients with advanced endometrial cancer. Study 309\/KEYNOTE-775 Society of Gynecologic Oncology 2021 Annual Meeting on Women\u2019s Cancer. Abstract 11512","DOI":"10.1016\/S0090-8258(21)00657-0"},{"key":"1383_CR22","doi-asserted-by":"publisher","first-page":"3134","DOI":"10.1200\/JCO.2018.78.6558","volume":"36","author":"C Cruz","year":"2018","unstructured":"Cruz C, Llop-Guevara A, Garber JE, Arun BK, Perez Fidalgo JA, Lluch A, Telli ML, Fernandez C, Kahatt C, Galmarini CM, Soto-Matos A, Alfaro V, Perez de la Haza A, Domchek SM, Antolin S, Vahdat L, Tung NM, Lopez R, Arribas J, Vivancos A, Baselga J, Serra V, Balmana J, Isakoff SJ (2018) Multicenter phase II study of lurbinectedin in BRCA-mutated and unselected metastatic advanced breast cancer and biomarker assessment substudy. J Clin Oncol 36:3134\u20133143","journal-title":"J Clin Oncol"},{"key":"1383_CR23","doi-asserted-by":"publisher","first-page":"340","DOI":"10.1016\/j.ejca.2022.06.024","volume":"172","author":"F Longo-Mu\u00f1oz","year":"2022","unstructured":"Longo-Mu\u00f1oz F, Castellano D, Alexandre J, Chawla SP, Fern\u00e1ndez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-Garc\u00eda E, Awada A, Santaballa A, Subbiah V (2022) Lurbinectedin in patients with pretreated neuroendocrine tumours: results from a phase II basket study. Eur J Cancer 172:340\u2013348","journal-title":"Eur J Cancer"},{"key":"1383_CR24","doi-asserted-by":"publisher","first-page":"1280","DOI":"10.1093\/annonc\/mdx111","volume":"28","author":"A Poveda","year":"2017","unstructured":"Poveda A, Del Campo JM, Ray-Coquard I, Alexandre J, Provansal M, Guerra Alia EM, Casado A, Gonzalez-Martin A, Fernandez C, Rodriguez I, Soto A, Kahatt C, Fernandez Teruel C, Galmarini CM, Perez de la Haza A, Bohan P, Berton-Rigaud D (2017) Phase II randomized study of PM01183 versus topotecan in patients with platinum-resistant\/refractory advanced ovarian cancer. Ann Oncol 28:1280\u20131287","journal-title":"Ann Oncol"},{"key":"1383_CR25","doi-asserted-by":"publisher","first-page":"237","DOI":"10.1016\/j.ygyno.2021.08.032","volume":"163","author":"S Gaillard","year":"2021","unstructured":"Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O\u2019Malley DM, Benjamin I, Pautier P, Lorusso D (2021) Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: a multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol 163:237\u2013245","journal-title":"Gynecol Oncol"},{"key":"1383_CR26","doi-asserted-by":"publisher","first-page":"2145","DOI":"10.1056\/NEJMoa2216334","volume":"388","author":"MR Mirza","year":"2023","unstructured":"Mirza MR, Chase DM, Slomovitz BM, dePont CR, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA, Investigators R (2023) Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med 388:2145\u20132158","journal-title":"N Engl J Med"},{"key":"1383_CR27","doi-asserted-by":"publisher","first-page":"2159","DOI":"10.1056\/NEJMoa2302312","volume":"388","author":"RN Eskander","year":"2023","unstructured":"Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel R, Shahin MS, Cantuaria GH, Girda E, Mathews C, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O\u2019Cearbhaill RE, Al Baghdadi T, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C (2023) Pembrolizumab plus chemotherapy in advanced endometrial cancer. N Engl J Med 388:2159\u20132170","journal-title":"N Engl J Med"},{"key":"1383_CR28","doi-asserted-by":"publisher","first-page":"752","DOI":"10.1200\/JCO.21.01874","volume":"40","author":"DM O'Malley","year":"2022","unstructured":"O\u2019Malley DM, Bariani GM, Cassier PA, Marabelle A, Hansen AR, De Jesus AA, Miller WH Jr, Safra T, Italiano A, Mileshkin L, Xu L, Jin F, Norwood K, Maio M (2022) Pembrolizumab in patients with microsatellite instability-high advanced endometrial cancer: results from the KEYNOTE-158 study. J Clin Oncol 40:752\u2013761","journal-title":"J Clin Oncol"},{"key":"1383_CR29","doi-asserted-by":"publisher","first-page":"e003777","DOI":"10.1136\/jitc-2021-003777","volume":"10","author":"A Oaknin","year":"2022","unstructured":"Oaknin A, Gilbert L, Tinker AV, Brown J, Mathews C, Press J, Sabatier R, O\u2019Malley DM, Samouelian V, Boni V, Duska L, Ghamande S, Ghatage P, Kristeleit R, Leath C III, Guo W, Im E, Zildjian S, Han X, Duan T, Veneris J, Pothuri B (2022) Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient\/microsatellite instability-high (dMMR\/MSI-H) or proficient\/stable (MMRp\/MSS) endometrial cancer: interim results from GARNET-a phase I, single-arm study. J Immunother Cancer 10:e003777","journal-title":"J Immunother Cancer"},{"key":"1383_CR30","doi-asserted-by":"publisher","first-page":"2904","DOI":"10.1200\/JCO.22.02152","volume":"41","author":"V Makker","year":"2023","unstructured":"Makker V, Colombo N, Herraez AC, Monk BJ, Mackay H, Santin AD, Miller DS, Moore RG, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim YM, Guerra Alia EM, Sanli UA, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, Lorusso D (2023) Lenvatinib plus pembrolizumab in previously treated advanced endometrial cancer: updated efficacy and safety from the randomized phase III study 309\/KEYNOTE-775. J Clin Oncol 41:2904\u20132910","journal-title":"J Clin Oncol"}],"container-title":["Investigational New Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-023-01383-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10637-023-01383-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-023-01383-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,7]],"date-time":"2023-10-07T11:04:00Z","timestamp":1696676640000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10637-023-01383-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,9]]},"references-count":30,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["1383"],"URL":"https:\/\/doi.org\/10.1007\/s10637-023-01383-2","relation":{},"ISSN":["0167-6997","1573-0646"],"issn-type":[{"value":"0167-6997","type":"print"},{"value":"1573-0646","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,9]]},"assertion":[{"value":"20 April 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 July 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 August 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All procedures performed were in accordance with the ethical standards of the institutional and\/or national research committees, and with the Declaration of Helsinki or comparable ethical standards.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all patients included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Alexandra Leary has grants or contracts from Agenus, Astra Zeneca, BMS, GSK, Iovance, MSD, OSE Immuno, Roche as principal investigator in clinical trials and from ARCAGY-GYENCO, AZ, Sanofi for translational research; has payment as invited speaker from Astra Zeneca, Clovis, GSK, Kephren publishing, Medscape; payment for consultancy from GLG and Orion, and payment for writing engagement from Onko+; has participation in Advisory Boards from Ability Pharma, Apmonia, Astra Zeneca, Blueprint, Clovis, GSK, Merck Serono, MSD, Tesaro and Zentaris; has participation in a steering committee from MSD; was IDMC member or chair for Clovis and Pfizer; and participated in an Academic Research Project for LX Repair and Owkin. Ana Oaknin has grants or contracts from Abbvie Deutschland Gmbh & Co Hg, Ability Pharmaceuticals, Advaxis, Agenus, Aprea Therapeutics AB, Astrazeneca AB, Beigene USA, Inc., Belgian Gynaecological Oncology Group (BGOG), Bristol\u2010Myers Squibb International Corporation (BMSM Clovis Oncology, Corcept Therapeutics, Eisai, F. Hoffmann\u2010La Roche, Grupo Espa\u00f1ol de Investigaci\u00f3n en C\u00e1ncer de Ovario (GEICO), Immunogen, Iovance Biotherapeutics, Lilly, Medimmune, Merck Healthcare, Merck Sharp & dohme, Millennium Pharmaceuticals, Mundipharma Research, Novartis Farmac\u00e9utica, Regeneron Pharmaceuticals, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, University Health Network, and Werastem; has payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from ESMO, Edizioni Minerva Medica SpA and Doctaforum Servicios S.L.; has support for attending meetings and\/or travel from AstraZeneca; Clovis Oncology; PharmaMar, and Roche; and participation on a Data Safety Monitoring Board or Advisory Board from Agenus, AstraZeneca, Clovis Oncology, Inc., Corcept Therapeutics, Deciphera Pharmaceutical, Eisai Europe Limited, EMD Serono, Inc., F. Hoffmann\u2010La Roche, GlaxoSmithKline, Immunogen, KL Logistics, Medison Pharma, Merck Sharp & Dohme de Espa\u00f1a, Mersana Therapeutics, Novocure GmbH, Pharma Mar, prIME Oncology, ROCHE FARMA, Sattucklabs, and Sutro Biopharma, Inc., as well as participation to non\u2010remunerated activities and non\u2010remunerated leadership roles for GCIC and GEICO. Daniel Castellano have payment for Advisory Board or Expert Opinion from Pfizer, Roche, BMS, MSD, Astellas, Astra Zeneca, Novartis, Gilead, Ipsen, Pierre Fabre, Sanofi, Eisai, Janssen and GSK. Geoffrey. I. Shappiro has payment to Dana-Farber Cancer Institute from PharmaMar for conduct of the clinical trial; has sponsored research agreement with payment to DFCI from Merck KGaA\/EMD-Serono, Merck & Co. and Lilly; has funding for investigator-initiated clinical trials to DFCI from Pfizer; consulting fees from XinThera, Inc.; has patent issued to Cyclacel Pharmaceuticals and Geoffrey I. Shapiro for dosage regimen for sapacitabine and seliciclib, and pending to Liam Cornell and Geoffrey I. Shapiro for compositions and methods for predicting response and resistance to CDK4\/6 inhibition; and has participation on advisory boards for Pfizer, Eli Lilly, Merck KGaA\/EMD-Serono, Bicycle Therapeutics, Fusion Pharmaceuticals, Cybrexa Therapeutics, Bayer, Boehringer Ingelheim, ImmunoMet, Asana, Artios, Atrin, Concarlo Holdings, Syros, Zentalks, CytomX Therapeutics, Blueprint Medicines, Kymera Therapeutics, and Janssen. Cristian Fern\u00e1ndez, Carmen Kahatt, Vicente Alfaro, Mariano Siguero, Daniel Rueda and Ali Zeaiter have personal fees for salary as full time employee from PharmaMar S.A. Cristian Fern\u00e1ndez, Carmen Kahatt, Vicente Alfaro, Daniel Rueda and Ali Zeaiter are stock ownership of PharmaMar S.A. Ahmad Awada has advisory role with Amgen, AstraZeneca, Bayer, Daiichi, EISAI, Genomic Health, Hengrui, Innate, Ipsen, Leo Pharma, Lilly, Merck, MSD, Novartis, Pfizer and Seattle Genetics; has speaker fees with Amgen, AstraZeneca, Bayer, Daiichi, EISAI, Genomic Health, Ipsen, Leo Pharma, Lilly, Merck, MSD, Novartis, Pfizer and Seattle Genetics; and has research grants to his Institute by BSM and Roche. Vivek Subbiah received grants from PharmaMar, Eli Lilly\/LOXO Oncology, Blueprint Medicines Corporation, Turning PointTherapeutics and Boston Pharmaceuticals; and grants fromHelsinn Pharmaceuticals during the conduct of the study; in addition, Vivek Subbiah received a grant and advisory board\/consultant position with Eli Lilly\/Loxo Oncology during the conduct of the study; research grants from Roche\/Genentech, Bayer, GlaxoSmithKline, Nanocarrier, Vegenics, Celgene, Northwest Biotherapeutics, Berghealth, Incyte, Fujifilm, D3, Pfizer, Multivir, Amgen, AbbVie, Alfa-sigma, Agensys, Boston Biomedical, Idera Pharma, Inhibrx, Exelixis, Blueprint Medicines, Altum, Dragonfly Therapeutics, Takeda, National Comprehensive Cancer Network, NCI-CTEP, University of Texas MD Anderson Cancer Center, Turning Point Therapeutics, Boston Pharmaceuticals, Novartis, PharmaMar and Medimmune; an advisory board\/consultant position with Helsinn, Incyte, QED Pharma, Daiichi-Sankyo, Signant Health, Novartis, Relay therapeutics, Roche and Medimmune; travel funds from PharmaMar, Incyte, ASCO, ESMO; and other support from Medscape, all outside the submitted work. The remaining authors made no disclosures.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}