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MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum

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Harvard

Monk, BJ, Grisham, RN, Banerjee, S, Kalbacher, E, Mirza, MR, Romero, I, Vuylsteke, P, Coleman, RL, Hilpert, F, Oza, AM, Westermann, A, Oehler, MK, Pignata, S, Aghajanian, C, Colombo, N, Drill, E, Cibula, D, Moore, KN, Christy-Bittel, J, Del Campo, JM, Berger, R, Marth, C, Sehouli, J, O'Malley, DM, Churruca, C, Boyd, AP, Kristensen, G, Clamp, A, Ray-Coquard, I & Vergote, I 2020, 'MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, bind 38, nr. 32, s. 3753-3762. https://doi.org/10.1200/JCO.20.01164

APA

Monk, B. J., Grisham, R. N., Banerjee, S., Kalbacher, E., Mirza, M. R., Romero, I., Vuylsteke, P., Coleman, R. L., Hilpert, F., Oza, A. M., Westermann, A., Oehler, M. K., Pignata, S., Aghajanian, C., Colombo, N., Drill, E., Cibula, D., Moore, K. N., Christy-Bittel, J., ... Vergote, I. (2020). MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 38(32), 3753-3762. https://doi.org/10.1200/JCO.20.01164

CBE

Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. 2020. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 38(32):3753-3762. https://doi.org/10.1200/JCO.20.01164

MLA

Vancouver

Author

Monk, Bradley J ; Grisham, Rachel N ; Banerjee, Susana ; Kalbacher, Elsa ; Mirza, Mansoor Raza ; Romero, Ignacio ; Vuylsteke, Peter ; Coleman, Robert L ; Hilpert, Felix ; Oza, Amit M ; Westermann, Anneke ; Oehler, Martin K ; Pignata, Sandro ; Aghajanian, Carol ; Colombo, Nicoletta ; Drill, Esther ; Cibula, David ; Moore, Kathleen N ; Christy-Bittel, Janna ; Del Campo, Josep M ; Berger, Regina ; Marth, Christian ; Sehouli, Jalid ; O'Malley, David M ; Churruca, Cristina ; Boyd, Adam P ; Kristensen, Gunnar ; Clamp, Andrew ; Ray-Coquard, Isabelle ; Vergote, Ignace. / MILO/ENGOT-ov11 : Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. I: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020 ; Bind 38, Nr. 32. s. 3753-3762.

Bibtex

@article{f3b13da4f2e74ca59d034d07702adae8,
title = "MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum",
abstract = "PURPOSE: Low-grade serous ovarian carcinomas (LGSOCs) have historically low chemotherapy responses. Alterations affecting the MAPK pathway, most commonly KRAS/BRAF, are present in 30%-60% of LGSOCs. The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC.METHODS: This was a 2:1 randomized study of binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC). Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety.RESULTS: A total of 303 patients were randomly assigned to an arm of the study at the time of interim analysis (January 20, 2016). Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled. Secondary efficacy end points were similar in the two groups: ORR 16% (complete response [CR]/partial responses[PRs], 32) versus 13% (CR/PRs, 13); median DOR, 8.1 months (range, 0.03 to ≥ 12.0 months) versus 6.7 months (0.03 to ≥ 9.7 months); and median OS, 25.3 versus 20.8 months for binimetinib and PCC, respectively. Safety results were consistent with the known safety profile of binimetinib; the most common grade ≥ 3 event was increased blood creatine kinase level (26%). Post hoc analysis suggests a possible association between KRAS mutation and response to binimetinib. Results from an updated analysis (n = 341; January 2019) were consistent.CONCLUSION: Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point, binimetinib showed activity in LGSOC across the efficacy end points evaluated. A higher response to chemotherapy than expected was observed and KRAS mutation might predict response to binimetinib.",
author = "Monk, {Bradley J} and Grisham, {Rachel N} and Susana Banerjee and Elsa Kalbacher and Mirza, {Mansoor Raza} and Ignacio Romero and Peter Vuylsteke and Coleman, {Robert L} and Felix Hilpert and Oza, {Amit M} and Anneke Westermann and Oehler, {Martin K} and Sandro Pignata and Carol Aghajanian and Nicoletta Colombo and Esther Drill and David Cibula and Moore, {Kathleen N} and Janna Christy-Bittel and {Del Campo}, {Josep M} and Regina Berger and Christian Marth and Jalid Sehouli and O'Malley, {David M} and Cristina Churruca and Boyd, {Adam P} and Gunnar Kristensen and Andrew Clamp and Isabelle Ray-Coquard and Ignace Vergote",
year = "2020",
month = nov,
day = "10",
doi = "10.1200/JCO.20.01164",
language = "English",
volume = "38",
pages = "3753--3762",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "32",

}

RIS

TY - JOUR

T1 - MILO/ENGOT-ov11

T2 - Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum

AU - Monk, Bradley J

AU - Grisham, Rachel N

AU - Banerjee, Susana

AU - Kalbacher, Elsa

AU - Mirza, Mansoor Raza

AU - Romero, Ignacio

AU - Vuylsteke, Peter

AU - Coleman, Robert L

AU - Hilpert, Felix

AU - Oza, Amit M

AU - Westermann, Anneke

AU - Oehler, Martin K

AU - Pignata, Sandro

AU - Aghajanian, Carol

AU - Colombo, Nicoletta

AU - Drill, Esther

AU - Cibula, David

AU - Moore, Kathleen N

AU - Christy-Bittel, Janna

AU - Del Campo, Josep M

AU - Berger, Regina

AU - Marth, Christian

AU - Sehouli, Jalid

AU - O'Malley, David M

AU - Churruca, Cristina

AU - Boyd, Adam P

AU - Kristensen, Gunnar

AU - Clamp, Andrew

AU - Ray-Coquard, Isabelle

AU - Vergote, Ignace

PY - 2020/11/10

Y1 - 2020/11/10

N2 - PURPOSE: Low-grade serous ovarian carcinomas (LGSOCs) have historically low chemotherapy responses. Alterations affecting the MAPK pathway, most commonly KRAS/BRAF, are present in 30%-60% of LGSOCs. The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC.METHODS: This was a 2:1 randomized study of binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC). Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety.RESULTS: A total of 303 patients were randomly assigned to an arm of the study at the time of interim analysis (January 20, 2016). Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled. Secondary efficacy end points were similar in the two groups: ORR 16% (complete response [CR]/partial responses[PRs], 32) versus 13% (CR/PRs, 13); median DOR, 8.1 months (range, 0.03 to ≥ 12.0 months) versus 6.7 months (0.03 to ≥ 9.7 months); and median OS, 25.3 versus 20.8 months for binimetinib and PCC, respectively. Safety results were consistent with the known safety profile of binimetinib; the most common grade ≥ 3 event was increased blood creatine kinase level (26%). Post hoc analysis suggests a possible association between KRAS mutation and response to binimetinib. Results from an updated analysis (n = 341; January 2019) were consistent.CONCLUSION: Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point, binimetinib showed activity in LGSOC across the efficacy end points evaluated. A higher response to chemotherapy than expected was observed and KRAS mutation might predict response to binimetinib.

AB - PURPOSE: Low-grade serous ovarian carcinomas (LGSOCs) have historically low chemotherapy responses. Alterations affecting the MAPK pathway, most commonly KRAS/BRAF, are present in 30%-60% of LGSOCs. The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC.METHODS: This was a 2:1 randomized study of binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC). Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety.RESULTS: A total of 303 patients were randomly assigned to an arm of the study at the time of interim analysis (January 20, 2016). Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled. Secondary efficacy end points were similar in the two groups: ORR 16% (complete response [CR]/partial responses[PRs], 32) versus 13% (CR/PRs, 13); median DOR, 8.1 months (range, 0.03 to ≥ 12.0 months) versus 6.7 months (0.03 to ≥ 9.7 months); and median OS, 25.3 versus 20.8 months for binimetinib and PCC, respectively. Safety results were consistent with the known safety profile of binimetinib; the most common grade ≥ 3 event was increased blood creatine kinase level (26%). Post hoc analysis suggests a possible association between KRAS mutation and response to binimetinib. Results from an updated analysis (n = 341; January 2019) were consistent.CONCLUSION: Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point, binimetinib showed activity in LGSOC across the efficacy end points evaluated. A higher response to chemotherapy than expected was observed and KRAS mutation might predict response to binimetinib.

U2 - 10.1200/JCO.20.01164

DO - 10.1200/JCO.20.01164

M3 - Journal article

C2 - 32822286

VL - 38

SP - 3753

EP - 3762

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 32

ER -

ID: 60987441