The NCI-MATCH trial: lessons for precision oncology

被引：79

作者：

O'Dwyer, Peter J. ^{[1
]}

Gray, Robert J. ^{[2
]}

Flaherty, Keith T. ^{[3
]}

Chen, Alice P. ^{[4
]}

Li, Shuli ^{[2
]}

Wang, Victoria ^{[2
]}

McShane, Lisa M. ^{[5
]}

Patton, David R. ^{[6
]}

Tricoli, James V. ^{[4
]}

Williams, P. Mickey ^{[7
]}

Iafrate, A. John ^{[3
]}

Sklar, Jeffrey ^{[8
]}

Mitchell, Edith P. ^{[9
]}

Takebe, Naoko ^{[4
]}

Sims, David J. ^{[7
]}

Coffey, Brent ^{[6
]}

Fu, Tony ^{[7
]}

Routbort, Mark ^{[10
]}

Rubinstein, Larry V. ^{[5
]}

Little, Richard F. ^{[4
]}

Arteaga, Carlos L. ^{[11
]}

Marinucci, Donna ^{[12
]}

Hamilton, Stanley R. ^{[13
]}

Conley, Barbara A. ^{[14
]}

Harris, Lyndsay N. ^{[14
]}

Doroshow, James H. ^{[4
]}

机构：

[1] Univ Penn, Philadelphia, PA 19104 USA

[2] ECOG ACRIN Biostat Ctr, Dana Farber Canc Inst, Boston, MA USA

[3] Massachusetts Gen Hosp, Canc Ctr, Boston, MA USA

[4] NCI, Div Canc Treatment & Diag, Bethesda, MD USA

[5] NCI, Biometr Res Program, Div Canc Treatment & Diag, Bethesda, MD USA

[6] NCI, Ctr Biomed Informat & Informat Technol, Bethesda, MD USA

[7] Frederick Natl Lab Canc Res, Frederick, MD USA

[8] Yale Univ, New Haven, CT USA

[9] Thomas Jefferson Univ Hosp, Philadelphia, PA USA

[10] Univ Texas MD Anderson Canc Ctr, Houston, TX USA

[11] UT Southwestern Simmons Comprehens Canc Ctr, Dallas, TX USA

[12] ECOG ACRIN Canc Res Grp, Philadelphia, PA USA

[13] City Hope Natl Med Ctr, Duarte, CA USA

[14] NCI, Canc Diag Program, Div Canc Treatment & Diag, Bethesda, MD USA

来源：

NATURE MEDICINE | 2023年 / 29卷 / 6期

关键词：

PHASE-II; SOLID TUMORS; CANCERS; BRAF; VEMURAFENIB; INHIBITION; VALIDATION; TRAMETINIB; MUTATIONS; THERAPY;

D O I：

10.1038/s41591-023-02379-4

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

The NCI-MATCH (Molecular Analysis for Therapy Choice) trial () was launched in 2015 as a genomically driven, signal-seeking precision medicine platform trial-largely for patients with treatment-refractory, malignant solid tumors. Having completed in 2023, it remains one of the largest tumor-agnostic, precision oncology trials undertaken to date. Nearly 6,000 patients underwent screening and molecular testing, with a total of 1,593 patients (inclusive of continued accrual from standard next-generation sequencing) being assigned to one of 38 substudies. Each substudy was a phase 2 trial of a therapy matched to a genomic alteration, with a primary endpoint of objective tumor response by RECIST criteria. In this Perspective, we summarize the outcomes of the initial 27 substudies in NCI-MATCH, which met its signal-seeking objective with 7/27 positive substudies (25.9%). We discuss key aspects of the design and operational conduct of the trial, highlighting important lessons for future precision medicine studies.

引用

页码：1349 / 1357

页数：9

共 59 条

[1]

Adashek J. J., 2022, MOL CANCER THER, DOI [10.1158/1535-7163, DOI 10.1158/1535-7163]

[2]

[Anonymous], NCI DICT CANC TERMS

[3] Nivolumab Is Effective in Mismatch Repair-Deficient Noncolorectal Cancers: Results From Arm Z1D-A Subprotocol of the NCI-MATCH (EAY131) Study [J].

Azad, Nilofer S. ;

Gray, Robert J. ;

Overman, Michael J. ;

Schoenfeld, Jonathan D. ;

Mitchell, Edith P. ;

Zwiebel, James A. ;

Sharon, Elad ;

Streicher, Howard ;

Li, Shuli ;

McShane, Lisa M. ;

Rubinstein, Larry ;

Patton, David R. ;

Williams, P. Mickey ;

Coffey, Brent ;

Hamilton, Stanley R. ;

Bahary, Nathan ;

Suga, J. Marie ;

Hatoum, Hassan ;

Abrams, Jeffrey S. ;

Conley, Barbara A. ;

Arteaga, Carlos L. ;

Harris, Lyndsay ;

O'Dwyer, Peter J. ;

Chen, Alice P. ;

Flaherty, Keith T. .

JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (03) :214-+

[4] Phase II Study of Afatinib in Patients With Tumors With Human Epidermal Growth Factor Receptor 2-Activating Mutations: Results From the National Cancer Institute-Molecular Analysis for Therapy Choice ECOG-ACRIN Trial (EAY131) Subprotocol EAY131-B [J].

Bedard, Philippe L. ;

Li, Shuli ;

Wisinski, Kari B. ;

Yang, Eddy S. ;

Limaye, Sewanti A. ;

Mitchell, Edith P. ;

Zwiebel, James A. ;

Moscow, Jeffrey A. ;

Gray, Robert J. ;

Wang, Victoria ;

McShane, Lisa M. ;

Rubinstein, Larry V. ;

Patton, David R. ;

Williams, P. Mickey ;

Hamilton, Stanley R. ;

Conley, Barbara A. ;

Arteaga, Carlos L. ;

Harris, Lyndsay N. ;

O'Dwyer, Peter J. ;

Chen, Alice P. ;

Flaherty, Keith T. .

JCO PRECISION ONCOLOGY, 2022, 6

[5] Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W [J].

Chae, Young K. ;

Hong, Fangxin ;

Vaklavas, Christos ;

Cheng, Heather H. ;

Hammerman, Peter ;

Mitchell, Edith P. ;

Zwiebel, James A. ;

Ivy, S. Percy ;

Gray, Robert J. ;

Li, Shuli ;

McShane, Lisa M. ;

Rubinstein, Larry V. ;

Patton, David ;

Williams, P. Mickey ;

Hamilton, Stanley R. ;

Mansfield, Aaron ;

Conley, Barbara A. ;

Arteaga, Carlos L. ;

Harris, Lyndsay N. ;

O'Dwyer, Peter J. ;

Chen, Alice P. ;

Flaherty, Keith T. .

JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (21) :2407-+

[6] Basket trial of TRK inhibitors demonstrates efficacy in TRK fusion-positive cancers [J].

Chen, Yu ;

Chi, Ping .

JOURNAL OF HEMATOLOGY & ONCOLOGY, 2018, 11

[7] Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma [J].

Choueiri, T. K. ;

Powles, T. ;

Burotto, M. ;

Escudier, B. ;

Bourlon, M. T. ;

Zurawski, B. ;

Juarez, V. M. Oyervides ;

Hsieh, J. J. ;

Basso, U. ;

Shah, A. Y. ;

Suarez, C. ;

Hamzaj, A. ;

Goh, J. C. ;

Barrios, C. ;

Richardet, M. ;

Porta, C. ;

Kowalyszyn, R. ;

Feregrino, J. P. ;

Zolnierek, J. ;

Pook, D. ;

Kessler, E. R. ;

Tomita, Y. ;

Mizuno, R. ;

Bedke, J. ;

Zhang, J. ;

Maurer, M. A. ;

Simsek, B. ;

Ejzykowicz, F. ;

Schwab, G. M. ;

Apolo, A. B. ;

Motzer, R. J. .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (09) :829-841

[8]

Clark A. S., 2020, CANCER RES, V79

[9] Differential Outcomes in Codon 12/13 and Codon 61 NRAS-Mutated Cancers in the Phase II NCI-MATCH Trial of Binimetinib in Patients with NRAS-Mutated Tumors [J].

Cleary, James M. ;

Wang, Victoria ;

Heist, Rebecca S. ;

Kopetz, E. Scott ;

Mitchell, Edith P. ;

Zwiebel, James A. ;

Kapner, Kevin S. ;

Chen, Helen X. ;

Li, Shuli ;

Gray, Robert J. ;

McShane, Lisa M. ;

Rubinstein, Larry V. ;

Patton, David R. ;

Meric-Bernstam, Funda ;

Dillmon, Melissa S. ;

Williams, P. Mickey ;

Hamilton, Stanley R. ;

Conley, Barbara A. ;

Aguirre, Andrew J. ;

O'Dwyer, Peter J. ;

Harris, Lyndsay N. ;

Arteaga, Carlos L. ;

Chen, Alice P. ;

Flaherty, Keith T. .

CLINICAL CANCER RESEARCH, 2021, 27 (11) :2996-3004

[10] Activity of trastuzumab and pertuzumab (HP) in patients with non-breast/gastroesophgeal HER2-amplified tumours: Results of the NCIMATCH trial (EAY131) subprotocol J [J].

Connolly, R. M. ;

Wang, V. ;

Hyman, D. M. ;

Grivas, P. ;

Mitchell, E. ;

Wright, J. ;

Sharon, E. ;

Gray, R. J. ;

Li, S. ;

McShane, L. ;

Rubinstein, L. ;

Patton, D. R. ;

Williams, P. M. ;

Hamilton, S. ;

Conley, B. ;

Arteaga, C. L. ;

Harris, L. ;

O'Dwyer, P. J. ;

Chen, A. ;

Flaherty, K. T. .

ANNALS OF ONCOLOGY, 2020, 31 :S479-S480

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