Abstract CT101: NCI-molecular analysis for therapy choice (NCI-MATCH) clinical trial: interim analysis
Authors: Conley Barbara A. , Gray Robert , Chen Alice , O’Dwyer Peter , Arteaga Carlos , Coffey Brent , Patton David , Li Shuli , McShane Lisa M. , Rubinstein Larry , Comis Robert , Abrams Jeffrey , Williams Paul M. , Lih Chih-Jian , Hamilton Stanley , Mitchell Edith , Zwiebel James , Flaherty Keith ,   NCI MATCH team
Published: July 2016

The NCI MATCH is an efficacy signal-finding trial to identify molecular alterations that can be matched to targeted treatments in tumor biopsies from patients (pts) with refractory solid tumors or lymphomas.br /&gt;METHODS: An Ion Torrent Oncomine panel sequencing assay and a binary PTEN immunohistochemistry assay were employed. NCI-MATCH opened in August 2015. A protocol-directed pause in screening for interim analysis occurred in November 2015 with goals to assess tumor biopsy feasibility and quality, performance of the CLIA-accredited laboratories, any unanticipated concerns with the study, the match rate for the first activated 10 arms and for planned arms, the spectrum of molecular abnormalities identified, histologic tumor types and demographics.

RESULTS: Between 8-12-15 and 11-11-15, 795 pts enrolled for screening and 739 biopsies were submitted. Biopsies were submitted from community (2/3) and academic (1/3) sites. Sequencing was completed on 645 of these specimens (87%). Median turn around time was 27 days but increased from 14 days in the first month to 36 days in the last month, correlating with marked increase in weekly accrual. The highest toxicity (Grade 3) possibly related to biopsy was &lt; 1%. The most frequent tumor types sequenced were colorectal (13%), breast (13%), ovarian (11%), non-small cell lung (7.4%), endometrial (7%), pancreatic (5%), head/neck (5%) esophageal/gastric (4%), cholangiocarcinoma and neuroendocrine (3% each), and small cell lung, prostate, bladder, and unknown primary (&lt;3% each). Fifty-six patients (9%) had actionable mutations of interest (aMOIs); of these, 33 pts (5.1%, 95%CI 3.5, 7.1%) met molecular eligibility for assignment to one of 10 treatment arms. The most common genetic mutations, amplifications or translocations were: PercentMutation/amplification/translocation52TP5319KRAS12PIK3CA10APC, CDH14-5CDKN2A3-4CCND13BRAF, PTEN, ESR1, CTNNB1, ERBB2, CCNE12.5EGFR, FBXW7,FGFR 1/2/3, MDM22KIT, BRCA 1/2, IDH 1/2, NF1, RB1

CONCLUSIONS: Accrual was brisk and biopsies were feasible and safe with adequate tumor yield and results. The match rate was lower than predicted for the first 10 treatment arms. Accrual of less common tumor histologic types exceeded expectations. Results from the interim analysis will inform the types of treatment and predicted match rate for additional MATCH arms. NCI-MATCH will re-open with increased capacity and additional treatment arms with a match rate goal of at least 20%.

Citation Format: Barbara A. Conley, Robert Gray, Alice Chen, Peter O’Dwyer, Carlos Arteaga, Brent Coffey, David Patton, Shuli Li, Lisa M. McShane, Larry Rubinstein, Robert Comis, Jeffrey Abrams, Paul M. Williams, Chih-Jian Lih, Stanley Hamilton, Edith Mitchell, James Zwiebel, Keith Flaherty, NCI MATCH team. NCI-molecular analysis for therapy choice (NCI-MATCH) clinical trial: interim analysis. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT101.