% IMPORTANT: The following is UTF-8 encoded. This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.
@ARTICLE{Wick:304464,
author = {W. Wick$^*$ and L.-M. Lanz$^*$ and A. Wick$^*$ and I.
Harting and S. Dettmer$^*$ and A. K. Suwala$^*$ and R.
Ketter and G. Tabatabai and C. Seliger and M. Glas and M. C.
Burger and M. Timmer and F. A. Ringel and I.
Mildenberger$^*$ and W. J. Schulz-Schaeffer and F.
Winkler$^*$ and L. König and C. Herold-Mende and A.
Eisenmenger$^*$ and S. Pfister$^*$ and M. Renovanz and M.
Bendszus and F. Sahm$^*$ and M. Platten$^*$ and T.
Kessler$^*$},
title = {{M}olecularly matched targeted therapies plus radiotherapy
in glioblastoma: the phase 1/2a {N}2{M}2 umbrella trial.},
journal = {Nature medicine},
volume = {nn},
issn = {1078-8956},
address = {[New York, NY]},
publisher = {Springer Nature},
reportid = {DKFZ-2025-01857},
pages = {nn},
year = {2025},
note = {#EA:B320#LA:B320# / epub},
abstract = {Advances in molecular understanding and diagnostic
precision of glioblastoma enable the identification of key
genetic alterations in a timely manner and, in principle,
allow treatments with targeted compounds based on molecular
markers. Here we report the results of the phase 1/2
umbrella trial NCT Neuro Master Match (N2M2), which
evaluated targeted treatments in 228 patients with newly
diagnosed glioblastoma without O6-methylguanine
DNA-methyltransferase promoter hypermethylation.
Stratification for treatment was conducted by a
trial-specific molecular tumor board across five subtrials,
each evaluating a targeted therapy-alectinib, idasanutlin,
palbociclib, vismodegib or temsirolimus-selected according
to the best-matching molecular alteration. Patients without
matching alterations were randomized between subtrials
without strong biomarkers using atezolizumab and asunercept,
and the standard of care (SOC), temozolomide. All received
radiotherapy. The primary endpoints were dose-limiting
toxicities (phase 1) and progression-free survival at 6
months (PFS-6; phase 2). Secondary endpoints included safety
and tolerability, as well as overall survival (OS). The
subtrials for alectinib and vismodegib did not open as they
did not have matching patients. The idasanutlin subtrial (n
= 9) was terminated early at the discretion of the
manufacturing company. The temsirolimus subtrial (n = 46)
demonstrated a PFS-6 of $39.1\%$ and median OS of 15.4
months in patients with activated mammalian target of
rapamycin (mTOR) signaling compared to a PFS-6 at $18.5\%$
in the SOC group (n = 54), meeting the primary endpoint. The
atezolizumab (n = 42), asunercept (n = 26) and palbociclib
(n = 41) subtrials did not meet the primary endpoint for
efficacy. The safety signals of N2M2 match prior experiences
with the drugs in quality and quantity; no relevant negative
interaction with the parallel radiotherapy was noted. The
results of the N2M2 trial support further investigation of
temsirolimus in addition to radiotherapy in patients with
newly diagnosed glioblastoma with activated mTOR signaling.
ClinicalTrials.gov registration: NCT03158389 .},
cin = {B320 / HD01 / W010 / B300 / D170 / B062},
ddc = {610},
cid = {I:(DE-He78)B320-20160331 / I:(DE-He78)HD01-20160331 /
I:(DE-He78)W010-20160331 / I:(DE-He78)B300-20160331 /
I:(DE-He78)D170-20160331 / I:(DE-He78)B062-20160331},
pnm = {312 - Funktionelle und strukturelle Genomforschung
(POF4-312)},
pid = {G:(DE-HGF)POF4-312},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:40913172},
doi = {10.1038/s41591-025-03928-9},
url = {https://inrepo02.dkfz.de/record/304464},
}