guest ::
| Home > Publications database > Early switch from run-in with targeted to immunotherapy in advanced BRAFV600-positive melanoma: final results of the randomised phase II ImmunoCobiVem trial. > print |
| Home > Publications database > Early switch from run-in with targeted to immunotherapy in advanced BRAFV600-positive melanoma: final results of the randomised phase II ImmunoCobiVem trial. > print |
| 001 | 301264 | ||
| 005 | 20250518020551.0 | ||
| 024 | 7 | _ | |a 10.1016/j.esmoop.2025.105053 |2 doi |
| 024 | 7 | _ | |a pmid:40345056 |2 pmid |
| 024 | 7 | _ | |a altmetric:177034949 |2 altmetric |
| 037 | _ | _ | |a DKFZ-2025-00949 |
| 041 | _ | _ | |a English |
| 082 | _ | _ | |a 610 |
| 100 | 1 | _ | |a Livingstone, E. |0 P:(DE-HGF)0 |b 0 |
| 245 | _ | _ | |a Early switch from run-in with targeted to immunotherapy in advanced BRAFV600-positive melanoma: final results of the randomised phase II ImmunoCobiVem trial. |
| 260 | _ | _ | |a [London] |c 2025 |b Elsevier |
| 336 | 7 | _ | |a article |2 DRIVER |
| 336 | 7 | _ | |a Output Types/Journal article |2 DataCite |
| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1747133155_13899 |2 PUB:(DE-HGF) |
| 336 | 7 | _ | |a ARTICLE |2 BibTeX |
| 336 | 7 | _ | |a JOURNAL_ARTICLE |2 ORCID |
| 336 | 7 | _ | |a Journal Article |0 0 |2 EndNote |
| 520 | _ | _ | |a Optimal sequencing of immune checkpoint inhibitors (ICIs) and targeted therapies (TTs) in BRAFV600-positive advanced melanoma should achieve rapid tumour control and durable progression-free survival (PFS), translating into prolonged overall survival (OS).The 1 : 1 randomised phase II ImmunoCobiVem trial compared-after a 3-month run-in phase with vemurafenib (VEM, 960 mg twice daily) and cobimetinib (COB, 60 mg daily days 21-28, q4w)-continuous VEM + COB until disease progression (PD1) and second-line atezolizumab (ATEZO, 1200 mg, q3w) in arm A versus early switch to ATEZO after run-in, followed by crossover to VEM + COB at PD1, in arm B. PFS from the start of run-in until PD1 was the primary endpoint (PFS1); secondary efficacy endpoints were OS, overall PFS (PFS2) and PFS3 (time from PD1 to PD after crossover, i.e. PD2) and best overall response rates (BORRs).The final analysis (median follow-up 57.0 months, interquartile range 22.7-63.0 months) confirmed longer PFS1 for continuous TT [arm A (69 patients) versus arm B (early switch, 66 patients); hazard ratio (HR) 0.61, 95% confidence interval (CI) 0.41-0.91, P = 0.006], but early switch to ICIs resulted in better long-term OS [4- and 5-year landmark OS 42% (95% CI 29% to 55%) and 40% (95% CI 27% to 53%) for arm A, and 53% (95% CI 38% to 65%) and 45% (95% CI 31% to 58%) for arm B; descriptive HR 1.17, 95% CI 0.71-1.91]. Absolute BORRs were 81% and 89%, respectively, with 15 (22%) and 19 (29%) patients achieving a complete response at least once along each sequence. At crossover, TT retreatment (arm B) resulted in higher PFS3 than second-line ICI (arm A).Early switch to ICIs after TT run-in (arm B) led to an improved, although not statistically significant, 4- and 5-year landmark OS compared with arm A. No subgroups were identified for which a TT run-in provided clinical benefit. The number of patients developing brain metastasis and the time to brain metastasis were not improved by an early TT to ICI switch. |
| 536 | _ | _ | |a 311 - Zellbiologie und Tumorbiologie (POF4-311) |0 G:(DE-HGF)POF4-311 |c POF4-311 |f POF IV |x 0 |
| 588 | _ | _ | |a Dataset connected to CrossRef, PubMed, , Journals: inrepo02.dkfz.de |
| 650 | _ | 7 | |a crossover design |2 Other |
| 650 | _ | 7 | |a immunotherapy |2 Other |
| 650 | _ | 7 | |a melanoma |2 Other |
| 650 | _ | 7 | |a sequential therapy |2 Other |
| 650 | _ | 7 | |a targeted therapy |2 Other |
| 700 | 1 | _ | |a Gogas, H. J. |b 1 |
| 700 | 1 | _ | |a Kandolf, L. |b 2 |
| 700 | 1 | _ | |a Meier, F. |b 3 |
| 700 | 1 | _ | |a Eigentler, T. K. |b 4 |
| 700 | 1 | _ | |a Ziemer, M. |b 5 |
| 700 | 1 | _ | |a Terheyden, P. |b 6 |
| 700 | 1 | _ | |a Gesierich, A. |b 7 |
| 700 | 1 | _ | |a Herbst, R. A. |b 8 |
| 700 | 1 | _ | |a Kähler, K. C. |b 9 |
| 700 | 1 | _ | |a Ziogas, D. C. |b 10 |
| 700 | 1 | _ | |a Mijušković, Ž |b 11 |
| 700 | 1 | _ | |a Garzarolli, M. |b 12 |
| 700 | 1 | _ | |a Garbe, C. |b 13 |
| 700 | 1 | _ | |a Roesch, A. |0 P:(DE-HGF)0 |b 14 |
| 700 | 1 | _ | |a Ugurel, S. |0 P:(DE-HGF)0 |b 15 |
| 700 | 1 | _ | |a Gutzmer, R. |b 16 |
| 700 | 1 | _ | |a Gaudy-Marqueste, C. |b 17 |
| 700 | 1 | _ | |a Kiecker, F. |b 18 |
| 700 | 1 | _ | |a Utikal, J. |0 P:(DE-He78)a229f7724466e7efadf4a1ace1ff8af3 |b 19 |u dkfz |
| 700 | 1 | _ | |a Hartmann, M. |b 20 |
| 700 | 1 | _ | |a Miethe, S. |0 P:(DE-HGF)0 |b 21 |
| 700 | 1 | _ | |a Eckhardt, S. |b 22 |
| 700 | 1 | _ | |a Zimmer, Laura |0 P:(DE-He78)8907fd1c83f2e7105a6ba98907ff9aa6 |b 23 |
| 700 | 1 | _ | |a Schadendorf, D. |0 P:(DE-HGF)0 |b 24 |
| 773 | _ | _ | |a 10.1016/j.esmoop.2025.105053 |g Vol. 10, no. 5, p. 105053 - |0 PERI:(DE-600)2844985-X |n 5 |p 105053 |t ESMO open |v 10 |y 2025 |x 2059-7029 |
| 909 | C | O | |o oai:inrepo02.dkfz.de:301264 |p VDB |
| 910 | 1 | _ | |a Deutsches Krebsforschungszentrum |0 I:(DE-588b)2036810-0 |k DKFZ |b 0 |6 P:(DE-HGF)0 |
| 910 | 1 | _ | |a Deutsches Krebsforschungszentrum |0 I:(DE-588b)2036810-0 |k DKFZ |b 14 |6 P:(DE-HGF)0 |
| 910 | 1 | _ | |a Deutsches Krebsforschungszentrum |0 I:(DE-588b)2036810-0 |k DKFZ |b 15 |6 P:(DE-HGF)0 |
| 910 | 1 | _ | |a Deutsches Krebsforschungszentrum |0 I:(DE-588b)2036810-0 |k DKFZ |b 19 |6 P:(DE-He78)a229f7724466e7efadf4a1ace1ff8af3 |
| 910 | 1 | _ | |a External Institute |0 I:(DE-HGF)0 |k Extern |b 21 |6 P:(DE-HGF)0 |
| 910 | 1 | _ | |a Deutsches Krebsforschungszentrum |0 I:(DE-588b)2036810-0 |k DKFZ |b 23 |6 P:(DE-He78)8907fd1c83f2e7105a6ba98907ff9aa6 |
| 910 | 1 | _ | |a Deutsches Krebsforschungszentrum |0 I:(DE-588b)2036810-0 |k DKFZ |b 24 |6 P:(DE-HGF)0 |
| 913 | 1 | _ | |a DE-HGF |b Gesundheit |l Krebsforschung |1 G:(DE-HGF)POF4-310 |0 G:(DE-HGF)POF4-311 |3 G:(DE-HGF)POF4 |2 G:(DE-HGF)POF4-300 |4 G:(DE-HGF)POF |v Zellbiologie und Tumorbiologie |x 0 |
| 914 | 1 | _ | |y 2025 |
| 915 | _ | _ | |a JCR |0 StatID:(DE-HGF)0100 |2 StatID |b ESMO OPEN : 2022 |d 2024-12-30 |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0200 |2 StatID |b SCOPUS |d 2024-12-30 |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0300 |2 StatID |b Medline |d 2024-12-30 |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0501 |2 StatID |b DOAJ Seal |d 2023-04-12T14:49:18Z |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0500 |2 StatID |b DOAJ |d 2023-04-12T14:49:18Z |
| 915 | _ | _ | |a Peer Review |0 StatID:(DE-HGF)0030 |2 StatID |b DOAJ : Anonymous peer review |d 2023-04-12T14:49:18Z |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0199 |2 StatID |b Clarivate Analytics Master Journal List |d 2024-12-30 |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0160 |2 StatID |b Essential Science Indicators |d 2024-12-30 |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)1030 |2 StatID |b Current Contents - Life Sciences |d 2024-12-30 |
| 915 | _ | _ | |a WoS |0 StatID:(DE-HGF)0113 |2 StatID |b Science Citation Index Expanded |d 2024-12-30 |
| 915 | _ | _ | |a DBCoverage |0 StatID:(DE-HGF)0150 |2 StatID |b Web of Science Core Collection |d 2024-12-30 |
| 915 | _ | _ | |a IF >= 5 |0 StatID:(DE-HGF)9905 |2 StatID |b ESMO OPEN : 2022 |d 2024-12-30 |
| 915 | _ | _ | |a Article Processing Charges |0 StatID:(DE-HGF)0561 |2 StatID |d 2024-12-30 |
| 915 | _ | _ | |a Fees |0 StatID:(DE-HGF)0700 |2 StatID |d 2024-12-30 |
| 920 | 1 | _ | |0 I:(DE-He78)ED01-20160331 |k ED01 |l DKTK Koordinierungsstelle Essen/Düsseldorf |x 0 |
| 920 | 1 | _ | |0 I:(DE-He78)A370-20160331 |k A370 |l KKE Dermatoonkologie |x 1 |
| 980 | _ | _ | |a journal |
| 980 | _ | _ | |a VDB |
| 980 | _ | _ | |a I:(DE-He78)ED01-20160331 |
| 980 | _ | _ | |a I:(DE-He78)A370-20160331 |
| 980 | _ | _ | |a UNRESTRICTED |
| Library | Collection | CLSMajor | CLSMinor | Language | Author |
|---|