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DC Field | Value | Language |
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dc.contributor.author | Lenz, H. J. | - |
dc.contributor.author | Overman, M. J. | - |
dc.contributor.author | Van Cutsem, E. | - |
dc.contributor.author | Limon, M. L. | - |
dc.contributor.author | Wong, Mark | - |
dc.contributor.author | Hendlisz, A. | - |
dc.contributor.author | Aglietta, M. | - |
dc.contributor.author | Garcia-Alfonso, P. | - |
dc.contributor.author | Neyns, B. | - |
dc.contributor.author | Gelsomino, F. | - |
dc.contributor.author | Cardin, D. B. | - |
dc.contributor.author | Dragovich, T. | - |
dc.contributor.author | Shah, U. | - |
dc.contributor.author | McCraith, S. | - |
dc.contributor.author | Wang, R. | - |
dc.contributor.author | Lei, M. | - |
dc.contributor.author | Yao, J. | - |
dc.contributor.author | Jin, L. | - |
dc.contributor.author | Lonardi, S. | - |
dc.date.accessioned | 2024-04-26T04:08:11Z | - |
dc.date.available | 2024-04-26T04:08:11Z | - |
dc.date.issued | 2024 | - |
dc.identifier.citation | Journal of Clinical Oncology 42(3, Supplement):97, 2024 | - |
dc.identifier.uri | https://wslhd.intersearch.com.au/wslhdjspui/handle/1/9514 | - |
dc.description.abstract | BACKGROUND: NIVO + IPI demonstrated robust, durable clinical benefit and was well tolerated as a 1L therapy in pts with MSI-H/dMMR mCRC in the phase 2 CheckMate 142 study (NCT02060188), leading to the inclusion of NIVO + IPI in the NCCN guidelines as an initial therapy option for these pts. At 52-mo median follow-up, 1L NIVO + IPI continued to demonstrate durable clinical benefit, and no new safety signals were identified. Here we report longer follow-up results. METHODS: Pts with MSI-H/dMMR mCRC and no prior treatment for metastatic disease received NIVO 3 mg/kg Q2W + IPI 1 mg/kg Q6W until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by investigator assessment (INV) per RECIST v1.1. Other key endpoints were disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), all by INV; overall survival (OS); and safety. RESULTS: In total, 45 pts received 1L NIVO + IPI. With median follow-up of 64.2 mo (range, 59.4-68.9 mo), ORR by INV was 71% (95% CI, 56-84%). The proportion of pts with a best overall response of complete response (CR) was 20%, partial response (PR) was 51%, stable disease (SD) was 13%, and progressive disease was 16%. Median DOR (mDOR) was not reached, and the 60-mo DOR rate was 72%. Median PFS (mPFS) by INV and median OS (mOS) were not reached, with 60-mo PFS and OS rates of 55% and 67%, respectively (Table). Among pts alive at the data cutoff (n = 31), 30 remained treatment-free after initial study treatment without receiving any subsequent systemic therapy, with a median treatment-free interval of 34.7 mo (range, 1.6-61.4 mo). Exploratory analysis by tumor mutational burden status will be presented. Safety data are shown in the Table. CONCLUSIONS: At 64-mo follow-up, NIVO + IPI continued to demonstrate clinically meaningful survival and durable responses, with mPFS, mOS, andmDORstill not reached, suggesting the potential for long-term clinical benefit. Safety remained consistent with previous data. These findings further support current recommendations for NIVO + IPI as a 1L treatment for pts with MSI-H/dMMR mCRC. | - |
dc.subject | Oncology | - |
dc.title | First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): 64-month (mo) follow-up from CheckMate 142 | - |
dc.type | Journal Article | - |
dc.type | Conference Abstract | - |
dc.identifier.doi | https://doi.org/10.1200/JCO.2024.42.3_suppl.97 | - |
dc.subject.keywords | Colon neoplasms | - |
dc.subject.keywords | microsatellite instability | - |
dc.subject.keywords | tumor mutational burden | - |
dc.subject.keywords | Turcot syndrome | - |
dc.subject.keywords | ipilimumab | - |
dc.subject.keywords | nivolumab | - |
dc.identifier.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.department | Oncology | - |
dc.contributor.wslhd | Wong, Mark | - |
dc.type.studyortrial | Clinical Trial, Phase II | - |
dc.identifier.affiliation | University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA | - |
dc.identifier.affiliation | The University of Texas MD Anderson Cancer Center, Houston, TX | - |
dc.identifier.affiliation | University Hospitals Gasthuisberg and University of Leuven (KU Leuven), Leuven, Belgium | - |
dc.identifier.affiliation | Hospital Universitario Virgen del Rocio, Sevilla, Spain | - |
dc.identifier.affiliation | Westmead Hospital, Sydney, Australia | - |
dc.identifier.affiliation | Institut Jules Bordet, Brussels, Belgium | - |
dc.identifier.affiliation | Candiolo Cancer Institute, FPO IRCCS, Candiolo, Italy | - |
dc.identifier.affiliation | Hospital Gral Universitario Gregorio Maranon, Madrid, Spain | - |
dc.identifier.affiliation | Universitair Ziekenhuis Brussel, Brussels, Belgium | - |
dc.identifier.affiliation | University Hospital of Modena, Modena, Italy | - |
dc.identifier.affiliation | Vanderbilt-Ingram Cancer Center, Nashville, TN | - |
dc.identifier.affiliation | Banner MD Anderson Cancer Center, Gilbert, AZ | - |
dc.identifier.affiliation | Lehigh Valley Cancer Institute, Allentown, PA | - |
dc.identifier.affiliation | Bristol Myers Squibb, Princeton, NJ | - |
dc.identifier.affiliation | Veneto Institute of Oncology IOV-IRCCS, Padua, Italy | - |
dc.identifier.facility | Blacktown | - |
dc.identifier.facility | Westmead | - |
dc.identifier.conferencename | 2024 ASCO Gastrointestinal Cancers Symposium. San Francisco, CA United States. | - |
Appears in Collections: | Blacktown Mount Druitt Hospital |
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