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Nivolumab, alone or with ipilimumab, for mismatch repair deficient metastatic colorectal cancer: A United Kingdom multicentre analysis of patient outcomes
Lam, J. J. M. Bridgewater, J. Alani, M. Mullamitha, Saifee A Braun, Michael S Kunene, V. Baijal, S. Holden, C. Aboud, K. Chopra, N.
Lam, J. J. M.
Bridgewater, J.
Alani, M.
Mullamitha, Saifee A
Braun, Michael S
Kunene, V.
Baijal, S.
Holden, C.
Aboud, K.
Chopra, N.
Citations
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Abstract
Background: Phase 1 and 2 clinical trials of immune checkpoint inhibitors (CPI) show
benefit for patients with mismatch repair deficient (dMMR) metastatic colorectal
cancer (mCRC). However, there is currently a lack of published, real-world data in this
area. We examined outcomes of patients with dMMR mCRC treated with either
nivolumab (NIVO) or nivolumab plus ipilimumab (NIVO+IPI).
Methods: We conducted a retrospective analysis of 49 patients from 13 UK sites. All
received NIVO (37/49) or NIVO+IPI (12/49) as part of the UK Bristol Myers Squibb
Individual Patient Supply Request Programme, as per Article 5/1 of Directive 2001/83/
EC. dMMR was confirmed by immunohistochemistry. The survival analysis cut-off date
was 01/05/2020.
Results: All 49 patients had dMMR cancer: 46 mCRC, 1 appendiceal and 2 small bowel
adenocarcinomas. Median age was 57 years (22e88); 55.1% were female; 59.2% had
right-sided tumours and 33.3% had BRAFv600E mutant tumours. Median performance
status was 1 (0-2). CPI was given to patients who had disease relapse within 6 months
of adjuvant chemotherapy, or in the second to fourth-line setting. Response rates are
summarised in the table. Median follow-up was 14.3 months (5.2e26.5). Overall
median progression free survival (PFS) was 9.5 months (1.4e26.6). Median PFS was
8.4 months (1.4e26.6) and 13.5 months (5.3e25.6) in the NIVO and NIVO+IPI groups
respectively. Median overall survival was not reached. There were 4 dose interruptions
due to grade 3 CPI-related adverse events and 1 discontinuation due to
grade 3 anaphylaxis, all observed on NIVO+IPI. There were no CPI-related deaths.
Conclusions: This real-world data analysis demonstrates clinical benefit and acceptable
toxicity consistent with prior trial results. This adds to the body of evidence
supporting the use of NIVO and NIVO+IPI in patients with previously treated dMMR
mCRC. Updated survival and clinico-pathological characteristics will be presented at ESMO 2020
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Lam JJM, Bridgewater J, Alani M, Mullamitha S, Braun M, Kunene V, et al. 502P Nivolumab, alone or with ipilimumab, for mismatch repair deficient metastatic colorectal cancer: A United Kingdom multicentre analysis of patient outcomes. Annals of Oncology. 2020;31:S453-S.