Although associated with lower toxicity, mFOLFOX plus nivolumab and ipilimumab administered in parallel was more effective in patients with gastric cancer than mFOLFOX induction followed by nivolumab plus ipilimumab, results from the Moonlight trial showed.
In patients with HER2-negative, metastatic, or locally advanced oesophagogastric adenocarcinoma, first-line treatment with mFOLFOX plus nivolumab has become the standard-of-care . However, this regimen comes with substantial toxicity (59% grade ≥3). One part of the phase 2 Moonlight trial (NCT03647969) compared the efficacy and safety of mFOLFOX and nivolumab plus ipilimumab administered either in parallel or sequential. Prof. Sylvie Lorenzen (Klinikum rechts der Isar, TU München, Germany) presented the results .
This part of the Moonlight trial enrolled 90 patients with previously untreated HER2-negative metastatic or locally advanced adenocarcinoma of the stomach or gastro-oesophageal junction. Participants were randomised 2:1 to parallel treatment with mFOLFOX, nivolumab and ipilimumab or 3 cycles of mFOLFOX induction followed by nivolumab plus ipilimumab (sequential arm). The primary endpoint was progression-free survival (PFS) at 6 months and the main secondary endpoints were overall survival, objective response rate (ORR), and safety.
After a median follow-up of 9.3 months, the median PFS was 7.29 months in the parallel arm versus 3.98 months in the sequential arm. PFS-rate at 6 months was 60% versus 30% (parallel vs sequential). In addition, parallel treatment favoured OS, ORR and median duration of response. Grade ≥3 treatment-related adverse events were more common in the parallel arm compared with the sequential arm (93% vs 73%).
“Although associated with higher toxicity, mFOLFOX chemotherapy plus nivolumab and ipilimumab administered in parallel was more effective compared with mFOLFOX induction followed by nivolumab plus ipilimumab. Therefore, these results do not support the concept of chemotherapy induction followed by immunotherapy, but should be interpreted with caution due to the small sample size and low PD-L1 expression rate in both arms (PD-L1 combined positive score [CPS] ≥1 in 41%; CPSparallel arm 43%; CPSsequential arm 40%)” closed Prof. Lorenzen.
- Janjigian YY, et al. Lancet 2021;398(10294):27–40.
- Lorenzen S, et al. FOLFOX plus nivolumab and ipilimumab versus FOLFOX induction followed by nivolumab and ipilimumab in patients with previously untreated advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction: Results from the randomized phase II Moonlight trial of the AIO. Abstract 1203O, ESMO Congress 2022, 09–13 September, Paris, France.
Copyright ©2022 Medicom Medical Publishers
« High pathological responses to neoadjuvant immune checkpoint inhibition in locally advanced dMMR colon cancer Next Article
New, highly selective inhibitor of FGFR2 driver alterations and resistance mutations »
Table of Contents: ESMO 2022
Letter from the Editor
High pathological responses to neoadjuvant immune checkpoint inhibition in locally advanced dMMR colon cancer
Fruquintinib: a potential new treatment for patients with refractory mCRC
Second-line avelumab is effective in patients with MSI-H/dMMR mCRC
Upper Gastrointestinal Cancer
Deep learning models predict the risk of relapse and the mutational profile in GIST
Addition of pembrolizumab to lenvatinib does not improve OS in advanced HCC
New, highly selective inhibitor of FGFR2 driver alterations and resistance mutations
Chemo-immunotherapy in gastric cancer is more effective when administered in parallel
Tumour infiltrating lymphocytes identify patients with immunogenic triple-negative breast cancer
OS benefit of abemaciclib in HR-positive/HER2-negative advanced breast cancer not (yet) statistically significant
OS benefit of sacituzumab govitecan in pre-treated HR-positive/HER2-negative metastatic breast cancer
A pathway from air pollution to lung cancer in non-smokers identified
Selective KRASG12C inhibitor sotorasib demonstrates superior PFS and ORR compared to docetaxel in previously treated patients with NSCLC
Promising clinical activity of tepotinib plus osimertinib in NSCLC with MET amplification after progression on first-line osimertinib
High pathological responses in borderline resectable NSCLC patients after induction with dual immunotherapy and concurrent chemoradiotherapy
Treatment with tumour-infiltrating lymphocytes for advanced melanoma outperforms ipilimumab
Neoadjuvant pembrolizumab outperforms adjuvant pembrolizumab in resectable stage III–IV melanomas
Survival-benefit of neoadjuvant T-VEC maintained over 5 years of follow-up
Baseline ctDNA predicts survival in resected stage III–IV melanoma
Genitourinary Cancer – Prostate Cancer
Overall survival benefit of abiraterone in mHSPC is maintained for 7 years
Limited benefit of adding long-term ADT to post-operative radiotherapy in prostate cancer
Intensified ADT benefits biochemical progression-free survival in biochemically relapsed prostate cancer
Genitourinary Cancer – Non-Prostate Cancer
Adjuvant nivolumab plus ipilimumab does not improve survival in patients with localised RCC at high risk of relapse after nephrectomy
Triple therapy improves progression-free survival in patients with advanced RCC versus dual therapy
Adjuvant atezolizumab does not improve outcomes for patients with RCC and increased risk of recurrence
OS benefit for advanced ovarian cancer patients treated with maintenance olaparib
Maintenance tegafur-uracil does not improve survival in locally advanced cervical cancer
Head and Neck Cancer
Adding first-line pembrolizumab to CRT in locally advanced HNSCC does not significantly prolong survival or event-free survival
5-FU-free chemotherapy combination as an alternative for first-line treatment of recurrent or metastatic HNSCC
Epstein Barr virus-specific autologous cytotoxic T lymphocytes do not improve survival in nasopharyngeal carcinoma