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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1203O - 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

Published date:
09/05/2022
Excerpt:
Pts received a median of 11 cycles in A1 vs 7 cycles in A2. Adverse events of grade ≥3 were seen in 93% of the pts for arm A1 and 73% for arm A2, serious adverse events (SAE) in 70% in arm A1 and 62% in A2. Median follow-up was 7.3 mo. PFS@6 was 57% in arm A1 vs 28% in A2 (p=.012) with median PFS 8.4 vs 4.0 mo, respectively (p=.006). Median OS was not yet reached in A1 vs 9.1 mo in A2, ORR was 47% vs 30%, respectively. The results were similar in the PD-L1+ group. FOLFOX chemotherapy plus nivolumab and ipilimumab administered in parallel was clearly more effective than FOLFOX induction followed by nivo and ipi. Although associated with lower toxicity, our study doesn’t support the use of sequential treatment in the first-line setting.
Secondary therapy:
FOLFOX