ArticleJournal for immunotherapy of cancer2025
Differential safety profiles of durvalumab monotherapy and durvalumab in combination with tremelimumab in adult patients with advanced cancers.
Article in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone for ARPI-pretreated and chemotherapy-naive metastatic castration-resistant prostate cancer: a pooled analysis of KEYNOTE-921 and CheckMate 7DX trials.International urology and nephrology · 2026Pooled it
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10 authors.
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Abstract
backgroundDurvalumab (D; anti-programmed cell death ligand 1 (PD-L1)) monotherapy or in combination with tremelimumab (T; anti-cytotoxic T lymphocyte antigen-4 (CTLA-4)) have demonstrated efficacy in advanced cancers. However, higher incidences of adverse events (AEs) and immune-mediated AEs (imAEs) were observed with D+T compared with D monotherapy in clinical trials. While safety data have been published from individual clinical trials of D with or without T, we report a comprehensive safety analysis of D and D+T in a broad population and across multiple tumor types.
methodsA retrospective analysis was conducted using safety data pooled from phase I to III clinical trials in patients with advanced non-small cell lung cancer (NSCLC), recurrent or metastatic squamous cell carcinoma of the head and neck, unresectable hepatocellular carcinoma (uHCC), gastric adenocarcinoma, or metastatic urothelial carcinoma, who received either D monotherapy (N=4,045; 13 clinical trials) or D+T (N=3,319; 14 clinical trials).
resultsCompared with D monotherapy, patients treated with D+T had higher incidences of maximum grade 3 or 4 AEs (49.5% vs 39.6%), treatment-related AEs of maximum grade 3 or 4 (22.1% vs 11.5%), any imAE (30.2% vs 17.4%), and imAEs of maximum grade 3 or 4 (11.0% vs 4.3%). The majority of imAEs were non-serious, low grade and manageable in both datasets. Higher incidences of imAEs with D+T were mainly driven by diarrhea/colitis (7.6% vs 1.9%) and dermatitis/rash (4.7% vs 1.6%). Fatal imAEs were infrequent and similar between D+T and D monotherapy (0.4% vs 0.3%). Across tumor types, hypothyroid events were the most frequently reported imAE of any grade (D+T: 9.7%; D monotherapy: 7.6%). As expected, given organ involvement, pneumonitis was most frequently reported in NSCLC (D+T: 5.4%; D monotherapy: 4.7%), while hepatic events were most frequently reported in uHCC (D+T: 7.9%; D monotherapy: 6.1%).
conclusionsHigher incidences of imAEs were observed with D+T compared with D monotherapy across tumor types; however, fatal imAEs were infrequent and similar in both datasets. ImAEs in the D+T dataset were consistent with the safety profiles of the individual agents and dual PD-(L)1 and CTLA-4 inhibition. Overall, the safety profiles of D monotherapy and D+T were tolerable and manageable across tumor types.
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