Phase 1 study of KHK2455, a long-acting, potent and selective IDO1 inhibitor, in combination with avelumab in patients with locally advanced or metastatic urothelial carcinoma

Background
Dual inhibition of indoleamine 2,3-dioxygenase 1 (IDO1) and programmed death-ligand 1 (PD-L1) may alleviate suppression of antitumor immune responses by overcoming redundant immunosuppressive pathways. This study evaluated the combination o…

CT-based deep foundation model for predicting immune checkpoint inhibitor-induced pneumonitis risk in lung cancer

Background
Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy, but can cause serious immune-related adverse events, with pneumonitis (ICI-P) being among the most severe. Early identification of high-risk patients before ICI initiat…

Neoadjuvant chemoimmunotherapy with afatinib for locally advanced head and neck squamous cell carcinoma (neoCHANCE-2): an open-label, single-arm, phase 2 study

Background
While immune checkpoint inhibitor-based neoadjuvant therapy shows promise in locally advanced head and neck squamous cell carcinoma (LA-HNSCC), the optimal regimen has yet to be established. We report, for the first time, a neoadjuvant trea…

Camrelizumab plus nimotuzumab as second-line therapy for advanced esophageal squamous cell carcinoma: a multicenter phase II study

Background
Therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) after first-line failure remain limited, particularly in patients previously exposed to immune checkpoint inhibitors (ICIs). We evaluated the efficacy, safety, and e…

Phase 1/1b open-label, first-in-human study of HER2xCD3xCD28 trispecific T-cell engager (SAR443216) in participants with R/R HER2-expressing solid tumors

Background
SAR443216 is an engineered human trispecific antibody that targets human epidermal growth factor receptor 2 (HER2)-positive (HER2+) cancer cells and activates T cells via co-engagement of cluster of differentiation (CD)3 and CD28. This firs…

Evaluating the potential of candidate surrogate endpoints for overall survival in treatment-naive metastatic melanoma treated with anti-PD-1-based regimens with or without anti-CTLA-4 therapy

Background
Using surrogates for overall survival (OS) may expedite the development of, and patient access to, novel treatments. We assessed potential surrogates for OS in patients with metastatic melanoma treated with nivolumab-containing regimens in …

AdvanTIG-301: a phase III study of ociperlimab plus tislelizumab and concurrent chemoradiotherapy in stage III unresectable non-small cell lung cancer

Background
Patients with unresectable stage III non-small cell lung cancer (NSCLC) have an unmet need for new therapies that improve survival. This phase III trial investigated the safety and efficacy of concurrent ociperlimab and tislelizumab plus co…

Pre-existing systemic immune state and dynamic myeloid remodeling shape response to neoadjuvant PD-L1 blockade

Background
Neoadjuvant immunotherapy has emerged as a promising strategy for patients with head and neck squamous cell carcinoma. However, the systemic immune mechanisms underlying treatment response remain insufficiently defined. This study evaluated…

AARS1-mediated lactylation reprograms macrophage lipid metabolism to restrict antitumor immunity

Background
Tumor-derived lactate has long been regarded as a metabolic waste product. However, accumulating evidence indicates that lactate also functions as a signaling molecule that actively remodels the tumor immune microenvironment. How lactate-dr…

DNA hypomethylation identifying clinical benefit subgroup of small-cell lung cancer: multi-omics analysis of a phase II trial with durvalumab plus olaparib as maintenance therapy

Background
Long-term survival of extensive-stage small-cell lung cancer (ES-SCLC) remains rare, with most patients experiencing disease progression during maintenance therapy. Poly (ADP-ribose) polymerase (PARP) inhibitors have the potential to confer…

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