CONTEXT
death, tumor, bleeding, NPC, nasopharyngeal necrosis
BLEEDING, RECURRENCE, TUMOR, ADVERSE EVENTS, DISEASE, NASOPHARYNGEAL CARCINOMA


There remains an unmet clinical need for the promising posterior line treatment for refractory nasopharyngeal carcinoma (NPC). Programmed cell death (ligand)–1 inhibitors combined with antiangiogenic therapy reportedly have potential synergistic antitumor activity. To our knowledge, this single-arm, Simon two-stage trial is the first trial to demonstrate the activity and safety of camrelizumab (an anti–PD-1 antibody) plus apatinib (a tyrosine kinase inhibitor targeting VEGFR2) in patients with recurrent/metastatic NPC who were refractory to at least one line of platinum-containing systemic therapy.
Camrelizumab plus apatinib had promising antitumor activity: objective response rate was 65.5% and disease control rate was 86.2%; median duration of response was not reached and median progression-free survival was 10.4 months (median follow-up, 12.4 months). 58.6% of patients experienced grade ≥ 3 treatment-related adverse events (TRAEs), and most of them could be resolved by dose interruption or reduction. One of the TRAEs associated with apatinib, nasopharyngeal necrosis, requires attention, and nasopharyngeal recurrence and reirradiation may be risk factors for it.
In patients with platinum refractory, recurrent or metastatic, endemic NPC, the combination of a PD-1 immune checkpoint inhibitor (ie, camrelizumab) and an oral VEGFR2 inhibitor (ie, apatinib) demonstrated remarkable clinical activity. A new safety signal of moderate to severe nasopharyngeal necrosis associated with bleeding was identified with this combination. Active tumor in the nasopharynx and a history of reirradiation were associated with this TRAE.**Relevance section written by The gemcitabine plus cisplatin regimen is the standard-of-care first-line treatment for patients with metastatic or recurrent NPC unsuitable for local treatment.Several PD-1 inhibitors have been approved by the US Food and Drug Administration for the subsequent-line treatment of recurrent or metastatic NPC (RM-NPC). Although a modest response rate (20.5%-34.0%) was recorded with PD-1 inhibitor monotherapy, the responses persisted (median > 12 months).Angiogenesis is a validated target in NPC.Camrelizumab is a fully humanized, high-affinity monoclonal antibody that binds to PD-1. Apatinib selectively inhibits vascular endothelial growth factor receptor-2 (VEGFR-2)