Contributors: Institut Català de la Salut; [Yang JC] Graduate Institute of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan. [Zhou C] Shanghai Pulmonary Hospital, Shanghai, China. [Jänne PA] Dana-Farber Cancer Institute, Boston, MA, USA. [Ramalingam SS] School of Medicine, Emory University, Atlanta, GA, USA. [Kim TM] Seoul National University Hospital, Seoul, South Korea. [Riely GJ] Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain; Vall d'Hebron Barcelona Hospital Campus
نبذة مختصرة : Mobocertinib has demonstrated durable clinical benefit in platinum-pretreated patients (PPP) with epidermal growth factor receptor exon 20 insertion-positive non-small cell lung cancer (NSCLC).Pooled safety analysis of two studies included patients with NSCLC (N = 257) treated with the recommended phase 2 dose (RP2D) of mobocertinib (160 mg once daily). We report overall safety (treatment-emergent adverse events [TEAEs]) in the RP2D population; characterization of GI and skin-related events in 114 PPP from a phase 1/2 study (NCT02716116); and clinical activity in PPP with and without dose reductions due to TEAEs.In the RP2D population (N = 257), the most common TEAEs were diarrhea (93%), nausea (47%), rash (38%), and vomiting (37%). In PPP (N = 114), median times to diarrhea onset and resolution were 5 and 2 days, respectively. Median times to onset and resolution of skin-related events were 9 and 78 days, respectively. Among PPP with (n = 29) or without (n = 85) dose reductions due to TEAEs, overall response rates were 21% and 31% and median durations of response were 5.7 and 17.5 months, respectively.GI and skin-related events are common with mobocertinib; minimizing dose reductions with proactive management may improve clinical outcomes.NCT02716116; NCT03807778.
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