دورية أكاديمية
Clinical Activity, Tolerability, and Long-term Follow-up of Durvalumab in Patients With Advanced NSCLC.
| العنوان: | Clinical Activity, Tolerability, and Long-term Follow-up of Durvalumab in Patients With Advanced NSCLC. |
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| المؤلفون: | Antonia, Scott J., Balmanoukian, Ani, Brahmer, Julie, Ou, Sai-Hong I., Hellmann, Matthew D., Kim, Sang-We, Ahn, Myung-Ju, Kim, Dong-Wan, Gutierrez, Martin, Liu, Stephen V., Schoffski, Patrick, Jager, Dirk, Jamal, Rahima, Jerusalem, Guy, Lutzky, Jose, Nemunaitis, John, Calabro, Luana, Weiss, Jared, Gadgeel, Shirish, Bhosle, Jaishree, Ascierto, Paolo A., Rebelatto, Marlon C., Narwal, Rajesh, Liang, Meina, Xiao, Feng, Antal, Joyce, Abdullah, Shaad, Angra, Natasha, Gupta, Ashok K., Khleif, Samir N., Segal, Neil H. |
| المصدر: | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 14 (10), 1794-1806 (2019) |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | durvalumab, efficacy, immunotherapy, non-small cell lung cancer, safety, oncology, Human health sciences, Oncology, Sciences de la santé humaine, Oncologie |
| الوصف: | INTRODUCTION: Durvalumab is a selective, high-affinity human IgG1 monoclonal antibody that blocks programmed cell death ligand-1 (PD-L1) binding to PD-1. Here we report safety and clinical activity in the non-small cell lung cancer (NSCLC) cohort of a Phase 1/2 trial that included multiple tumor types (Study 1108; NCT01693562). METHODS: Patients with stage IIIB-IV NSCLC (squamous or nonsquamous) received durvalumab 10 mg/kg q2w for 12 months or until confirmed progressive disease or unacceptable toxicity. Primary objectives were safety and antitumor activity. Tumoral PD-L1 expression was assessed using the VENTANA SP263 Assay. Responses were assessed by blinded independent central review (RECIST v1.1). Adverse events were graded according to NCI CTCAE v4.03. RESULTS: Of 304 patients, 79.0% were previously treated. Confirmed objective response rate was 21.8% in patients with >/=25% PD-L1 expression and 6.4% in those with <25%; 25.9% in first-line patients and 12.7% in previously treated patients; 14.0% in squamous and 16.7% in nonsquamous disease. Median OS was 12.4 months and median PFS was 1.7 months; both were numerically longer in the PD-L1 >/=25% group than in the PD-L1 <25% group (OS 16.4 vs 7.6 months; PFS 2.6 vs 1.4 months). Treatment-related adverse events occurred in 57.2%, were Grade 3/4 in 10.2%, and led to discontinuation in 5.6%. One patient (0.3%) died of treatment-related pneumonia with underlying pneumonitis. CONCLUSIONS: Durvalumab was clinically active irrespective of histology in this mostly pretreated population, with a manageable safety profile. Response rates and survival appeared to be enhanced in patients with greater tumoral PD-L1 expression. |
| نوع الوثيقة: | journal article http://purl.org/coar/resource_type/c_6501Test article peer reviewed |
| اللغة: | English |
| العلاقة: | urn:issn:1556-0864; urn:issn:1556-1380 |
| DOI: | 10.1016/j.jtho.2019.06.010 |
| الوصول الحر: | https://orbi.uliege.be/handle/2268/240264Test |
| حقوق: | restricted access http://purl.org/coar/access_right/c_16ecTest info:eu-repo/semantics/restrictedAccess |
| رقم الانضمام: | edsorb.240264 |
| قاعدة البيانات: | ORBi |
| DOI: | 10.1016/j.jtho.2019.06.010 |
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