FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review

被引：37

作者：

Vellanki, Paz J. ^{[1
]}

Mulkey, Flora ^{[1
]}

Jaigirdar, Adnan A. ^{[1
]}

Rodriguez, Lisa ^{[1
]}

Wang, Yibo ^{[1
]}

Xu, Yuan ^{[1
]}

Zhao, Hong ^{[1
]}

Liu, Jiang ^{[1
]}

Howe, Grant ^{[2
]}

Wang, Jian ^{[2
]}

Choo, Qiuyi ^{[3
]}

Golding, Sarah J. ^{[4
]}

Mansell, Victoria ^{[4
]}

Korsah, Kwadwo ^{[1
]}

Spillman, Dianne ^{[5
]}

de Claro, R. Angelo ^{[1
,5
]}

Pazdur, Richard ^{[5
]}

Beaver, Julia A. ^{[5
]}

Singh, Harpreet ^{[1
,5
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[2] Hlth Canada, Ottawa, ON, Canada

[3] Hlth Sci Author, Singapore, Singapore

[4] Therapeut Goods Adm, Canberra, ACT, Australia

[5] US FDA, Oncol Ctr Excellence, Silver Spring, MD 20993 USA

来源：

CLINICAL CANCER RESEARCH | 2021年 / 27卷 / 13期

关键词：

PEMBROLIZUMAB; THERAPY;

D O I：

10.1158/1078-0432.CCR-20-4338

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

On May 26, 2020, the FDA approved nivolumab with ipili-mumab and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The approval was based on results from Study CA2099LA (CheckMate 9LA), an open-label trial in which 719 patients with NSCLC were randomized to receive nivolumab with ipilimumab and two cycles of chemotherapy (n = 361) or four cycles of platinum-doublet chemotherapy (n = 358). Overall survival (OS) was improved for patients who received nivolumab with ipilimumab and chemotherapy, with a median OS of 14.1 months [95% confidence interval (CI), 13.2-16.2] compared with 10.7 months (95% CI, 9.5-12.5) for patients who received chemotherapy (HR, 0.69; 96.71% CI, 0.55-0.87; P = 0.0006). Progression-free survival and overall response rate per blinded independent central review were also statistically significant. This was the first NSCLC application reviewed under FDA's Project Orbis, in collaboration with Singapore's Health Sciences Authority, Australia's Therapeutic Goods Administration, and Health Canada. The benefit-risk analysis supports FDA's approval of nivolumab with ipilimumab and chemotherapy.

引用

页码：3522 / 3527

页数：6

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