First subsequent treatment after discontinuation of durvalumab in unresectable, stage III NSCLC patients from PACIFIC.

Authors

null

David Planchard

Gustave Roussy, Villejuif, France

David Planchard , Byoung Chul Cho , Jhanelle Elaine Gray , Luis G. Paz-Ares , Mustafa Ozguroglu , Augusto E. Villegas , Davey B. Daniel , David Vicente , Shuji Murakami , Rina Hui , Takayasu Kurata , Alberto Chiappori , Ki Hyeong Lee , Maike De Wit , Yu Gu , Catherine Wadsworth , Phillip A. Dennis , Scott Joseph Antonia

Organizations

Gustave Roussy, Villejuif, France, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, Hospital Universitario 12 de Octubre, CiberOnc, Universidad Complutense and CNIO, Madrid, Spain, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey, Cancer Specialists of North Florida, Jacksonville, FL, Tennessee Oncology, Chattanooga, TN, Hospital Universitario Virgen Macarena, Seville, Spain, Kanagawa Cancer Center, Yokohama, Japan, Westmead Hospital and the University of Sydney, Sydney, NSW, Australia, Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea, Vivantes Klinikum Neukoelln, Berlin, Germany, MedImmune, Gaithersburg, MD, AstraZeneca, Alderley Park, United Kingdom, AstraZeneca, Gaithersburg, MD

Research Funding

Pharmaceutical/Biotech Company

Background: In the phase 3 PACIFIC trial of unresectable, stage III NSCLC patients (pts) without progression after concurrent chemoradiotherapy (cCRT), durvalumab (durva) significantly improved PFS and OS with similar safety compared to placebo (pbo). We performed exploratory analyses to characterize first subsequent treatment (Tx) after discontinuation of durva. Methods: Pts with WHO PS 0/1 and any tumor PD-L1 status were randomized (2:1) 1–42 days after ≥2 cycles of platinum-based cCRT to durva 10 mg/kg IV or pbo Q2W up to 12 months, stratified by age, sex and smoking history. Pts were classified by the use or not of first subsequent Tx and category of first systemic Tx (platinum doublet CT [PDCT], single-agent CT [SCT], immunotherapy [IT] or targeted therapy [TT]). Results: As of Mar 22, 2018, 216/476 (45.4%) and 153/237 (64.6%) in the durva and pbo arms, respectively, had a RECIST-based PFS event per BICR (5.7% and 8.4% due to death). 195 (41.0%) and 128 (54.0%) received first subsequent Tx, most of which were systemic Tx (158 [33.2%] and 109 [46.0%]): PDCT (16.4% and 19.0%), SCT (8.6% and 8.4%), IT (4.2% and 13.5%) or TT (3.8% and 5.1%); 7.8% and 8.0% received RT only. Time to first subsequent therapy or death (TFST) was longer with durva vs pbo (HR 0.58; 95% CI 0.47–0.72; median 21.0 vs 10.4 months). Baseline characteristics of pts with or without first subsequent Tx were similar, and similar across durva or pbo arms. Among pts with systemic Tx, baseline characteristics (including pre-cCRT PD-L1 status) were generally similar, except pts on TT, more of whom were EGFR+ (70.0% vs 0–6.6% of other systemic Tx groups) with commonly associated phenotypes (more females, Asians, non-smokers and non-squamous pts). Best overall response to first systemic Tx will be presented. Conclusions: Due to longer PFS and fewer progression events with durva vs pbo, fewer pts on durva required subsequent Tx and, per TFST, much later. With the exception of IT, use of each subsequent Tx was similar between the durva and pbo arms with PDCT the most common. Baseline characteristics were similar for pts with or without first subsequent Tx and pts who received first systemic Tx, except for pts who received TT, as expected due to their molecular profile.

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Metastatic

Track

Lung Cancer

Sub Track

Metastatic Non–Small Cell Lung Cancer

Citation

J Clin Oncol 37, 2019 (suppl; abstr 9054)

DOI

10.1200/JCO.2019.37.15_suppl.9054

Abstract #

9054

Poster Bd #

377

Abstract Disclosures