Abstract 339TiP
Background
Non-small-cell lung cancer (NSCLC) represents >80% of lung cancer cases worldwide and 30% of patients (pts) present with Stage III disease. Historically, platinum-based CRT has been the standard of care (SoC) for such pts, yet outcomes are poor. Durvalumab (durva) is a selective, high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. Results from the PACIFIC trial of durva in pts with locally advanced, unresectable, Stage III NSCLC, who did not progress on concurrent CRT (cCRT), showed significant improvements in progression-free survival (PFS) and overall survival (OS) with durva vs placebo (PFS: HR 0.52; 95% CI 0.42–0.65; P < 0.001; OS: HR 0.68; 99.73% CI 0.47–0.997; P = 0.0025), and similar safety profiles (Antonia et al, NEJM 2017; 2018). Consequently, treatment with durva after CRT, the PACIFIC regimen, is quickly becoming the new SoC. However, the PACIFIC trial only assessed pts who had received cCRT, but due to the higher toxicity of this approach, some patients may be better suited to sequential CRT (sCRT). Therefore, the objective of the PACIFIC-5 (NCT03706690) study is to assess durva post-CRT in a broader population, including pts with NSCLC who did not progress following either platinum-based cCRT or sCRT.
Trial design
PACIFIC-5 is a phase 3, randomized, double-blind, placebo-controlled, multicenter study. Approximately 360 pts with histologically or cytologically confirmed Stage III, locally advanced, unresectable NSCLC will be enrolled from China and the rest of the world. Eligible pts have not progressed following definitive, platinum-based cCRT or sCRT, and are in complete response, partial response or have stable disease. Pts are being randomized 2:1 to receive either durva (1500 mg i.v.) every 4 weeks, or placebo, until disease progression, toxicity or withdrawal of consent. The primary endpoint is PFS per blinded independent central review; OS is the key secondary endpoint. Other secondary endpoints include OS24, overall response rate, duration of response, PFS2, PFS12, PFS18, time to distant metastases, pt-reported outcomes, durva pharmacokinetics and immunogenicity, and safety assessments. Recruitment is ongoing.
Clinical trial identification
NCT03706690.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
Y-L. Wu: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Sanofi; Advisory / Consultancy: Merck; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim. Y-C. Kim: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Boehringer Ingelheim. P. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. Y. Qin: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. E. Macpherson: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. P.A. Dennis: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.
Resources from the same session
184P - Expression pattern of CDK12 protein in gastric cancer and its positive correlation with CD8+ cell density and CCL12 expression
Presenter: Jun Ji
Session: Poster display session
Resources:
Abstract
185P - Evaluation of the effect of cholesorption on the concentration of TNF-α in the serum of the blood in tumours of the biliopancreatoduodenal zone
Presenter: Marufjon Salokhiddinov
Session: Poster display session
Resources:
Abstract
186P - Efficacy and safety of sorafenib following hepatic resection in patients with hepatocellular carcinoma: A meta-analysis
Presenter: Yang Yuan
Session: Poster display session
Resources:
Abstract
187P - Correlation between spleenic dose and grade of hematological toxicity in chemoradiation of stomach
Presenter: Umesh Velu
Session: Poster display session
Resources:
Abstract
188P - Survival and prognostic factors in cholangiocarcinoma: A single-center experience
Presenter: Sonngwit Payapwattanawong
Session: Poster display session
Resources:
Abstract
189P - Stereotactic body radiotherapy in primary hepatocellular carcinoma and oligometastatis to liver: A single Institution experience
Presenter: Sayan Paul
Session: Poster display session
Resources:
Abstract
190P - Details of response with first-line gemcitabine and nab-paclitaxel therapy in patients with advanced pancreatic cancer
Presenter: Yusuke Nagata
Session: Poster display session
Resources:
Abstract
191P - Assessment of efficacy and safety of sorafenib versus no treatment in Egyptian hepatocellular carcinoma patients
Presenter: Noha El Baghdady
Session: Poster display session
Resources:
Abstract
192P - Clinical importance of the determination of interleukin-6 in bile and blood in tumours of biliopancreatoduodenal zone
Presenter: Marufjon Salokhiddinov
Session: Poster display session
Resources:
Abstract
193P - Metastatic carcinoma gall bladder: A clinicoepidemiological profile of Indian patients
Presenter: Anvesh Rathore
Session: Poster display session
Resources:
Abstract