19th World Conference on Lung Cancer
Conference Program for the 19th World Conference on Lung Cancer in Toronto, Canada
Download PDF of the Abstract Book: Click Here.
- Sept 23 - 26, 2018
- Total Presentations: 2487
September 23 Sun
Sep 23 Monday
September 24 Mon
Sep 24 Tuesday
September 25 Tue
Sep 25 Wednesday
September 26 Wed
PL02 - Presidential Symposium - Top 5 Abstracts
- 08:15 - 09:45
- Location: Plenary Hall
- Type: Plenary Session
- Track: Advanced NSCLC
PL02.09 - Nintedanib + Pemetrexed/Cisplatin in Patients with Unresectable MPM: Phase III Results from the LUME-Meso Trial
09:15 - 09:25 | Presenting Author(s): Giorgio Vittorio Scagliotti | Author(s): Rabab Gaafar, Anna K. Nowak, Takashi Nakano, Jan Van Meerbeeck, Sanjay Popat, Nicholas Vogelzang, Federica Grosso, Rasha Aboelhassan, Marko Jakopovic, Giovanni L Ceresoli, Paul Taylor, Francisco Orlandi, Dean A Fennell, Silvia Novello, Arnaud Scherpereel, Ute Von Wangenheim, Miyoung Kim, José Barrueco, Anne S. Tsao
Nintedanib targets VEGFR 1–3, PDGFR α/β, FGFR 1–3, Src and Abl kinases, all implicated in malignant pleural mesothelioma (MPM) pathophysiology. This global Phase II/III, randomised, double-blind study investigated pemetrexed/cisplatin in combination with nintedanib or pemetrexed/cisplatin in combination with placebo, followed by nintedanib or placebo maintenance, in patients with unresectable MPM. In the double-blind, randomised Phase II part, nintedanib plus pemetrexed/cisplatin improved PFS vs placebo (HR=0.56; 95% CI: 0.34–0.91; p=0.017; median 9.4 vs 5.7 months).
In Phase III, chemotherapy-naïve patients with epithelioid MPM (ECOG PS 0–1) were randomised 1:1 to receive up to six cycles of pemetrexed (500 mg/m2)/cisplatin (75 mg/m2) on Day 1, plus nintedanib (200 mg bid) or matched placebo on Days 2–21. After combination treatment, patients without disease progression received nintedanib or placebo maintenance. The primary endpoint (PFS by investigator assessment) and key secondary endpoint (OS) were planned to be analysed by hierarchical testing, with an interim OS analysis at the time of the primary PFS analysis. PFS was also assessed by independent central review. Based on the assumed treatment effect (HR=0.63), the study had 90% power to detect a statistically significant and clinically meaningful improvement in PFS.
In total, 458 patients were randomised. Baseline patient characteristics and oncological history were similar between treatment arms. Median duration of nintedanib or placebo administration was 5.3 and 5.1 months, respectively. After 250 events, there was no difference in PFS between nintedanib and placebo arms (HR=1.01; 95% CI: 0.79–1.30; p=0.91; median 6.8 vs 7.0 months, respectively). PFS by central independent review was similar (242 events; HR=0.99; 95% CI: 0.77–1.28; p=0.96; median 6.8 months in each arm). In the interim OS analysis (127 deaths [28% of events]), median OS was 14.4 vs 16.1 months (nintedanib vs placebo; HR=1.12; 95% CI: 0.79–1.58; p=0.54). There were no unexpected safety findings. The proportion of patients with Grade ≥3 AEs was higher with nintedanib than with placebo (72% vs 62%). The most frequently reported Grade ≥3 AE by medical concept in both treatment arms was neutropenia (nintedanib: 32%; placebo: 24%). The proportion of deaths due to serious AEs was 4.0% (nintedanib) and 7.5% (placebo).
The primary endpoint of the Phase III part of LUME-Meso was not met ‒ Phase II findings were not confirmed. The reported safety profile was consistent with the known safety profiles of nintedanib and pemetrexed/cisplatin.
PR02 - Press Conference
- 09:45 - 10:30
- Location: Plenary Hall
- Type: Press Conference