Pneumologie 2018; 72(S 01): S39-S40
DOI: 10.1055/s-0037-1619221
Sektion 11 – Pneumologische Onkologie
Posterbegehung – Titel: Lungenkarzinom I
Georg Thieme Verlag KG Stuttgart · New York

Efficacy and safety results from AvaALL: an open-label, randomized phase III trial of standard of care (SOC) with or without continuous bevacizumab (Bev) treatment beyond progression (PD) in patients (pts) with advanced non-small-cell lung cancer (NSCLC) progressing after first-line Bev and chemotherapy (chemo)

F Griesinger
1   Department of Hematology and Oncology, University Hospital, Pius-Hospital Oldenburg
,
J Bennouna
2   Institut de Cancérologie de L'ouest, Nantes
,
J de Castro Carpeno
3   Translational Oncology Unit at Medical Oncology Division; Hospital Universitario La Paz; Idipaz
,
AM Dingemans
4   Department of Pulmonology; Maastricht University Medical Center
,
F Grossi
5   Lung Cancer Unit, National Institute for Cancer Research, Genova, Italien
,
C Langer
6   Thoracic Oncology Unit; Abramson Cancer Center; University of Pennsylvania, Philadelphia
,
Y Ohe
7   National Cancer Center Hospital, Tokyo
,
K Syrigos
8   Athens Medical Center; National & Kapodistrian University of Athens Medical School
,
N Thatcher
9   Christie Hospital NHS Trust, Manchester
,
A Das-Gupta
10   F.Hoffmann-La Roche, Basel
,
M Donica
10   F.Hoffmann-La Roche, Basel
,
V Smoljanovic
10   F.Hoffmann-La Roche, Basel
,
C Gridelli
11   Division of Medical Oncology; S.G. Moscati Hospital, Avellino, Italien
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

Also available at
 

Background:

The role of treatment with Bev beyond PD is unclear in the multiline treatment strategy of advanced NSCLC. AvaALL (NCT01351415), a multinational, open-label, randomized phase III trial, assessed continuous Bev and SOC beyond first PD (PD1) in pts with NSCLC following first-line treatment with platinum-based chemo plus Bev. Here we present efficacy and safety data from AvaALL.

Methods:

Pts with NSCLC who received 4 – 6 cycles of chemo + Bev and ≥2 cycles of maintenance Bev were randomized after PD1 to second-line SOC therapy (docetaxel, pemetrexed or erlotinib)± Bev. After second PD (PD2) and third PD (PD3), pts received third-line or fourth-line SOC ± Bev treatment, respectively. Primary endpoint was overall survival (OS). Secondary endpoints were OS rates (6, 12, and 18-months [mos]), progression-free survival (PFS) from PD1 to PD2/from PD2 to PD3, overall response rate (ORR), disease control rate (DCR), and safety. Data cut-off: 24 Jun 2016.

Results:

Overall, 485 pts were randomized (n = 475 treated). Pt characteristics were well balanced between the two arms. Bev plus chemo resulted in a median OS of 11.9 mos versus 10.2 mos for SOC alone (HR 0.84, 90% CI 0.71 – 1.00; p = 0.1016; 387 OS events). The primary endpoint was not met (416 OS events were required, at 10% two-sided significance level). OS rates were 10% higher in the Bev arm vs. SOC alone at 6-, 12- and 18-mos. Median PFS2 was 4.9 mos with Bev vs. 3.8 mos with SOC (HR 0.85, 90% CI 0.72 – 1.00; p = 0.0907). PFS3 was significantly improved (3.5 mos for Bev, 2.4 mos for SOC; HR 0.65, 90% CI 0.51 – 0.84; p = 0.0047). ORR and DCR were slightly higher in the Bev arm versus the SOC arm (ORR 9.7% vs. 6.7%; DCR 86.2% vs. 79.3%, respectively). No new safety signals were identified. Grade ≥3 adverse events were reported in 78.2% of Bev pts and 61.6% of SOC pts.

Conclusions:

Although the primary endpoint was not met, efficacy data suggest a positive trend for continued Bev plus SOC after PD1 compared with SOC alone. No cumulative safety signals were identified.

Funding:

F. Hoffmann-La Roche