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NSCLC, metastatic 1

3220 - ABOUND.2L+: nab-paclitaxel (nab-P) +/- CC-486 or durvalumab in previously treated patients with advanced non-small cell lung cancer (NSCLC)

Date

08 Sep 2017

Session

NSCLC, metastatic 1

Presenters

Daniel Morgensztern

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

D. Morgensztern1, T.J. Ong2, M. Cobo Dols3, S. Ponce Aix4, P.E. Postmus5, C. Lewanski6, J. Bennouna7, J.R. Fischer8, O.J. Vidal9, D.J. Stewart10, G. Fasola11, A. Ardizoni12, J. Weaver2, M. Wolfsteiner13, D. Talbot14, R. Govindan1

Author affiliations

  • 1 Division Of Oncology, Washington University School of Medicine, 63110 - St Louis/US
  • 2 Medical Oncology, Celgene Corporation, Summit/US
  • 3 Medical Oncology, Hospital Regional Universitario Carlos Haya – Hospital General, Malaga/ES
  • 4 Oncology, Unidad de Investigación Clínica de Cáncer Pulmón H12O-CNIO,, Madrid/ES
  • 5 Medical Oncology, Clatterbridge Cancer Centre, Liverpool/GB
  • 6 Medical Oncology, Charing Cross Hospital, London/GB
  • 7 Thoracic Oncology, Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique, Nantes, Loire-Atlantique/FR
  • 8 Medical Oncology, Lungenklinik Löwenstein, Löwenstein, Baden-Württemberg/DE
  • 9 Oncology, Hospital Universitari i Politècnic La Fe, Valencia/ES
  • 10 Medicine, Ottawa Hospital, Ottawa/CA
  • 11 Oncology, University Hospital Santa Maria della misericordia, Udine/IT
  • 12 Oncology, Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi, Bologna/IT
  • 13 Oncology, PRA Health Sciences, Lenexa/US
  • 14 Oncology, Oxford University Hospitals Trust, Oxford/GB
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Abstract 3220

Background

Therapy selection for previously treated patients with advanced NSCLC is evolving. ABOUND.2L+ evaluated safety and efficacy of nab-P monotherapy, nab-P + the epigenetic modifying agent CC-486, and nab-P + the PD-L1 inhibitor durvalumab.

Methods

Patients with advanced nonsquamous NSCLC and ≤ 1 prior chemotherapy were randomized to nab-P 100 mg/m2 on days 8 and 15 + CC-486 200 mg QD on days 1-14 or nab-P alone 100 mg/m2 on days 1 and 8, both administered q3w. The protocol was amended to include a nab-P + durvalumab arm (nab-P 100 mg/m2 on days 1 and 8 + durvalumab 1125 mg on day 15, q3w), which began enrolling after the other arms had completed enrollment and allowed the inclusion of patients with squamous histology or prior immunotherapy treatment. For all patients, treatment continued until unacceptable toxicity or tumor progression.

Results

A total of 240 patients were enrolled. In the nab-P + CC-486 and nab-P arms, the median number of cycles was 4 and the median cumulative dose of nab-P was 600 and 800 mg/m2, respectively. Grade 3 or 4 (G3/4) treatment-emergent adverse events (AEs) were 59.5% and 54.4%, respectively. The most frequent hematologic G3/4 AEs were neutropenia (16.5% vs 10.1%) and anemia (1.3% vs 7.6%). G3/4 peripheral neuropathy occurred in 2.5% vs 7.6% of patients (nab-P + CC-486 vs nab-P). Adding CC-486 to nab-P did not result in improvements in PFS, OS, ORR, or DCR (Table). Preliminary data for 79 patients in the nab-P + durvalumab arm showed a median PFS of 4.4 months, median OS not estimable, a 20% ORR, and a 71% DCR. No new safety signals were identified.

Table:

LBA48

nab-P + CC-486 n = 81nab-P n = 80
Efficacy
Primary endpoint
Median PFS, months3.24.2
HR (95% CI) 1.3 (0.9 - 2.0)
Secondary endpoints
Median OS, months8.412.7
HR (95% CI) 1.4 (0.88 - 2.31)
ORR, n (%)a11 (13.6)11 (13.8)
Response rate ratio (95% CI) 0.99 (0.45 - 2.15)
Complete response Partial response Stable disease Progressive disease DCR (≥ stable disease)0 11 (13.6) 41 (50.6) 22 (27.2) 52 (64.2)0 11 (13.8) 43 (53.8) 19 (23.8) 54 (67.5)

DCR, disease control rate; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.

a

Response rate was based on the intent-to-treat population; however, 14 patients did not have a response assessment.

Conclusions

Single-agent nab-P is promising in previously treated nonsquamous NSCLC; addition of CC-486 did not appear to benefit patients clinically. Updated data for the ongoing durvalumab combination arm of the study will be presented. NCT02250326.

Clinical trial identification

NCT02250326

Legal entity responsible for the study

Celgene

Funding

Celgene Corporation

Disclosure

D. Morgensztern: Consultant: Celgene, Abbvie and Bristol-Myers Squibb. T.J. Ong, J. Weaver: Full-time employee: Celgene Corporation. P.E. Postmus: Advisory Board: Advisory board Celgene, AstraZeneca, Roche, BMS, BI, Janssen, MSD, Clovis. C. Lewanski: Advisory Board Member: Eli Lilly. J. Bennouna: Advisory Board: Roche, Boehringer-Ingelheim, Astra-Zeneca, BMS; Honoraria: Roche, Boehringer-Ingelheim, Astra-Zeneca, BMS. J.R. Fischer: Employment: Klinik Löwenstein; Advisory Board: Astra Zeneca, BMS, Celgene, Roche, MSD, Boehringer; Consultant: Celgene; Speaker’s Bureau: Astra Zeneca, Celgene, Roche, BMS; Honoraria: Astra Zeneca, BMS, Celgene, Roche, MSD, Boehringer. D.J. Stewart: Grants/Research Support Recipient: Clinical trials support: Celgene, Boehringer Ingelheim, Astra Zeneca, Novartis, Bristol-Myers Squibb; Advisory Board: Roche Canada; Pfizer Canada; Boehringer Ingleheim Canada, Amgen, Novartis Canada. A. Ardizoni: Honoraria from Eli-Lilly, BMS, MSD, Boehringer. M. Wolfsteiner: Employment: FTE at PRA Health Sciences, contracted for Celgene (current). D. Talbot: Honoraria - Pfizer; Pierre Fabre Consulting or Advisory Role - Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Lilly; Novartis; Pfizer; Roche Travel, Accommodations, Expenses - Bristol-Myers Squibb; Ipsen; Lilly; Merck Sharp & Dohme; Novartis. R. Govindan: Honoraria - Boehringer Ingelheim Consulting or Advisory Role - Abbvie; Bayer; Boehringer Ingelheim; Celgene; Clovis Oncology; Genentech/Roche; GlaxoSmithKline; Helsinn Therapeutics; Novartis Research Funding - Abbvie (Inst); Bayer (Inst); GlaxoSmithKline (Inst); MethylGene (Inst) Travel, Accommodations, Expenses - Amgen; Boehringer Ingelheim; Celgene; Genentech; GlaxoSmithKline; Merck All other authors have declared no conflicts of interest.

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