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Cancer Therapy: Clinical

Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non–Small Cell Lung Cancer

Suresh S. Ramalingam, Normand Blais, Julien Mazieres, Martin Reck, C. Michael Jones, Erzsebet Juhasz, Laszlo Urban, Sergey Orlov, Fabrice Barlesi, Ebenezer Kio, Ulrich Keiholz, Qin Qin, Jiang Qian, Caroline Nickner, Juliann Dziubinski, Hao Xiong, Peter Ansell, Mark McKee, Vincent Giranda and Vera Gorbunova
Suresh S. Ramalingam
1Emory University, Winship Cancer Center, Atlanta, Georgia.
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  • For correspondence: ssramal@emory.edu
Normand Blais
2CHUM - Hôpital Notre-Dame, Montreal, Canada.
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Julien Mazieres
3Larrey Hospital - CHU Toulouse, Toulouse, France.
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Martin Reck
4LungenClinic Grosshansdorf, Airway Research Center North (ARCN), member of the German center for lung research (DZL), Grosshansdorf, Germany.
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C. Michael Jones
5The Jones Clinic, New Albany, Mississippi.
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Erzsebet Juhasz
6Országos Koranvi TBC és Pulmonologiai Intézet, Budapest, Hungary.
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Laszlo Urban
7Mátra Gyógyintézet, Mátraháza, Hungary.
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Sergey Orlov
8Pavlov Medical University, St Petersburg, Russia.
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Fabrice Barlesi
9Aix Marseille University; Assistance Publique Hôpitaux de Marseille, Marseille, France.
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Ebenezer Kio
10IU Health Goshen Center for Cancer Care, Goshen, Indiana.
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Ulrich Keiholz
11Charité, Berlin, Germany.
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Qin Qin
12AbbVie Inc., North Chicago, Illinois.
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Jiang Qian
12AbbVie Inc., North Chicago, Illinois.
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Caroline Nickner
13AbbVie Inc., Saint Laurent, Quebec, Canada.
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Juliann Dziubinski
12AbbVie Inc., North Chicago, Illinois.
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Hao Xiong
12AbbVie Inc., North Chicago, Illinois.
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Peter Ansell
12AbbVie Inc., North Chicago, Illinois.
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Mark McKee
12AbbVie Inc., North Chicago, Illinois.
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Vincent Giranda
12AbbVie Inc., North Chicago, Illinois.
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Vera Gorbunova
14Institution of Russian Academy of Medical Science, Russian Oncological Research Center, Moscow, Russia.
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DOI: 10.1158/1078-0432.CCR-15-3069 Published April 2017
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    Figure 1.

    CONSORT diagram. aOne declining performance status; 1 death. Carbo, carboplatin.

  • Figure 2.
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    Figure 2.

    Best percentage change in the sum of target lesions sizes. A, Veliparib BID and carbo/paclitaxel (ORR, 32.4%; 95% CI, 23.6–42.2). B, Placebo BID and carbo/paclitaxel (ORR, 32.1%; 95% CI, 19.9–46.3). Carbo, carboplatin.

Tables

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  • Table 1.

    Demographics and baseline characteristics

    CharacteristicPlacebo BID and carbo/paclitaxel (N = 53)Veliparib BID and carbo/paclitaxel (N = 105)
    Median age (range), y62 (46–79)63 (33–84)
    Sex, n (%)
     Male32 (60)75 (71)
     Female21 (40)30 (29)
    Race
     White52 (98)102 (97)
     Black1 (2)2 (2)
     American Indian/Alaskan Native0 (0)1 (1)
    Histology, n (%)
     Squamous25 (47)51 (49)
     Nonsquamous28 (53)54 (51)
    Smoking history, n (%)
     Current31 (58)64 (61)
     Former14 (26)28 (27)
     Never8 (15)13 (12)
    EGFR status, n (%)
     Wild-type49 (92)91 (87)
     Missing4 (8)14 (13)
    Tumor burden at time of enrollment, n (%)
     Locally advanced15 (28)22 (21)
     Metastatic38 (72)83 (79)
    Baseline ECOG, n (%)
     017 (32)35 (33)
     136 (68)70 (67)
    • Abbreviations: carbo, carboplatin.

  • Table 2.

    Summary of AEs

    AEsPlacebo BID and carbo/paclitaxel (N = 52)Veliparib BID and carbo/paclitaxel (N = 105)
    Any grade AE, n (%)46 (89)101 (96)
    Any grade ≥3 AE, n (%)30 (58)72 (69)
    Any SAE12 (23)28 (27)
     Alopecia22 (42)41 (39)
     Neutropenia15 (29)38 (36)
     Anemia21 (40)33 (31)
     Nausea13 (25)29 (28)
     Peripheral neuropathy13 (25)25 (24)
     Fatigue13 (25)24 (23)
     Arthralgia7 (13)20 (19)
     Dyspnea6 (12)16 (15)
     Decreased appetite9 (17)14 (13)
     Diarrhea8 (15)13 (12)
     Thrombocytopenia8 (15)13 (12)
     Myalgia4 (8)13 (12)
     Pain6 (12)12 (11)
     Constipation7 (13)9 (9)
     Cough8 (15)8 (8)
    Unbalanced AE, n (%)
     Leukopenia0 (0)12 (11)
    Grade ≥3 AEs, n (%)
     Neutropenia12 (23)20 (19)
     Anemia5 (10)11 (10)
     Alopecia3 (6)7 (7)
     Leukopenia0 (0)6 (6)
     Thrombocytopenia3 (6)5 (5)
     Nausea0 (0)4 (4)
     Hyperkalemia1 (2)4 (4)
     Arthralgia0 (0)3 (3)
     Fatigue0 (0)3 (3)
     Hypersensitivity0 (0)3 (3)
     Hyponatremia1 (2)2 (2)
     Myalgia0 (0)2 (2)
     Weight loss0 (0)2 (2)
    • NOTE: Analyses of safety were performed using data from the 157 patients who received at least 1 dose of study drug. Toxicity of any grade occurring in ≥10% of patients and grade ≥3 occurring in >1 patient are reported.

    • Abbreviations: carbo, carboplatin; SAE, serious adverse event.

  • Table 3.

    Reasons for discontinuation of study drug

    Primary reason for veliparib/placebo discontinuationPlacebo BID and carbo/paclitaxel (N = 53)Veliparib BID and carbo/paclitaxel (N = 105)
    Completed treatment27 (50.9%)51 (48.6%)
    Progression of disease13 (24.5%)22 (21.0%)
    Adverse event related to progression2 (3.8%)8 (7.6%)
    Adverse event not related to progression10 (18.9%)14 (13.3%)
    Withdrew consent2 (3.8%)9 (8.6%)
    Lost to follow-up01 (1.0%)
    Other1 (1.9%)6 (5.7%)
    • Abbreviation: carbo, carboplatin.

  • Table 4.

    Overview of results for primary and secondary endpoints

    PFS median (95% CI), moOS median (95% CI), moORR, % (95% CI)DOR median (95% CI), mo
    Placebo BID and carbo/paclitaxel (N = 53)4.2 (3.1–5.6)9.1 (5.4–12.3)32.1 (19.9–46.3)4.3 (2.8–NA)
     Squamous (n = 25)4.1 (2.8–NA)8.4 (5.0–12.9)
     Nonsquamous (n = 28)5.0 (2.8–5.7)11.1 (4.8–14.6)
    Veliparib BID and carbo/paclitaxel (N = 105)5.8 (4.3–6.5)11.7 (8.8–13.7)32.4 (23.6–42.2)6.9 (4.5–7.0)
     Squamous (n = 51)6.5 (4.4–8.4)10.3 (8.3–13.2)
     Nonsquamous (n = 54)5.6 (2.8–6.4)12.8 (8.0–17.2)
    HR (95%CI)
     All patients (N = 158)0.72 (0.45–1.15)0.80 (0.54–1.18)0.47 (0.16–1.42)
      Squamous (n = 76)0.54 (0.26–1.12)0.73 (0.43–1.24)
      Nonsquamous (n = 82)0.87 (0.48–1.59)0.90 (0.51–1.58)
    Adjusted HRa (95% CI)
     All patients (N = 158)0.56 (0.35–0.90)0.72 (0.49–1.07)
      Squamous (n = 76)0.43 (0.20–0.94)0.70 (0.39–1.21)
      Nonsquamous (n = 82)0.73 (0.39–1.36)0.77 (0.43–1.37)
    • Abbreviation: carbo, carboplatin.

    • ↵aHR adjusted for ECOG performance status and gender.

  • Table 5.

    Post-study therapies

    Post-study therapyPlacebo BID and carbo/paclitaxel (N = 53)Veliparib BID and carbo/paclitaxel (N = 105)
    Without any therapy31 (58.5%)46 (43.8%)
    With at least one therapy22 (41.5%)59 (56.2%)
    Type of medications in post-study therapya
     Docetaxel5 (9.4%)14 (13.3%)
     Erlotinib2 (3.8%)14 (13.3%)
     Gemcitabine4 (7.5%)14 (13.3%)
     Pemetrexed5 (9.4%)21 (20.0%)
     Other12 (22.6%)40 (38.1%)
    • Abbreviation: carbo, carboplatin.

    • ↵aPatients who were on multiple medications in a therapy are counted under each medication.

Additional Files

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  • Supplementary Data

    • Supplemental Materials - Supplemental Table 1. Demographics and baseline characteristics by histology: squamous cell Supplemental Table 2. Demographics and baseline characteristics by histology: non-squamous cell Supplemental Table 3. Mean {plus minus} SD pharmacokinetic parameters of veliparib on cycle 1 day 3 Supplemental Table 4. Mean {plus minus} SD (median) plasma concentrations of paclitaxel and carboplatin at 5 min before ending paclitaxel and carboplatin infusions, respectively Supplemental Figure 1: Progression-free survival (A) and overall survival (B) in responders and non-responders
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Clinical Cancer Research: 23 (8)
April 2017
Volume 23, Issue 8
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Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non–Small Cell Lung Cancer
Suresh S. Ramalingam, Normand Blais, Julien Mazieres, Martin Reck, C. Michael Jones, Erzsebet Juhasz, Laszlo Urban, Sergey Orlov, Fabrice Barlesi, Ebenezer Kio, Ulrich Keiholz, Qin Qin, Jiang Qian, Caroline Nickner, Juliann Dziubinski, Hao Xiong, Peter Ansell, Mark McKee, Vincent Giranda and Vera Gorbunova
Clin Cancer Res April 15 2017 (23) (8) 1937-1944; DOI: 10.1158/1078-0432.CCR-15-3069

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Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non–Small Cell Lung Cancer
Suresh S. Ramalingam, Normand Blais, Julien Mazieres, Martin Reck, C. Michael Jones, Erzsebet Juhasz, Laszlo Urban, Sergey Orlov, Fabrice Barlesi, Ebenezer Kio, Ulrich Keiholz, Qin Qin, Jiang Qian, Caroline Nickner, Juliann Dziubinski, Hao Xiong, Peter Ansell, Mark McKee, Vincent Giranda and Vera Gorbunova
Clin Cancer Res April 15 2017 (23) (8) 1937-1944; DOI: 10.1158/1078-0432.CCR-15-3069
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