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    Clinical Trial Results:
    Multiple, fixed-dose, comparative efficacy and safety evaluation of RGB-02 and Neulasta® in patients undergoing chemotherapy treatment known to induce neutropenia.

    Summary
    EudraCT number
    		 2013-003166-14
    Trial protocol
    		 CZ   HU   BG   HR  
    Global end of trial date
    08 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RGB-02-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gedeon Richter Plc
    Sponsor organisation address
    Gyömrői út 19-21, Budapest, Hungary, H-1103
    Public contact
    Dr. Balázs Lázár, Gedeon Richter Plc., +36 1 432 6437, RA.ctaRichter@richter.hu
    Scientific contact
    Medical Information Scientific Service, Gedeon Richter Plc., +36 1 5057032, medinfo@richter.hu
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to assess and compare the efficacy and safety of RGB-02 versus Neulasta® (both subcutaneous [s.c.] injections) in breast cancer patients receiving myelosuppressive chemotherapy.
    Protection of trial subjects
    This study was conducted in compliance with Independent Ethics Committee (IEC) and the International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP-E6) Guidelines, in accordance with applicable regulations regarding clinical safety data management (E2A, E2B[R3]), European Community directives 2001/20, 2001/83, 2003/94 and 2005/28 as enacted into local law, and with ICH guidelines regarding scientific integrity (E4, E8, E9 and E10). In addition, this study was compliant to all local regulatory requirements, and requirements for data protection. Before initiating the study, the Investigator/institution had to have written and dated approval/favorable opinion from the IEC for the study protocol, written Informed Consent Form (ICF), any consent form updates, patient recruitment procedures (e.g., advertisements) and any written information to be provided to patients, and a statement from the IEC that they complied with GCP requirements. The IEC approval had to identify the protocol version as well as the documents reviewed.
    Background therapy
    		 On Day 1 of each cycle, patients received 60 mg/m2 doxorubicin intravenous (i.v.) infusion followed approximately 1 hour later by i.v. infusion of 75 mg/m2 docetaxel. Chemotherapy was repeated every 3 weeks for up to 4 cycles. In each cycle, all patients received standard oral corticosteroid premedication on 3 consecutive days starting on Day -1 (the day before chemotherapy was administered).
    Evidence for comparator
    		 RGB-02 (pegfilgrastim) is an investigational medicinal product (IMP) under development as a biosimilar to the pegfilgrastim Neulasta® which has been approved in the European Union (EU) since 2002 for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). The active substance of RGB-02 and Neulasta® is a covalent conjugate of recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) with a single 20 kDa polyethylene glycol (PEG).
    Actual start date of recruitment
    28 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Croatia: 5
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Hungary: 48
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Russian Federation: 84
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Ukraine: 55
    Worldwide total number of subjects
    239
    EEA total number of subjects
    88
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    234
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 28 January 2014 (first patient first visit) and 08 April 2015 (last patient last visit) a total of 270 patients were screened at 35 of the 40 sites that were opened for this study. Of these, 239 were randomized at 32 sites (in Russia, Hungary, Ukraine, Romania, Czech Republic, Serbia, Bulgaria, Croatia).

    Pre-assignment
    Screening details
    		 The study started with a 21-day screening period. During the screening period, the eligibility of the patients to participate in the study was assessed. The randomization was performed on Day -1 or Day 1 of Cycle 1, before chemotherapy administration.

    Period 1
    Period 1 title
    All randomized subjects (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The treatment was administered in a double-blind manner during the first 2 cycles. After the second cycle (from Cycle 3 onwards), the treatment administration became open-label. Relabeling of Neulasta® syringes and overlabeling of the needle caps of both the test and reference products was used to ensure the blinding. Due to the blinding solution, the syringes for both IMPs were properly blinded so that they were not identifiable either by the pharmacist, the IMP administrator, or the patient

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RGB-02
    Arm description
    		 All subjects randomized to receive RGB-02 (test product) during Cycles 1-4. In addition to the 4 cycles of chemotherapy, 2 additional cycles (Cycles 5-6) with the same regimen were allowed if deemed necessary by the Investigator. For those patients who received more than 4 cycles, RGB-02 was administered as supportive therapy. 3-weeks per cycle. A Follow-up Visit was performed 6 months (± 10 days) after the first IMP administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RGB-02
    Investigational medicinal product code
    RGB-02
    Other name
    pegfilgrastim 6 mg/0.6 mL (test product)
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of RGB-02 pre-filled syringes 6 mg/0.6 mL for subcutaneous (s.c.) administration during Cycles 1-4. Administrated on Day 2 of the cycle approximately 24h after chemotherapy.

    Arm title
    		 Neulasta® + RGB-02
    Arm description
    		 All subjects randomized to receive Neulasta® (reference product) during Cycles 1 and 2 under double-blind conditions and who were switched to receive RGB-02 (test product) under open label conditions starting with Cycle 3. In addition to the 4 cycles of chemotherapy, 2 additional cycles (Cycles 5-6) with the same regimen were allowed if deemed necessary by the Investigator. For those patients who received more than 4 cycles, RGB-02 was administered as supportive therapy. 3-weeks per cycle. . A Follow-up Visit was performed 6 months (± 10 days) after the first IMP administration.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neulasta®
    Investigational medicinal product code
    Other name
    pegfilgrastim 6 mg/0.6 mL
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of Neulasta® pre-filled syringes 6 mg/0.6 mL for subcutaneous (s.c.) administration during Cycles 1 and 2. Administrated on Day 2 of the cycle approximately 24h after chemotherapy.

    Investigational medicinal product name
    RGB-02
    Investigational medicinal product code
    RGB-02
    Other name
    pegfilgrastim 6 mg/0.6 mL (test product)
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of RGB-02 pre-filled syringes 6 mg/0.6 mL for subcutaneous (s.c.) administration during Cycles 3 and 4. Administrated on Day 2 of the cycle approximately 24h after chemotherapy.

    Number of subjects in period 1
    		RGB-02 Neulasta® + RGB-02
    Started
    121
    118
    Completed
    115
    109
    Not completed
    6
    9
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    3
         Physician decision
    1
    -
         Adverse event, non-fatal
    3
    3
         other
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RGB-02
    Reporting group description
    		 All subjects randomized to receive RGB-02 (test product) during Cycles 1-4. In addition to the 4 cycles of chemotherapy, 2 additional cycles (Cycles 5-6) with the same regimen were allowed if deemed necessary by the Investigator. For those patients who received more than 4 cycles, RGB-02 was administered as supportive therapy. 3-weeks per cycle. A Follow-up Visit was performed 6 months (± 10 days) after the first IMP administration.

    Reporting group title
    Neulasta® + RGB-02
    Reporting group description
    		 All subjects randomized to receive Neulasta® (reference product) during Cycles 1 and 2 under double-blind conditions and who were switched to receive RGB-02 (test product) under open label conditions starting with Cycle 3. In addition to the 4 cycles of chemotherapy, 2 additional cycles (Cycles 5-6) with the same regimen were allowed if deemed necessary by the Investigator. For those patients who received more than 4 cycles, RGB-02 was administered as supportive therapy. 3-weeks per cycle. . A Follow-up Visit was performed 6 months (± 10 days) after the first IMP administration.

    Reporting group values
    		 RGB-02 Neulasta® + RGB-02 Total
    Number of subjects
    		 121 118 239
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 117 117 234
        From 65-84 years
    		 4 1 5
    Gender categorical
    Units: Subjects
        Female
    		 121 118 239
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    RGB-02
    Reporting group description
    		 All subjects randomized to receive RGB-02 (test product) during Cycles 1-4. In addition to the 4 cycles of chemotherapy, 2 additional cycles (Cycles 5-6) with the same regimen were allowed if deemed necessary by the Investigator. For those patients who received more than 4 cycles, RGB-02 was administered as supportive therapy. 3-weeks per cycle. A Follow-up Visit was performed 6 months (± 10 days) after the first IMP administration.

    Reporting group title
    Neulasta® + RGB-02
    Reporting group description
    		 All subjects randomized to receive Neulasta® (reference product) during Cycles 1 and 2 under double-blind conditions and who were switched to receive RGB-02 (test product) under open label conditions starting with Cycle 3. In addition to the 4 cycles of chemotherapy, 2 additional cycles (Cycles 5-6) with the same regimen were allowed if deemed necessary by the Investigator. For those patients who received more than 4 cycles, RGB-02 was administered as supportive therapy. 3-weeks per cycle. . A Follow-up Visit was performed 6 months (± 10 days) after the first IMP administration.

    Subject analysis set title
    Per Protocol - RGB-02 (Cycle 1)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol populations were defined cycle by cycle (Cycles 1 to 4). The PP population for the respective cycle included all patients in the FAS who had no major protocol deviations with a possible impact on the efficacy variables prior to completion of that cycle within the RGB-02 arm. FAS = Full Analysis Set

    Subject analysis set title
    Per Protocol - Neulasta® + RGB-02 (Cycle 1)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol populations were defined cycle by cycle (Cycles 1 to 4). The PP population for the respective cycle included all patients in the FAS who had no major protocol deviations with a possible impact on the efficacy variables prior to completion of that cycle within the Neulasta® + RGB-02 arm. FAS = Full Analysis Set

    Subject analysis set title
    Full Analysis Set - RGB-02
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects who had data for at least one efficacy endpoint within the RGB-02 arm.

    Subject analysis set title
    Full Analysis Set - Neulasta® + RGB-02
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects who had data for at least one efficacy endpoint within the Neulasta® + RGB-02 arm.

    Primary: DSN (duration of severe neutropenia) in Cycle 1

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    End point title
    		 DSN (duration of severe neutropenia) in Cycle 1
    End point description
    Duration of severe neutropenia was defined as the number of days from the time of the first ANC value < 0.5 x10^9/L until the time of the first ANC value after this where the ANC value was ≥ 0.5 x10^9/L. ANC=absolute neutrophil count
    End point type
    Primary
    End point timeframe
    Cycle 1.
    End point values
    		 Per Protocol - RGB-02 (Cycle 1) Per Protocol - Neulasta® + RGB-02 (Cycle 1) Full Analysis Set - RGB-02 Full Analysis Set - Neulasta® + RGB-02
    Number of subjects analysed
    112
    111
    121
    117
    Units: Days
        arithmetic mean (standard deviation)
    1.7 ( 1.14 )
    1.6 ( 1.31 )
    1.8 ( 1.28 )
    1.7 ( 1.45 )
    Statistical analysis title
    		 LS Mean difference (RGB-02 vs Neulasta®) for FAS
    Statistical analysis description
    The estimated difference in mean duration of severe neutropenia between the 2 treatment arms and the 2-sided 95% CI for the difference between means were calculated using an analysis of covariance (ANCOVA) model with treatment, country, chemotherapy treatment setting (neoadjuvant or adjuvant), and baseline ANC value as factors in the model. FAS = Full Analysis Set population
    Comparison groups
    Full Analysis Set - RGB-02 v Full Analysis Set - Neulasta® + RGB-02
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Least Squares mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.4
    Notes
    [1] - If the upper limit of the 95% CI for the difference in means is ≤ 1 day and the lower bound of the 95% CI for the difference in means is ≥ -1 day, then the means in the 2 groups will be considered equivalent.
    Statistical analysis title
    		 LS Mean difference (RGB-02 vs Neulasta®) for PP
    Statistical analysis description
    The estimated difference in mean duration of severe neutropenia between the 2 treatment arms and the 2-sided 95% CI for the difference between means were calculated using an analysis of covariance (ANCOVA) model with treatment, country, chemotherapy treatment setting (neoadjuvant or adjuvant), and baseline ANC value as factors in the model. PP = Per Protocol population
    Comparison groups
    Per Protocol - RGB-02 (Cycle 1) v Per Protocol - Neulasta® + RGB-02 (Cycle 1)
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Least Squares mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.4
    Notes
    [2] - If the upper limit of the 95% CI for the difference in means is ≤ 1 day and the lower bound of the 95% CI for the difference in means is ≥ -1 day, then the means in the 2 groups will be considered equivalent.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Safety population - RGB-02 (Cycle 1-2)
    Reporting group description
    		 All randomized subjects who received at least 1 dose of RGB-02 during Cycle 1 and 2 within RGB-02 arm.

    Reporting group title
    Safety population - Neulasta® (Cycle 1-2)
    Reporting group description
    		 All randomized subjects who received at least 1 dose of Neulasta® during Cycle 1 and 2 within Neulasta® + RGB-02 arm.

    Serious adverse events
    		 Safety population - RGB-02 (Cycle 1-2) Safety population - Neulasta® (Cycle 1-2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 121 (8.26%)
    8 / 117 (6.84%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Lymphorrhoea
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    5 / 121 (4.13%)
    6 / 117 (5.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 117 (1.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenitis haemorrhagic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive duodenitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic infection
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population - RGB-02 (Cycle 1-2) Safety population - Neulasta® (Cycle 1-2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    97 / 121 (80.17%)
    109 / 117 (93.16%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 121 (4.96%)
    9 / 117 (7.69%)
         occurrences all number
    6
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    25 / 121 (20.66%)
    29 / 117 (24.79%)
         occurrences all number
    25
    29
    Fatigue
         subjects affected / exposed
    15 / 121 (12.40%)
    18 / 117 (15.38%)
         occurrences all number
    15
    18
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    13 / 121 (10.74%)
    10 / 117 (8.55%)
         occurrences all number
    13
    10
    Anaemia
         subjects affected / exposed
    7 / 121 (5.79%)
    6 / 117 (5.13%)
         occurrences all number
    7
    6
    Neutropenia
         subjects affected / exposed
    6 / 121 (4.96%)
    6 / 117 (5.13%)
         occurrences all number
    6
    6
    Febrile neutropenia
         subjects affected / exposed
    5 / 121 (4.13%)
    6 / 117 (5.13%)
         occurrences all number
    5
    6
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    7 / 121 (5.79%)
    6 / 117 (5.13%)
         occurrences all number
    7
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    53 / 121 (43.80%)
    49 / 117 (41.88%)
         occurrences all number
    53
    49
    Stomatitis
         subjects affected / exposed
    15 / 121 (12.40%)
    9 / 117 (7.69%)
         occurrences all number
    15
    9
    Vomiting
         subjects affected / exposed
    10 / 121 (8.26%)
    11 / 117 (9.40%)
         occurrences all number
    10
    11
    Constipation
         subjects affected / exposed
    12 / 121 (9.92%)
    4 / 117 (3.42%)
         occurrences all number
    12
    4
    Diarrhoea
         subjects affected / exposed
    25 / 121 (20.66%)
    14 / 117 (11.97%)
         occurrences all number
    25
    14
    Abdominal pain
         subjects affected / exposed
    8 / 121 (6.61%)
    2 / 117 (1.71%)
         occurrences all number
    8
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    75 / 121 (61.98%)
    86 / 117 (73.50%)
         occurrences all number
    75
    86
    Erythema
         subjects affected / exposed
    8 / 121 (6.61%)
    11 / 117 (9.40%)
         occurrences all number
    8
    11
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    17 / 121 (14.05%)
    24 / 117 (20.51%)
         occurrences all number
    17
    24
    Arthralgia
         subjects affected / exposed
    9 / 121 (7.44%)
    11 / 117 (9.40%)
         occurrences all number
    9
    11
    Myalgia
         subjects affected / exposed
    6 / 121 (4.96%)
    5 / 117 (4.27%)
         occurrences all number
    6
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 121 (7.44%)
    7 / 117 (5.98%)
         occurrences all number
    9
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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