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Clinical Trial Results:
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

Summary
EudraCT number	2017-004134-29
Trial protocol	GB DE IE ES DK PL
Global end of trial date	09 Sep 2020

Results information
Results version number	v1
This version publication date	25 Mar 2021
First version publication date	25 Mar 2021
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

VX17-659-105

ISRCTN number

-

US NCT number

NCT03447262

WHO universal trial number (UTN)

-

Sponsor organisation name

Vertex Pharmaceuticals Incorporated

Sponsor organisation address

50 Northern Avenue, Boston, Massachusetts, United States,

Public contact

Vertex Pharmaceuticals Incorporated, Medical Monitor, +1 617-341-6777, medicalinfo@vrtx.com

Scientific contact

Vertex Pharmaceuticals Incorporated, Medical Monitor, +1 617-341-6777, medicalinfo@vrtx.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-002191-PIP02-17

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?

Yes

Analysis stage

Final

Date of interim/final analysis

27 Oct 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

09 Sep 2020

Global end of trial reached?

Yes

Global end of trial date

09 Sep 2020

Was the trial ended prematurely?

No

Main objective of the trial

To evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.

Protection of trial subjects

The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Council on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

13 Jul 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

1 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 57

Country: Number of subjects enrolled

United States: 262

Country: Number of subjects enrolled

Australia: 49

Country: Number of subjects enrolled

United Kingdom: 33

Country: Number of subjects enrolled

Ireland: 23

Country: Number of subjects enrolled

Israel: 19

Country: Number of subjects enrolled

Spain: 19

Country: Number of subjects enrolled

Canada: 9

Country: Number of subjects enrolled

Switzerland: 7

Country: Number of subjects enrolled

Denmark: 4

Country: Number of subjects enrolled

Poland: 2

Worldwide total number of subjects

484

EEA total number of subjects

105

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)

119

Adults (18-64 years)

365

From 65 to 84 years

0

85 years and over

0

Subject disposition

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Recruitment details

-

Screening details

This study was conducted in CF subjects aged 12 years or older who participated in parent studies VX17-659-102 (NCT03447249) and VX17-659-103 (NCT03460990). Eligible subjects from parent studies were enrolled in this study.

Period 1 title

Triple Combination Treatment Period (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

VX-659/TEZ/IVA TC

Arm description

Subjects received VX-659/TEZ/IVA for 96 weeks in TC treatment period.

Arm type

Experimental

Investigational medicinal product name

VX-659/TEZ/IVA

Investigational medicinal product code

VX-659/VX-661/VX-770

Other name

VX-659/Tezacaftor/Ivacaftor

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received VX-659/TEZ/IVA fixed-dose combination once daily in the morning.

Investigational medicinal product name

IVA

Investigational medicinal product code

VX-770

Other name

Ivacaftor

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received IVA once daily in the evening.

Number of subjects in period 1 ^[1]	VX-659/TEZ/IVA TC
Started	481
Completed	2
Not completed	479
Death	2
Other	4
Adverse event	7
Study termination by sponsor	455
Withdrawal of consent (not due to AE)	2
Commercial drug is available for subject	9

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The total of 484 subjects were enrolled from the parent studies. Out of which, 3 subjects were enrolled but never dosed in this study. Therefore, 481 subjects are included in subject disposition and baseline sections.

Baseline characteristics

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Reporting group title

VX-659/TEZ/IVA TC

Reporting group description

Subjects received VX-659/TEZ/IVA for 96 weeks in TC treatment period.

Reporting group values	VX-659/TEZ/IVA TC	Total
Number of subjects	481	481
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	26.9 ( 9.7 )	-
Gender categorical
Units: Subjects
Female	219	219
Male	262	262

End points

Top of page

Reporting group title

VX-659/TEZ/IVA TC

Reporting group description

Subjects received VX-659/TEZ/IVA for 96 weeks in TC treatment period.

Primary: Safety and Tolerability as Assessed by Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Top of page

End point title

Safety and Tolerability as Assessed by Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) ^[1]

End point description

End point type

Primary

End point timeframe

Day 1 up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 100)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive statistics were planned. No statistical comparisons were planned for this endpoint.

End point values	VX-659/TEZ/IVA TC
Number of subjects analysed	481
Units: subjects
Subjects with TEAEs	470
Subjects with Serious TEAEs	99

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Day 1 up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 100)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

VX-659/TEZ/IVA TC

Reporting group description

Subjects received VX-659/TEZ/IVA for 96 weeks in TC treatment period.

Serious adverse events	VX-659/TEZ/IVA TC
Total subjects affected by serious adverse events
subjects affected / exposed	99 / 481 (20.58%)
number of deaths (all causes)	2
number of deaths resulting from adverse events
General disorders and administration site conditions
Generalised oedema
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Granulomatous pneumonitis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Haemoptysis
subjects affected / exposed	5 / 481 (1.04%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Increased bronchial secretion
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Psychiatric disorders
Delirium
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Breathing-related sleep disorder
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Anxiety
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Product issues
Device leakage
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Investigations
Aspartate aminotransferase increased
subjects affected / exposed	4 / 481 (0.83%)
occurrences causally related to treatment / all	4 / 5
deaths causally related to treatment / all	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	4 / 481 (0.83%)
occurrences causally related to treatment / all	4 / 5
deaths causally related to treatment / all	0 / 0
Pulmonary function test decreased
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gamma-glutamyltransferase increased
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	3 / 3
deaths causally related to treatment / all	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Injury, poisoning and procedural complications
Alcohol poisoning
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Contusion
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Forearm fracture
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Stoma site extravasation
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Intentional overdose
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Restrictive cardiomyopathy
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac failure acute
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Nervous system disorders
Syncope
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Seizure
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Abdominal pain
subjects affected / exposed	3 / 481 (0.62%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Constipation
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Distal intestinal obstruction syndrome
subjects affected / exposed	6 / 481 (1.25%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Duodenitis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastritis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Mechanical ileus
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vomiting
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatobiliary disorders
Cholangitis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Biliary colic
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bile duct stone
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Autoimmune hepatitis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cholecystitis
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Hydronephrosis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nephrolithiasis
subjects affected / exposed	3 / 481 (0.62%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Pelvi-ureteric obstruction
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Compartment syndrome
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Infections and infestations
Bacterial disease carrier
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bronchitis bacterial
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
H1N1 influenza
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Mastoiditis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Lower respiratory tract infection bacterial
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	2 / 2
deaths causally related to treatment / all	0 / 0
Influenza
subjects affected / exposed	4 / 481 (0.83%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Infective pulmonary exacerbation of cystic fibrosis
subjects affected / exposed	40 / 481 (8.32%)
occurrences causally related to treatment / all	0 / 53
deaths causally related to treatment / all	0 / 0
Medical device site cellulitis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Pneumonia pseudomonal
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sepsis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tonsillitis
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular device infection
subjects affected / exposed	2 / 481 (0.42%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diabetes mellitus
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 481 (0.21%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	VX-659/TEZ/IVA TC
Total subjects affected by non serious adverse events
subjects affected / exposed	446 / 481 (92.72%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	43 / 481 (8.94%)
occurrences all number	55
Blood creatine phosphokinase increased
subjects affected / exposed	37 / 481 (7.69%)
occurrences all number	43
Aspartate aminotransferase increased
subjects affected / exposed	42 / 481 (8.73%)
occurrences all number	51
Nervous system disorders
Headache
subjects affected / exposed	51 / 481 (10.60%)
occurrences all number	69
General disorders and administration site conditions
Fatigue
subjects affected / exposed	31 / 481 (6.44%)
occurrences all number	34
Pyrexia
subjects affected / exposed	56 / 481 (11.64%)
occurrences all number	64
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	42 / 481 (8.73%)
occurrences all number	51
Vomiting
subjects affected / exposed	27 / 481 (5.61%)
occurrences all number	33
Nausea
subjects affected / exposed	36 / 481 (7.48%)
occurrences all number	46
Diarrhoea
subjects affected / exposed	42 / 481 (8.73%)
occurrences all number	47
Abdominal pain upper
subjects affected / exposed	26 / 481 (5.41%)
occurrences all number	36
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	126 / 481 (26.20%)
occurrences all number	205
Sinus congestion
subjects affected / exposed	27 / 481 (5.61%)
occurrences all number	39
Rhinorrhoea
subjects affected / exposed	40 / 481 (8.32%)
occurrences all number	50
Respiration abnormal
subjects affected / exposed	28 / 481 (5.82%)
occurrences all number	30
Oropharyngeal pain
subjects affected / exposed	80 / 481 (16.63%)
occurrences all number	106
Nasal congestion
subjects affected / exposed	53 / 481 (11.02%)
occurrences all number	66
Sputum increased
subjects affected / exposed	69 / 481 (14.35%)
occurrences all number	90
Haemoptysis
subjects affected / exposed	39 / 481 (8.11%)
occurrences all number	57
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	28 / 481 (5.82%)
occurrences all number	37
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
subjects affected / exposed	149 / 481 (30.98%)
occurrences all number	264
Influenza
subjects affected / exposed	40 / 481 (8.32%)
occurrences all number	45
Upper respiratory tract infection
subjects affected / exposed	104 / 481 (21.62%)
occurrences all number	178
Sinusitis
subjects affected / exposed	30 / 481 (6.24%)
occurrences all number	45
Nasopharyngitis
subjects affected / exposed	97 / 481 (20.17%)
occurrences all number	163
Viral upper respiratory tract infection
subjects affected / exposed	38 / 481 (7.90%)
occurrences all number	53

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

26 Jan 2018

Amended to add study drug dose and tablet strength. Clarified completion of study participation and study drug interruptions and discontinuation scenarios.

23 Oct 2018

Amended to update stopping rules and add clarifications on descriptions for efficacy and pharmacodynamics variables.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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