Trial Outcomes & Findings for A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC) (NCT NCT03353675)

Last Updated: 2022-01-11

Results Overview

Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

15 months

Results posted on

2022-01-11

Participant Flow

The study was conducted at 2 study sites in United States, 4 sites in France, 2 sites in Hungary and 1 site in Belgium.

A total of 44 participants were enrolled and treated with at least one administration of each study drug.

Participant milestones

Participant milestones
Measure	TG4010/Chemotherapy/Nivolumab TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Overall Study STARTED	44
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	TG4010/Chemotherapy/Nivolumab TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Overall Study Adverse Event	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TG4010/Chemotherapy/Nivolumab n=44 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Age, Categorical <=18 years	0 Participants n=44 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=44 Participants
Age, Categorical >=65 years	16 Participants n=44 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 8.64 • n=44 Participants
Sex: Female, Male Female	17 Participants n=44 Participants
Sex: Female, Male Male	27 Participants n=44 Participants
Region of Enrollment Belgium	6 participants n=44 Participants
Region of Enrollment Hungary	6 participants n=44 Participants
Region of Enrollment United States	6 participants n=44 Participants
Region of Enrollment France	26 participants n=44 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 0	21 participants n=44 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 1	23 participants n=44 Participants
Body Mass Index (BMI)	24.4 kg/m^2 n=44 Participants
PD-L1 percentage of stained cells <1	22 Participants n=44 Participants
PD-L1 percentage of stained cells 1 - <50	22 Participants n=44 Participants
PD-L1 percentage of stained cells ≥50	0 Participants n=44 Participants

PRIMARY outcome

Timeframe: 15 months

Population: The Evaluable Patient's Population is the primary population for efficacy analyses. Evaluable Patient's Population consists of all participants without major protocol deviation and have at least one baseline and one post-baseline evaluable CT-scan after study treatment start except early disease progression and death due to lung cancer.

Outcome measures

Outcome measures
Measure	TG4010/Chemotherapy/Nivolumab n=40 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Objective Response Rate (ORR)	32.5 percentage of participants Interval 20.4 to 46.6

SECONDARY outcome

Timeframe: 28 months

Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval.

Outcome measures

Outcome measures
Measure	TG4010/Chemotherapy/Nivolumab n=40 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Progression Free Survival (PFS)	5.7 Months Interval 1.5 to 11.1

SECONDARY outcome

Timeframe: 15 months

Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD).

Outcome measures

Outcome measures
Measure	TG4010/Chemotherapy/Nivolumab n=40 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Disease Control Rate (DCR)	75.0 percentage of participants Interval 61.3 to 85.8

SECONDARY outcome

Timeframe: 28 months

Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause. The Kaplan-Meier estimator was used to estimate median OS and its confidence interval.

Outcome measures

Outcome measures
Measure	TG4010/Chemotherapy/Nivolumab n=40 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Overall Survival	14.9 Months Interval 8.0 to The upper limit of 95% confidence interval for overall survival was not reached by the end of the study period because too few participants with events to calculate upper confidence interval.

SECONDARY outcome

Timeframe: 28 months

Population: Responders: all evaluable participants with complete response or partial response. The start date was the date of first documented response (complete response or partial response) and the end date was the date of first documented disease progression. If no progression has been observed at the cut-off date of analysis or at the date when a subsequent cancer therapy was started, duration of response was censored at the date of the last evaluable tumor assessment.

Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer.

Outcome measures

Outcome measures
Measure	TG4010/Chemotherapy/Nivolumab n=13 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Duration of Overall Response (DoR)	74.9 Weeks Interval 19.4 to 92.6

SECONDARY outcome

Timeframe: 28 months

Population: Safety population (all treated participants)

The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities.

Outcome measures

Outcome measures
Measure	TG4010/Chemotherapy/Nivolumab n=44 Participants TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Number of Participants With Adverse Events or Abnormalities Adverse events	44 Participants
Number of Participants With Adverse Events or Abnormalities Serious adverse events	28 Participants
Number of Participants With Adverse Events or Abnormalities Adverse events of special interest	37 Participants
Number of Participants With Adverse Events or Abnormalities Immune-mediated adverse events	14 Participants
Number of Participants With Adverse Events or Abnormalities Grade 3/4 laboratories abnormalities	31 Participants

Adverse Events

TG4010/Chemotherapy/Nivolumab

Serious events: 28 serious events

Other events: 43 other events

Deaths: 28 deaths

Serious adverse events

Serious adverse events
Measure	TG4010/Chemotherapy/Nivolumab n=44 participants at risk TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	4.5% 2/44 • Number of events 2 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Blood and lymphatic system disorders THROMBOCYTOPENIA	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders VOMITING	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders ABDOMINAL PAIN	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders AUTOIMMUNE COLITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders COLITIS ULCERATIVE	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders DIARRHOEA	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders DUODENITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders PANCREATITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	20.5% 9/44 • Number of events 9 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders FATIGUE	4.5% 2/44 • Number of events 2 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders CONDITION AGGRAVATED	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Hepatobiliary disorders CHOLANGITIS ACUTE	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Immune system disorders ANAPHYLACTIC REACTION	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations PNEUMONIA	4.5% 2/44 • Number of events 2 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations BARTHOLINITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations BRAIN ABSCESS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations CELLULITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations DIVERTICULITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations FEBRILE INFECTION	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations SEPTIC SHOCK	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Investigations BLOOD CREATININE INCREASED	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Metabolism and nutrition disorders DEHYDRATION	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Metabolism and nutrition disorders HYPERCALCAEMIA	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Metabolism and nutrition disorders HYPERGLYCAEMIA	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders CEREBRAL INFARCTION	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders CEREBRAL ISCHAEMIA	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders HEADACHE	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders ISCHAEMIC STROKE	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders LOSS OF CONSCIOUSNESS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders NEUROPATHY PERIPHERAL	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Renal and urinary disorders ACUTE KIDNEY INJURY	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Reproductive system and breast disorders PROSTATITIS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	4.5% 2/44 • Number of events 2 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Skin and subcutaneous tissue disorders RASH	2.3% 1/44 • Number of events 1 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Vascular disorders DEEP VEIN THROMBOSIS	4.5% 2/44 • Number of events 2 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.

Other adverse events

Other adverse events
Measure	TG4010/Chemotherapy/Nivolumab n=44 participants at risk TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks
Blood and lymphatic system disorders ANAEMIA	54.5% 24/44 • Number of events 43 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Blood and lymphatic system disorders LEUKOPENIA	11.4% 5/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Blood and lymphatic system disorders NEUTROPENIA	31.8% 14/44 • Number of events 21 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Blood and lymphatic system disorders THROMBOCYTOPENIA	29.5% 13/44 • Number of events 20 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Endocrine disorders HYPOTHYROIDISM	9.1% 4/44 • Number of events 4 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Eye disorders LACRIMATION INCREASED	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders ABDOMINAL PAIN	9.1% 4/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders CONSTIPATION	36.4% 16/44 • Number of events 17 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders DIARRHOEA	38.6% 17/44 • Number of events 23 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders DRY MOUTH	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders NAUSEA	59.1% 26/44 • Number of events 31 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders STOMATITIS	15.9% 7/44 • Number of events 8 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Gastrointestinal disorders VOMITING	18.2% 8/44 • Number of events 10 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders ASTHENIA	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders FATIGUE	65.9% 29/44 • Number of events 39 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders INJECTION SITE ERYTHEMA	11.4% 5/44 • Number of events 6 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders INJECTION SITE PAIN	11.4% 5/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders INJECTION SITE REACTION	13.6% 6/44 • Number of events 6 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders OEDEMA PERIPHERAL	20.5% 9/44 • Number of events 11 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
General disorders PYREXIA	11.4% 5/44 • Number of events 7 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Infections and infestations CONJUNCTIVITIS	11.4% 5/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	9.1% 4/44 • Number of events 4 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	11.4% 5/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Investigations BLOOD CREATININE INCREASED	15.9% 7/44 • Number of events 7 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Investigations LIPASE INCREASED	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Investigations WEIGHT DECREASED	18.2% 8/44 • Number of events 8 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Metabolism and nutrition disorders DECREASED APPETITE	29.5% 13/44 • Number of events 15 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Metabolism and nutrition disorders HYPOKALAEMIA	20.5% 9/44 • Number of events 13 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Musculoskeletal and connective tissue disorders MYALGIA	13.6% 6/44 • Number of events 6 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	11.4% 5/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	9.1% 4/44 • Number of events 4 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders DIZZINESS	9.1% 4/44 • Number of events 4 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders DYSGEUSIA	18.2% 8/44 • Number of events 8 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders HEADACHE	20.5% 9/44 • Number of events 9 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Nervous system disorders PARAESTHESIA	18.2% 8/44 • Number of events 8 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders COUGH	27.3% 12/44 • Number of events 13 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	29.5% 13/44 • Number of events 14 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	9.1% 4/44 • Number of events 5 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Skin and subcutaneous tissue disorders ALOPECIA	6.8% 3/44 • Number of events 3 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Skin and subcutaneous tissue disorders DRY SKIN	15.9% 7/44 • Number of events 7 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Skin and subcutaneous tissue disorders PRURITUS	9.1% 4/44 • Number of events 4 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Skin and subcutaneous tissue disorders RASH	15.9% 7/44 • Number of events 9 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Vascular disorders FLUSHING	6.8% 3/44 • Number of events 4 • Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.

Additional Information

Director of Medical Affairs

Transgene

Phone: + 33 (0)3 88 27 91 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place