NCT03164616 · OUTCOME
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). · Source last updated 2026-03-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, durvalumab).
What was measured
Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against durvalumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples.
Analysis population: Global cohort: The ADA evaluable patients included those in the safety analysis set with non-missing baseline ADA sample and at least 1 post-baseline ADA sample. ADA for durvalumab was performed for the T + D + SoC and D + SoC treatment arms only. The denominator was durvalumab ADA evaluable patients.
Groups in this outcome
T + D + SoC
During chemotherapy (combination) stage:
Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
D + SoC
During chemotherapy (combination) stage:
Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| T + D + SoC | 286 |
|---|
| D + SoC | 285 |
|---|
Reported measurements
ADA positive at any visit (ADA prevalence)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-emergent ADA positive (ADA incidence)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-boosted ADA
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-induced ADA (ADA positive post-baseline only)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA positive at baseline only
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
ADA positive post-baseline and positive at baseline
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Persistently positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Transiently positive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
nAb positive at any visit
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T + D + SoC | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| D + SoC | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 33
- title
- ADA positive at any visit (ADA prevalence)
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 19
- title
- Treatment-emergent ADA positive (ADA incidence)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Treatment-boosted ADA
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 18
- title
- Treatment-induced ADA (ADA positive post-baseline only)
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 13
- title
- ADA positive at baseline only
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- title
- ADA positive post-baseline and positive at baseline
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- title
- Persistently positive
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 13
- title
- Transiently positive
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- nAb positive at any visit
- denoms
- counts
- group Id
- OG000
- value
- 286
- group Id
- OG001
- value
- 285
- units
- Participants
- description
- Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against durvalumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples.
- groups
- description
- During chemotherapy (combination) stage:
Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
- id
- OG000
- title
- T + D + SoC
- description
- During chemotherapy (combination) stage:
Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
- id
- OG001
- title
- D + SoC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Global cohort: The ADA evaluable patients included those in the safety analysis set with non-missing baseline ADA sample and at least 1 post-baseline ADA sample. ADA for durvalumab was performed for the T + D + SoC and D + SoC treatment arms only. The denominator was durvalumab ADA evaluable patients.
- reporting Status
- POSTED
- time Frame
- Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, durvalumab).
- title
- Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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