TriangleNCT03037385 · OUTCOME
Phase 2: Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 7 years
What was measured
PFS was defined as the time from the first dose of pralsetinib to the date of first documented PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). PFS was analyzed using KM methods.
Analysis population: Efficacy population included all participants who have been exposed to at least one dose of the study drug at the RP2D. As pre-specified in the SAP, PFS was to be assessed in participants with RET-fusion positive NSCLC, RET-mutation MTC, RET-fusion TC, and RET-fusion solid tumors other than NSCLC and TC. Hence, only the data for these arms is presented here. Overall number analyzed is the number of participants with data available for analysis.
Groups in this outcome
RET- Fusion Positive NSCLC With Prior Platinum Treatment
Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-fusion Positive NSCLC With Non-platinum Systemic Treatment
Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment
Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment
Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment
Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-fusion Positive TC
Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-fusion Positive Solid Tumors Other Than NSCLC and TC
Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| Group | Source count |
|---|---|
| RET- Fusion Positive NSCLC With Prior Platinum Treatment | 141 |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | 24 |
| RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | 116 |
| RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | 67 |
| RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | 78 |
| RET-fusion Positive TC | 31 |
| RET-fusion Positive Solid Tumors Other Than NSCLC and TC | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RET- Fusion Positive NSCLC With Prior Platinum Treatment | 16.4 | Not reported | 11.4 | 23.5 | Not reported |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | 13.0 | Not reported | 9.3 | 35.1 | Not reported |
| RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | 12.1 | Not reported | 9.2 | 16.6 | Not reported |
| RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | 24.9 | Not reported | 19.9 | 35.0 | Not reported |
| RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | 55.3 | Not reported | 37.2 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| RET-fusion Positive TC | NA | Not reported | 14.7 | NA | The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| RET-fusion Positive Solid Tumors Other Than NSCLC and TC | 7.0 | Not reported | 3.9 | 12.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.4
- upper Limit
- 23.5
- value
- 16.4
- group Id
- OG001
- lower Limit
- 9.3
- upper Limit
- 35.1
- value
- 13.0
- group Id
- OG002
- lower Limit
- 9.2
- upper Limit
- 16.6
- value
- 12.1
- group Id
- OG003
- lower Limit
- 19.9
- upper Limit
- 35.0
- value
- 24.9
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG004
- lower Limit
- 37.2
- upper Limit
- NA
- value
- 55.3
- comment
- The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 14.7
- upper Limit
- NA
- value
- NA
- group Id
- OG006
- lower Limit
- 3.9
- upper Limit
- 12.8
- value
- 7.0
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 116
- group Id
- OG003
- value
- 67
- group Id
- OG004
- value
- 78
- group Id
- OG005
- value
- 31
- group Id
- OG006
- value
- 28
- units
- Participants
- description
- PFS was defined as the time from the first dose of pralsetinib to the date of first documented PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). PFS was analyzed using KM methods.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG000
- title
- RET- Fusion Positive NSCLC With Prior Platinum Treatment
- description
- Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG001
- title
- RET-fusion Positive NSCLC With Non-platinum Systemic Treatment
- description
- Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG002
- title
- RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment
- description
- Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG003
- title
- RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment
- description
- Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG004
- title
- RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment
- description
- Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG005
- title
- RET-fusion Positive TC
- description
- Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG006
- title
- RET-fusion Positive Solid Tumors Other Than NSCLC and TC
- param Type
- MEDIAN
- population Description
- Efficacy population included all participants who have been exposed to at least one dose of the study drug at the RP2D. As pre-specified in the SAP, PFS was to be assessed in participants with RET-fusion positive NSCLC, RET-mutation MTC, RET-fusion TC, and RET-fusion solid tumors other than NSCLC and TC. Hence, only the data for these arms is presented here. Overall number analyzed is the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 7 years
- title
- Phase 2: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice