TriangleNCT03037385 · OUTCOME
Phase 2: CBR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 79.8 months
What was measured
CBR was defined as the percentage of participants with CR or PR, or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). CBR and its two-sided 95% CI, which is based on the exact binomial distribution (Clopper-Pearson), were presented.
Analysis population: RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy 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.
RET-altered Solid Tumors Previously Treated With RET Inhibitor
Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-mutation Positive Tumors Other Than MTC
Participants who had RET-mutation positive solid tumors 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 | 130 |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | 23 |
| RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | 106 |
| RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | 60 |
| RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | 72 |
| RET-fusion Positive TC | 27 |
| RET-fusion Positive Solid Tumors Other Than NSCLC and TC | 28 |
| RET-altered Solid Tumors Previously Treated With RET Inhibitor | 21 |
| RET-mutation Positive Tumors Other Than MTC | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RET- Fusion Positive NSCLC With Prior Platinum Treatment | 74.6 | Not reported | 66.2 | 81.8 | Not reported |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | 78.3 | Not reported | 56.3 | 92.5 | Not reported |
| RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | 80.2 | Not reported | 71.3 | 87.3 | Not reported |
| RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | 80.0 | Not reported | 67.7 | 89.2 | Not reported |
| RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | 90.3 | Not reported | 81.0 | 96.0 | Not reported |
| RET-fusion Positive TC | 85.2 | Not reported | 66.3 | 95.8 | Not reported |
| RET-fusion Positive Solid Tumors Other Than NSCLC and TC | 60.7 | Not reported | 40.6 | 78.5 | Not reported |
| RET-altered Solid Tumors Previously Treated With RET Inhibitor | 28.6 | Not reported | 11.3 | 52.2 | Not reported |
| RET-mutation Positive Tumors Other Than MTC | 23.1 | Not reported | 5.0 | 53.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66.2
- upper Limit
- 81.8
- value
- 74.6
- group Id
- OG001
- lower Limit
- 56.3
- upper Limit
- 92.5
- value
- 78.3
- group Id
- OG002
- lower Limit
- 71.3
- upper Limit
- 87.3
- value
- 80.2
- group Id
- OG003
- lower Limit
- 67.7
- upper Limit
- 89.2
- value
- 80.0
- group Id
- OG004
- lower Limit
- 81.0
- upper Limit
- 96.0
- value
- 90.3
- group Id
- OG005
- lower Limit
- 66.3
- upper Limit
- 95.8
- value
- 85.2
- group Id
- OG006
- lower Limit
- 40.6
- upper Limit
- 78.5
- value
- 60.7
- group Id
- OG007
- lower Limit
- 11.3
- upper Limit
- 52.2
- value
- 28.6
- group Id
- OG008
- lower Limit
- 5.0
- upper Limit
- 53.8
- value
- 23.1
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 106
- group Id
- OG003
- value
- 60
- group Id
- OG004
- value
- 72
- group Id
- OG005
- value
- 27
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 13
- units
- Participants
- description
- CBR was defined as the percentage of participants with CR or PR, or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). CBR and its two-sided 95% CI, which is based on the exact binomial distribution (Clopper-Pearson), were presented.
- 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
- description
- Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG007
- title
- RET-altered Solid Tumors Previously Treated With RET Inhibitor
- description
- Participants who had RET-mutation positive solid tumors received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG008
- title
- RET-mutation Positive Tumors Other Than MTC
- param Type
- NUMBER
- population Description
- RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 79.8 months
- title
- Phase 2: CBR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice