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NCT03037385 · OUTCOME

Phase 2: Overall Survival (OS)

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors · Source last updated 2025-05-31

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

OS was defined as the time from the first dose of pralsetinib to the date of death due to any causes.

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, OS 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.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
RET- Fusion Positive NSCLC With Prior Platinum Treatment141
RET-fusion Positive NSCLC With Non-platinum Systemic Treatment24
RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment116
RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment67
RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment78
RET-fusion Positive TC31
RET-fusion Positive Solid Tumors Other Than NSCLC and TC29

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RET- Fusion Positive NSCLC With Prior Platinum Treatment39.7Not reported27.853.2Not reported
RET-fusion Positive NSCLC With Non-platinum Systemic Treatment46.0Not reported19.162.4Not reported
RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment50.1Not reported28.3NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment42.2Not reported31.2NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
RET-mutation MTC With No Prior Cabozantinib or Vandetanib TreatmentNANot reportedNANAThe median and 95% CI was not estimable due to insufficient number of participants with events.
RET-fusion Positive TCNANot reported19.4NAThe 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 TC10.3Not reported6.825.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.8
        upper Limit
        53.2
        value
        39.7
      2. group Id
        OG001
        lower Limit
        19.1
        upper Limit
        62.4
        value
        46.0
      3. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        28.3
        upper Limit
        NA
        value
        50.1
      4. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG003
        lower Limit
        31.2
        upper Limit
        NA
        value
        42.2
      5. comment
        The median and 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. 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
        19.4
        upper Limit
        NA
        value
        NA
      7. group Id
        OG006
        lower Limit
        6.8
        upper Limit
        25.2
        value
        10.3
denoms
  1. counts
    1. group Id
      OG000
      value
      141
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      116
    4. group Id
      OG003
      value
      67
    5. group Id
      OG004
      value
      78
    6. group Id
      OG005
      value
      31
    7. group Id
      OG006
      value
      29
    units
    Participants
description
OS was defined as the time from the first dose of pralsetinib to the date of death due to any causes.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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, OS 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.
reporting Status
POSTED
time Frame
Up to approximately 7 years
title
Phase 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice