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NCT02054806 · OUTCOME

Duration of Response (DOR)

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) · Source last updated 2023-10-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to approximately 86 months

What was measured

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type.

Analysis population: The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1, had the intended indication, and experienced a response. Per protocol-specified definition, DOR could not be analyzed in arms which did not have a confirmed response of CR or PR.

Groups in this outcome

Cohort A1: Colon or Rectal Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.

Cohort A2: Anal Canal Squamous Cell Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.

Cohort A3: Pancreas Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with Pancreas Adenocarcinoma.

Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).

Cohort A5: Biliary Tract Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).

Cohort A6: Carcinoid Tumors

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.

Cohort A7: Neuroendocrine Carcinomas

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).

Cohort B1: ER Positive HER2 Negative Breast Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ER positive HER2 negative breast cancer.

Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.

Cohort B3: Endometrial Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled endometrial carcinoma.

Cohort B4: Cervical Squamous Cell Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled cervical squamous cell cancer.

Cohort B5: Vulvar Squamous Cell Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.

Cohort C1: Small Cell Lung Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.

Cohort C2: Mesothelioma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).

Cohort D1: Thyroid Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).

Cohort D2: Salivary Gland Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.

Cohort D3: Nasopharyngeal Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.

Cohort E1: Glioblastoma Multiforme

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.

Cohort E2: Leiomyosarcoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.

Cohort E3: Prostate Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.

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

Analysis denominator · Participants

GroupSource count
Cohort A1: Colon or Rectal Adenocarcinoma1
Cohort A2: Anal Canal Squamous Cell Carcinoma5
Cohort A3: Pancreas Adenocarcinoma0
Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma7
Cohort A5: Biliary Tract Adenocarcinoma4
Cohort A6: Carcinoid Tumors4
Cohort A7: Neuroendocrine Carcinomas1
Cohort B1: ER Positive HER2 Negative Breast Cancer3
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma3
Cohort B3: Endometrial Carcinoma3
Cohort B4: Cervical Squamous Cell Cancer4
Cohort B5: Vulvar Squamous Cell Carcinoma1
Cohort C1: Small Cell Lung Cancer8
Cohort C2: Mesothelioma5
Cohort D1: Thyroid Cancer3
Cohort D2: Salivary Gland Carcinoma3
Cohort D3: Nasopharyngeal Carcinoma7
Cohort E1: Glioblastoma Multiforme2
Cohort E2: Leiomyosarcoma1
Cohort E3: Prostate Adenocarcinoma3

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort A1: Colon or Rectal AdenocarcinomaNANot reportedNANANA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort A2: Anal Canal Squamous Cell Carcinoma28.9Not reported3.8NANA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma14.5Not reported5.6NANA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort A5: Biliary Tract AdenocarcinomaNANot reported6.0NANA = Median, upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort A6: Carcinoid Tumors10.1Not reported6.9NANA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort A7: Neuroendocrine Carcinomas25.1Not reported25.125.1Not reported
Cohort B1: ER Positive HER2 Negative Breast Cancer12.0Not reported7.415.9Not reported
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma37.0Not reported34.4NANA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort B3: Endometrial Carcinoma68.5Not reported17.5NANA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort B4: Cervical Squamous Cell Cancer5.4Not reported4.17.5Not reported
Cohort B5: Vulvar Squamous Cell Carcinoma3.9Not reported3.93.9Not reported
Cohort C1: Small Cell Lung CancerNANot reportedNANANA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Cohort C2: Mesothelioma12.0Not reported3.744.4Not reported
Cohort D1: Thyroid Cancer8.4Not reported4.620.3Not reported
Cohort D2: Salivary Gland Carcinoma3.9Not reported3.520.6Not reported
Cohort D3: Nasopharyngeal Carcinoma15.0Not reported4.834.0Not reported
Cohort E1: Glioblastoma Multiforme15.6Not reported8.322.8Not reported
Cohort E2: Leiomyosarcoma12.4Not reported12.412.4Not reported
Cohort E3: Prostate Adenocarcinoma14.2Not reported13.531.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG001
        lower Limit
        3.8
        upper Limit
        NA
        value
        28.9
      3. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG003
        lower Limit
        5.6
        upper Limit
        NA
        value
        14.5
      4. comment
        NA = Median, upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG004
        lower Limit
        6.0
        upper Limit
        NA
        value
        NA
      5. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG005
        lower Limit
        6.9
        upper Limit
        NA
        value
        10.1
      6. group Id
        OG006
        lower Limit
        25.1
        upper Limit
        25.1
        value
        25.1
      7. group Id
        OG007
        lower Limit
        7.4
        upper Limit
        15.9
        value
        12.0
      8. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG008
        lower Limit
        34.4
        upper Limit
        NA
        value
        37.0
      9. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG009
        lower Limit
        17.5
        upper Limit
        NA
        value
        68.5
      10. group Id
        OG010
        lower Limit
        4.1
        upper Limit
        7.5
        value
        5.4
      11. group Id
        OG011
        lower Limit
        3.9
        upper Limit
        3.9
        value
        3.9
      12. comment
        NA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
        group Id
        OG012
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      1
    units
    Participants
description
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type.
dispersion Type
Full Range
groups
  1. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
    id
    OG000
    title
    Cohort A1: Colon or Rectal Adenocarcinoma
  2. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
    id
    OG001
    title
    Cohort A2: Anal Canal Squamous Cell Carcinoma
  3. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with Pancreas Adenocarcinoma.
    id
    OG002
    title
    Cohort A3: Pancreas Adenocarcinoma
  4. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
    id
    OG003
    title
    Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
  5. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
    id
    OG004
    title
    Cohort A5: Biliary Tract Adenocarcinoma
  6. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
    id
    OG005
    title
    Cohort A6: Carcinoid Tumors
  7. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
    id
    OG006
    title
    Cohort A7: Neuroendocrine Carcinomas
  8. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ER positive HER2 negative breast cancer.
    id
    OG007
    title
    Cohort B1: ER Positive HER2 Negative Breast Cancer
  9. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
    id
    OG008
    title
    Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
  10. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled endometrial carcinoma.
    id
    OG009
    title
    Cohort B3: Endometrial Carcinoma
  11. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled cervical squamous cell cancer.
    id
    OG010
    title
    Cohort B4: Cervical Squamous Cell Cancer
  12. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
    id
    OG011
    title
    Cohort B5: Vulvar Squamous Cell Carcinoma
param Type
MEDIAN
population Description
The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1, had the intended indication, and experienced a response. Per protocol-specified definition, DOR could not be analyzed in arms which did not have a confirmed response of CR or PR.
reporting Status
POSTED
time Frame
Up to approximately 86 months
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Independent clinical review pending · Not medical advice