From Trial Protocol to Routine Practice: Evaluating Real-World Evidence for Later-Line Treatments in Advanced Colorectal Cancer
PeerVoice
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Aug 13, 2024
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About This Presentation
Richard Kim, MD and Marc Peeters, MD, PhD discuss advanced colorectal cancer in this CE activity titled "From Trial Protocol to Routine Practice: Evaluating Real-World Evidence for Later-Line Treatments in Advanced Colorectal Cancer." For the full presentation, please visit us at www.peerv...
Slide Content
PeerVoice
From Trial Protocol to Routine Practice: Evaluating Real-World Evidence for
Later-Line Treatments in Advanced Colorectal Cancer
Learning Objectives
Identify the key differences between clinical-trial data and real-world evidence (RWE)
Evaluate available RWE related to the later-line treatment of advanced colorectal
cancer (CRC)
Apply both clinical-trial data and RWE when designing regimens for patients with
advanced CRC
PeerVoice is an EBAC® accredited provider since 2022.
www.peervoice.com/JQC870 Copyright © 2010-2024, P
From Trial Protocol to Routine Practice: Evaluating Real-World Evidence for
Later-Line Treatments in Advanced Colorectal Cancer
Learning Objectives
Identify the key differences between clinical-trial data and real-world evidence (RWE)
Evaluate available RWE related to the later-line treatment of advanced colorectal
cancer (CRC)
Apply both clinical-trial data and RWE when designing regimens for patients with
advanced CRC
PeerVoice is an EBAC® accredited provider since 2022.
www.peervoice.com/JQC870 Copyright © 2010-2024, P
PeerVoice
Part 1 of 2: The Evidence Is Getting Real: What Have We Learned About
Sequencing Later-Line Treatments in Advanced CRC From the Real World
Richard Kim, MD
Professor
University of South Florida
Service Chief of Gl Oncology
Moffitt Cancer Center
Tampa, Florida, USA
Marc Peeters, MD, PhD
Full Professor
Antwerp University
CEO
Antwerp University Hospital
Antwerp, Belgium
Copyright © 2010-202.
Part 1 of 2: The Evidence Is Getting Real: What Have We Learned About
Sequencing Later-Line Treatments in Advanced CRC From the Real World
Richard Kim, MD
Professor
University of South Florida
Service Chief of Gl Oncology
Moffitt Cancer Center
Tampa, Florida, USA
Marc Peeters, MD, PhD
Full Professor
Antwerp University
CEO
Antwerp University Hospital
Antwerp, Belgium
Copyright © 2010-202.
PeerVoice
Richard Kim, MD, has a financial interest/relationship or affiliation in the form of:
Speakers Bureau participant with AstraZeneca and Incyte.
Advisory Board for AstraZeneca; Eisai Co, Ltd; Exelixis, Inc.; F. Hoffmann-La Roche
Ltd. Ipsen Biopharmaceuticals, Inc.; and Pfizer Inc.
Speaker or participant in accredited CME/CPD for Bayer AG.
Marc Peeters, MD, PhD, has a financial interest/relationship or affiliation in the
form of:
Advisory Board for Amgen Inc.; Bayer AG; BIMINI Biotech.; Bristol Myers Squibb
Company; Qurin; and Remecare.
www.peervoice.com/JQC870 Copyright © 2010-2024, PeerVoice
Richard Kim, MD, has a financial interest/relationship or affiliation in the form of:
Speakers Bureau participant with AstraZeneca and Incyte.
Advisory Board for AstraZeneca; Eisai Co, Ltd; Exelixis, Inc.; F. Hoffmann-La Roche
Ltd. Ipsen Biopharmaceuticals, Inc.; and Pfizer Inc.
Speaker or participant in accredited CME/CPD for Bayer AG.
Marc Peeters, MD, PhD, has a financial interest/relationship or affiliation in the
form of:
Advisory Board for Amgen Inc.; Bayer AG; BIMINI Biotech.; Bristol Myers Squibb
Company; Qurin; and Remecare.
www.peervoice.com/JQC870 Copyright © 2010-2024, PeerVoice
PeerVoice
Differences Between RWE and RCTs
Real-World Evidence (RWE) Randomised Controlled Trials (RCTs)
Complements RCTs Considered gold standard
Less costly Costly
Provides information on patient Patient population well defined with
population not represented in RCTs specific eligibility criteria
Limited sample size, prior calculation of
14 im iF A
Lage sample are sample size needed
Uncovers toxicities that require Acute and common toxicities are
long-term follow-up revealed
Typically not suitable for new drug
approval Considered suitable for drug approvals
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Differences Between RWE and RCTs
Real-World Evidence (RWE) Randomised Controlled Trials (RCTs)
Complements RCTs Considered gold standard
Less costly Costly
Provides information on patient Patient population well defined with
population not represented in RCTs specific eligibility criteria
Limited sample size, prior calculation of
14 im iF A
Lage sample are sample size needed
Uncovers toxicities that require Acute and common toxicities are
long-term follow-up revealed
Typically not suitable for new drug
approval Considered suitable for drug approvals
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Long-Term Response (LTR) to REG in mCRC
Updated Analysis From Flatiron:
Retrospective cohort study with de-identified US EHR database
Study Period (1 Jan 2013 to 30 Now 2023)
Index date: tiation of REG during patient selection period
Inclusion
+ Patients
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Long-Term Response (LTR) to REG in mCRC
Updated Analysis From Flatiron:
Retrospective cohort study with de-identified US EHR database
Study Period (1 Jan 2013 to 30 Now 2023)
Index date: tiation of REG during patient selection period
Inclusion
+ Patients
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REG LTR: Patient and Disease Characteristics at Index
LTRS LTR6
Patient Characteristi acer)
Male sex 56
Median age
<65 y 50 50 50
>65 y 50 50 50
Stage at initial CRC diagnosis
of 3 3 4
U 16 14 17
uM 30 32 33
Vv 48 46 42
ECOG PS
on 67 68 68
2-4 12 13 12
Received prior BEV 67 63 60
Initiated REG 2013-2018 40 40 39
Initiated REG 2019-2022 60 60 6
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REG LTR: Patient and Disease Characteristics at Index
LTRS LTR6
Patient Characteristi acer)
Male sex 56
Median age
<65 y 50 50 50
>65 y 50 50 50
Stage at initial CRC diagnosis
of 3 3 4
U 16 14 17
uM 30 32 33
Vv 48 46 42
ECOG PS
on 67 68 68
2-4 12 13 12
Received prior BEV 67 63 60
Initiated REG 2013-2018 40 40 39
Initiated REG 2019-2022 60 60 6
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G LTR: Site of Metastasis at Index
EM Non-liver
LTR6
(n = 250) IM Livers
BE Unknown/missing
LTRS
(n= 367)
LTR4
(n = 544)
o 1 20 30 40 50 60 70
Proportion of Patients by LTR, %
* Liver includes liver only, liver with lung, and liver with other site(s) of metastases.
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G LTR: Site of Metastasis at Index
EM Non-liver
LTR6
(n = 250) IM Livers
BE Unknown/missing
LTRS
(n= 367)
LTR4
(n = 544)
o 1 20 30 40 50 60 70
Proportion of Patients by LTR, %
* Liver includes liver only, liver with lung, and liver with other site(s) of metastases.
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REG LTR: Tumour Sidedness at Index
LTR4 LTR5 LTR6
(n = 544) (n = 367) (n = 250)
D 4 * 7
Left Right MI Unknown/missing
Patients with multiple records for tumour sidedness were categorised as unknown/missing. Left included left side, rectosigmoid, rectum, and
splenic flexure.
ice.com/JQC870 Copyright © 2010-2024, PoorVeice
REG LTR: Tumour Sidedness at Index
LTR4 LTR5 LTR6
(n = 544) (n = 367) (n = 250)
D 4 * 7
Left Right MI Unknown/missing
Patients with multiple records for tumour sidedness were categorised as unknown/missing. Left included left side, rectosigmoid, rectum, and
splenic flexure.
ice.com/JQC870 Copyright © 2010-2024, PoorVeice
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REG LTR: Line and Duration of Treatment
Proportion of Patients by REG Treatment Line, %
(0) 5 10 15 20 25 30 35
= LTR6 (n = 250)
m LTRS (n= 367)
= LTRA (n = 544)
R4 LTR5
6L Treatment Duration/History 67)
un Median TTD of REG, mo (95% Cl) So = 28
8L+ " (57-63) | (70-79) | (86-101
Median follow-up time from 107 13.0 146
index, mo (IQR) (7.2-17.2) | (81-20.2) | (9.9-22.3)
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REG LTR: Line and Duration of Treatment
Proportion of Patients by REG Treatment Line, %
(0) 5 10 15 20 25 30 35
= LTR6 (n = 250)
m LTRS (n= 367)
= LTRA (n = 544)
R4 LTR5
6L Treatment Duration/History 67)
un Median TTD of REG, mo (95% Cl) So = 28
8L+ " (57-63) | (70-79) | (86-101
Median follow-up time from 107 13.0 146
index, mo (IQR) (7.2-17.2) | (81-20.2) | (9.9-22.3)
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Sequential REG and TAS-102 + BEV in Refractory mCRC
Updated Analysis From Flatiron:
Retrospective cohort study with de-identified US EHR database
En
Index date: Treatment initiation during patient selection
period (on or after Jan 2015)
od
mo prior to ind
dat
trial enrolment during study period
e.com/JQC870 Copyright © 2010-2024, PeerVoice
Sequential REG and TAS-102 + BEV in Refractory mCRC
Updated Analysis From Flatiron:
Retrospective cohort study with de-identified US EHR database
En
Index date: Treatment initiation during patient selection
period (on or after Jan 2015)
od
mo prior to ind
dat
trial enrolment during study period
e.com/JQC870 Copyright © 2010-2024, PeerVoice
PeerVoice
Sequential REG and TAS-102 + BEV:
Patient and Disease Characteristics at Index
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T Patient Characteristics
(n= 393) (LLO | (Cont'd), % (n= 393) (n= 425)
Stage at initial CRC diagnosis Median time since diagnosis, 246 245
on 3 3 mo (IQR) (66-357) | (17.3-36.0)
" 10 2 =
i a = r anti-EGFR 33 36
w 55 56 Prior BEV 78 79
ECOG PS TAS-102 + BEV 1 15
on 7 zul Neutropenia
22 8 10 Moderate (0.5-10 x 10°/L) 4 a
Unknown/missing 21 19 Severe (<0. x 109/L) a a
KRAS mutation 47 46 Myelosuppression intervention
BRAF mutation 1 4 G-CSF 50 53
UP Erythropoietin E 9
Line of index treatment
1 7 6
2 7 16
3 42 41
4 22 25
25 12 1
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2024, PeerVoice
Sequential REG and TAS-102 + BEV:
Patient and Disease Characteristics at Index
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T Patient Characteristics
(n= 393) (LLO | (Cont'd), % (n= 393) (n= 425)
Stage at initial CRC diagnosis Median time since diagnosis, 246 245
on 3 3 mo (IQR) (66-357) | (17.3-36.0)
" 10 2 =
i a = r anti-EGFR 33 36
w 55 56 Prior BEV 78 79
ECOG PS TAS-102 + BEV 1 15
on 7 zul Neutropenia
22 8 10 Moderate (0.5-10 x 10°/L) 4 a
Unknown/missing 21 19 Severe (<0. x 109/L) a a
KRAS mutation 47 46 Myelosuppression intervention
BRAF mutation 1 4 G-CSF 50 53
UP Erythropoietin E 9
Line of index treatment
1 7 6
2 7 16
3 42 41
4 22 25
25 12 1
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2024, PeerVoice
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Sequential REG and TAS-102 + BEV: Overall Survival
Third- Fourth-Line Setting
pe 008) | 104 6
Median olow-op mR) | 12 (62 98 69-18)
a ees i 2 [esac me ia
2 RT vs o | [Adjusted HR
> DE (090 (076-120) a ES oo |
2 re]
8 ©
2 a
& 2 ow
— R-T cohort —R-T cohort
— T-R cohort T-R cohort
o EE + + Par Tuer EEE +
Time, mo Time, mo
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Sequential REG and TAS-102 + BEV: Overall Survival
Third- Fourth-Line Setting
pe 008) | 104 6
Median olow-op mR) | 12 (62 98 69-18)
a ees i 2 [esac me ia
2 RT vs o | [Adjusted HR
> DE (090 (076-120) a ES oo |
2 re]
8 ©
2 a
& 2 ow
— R-T cohort —R-T cohort
— T-R cohort T-R cohort
o EE + + Par Tuer EEE +
Time, mo Time, mo
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Sequential REG and TAS-102 + BEV:
Neutropenia and Myelosuppression
R-T T-R
Outcome, % (n = 393) (n = 425)
Neutropenia
Mild (>1.0-1.5 x 102/L) 1 <
Moderate (0.5-1.0 x 109/L) 26 32
Severe (<0.5 x 109/L) 12 16
Myelosuppression intervention
G-CSF or erythropoietin during sequential therapy 22 24
Overall G-CSF use 14 18
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Sequential REG and TAS-102 + BEV:
Neutropenia and Myelosuppression
R-T T-R
Outcome, % (n = 393) (n = 425)
Neutropenia
Mild (>1.0-1.5 x 102/L) 1 <
Moderate (0.5-1.0 x 109/L) 26 32
Severe (<0.5 x 109/L) 12 16
Myelosuppression intervention
G-CSF or erythropoietin during sequential therapy 22 24
Overall G-CSF use 14 18
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Abbreviations and References
Differences Between RWE and RCTs
Abbreviation(s): RCT: randomised controlled trial; RWE: real-world evidence.
Reference(s): Gyawali B et al. JCO Precis Oncol. 2017;11-5.
Long-Term Response (LTR) to REG in mCRC
Abbreviation(s): EHR: electronic health record; EOS: end of study; GIST: gastrointestinal stromal tumour,
HCC: hepatocellular carcinoma; LTR: long-term response; mCRC: metastatic colorectal cancer (CRC);
NMSC: nonmelanoma skin cancer; REG: regorafenib.
Reference(s): Kim RD et al. European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI
2024). Abstract 83P.
REG LTR: Patient and Disease Characteristics at Index
Abbreviation(s): BEV: bevacizumab; ECOG: Eastern Cooperative Oncology Group; PS: performance status.
Reference(s): Kim RD et al. ESMO Gl 2024. Abstract 83P.
REG LTR: Site of Metastasis at Index
im RD et al. ESMO GI 2024. Abstract 83P.
Reference(s):
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Abbreviations and References
Differences Between RWE and RCTs
Abbreviation(s): RCT: randomised controlled trial; RWE: real-world evidence.
Reference(s): Gyawali B et al. JCO Precis Oncol. 2017;11-5.
Long-Term Response (LTR) to REG in mCRC
Abbreviation(s): EHR: electronic health record; EOS: end of study; GIST: gastrointestinal stromal tumour,
HCC: hepatocellular carcinoma; LTR: long-term response; mCRC: metastatic colorectal cancer (CRC);
NMSC: nonmelanoma skin cancer; REG: regorafenib.
Reference(s): Kim RD et al. European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI
2024). Abstract 83P.
REG LTR: Patient and Disease Characteristics at Index
Abbreviation(s): BEV: bevacizumab; ECOG: Eastern Cooperative Oncology Group; PS: performance status.
Reference(s): Kim RD et al. ESMO Gl 2024. Abstract 83P.
REG LTR: Site of Metastasis at Index
im RD et al. ESMO GI 2024. Abstract 83P.
Reference(s):
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Abbreviations and References (Cont'd)
REG LTR: Tumour Sidedness at Index
Reference(s): Kim RD et al. ESMO Gl 2024. Abstract 83P.
REG LTR: Line and Duration of Treatment
Abbreviation(s): IQR: interquartile range; TTD: time to discontinuation.
Reference(s): Kim RD et al. ESMO Gl 2024. Abstract 83P.
Sequential REG and TAS-102 + BEV in Refractory mCRC
Abbreviation(s): R-T: REG followed by trifluridine/tipiracil (TAS-102) £ BEV; T-R: TAS-102 + BEV followed by REG.
Reference(s): Bekaii-Saab T et al. ESMO Congress 2023 (ESMO 2023). Abstract 616P.
Sequential REG and TAS-102 + BEV: Patient and Disease Characteristics at Index
Abbreviation(s): EGFR: epidermal growth factor receptor; G-CSF: granulocyte colony-stimulating factor.
Reference(s): Bek: aab T et al. ESMO 2023. Abstract 616P.
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Abbreviations and References (Cont'd)
REG LTR: Tumour Sidedness at Index
Reference(s): Kim RD et al. ESMO Gl 2024. Abstract 83P.
REG LTR: Line and Duration of Treatment
Abbreviation(s): IQR: interquartile range; TTD: time to discontinuation.
Reference(s): Kim RD et al. ESMO Gl 2024. Abstract 83P.
Sequential REG and TAS-102 + BEV in Refractory mCRC
Abbreviation(s): R-T: REG followed by trifluridine/tipiracil (TAS-102) £ BEV; T-R: TAS-102 + BEV followed by REG.
Reference(s): Bekaii-Saab T et al. ESMO Congress 2023 (ESMO 2023). Abstract 616P.
Sequential REG and TAS-102 + BEV: Patient and Disease Characteristics at Index
Abbreviation(s): EGFR: epidermal growth factor receptor; G-CSF: granulocyte colony-stimulating factor.
Reference(s): Bek: aab T et al. ESMO 2023. Abstract 616P.
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Abbreviations and References (Cont'd)
Sequential REG and TAS-102 + BEV: Overall Survival
Abbreviation(s): 3L: third line; 4L: fourth line; OS: overall survival.
Reference(s): Bekaii-Saab T et al. ESMO 2023. Abstract 616P.
Sequential REG and TAS-102 + BEV: Neutropenia and Myelosuppression
Reference(s): Bekaii-Saab T et al. ESMO 2023. Abstract 616P.
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Abbreviations and References (Cont'd)
Sequential REG and TAS-102 + BEV: Overall Survival
Abbreviation(s): 3L: third line; 4L: fourth line; OS: overall survival.
Reference(s): Bekaii-Saab T et al. ESMO 2023. Abstract 616P.
Sequential REG and TAS-102 + BEV: Neutropenia and Myelosuppression
Reference(s): Bekaii-Saab T et al. ESMO 2023. Abstract 616P.
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Part 2 of 2: The Real Deal: Optimising the Use of Later-Line Treatments
for Advanced CRC in the Real World
Richard Kim, MD
Professor
University of South Florida
Service Chief of Gl Oncology
Moffitt Cancer Center
Tampa, Florida, USA
Marc Peeters, MD, PhD
Full Professor
Antwerp University
CEO
Antwerp University Hospital
Antwerp, Belgium
Copyright © 2010-202.
Part 2 of 2: The Real Deal: Optimising the Use of Later-Line Treatments
for Advanced CRC in the Real World
Richard Kim, MD
Professor
University of South Florida
Service Chief of Gl Oncology
Moffitt Cancer Center
Tampa, Florida, USA
Marc Peeters, MD, PhD
Full Professor
Antwerp University
CEO
Antwerp University Hospital
Antwerp, Belgium
Copyright © 2010-202.
PeerVoice
Richard Kim, MD, has a financial interest/relationship or affiliation in the form of:
Speakers Bureau participant with AstraZeneca and Incyte.
Advisory Board for AstraZeneca; Eisai Co, Ltd; Exelixis, Inc.; F. Hoffmann-La Roche
Ltd. Ipsen Biopharmaceuticals, Inc.; and Pfizer Inc.
Speaker or participant in accredited CME/CPD for Bayer AG.
Marc Peeters, MD, PhD, has a financial interest/relationship or affiliation in the
form of:
Advisory Board for Amgen Inc.; Bayer AG; BIMINI Biotech.; Bristol Myers Squibb
Company; Qurin; and Remecare.
www.peervoice.com/JQC870 Copyright © 2010-2024, PeerVoice
Richard Kim, MD, has a financial interest/relationship or affiliation in the form of:
Speakers Bureau participant with AstraZeneca and Incyte.
Advisory Board for AstraZeneca; Eisai Co, Ltd; Exelixis, Inc.; F. Hoffmann-La Roche
Ltd. Ipsen Biopharmaceuticals, Inc.; and Pfizer Inc.
Speaker or participant in accredited CME/CPD for Bayer AG.
Marc Peeters, MD, PhD, has a financial interest/relationship or affiliation in the
form of:
Advisory Board for Amgen Inc.; Bayer AG; BIMINI Biotech.; Bristol Myers Squibb
Company; Qurin; and Remecare.
www.peervoice.com/JQC870 Copyright © 2010-2024, PeerVoice
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REG Flexible Dosing in mCRC
Phase 2 ReDOS: REG first-cycle dose escalation showed comparable activity and
lower incidence of AEs vs standard dosing; this was a retrospective cohort study
with chart review by physicians recruited from the IQVIA OneKey database
> Fa
e
Index dete: Earbest use of REG during
the index period (can be any LOT)
+ Dose at REG initiation
Evaluated baseline (pre-index) parameters
+ Comorbiditios
Copyright © 2010-2024, PeerVoice
REG Flexible Dosing in mCRC
Phase 2 ReDOS: REG first-cycle dose escalation showed comparable activity and
lower incidence of AEs vs standard dosing; this was a retrospective cohort study
with chart review by physicians recruited from the IQVIA OneKey database
> Fa
e
Index dete: Earbest use of REG during
the index period (can be any LOT)
+ Dose at REG initiation
Evaluated baseline (pre-index) parameters
+ Comorbiditios
Copyright © 2010-2024, PeerVoice
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REG Flexible Dosing: Treatment Patterns by Regimen
treatment initiation mala
160 s o 100
120 2 59 o
20 1 28 o
40 i 3 o
Dose at ond of treatment maid
160 43 a 1 100
120 35 49 60 o
20 20 Ed 36 0
40 2 3 3 o
Dose intensity, mala
‘Moan (SD) 5532685) | more) | 107085) | 150000)
Medion 1200 1200 1200 1600
10 (03) (1200-1500) | (200-1200) | (200-1600) | (1600-1600)
Median number of cycles received n 30 30 50 30
(Gr [01 031) (oso) | (os | 0-60) | (20-50
Maximum number of eyes intinted
1 0 9 o 2
2 5 24 7 7
23 n E ES 6a
Duration of treatment 7150 EC] n=30 n=2
Cunt the first »2-wi gap). mo
Mean (SD) 22(18) 20(14) 2001 102)
Medion 14 14 19 10
(OR [Qt Q3)) (09-30) (09-29) (09-40) (09-34)
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REG Flexible Dosing: Treatment Patterns by Regimen
treatment initiation mala
160 s o 100
120 2 59 o
20 1 28 o
40 i 3 o
Dose at ond of treatment maid
160 43 a 1 100
120 35 49 60 o
20 20 Ed 36 0
40 2 3 3 o
Dose intensity, mala
‘Moan (SD) 5532685) | more) | 107085) | 150000)
Medion 1200 1200 1200 1600
10 (03) (1200-1500) | (200-1200) | (200-1600) | (1600-1600)
Median number of cycles received n 30 30 50 30
(Gr [01 031) (oso) | (os | 0-60) | (20-50
Maximum number of eyes intinted
1 0 9 o 2
2 5 24 7 7
23 n E ES 6a
Duration of treatment 7150 EC] n=30 n=2
Cunt the first »2-wi gap). mo
Mean (SD) 22(18) 20(14) 2001 102)
Medion 14 14 19 10
(OR [Qt Q3)) (09-30) (09-29) (09-40) (09-34)
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REG Flexible Dosing: TTD by Regimen
Dos:
Outcom: Overall ReDOS Adjusted Standard
TTD for noncensored patients, mo n=85 n=54 n=18 het:
Mean (SD) 4.9 (43) 4.8 (4.9) 4.6 (1.7) 5.1(3.5)
Median 3.9 3.0 45 5.0
IQR (QI, Q3) 2.0-6.0 2.0-5.0 3.0-6.0 15-7.5
Reasons for discontinuation, % n=136 n=81 n=23 n=32
Distant progression/relapse 51 56 65 28
Local progression/relapse 4 1 7 3
Patient choice 4 1 13 3
Poor PS 15 19 7 3
Side effects 6 7 9 o
Death 39 33 65 34
Lost to follow-up 1 1 Le) o
Course complete 1 1 [e] o
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REG Flexible Dosing: TTD by Regimen
Dos:
Outcom: Overall ReDOS Adjusted Standard
TTD for noncensored patients, mo n=85 n=54 n=18 het:
Mean (SD) 4.9 (43) 4.8 (4.9) 4.6 (1.7) 5.1(3.5)
Median 3.9 3.0 45 5.0
IQR (QI, Q3) 2.0-6.0 2.0-5.0 3.0-6.0 15-7.5
Reasons for discontinuation, % n=136 n=81 n=23 n=32
Distant progression/relapse 51 56 65 28
Local progression/relapse 4 1 7 3
Patient choice 4 1 13 3
Poor PS 15 19 7 3
Side effects 6 7 9 o
Death 39 33 65 34
Lost to follow-up 1 1 Le) o
Course complete 1 1 [e] o
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OSERO: Sequential REG and TAS-102 + BEV in mCRC
OSERO: Non- intervention, prospective, observational study in Japan
Key Inclusion Criteria
+ ECOGPSOor1 Patients juled to
+ Refractory to or intolerant of fluoropyrimidine,
oxaliplatin, irinotecan, anti-VEGF(R) mAb, and Fe EV
anti-EGFR mAb if RAS wt
Planning to receive sequential treatment with REG Tnalenrelment
and TAS-102 + BEV Bee
No prior history of REG and TAS-102
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R-T + BEV
T-R
T+ BEV-R
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OSERO: Sequential REG and TAS-102 + BEV in mCRC
OSERO: Non- intervention, prospective, observational study in Japan
Key Inclusion Criteria
+ ECOGPSOor1 Patients juled to
+ Refractory to or intolerant of fluoropyrimidine,
oxaliplatin, irinotecan, anti-VEGF(R) mAb, and Fe EV
anti-EGFR mAb if RAS wt
Planning to receive sequential treatment with REG Tnalenrelment
and TAS-102 + BEV Bee
No prior history of REG and TAS-102
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R-T + BEV
T-R
T+ BEV-R
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OSERO Sequential REG and TAS-102 + BEV in mCRC: Survival
PFS REG os
—TAS-102
100 —TAS-102 + BEV ¡09
so 20
80 80
70 70
60 so
®
gs ae
É
30 S 30
20 20
10 Le
E o
a we ZUR 2 ew OM m2
Time, mo Time, mo
REG
Median PFS, mo 19 21 37 Median OS, mo, ns
HP) HR
Loa vna exe) TS 02 ve REG 072,043)
TAS-102 + BEV vs TAS-102 059 (0001) TAS-102 + BEV vs TAS-102 073 (030)
TAS-102 + BEV vs REG 0.39 (< 0001) TAS-102 + BEV vs REG 103 (828)
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Copyright © 2010-2024, PeerVoice
OSERO Sequential REG and TAS-102 + BEV in mCRC: Survival
PFS REG os
—TAS-102
100 —TAS-102 + BEV ¡09
so 20
80 80
70 70
60 so
®
gs ae
É
30 S 30
20 20
10 Le
E o
a we ZUR 2 ew OM m2
Time, mo Time, mo
REG
Median PFS, mo 19 21 37 Median OS, mo, ns
HP) HR
Loa vna exe) TS 02 ve REG 072,043)
TAS-102 + BEV vs TAS-102 059 (0001) TAS-102 + BEV vs TAS-102 073 (030)
TAS-102 + BEV vs REG 0.39 (< 0001) TAS-102 + BEV vs REG 103 (828)
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OSERO Sequential REG and TAS-102 + BEV in mCRC:
Treatment Patterns by Regimen
REG TAS-102
Outcome, % (En)
Initial dose of REG, mg
160 60 - -
120 416 - -
80 523 - -
Initial dose of TAS-102, mg/m?
35 - 825 916
30 - 16.3 71
Other = 13 13
Biweekly treatment schedule of TAS-102 + BEV = = 150
Implementation of sequential therapy 624 375 628
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OSERO Sequential REG and TAS-102 + BEV in mCRC:
Treatment Patterns by Regimen
REG TAS-102
Outcome, % (En)
Initial dose of REG, mg
160 60 - -
120 416 - -
80 523 - -
Initial dose of TAS-102, mg/m?
35 - 825 916
30 - 16.3 71
Other = 13 13
Biweekly treatment schedule of TAS-102 + BEV = = 150
Implementation of sequential therapy 624 375 628
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OSERO Sequential REG and TAS-102 + BEV in mCRC: Safety
S nto e 228)
Neutropenia 40.0
‘Anaemia 120
Thrombocytopenia 49
Nausea 22
Anorexia 44
Diarrhoea 13 09
Fatigue 13 36
coro = ES a9
Hypertension ns 0.0 31
Proteinuria 122 0.0 09
ALT increased 41 13 04
AST increased 54 00 13
Blood bilirubin increased 34 13 18
Febrile neutropenia 00 13 40
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OSERO Sequential REG and TAS-102 + BEV in mCRC: Safety
S nto e 228)
Neutropenia 40.0
‘Anaemia 120
Thrombocytopenia 49
Nausea 22
Anorexia 44
Diarrhoea 13 09
Fatigue 13 36
coro = ES a9
Hypertension ns 0.0 31
Proteinuria 122 0.0 09
ALT increased 41 13 04
AST increased 54 00 13
Blood bilirubin increased 34 13 18
Febrile neutropenia 00 13 40
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Abbreviations and References
REG Flexible Dosing in mCRC
Abbreviation(s): AE: adverse event; ECOG: Eastern Cooperative Oncology Group; LOT: line of therapy;
MCRC: metastatic colorectal cancer (CRC); PS: performance status; REG: regorafenib; RWE: real-world evidence.
Reference(s): Peeters M et al. American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2024
(ASCO GI 2024). Abstract 47.
REG Flexible Dosing: Treatment Patterns by Regimen
Abbreviation(s): IQR: interquartile range; Q: quartile; SD: standard deviation.
Reference(s): Peeters M et al. ASCO Gl 2024. Abstract 47.
REG Flexible Dosing: TTD by Regimen
Abbreviation(s): TTD: time to treatment discontinuation.
Reference(s): Peeters M et al. ASCO Gl 2024. Abstract 47.
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Abbreviations and References
REG Flexible Dosing in mCRC
Abbreviation(s): AE: adverse event; ECOG: Eastern Cooperative Oncology Group; LOT: line of therapy;
MCRC: metastatic colorectal cancer (CRC); PS: performance status; REG: regorafenib; RWE: real-world evidence.
Reference(s): Peeters M et al. American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2024
(ASCO GI 2024). Abstract 47.
REG Flexible Dosing: Treatment Patterns by Regimen
Abbreviation(s): IQR: interquartile range; Q: quartile; SD: standard deviation.
Reference(s): Peeters M et al. ASCO Gl 2024. Abstract 47.
REG Flexible Dosing: TTD by Regimen
Abbreviation(s): TTD: time to treatment discontinuation.
Reference(s): Peeters M et al. ASCO Gl 2024. Abstract 47.
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Abbreviations and References (Cont'd)
OSERO: Sequential REG and TAS-102 + BEV in mCRC
Abbreviation(s): BEV: bevacizumab; EGFR: epidermal growth factor receptor; mAb: monoclonal antibody;
R-T: REG followed by trifluridine/tipiracil (TAS-102) + BEV; T-R: TAS-102 + BEV followed by REG;
TAS: trifluridine/tipiracil, VEGF(R): vascular endothelial growth factor (receptor); wt: wild-type.
Reference(s): Chida A et al. ASCO-Gl 2024. Abstract 103.
OSERO Sequential REG and TAS-102 + BEV in mCRC: Survival
Abbreviation(s): OS: overall survival; PFS: progression-free survival.
Reference(s): Chida A et al. ASCO-GI 2024. Abstract 103.
OSERO Sequential REG and TAS-102 + BEV in mCRC: Treatment Patterns by Regimen
Reference(s): Chida A et al. ASCO-Gl 2024. Abstract 103.
OSERO Sequential REG and TAS-102 + BEV in mCRC: Safety
Abbreviation(s): ALT: alanine transaminase; AST: aspartate aminotransferase.
Reference(s): Chida A et al. ASCO-GI 2024. Abstract 103.
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Abbreviations and References (Cont'd)
OSERO: Sequential REG and TAS-102 + BEV in mCRC
Abbreviation(s): BEV: bevacizumab; EGFR: epidermal growth factor receptor; mAb: monoclonal antibody;
R-T: REG followed by trifluridine/tipiracil (TAS-102) + BEV; T-R: TAS-102 + BEV followed by REG;
TAS: trifluridine/tipiracil, VEGF(R): vascular endothelial growth factor (receptor); wt: wild-type.
Reference(s): Chida A et al. ASCO-Gl 2024. Abstract 103.
OSERO Sequential REG and TAS-102 + BEV in mCRC: Survival
Abbreviation(s): OS: overall survival; PFS: progression-free survival.
Reference(s): Chida A et al. ASCO-GI 2024. Abstract 103.
OSERO Sequential REG and TAS-102 + BEV in mCRC: Treatment Patterns by Regimen
Reference(s): Chida A et al. ASCO-Gl 2024. Abstract 103.
OSERO Sequential REG and TAS-102 + BEV in mCRC: Safety
Abbreviation(s): ALT: alanine transaminase; AST: aspartate aminotransferase.
Reference(s): Chida A et al. ASCO-GI 2024. Abstract 103.
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