Metastatic Colorectal Cancer

Dirk Arnold
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A lesson in re-thinking strategies
 3rd and further line
mCRC

Hendlisz et al., J Clin Oncol 2010

 Unpretreated mCRC

Wasan et al., Lancet Oncol 2017

 EPOCH Trial: Design
Study Design
N=215
Key Eligibility Y-90 Glassa +
• Unresectable unilobar or
Chemotherapy
bilobar colorectal liver +/ - ta rgeted thera py Follow up
metastases Stratification every 8
• Able to receive second- • Unilobar/ weeks until
line irinotecan or Bilobar R 1:1 irinotecan or disease
oxaliplatin-based disease Survival
N=428 oxaliplatin-based progression
chemotherapy • KRAS status / hepatic follow-up
• Measurable disease by 95 sites chemotherapy
• Irinotecan- or disease
RECIST 1.1 Oxaliplatin- progression
• Performance status 0 or 1 based 1st-line or death
• Bilirubin ≤1.2 upper limit of therapy
normal N=213
• Albumin ≥ 3.0 gm/dL Chemotherapy
+/ - ta rgeted thera py

a TAREwith Y90 glass microspheres (TheraSphereTM, Boston Scientific Corporation). Cycle 1= chemotherapy, Y-90 TARE replace Cycle 2, Cycle 3 resume
chemotherapy ± targeted therapy.
Chauhan N, Mulcahy MF, Salem R, et al. JMIR Res Protoc. 2019;8(1):e11545. doi: 10.2196/11545.

Mary F. Mulcahy, MD Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

CAUTION: Investigational device. Limited by Federal law to investigational use only. TheraSphere is not indicated as intended treatment of patients with metastatic colorectal cancer.
6
Mulcahy et al., ESMO 2021; #LBA21; Mulcahy et al., J Clin Oncol 2021
EPOCH Trial: Patient characteristics
Patient and Disease Characteristics Y-90 + Chemo
(N=215)
Chemo
(N=213)
Y-90 + Chemo Chemo
Bilobar disease 176 (81.9%) 173 (81.2%)
(N=215) (N=213)
Liver Tumor Burdena
Median Age 63.0 years 60.0 years
< 10% 124 (57.7%) 121 (56.8%)
Male 135 (62.8%) 138 (64.8%)
≥ 10% to < 25% 54 (25.1%) 47 (22.1%)
Region
≥ 25% 29 (13.5%) 28 (13.1%)
No. America 63 (29.3%) 56 (26.3%)
Maximum Liver Lesion
Europe 131 (60.9%) 145 (68.1%) 162 (75.3%) 142 (66.7%)
Size ≥ 40 mma
Asia 21 (9.8%) 12 (5.6%) Primary tumor in situ 83 (38.6%) 69 (32.4%)
ECOG 0 119 (55.3%) 133 (62.4%) Left side primary tumor 150 (69.8%) 136 (63.8%)
Albumin ≥ LLN 182 (84.7%) 177 (83.1%) Extrahepatic Lesions at
113 (52.6%) 95 (44.6%)
Baseline
CEA ≥ 35 ng/mL 116 (54.0%) 105 (49.3%)
Number of Hepatic Lesions
KRAS Status <3 25 (11.6%) 21 (9.9%)
Mutant 100 (46.5%) 100 (46.9%) 3-5 40 (18.6%) 38 (17.8%)
6-10 54 (25.1%) 60 (28.2%)
Wild type 115 (53.5%) 113 (53.1%) > 10 88 (40.9%) 77 (36.2%)
Missing 8 (3.7%) 17 (8.0%)
Mary F. Mulcahy, MD Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

CAUTION: Investigational device. Limited by Federal law to investigational use only. TheraSphere is not indicated as intended treatment of patients with metastatic colorectal cancer.

7
Mulcahy et al., ESMO 2021; #LBA21; Mulcahy et al., J Clin Oncol 2021
 EPOCH Trial: Primary endpoints, PFS and hepatic PFS
CH
ary Trial: prim
Endpoint: ary endpoints,
Progression Free Survival PFS and hepatic PFS
% Progression-Free Survival (95% CI)
6M 12 M 18 M
65.2 25.8 16.7
Y-90 + Chemo (N=215)
(58.0, 71.5) (18.9, 33.1) (10.6, 23.9)

Chemo (N=213) HR=0.69

55.4
(47.2, 62.8)
13.2
(7.5, 20.5)
1.8
(0.2, 8.1)
HR=0.59
Y-90 + Chemo: median 8.0 M (95% Cl: 7.2, 9.2)
Chemo: median 7.2 M (95% Cl: 5.7, 7.6)
HR: 0.69 (0.54, 0.88); p<0.0013
PrimaryFree
Endpoint:
SurvivalHepatic Progression Free Survival
CH Trial:
mary prim
Endpoint: ary endpoints,
Progression PFS and hepatic PFS % Hepatic Progression-Free Survival (95% CI)
% Progression-Free Survival (95% CI)

Update Medizinische Onkologie

6M 12 M 18 M
6M 12 M 18 M
70.7 29.8 19.8
65.2 Y-90 + Chemo16.7
25.8 (N=215)
Y-90independent
for progression free survival according to RECIST 1.1 by blinded + Chemocentral
(N=215)review. (63.6, 76.6) (22.4, 37.6) (13.0, 27.6)

Herbst 2021
e-sided p. Success criteria for the study were met (both PFS and hPFS p-values ≤0.00248). (58.0, 71.5) (18.9, 33.1) (10.6, 23.9)
received subsequent mCRC therapy prior to their last tumor assessment or PD or death were censored at their last tumor assessment prior to subsequent 55.2 13.5 1.9
y. Patients who had PD or death immediately after ≥2 missed visits were censored at their last tumor55.4 Chemo
13.2
assessment prior to the (N=213)1.8
2 missed visits.
Chemo (N=213) (47.1, 62.7) (7.7, 20.9) (0.2, 8.3)
(47.2, 62.8) (7.5, 20.5) (0.2, 8.1)

Kolorektales Karzinom
Mary F. Mulcahy, MD Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Y-90 + Chemo: median 8.0 M (95% Cl: 7.2, 9.2) Y-90 + Chemo: median 9.1 M (95% Cl: 7.8, 9.7)
vestigational device. Limited by Federal law to investigational use only. TheraSphere is not indicated as intended treatment of patients with metastatic colorectal cancer.
Chemo: median 7.2 M (95% Cl: 5.7, 7.6) Chemo: median 7.2 M (95% Cl: 5.7, 7.6)
HR: 0.69 (0.54, 0.88); p<0.0013 HR: 0.59 (0.46, 0.77); p<0.0001
Primary Endpoint: Hepatic Progression Free Survival
Dirk Arnold % Hepatic Progression-Free Survival (95% CI)

Update Medizinische Onkologie

6M 12 M 18 M
70.7 29.8 19.8
Y-90 + Chemo (N=215)
Mulcahy et al., J Clin Oncol 2021
eier for progression free survival according to RECIST 1.1 by blinded independent central review.
al., ESMO 2021; #LBA21; Mulcahy et al., J Clin Oncol 2021
(63.6, 76.6)
Kaplan-Meier for progression free survival according to RECIST 1.1 by blinded independent central review.
(22.4, 37.6) (13.0, 27.6)
, one-sided p. Success criteria for the study were met (both PFS and hPFS p-values ≤0.00248).
Kongressnachlese ESMO 2021 *Log-rank, one-sided p. Success criteria for the study were met (both PFS and hPFS p-values ≤0.00248).
Patients who received subsequent mCRC therapy prior to their last tumor assessment or PD or death were censored at their last tumor13.5
55.2 1.9
who received subsequent mCRC therapy prior to their last tumor assessment or PD or death were censored at their last tumor assessment prior to subsequent
assessment prior to subsequent
EPOCH trial: Subgroups
Treatment Effect
on PFS in
Patient Subgroups *
Key characteristics of interest associated
with a PFS benefit with Y-90+chemo
include:
*
• Tumors with KRAS mutation
• Hepatic tumor burden ≥10 to <25%
• < 3 lesions *
• Left sided primary tumor
• Addition of a biologic agent *

*
Mary F. Mulcahy, MD Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

CAUTION: Investigational device. Limited by Federal law to investigational use only. TheraSphere is not indicated as intended treatment of patients with metastatic colorectal cancer.

Mulcahy et al., ESMO 2021; #LBA21

EPOCH Trial: secondary
Secondary endpoint
Endpoint: Overall OS
Survival
% Overall Survival (95% CI)
6M 12 M 18 M
88.5 56.3 36.4
Y-90 + Chemo (N=215)
(83.3, 92.1) (49.2, 62.8) (29.7, 43.1)
87.8 62.4 34.3
Chemo (N=213)
(82.3, 91.7) (55.0, 68.9) (27.5, 41.2)

Y-90 + Chemo: median 14.0 M (95% Cl: 11.8, 15.5)

Chemo: median 14.4 M (95% Cl: 12.8, 16.4)
HR: 1.07 (0.86, 1.32); p<0.28

Kaplan-Meier for overall survival. For each patient not known to have died, overall survival is censored at the time of last date known to be alive. aLog-rank, one-sided p.

Mary F. Mulcahy, MD Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

CAUTION: Investigational device. Limited by Federal law to investigational use only. TheraSphere is not indicated as intended treatment of patients with metastatic colorectal cancer.

Mulcahy et al., ESMO 2021; #LBA21; Mulcahy et al., J Clin Oncol 2021
EPOCH-Studie: Treatment-related Adverse Events
(TRAE)
Safety Summary: Treatment Emergent Adverse Events
Y-90 + Chemo (N=187) Chemo (N=207)
Any TEAEs (n, %) 181 (96.8%) 194 (93.7%)
Chemotherapy-Related TEAEs 172 (92.0%) 189 (91.3%)
Adverse Device Events (ADEs) 103 (55.1%) 0
Angiographic Procedure-Related TEAEs 55 (29.4%) 2 (1.0%)
TEAEs with CTCAE ≥ Grade 3 128 (68.4%) 102 (49.3%)
Serious TEAEs 70 (37.4%) 43 (20.8%)
Serious Treatment Emergent ADEs 20 (10.7%) 0
TEAEs Leading to Fatal Outcome 8 (4.3%) 4 (1.9%)
TEAEs Requiring Discontinuation of Chemotherapy 24 (12.8%) 25 (12.1%)
TEAEs collected until disease progression or 30 days after discontinuation of study therapy, whichever came first
Safety population, based on treatment received. TEAEs are adverse events which were not present at the initiation of chemotherapy or angiogram or
worsened in severity following the first dose of chemotherapy or date of angiogram.

Mary F. Mulcahy, MD Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

CAUTION: Investigational device. Limited by Federal law to investigational use only. TheraSphere is not indicated as intended treatment of patients with metastatic colorectal cancer.
Mulcahy et al., ESMO 2021; #LBA21; Mulcahy et al., J Clin Oncol 2021
Some lessons in applied tumour biology
 Prevalence of potentially actionable alterations
Prevalence of potentially actionable alterations
N= 296 BRAF V600E
N= 39

13% KRAS G12C

N= 10
1%
3% 1% HER2 ampl

3%
N= 4
21% of pts with
HER2 mut
targetable alterations
N= 2

MSI-H
N= 8

79% No actionable alteration

N= 233

No NTRK1-3, ROS1, ALK or MET amplification were detected.

Antoniotti et al., ESMO GI 2020

Antoniotti et al., ESMO GI 2020

 KRAS: Downstream signaling

Hong et al., ESMO Virtual Congress 2020.

Targeting KRAS G12c mutations

• KRAS G12C: specific inhibitors in clinical development

• Prevalence: ca. 3%

Canon J et al., Nature 2019; Fakih M et al., ASCO 2020

KRAS Mutations: CodeBreaK 100 in NSCLC
 Is G12c inhibition really tumor agnostic?…..

Hong et al., N Engl J Med 2020

KRYSTAL-1: Adagrasib (MRTX849) as
Monotherapy or in Combination With
Cetuximab in Patients With Colorectal
Cancer Harboring a KRASG12C Mutation
Jared Weiss1, Rona Yaeger2, Melissa L. Johnson3, Alexander I. Spira4,
Samuel J. Klempner5, Minal Barve6, James G. Christensen7, Andrew S. Chi7,
Hirak Der-Torossian7, Karen Velastegui7, Thian Kheoh7, Sai-Hong Ignatius Ou8
1University of North Carolina-Chapel Hill, Lineberger Comprehensive Cancer Center, Chapel Hill, North
Carolina, USA; 2Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA;
3Sarah Cannon Research Institute, Tennessee Oncology, Nashville, Tennessee, USA; 4Virginia Cancer

Specialists, US Oncology Research, Fairfax, Virginia, USA; 5Massachusetts General Hospital, Cancer
Center, Boston, Massachusetts, USA; 6Mary Crowley Cancer Research, Dallas, Texas, USA; 7Mirati
Therapeutics, Inc., San Diego, California, USA; 8University of California Irvine, Chao Family
Comprehensive Cancer Center, Orange, California, USA.

Copies of this presentation can be obtained through Quick Response (QR). Copies are for personal use only and
may not be reproduced without permission of the authors.
 KRYSTAL-1: Adagrasib (MRTX849) KRASG12C Inhibitor ± Cetuximab in CRC

KRYSTAL-1 (849-001) Study Design

Phase 1 Phase 1b Phase 2
Dose Escalation Dose Expansion and Combination Monotherapy Treatment
Key Eligibility
Criteria Adagrasib monotherapy
600 mg BID Expansion in solid tumors
(Up to n=565) n=2 (CRC) NSCLCh,i
1200 mg QD Adagrasib brain metastases
in solid tumors
• Solid tumor with a
KRASG12C 600 mg QD Adagrasib NSCLC CRCi,j
mutationa treatment-naivec n=44
• Unresectable or 300 mg QDb Adagrasib NSCLC prior
metastatic disease KRASG12C inhibitor
• No available
150 mg QDb Adagrasib + pembro in NSCLCd Other Solid Tumorsi
treatment with
curative intent or
available standard Phase 1 Endpoints Phase 2 Endpoints Adagrasib + afatinib in NSCLC
of care Primary: Safety, MTD, PK, RP2D Primary: ORR (RECIST 1.1)
Adagrasib + cetuximab
NSCLC KRASG12C and
Secondary: Objective response Secondary: Safety STK11 Treatment-Naivec,i
in CRCe,f,g
(RECIST 1.1), DOR, PFS, OS
n=32

• Previously reported data demonstrated the clinical activity of adagrasib in patients with pretreated CRC with a KRASG12C mutation9
• Here we report preliminary data for adagrasib 600 mg BID as monotherapy (n=2 in Phase 1/1b and n=44 in Phase 2; median follow-up: 8.9
months) and in combination with cetuximab (n=32; median follow-up: 7 months) in patients with pretreated CRC with a KRASG12C mutation
• Data as of 25 May 2021 (monotherapy), 9 July 2021 (cetuximab combination)
aTissue test and/or ctDNA allowed for Phase 1/1b eligibility. bPatients subsequently dose escalated up to 600 mg BID. cPatients must have declined 1L systemic therapy. dSubjects receiving prior treatment with a KRASG12C inhibitor not
eligible. eSubjects receiving prior treatment with a KRASG12C inhibitor eligible for the Phase 1b adagrasib + cetuximab cohort. fPatients who received cetuximab who experienced clinical benefit had the option to continue on adagrasib alone.
gCetuximab was administered IV at a dose of 400 mg/m 2 followed by 250 mg/m2 QW, or 500 mg/m2 Q2W (Phase 1b). hTrial is registrational. iKRASG12C mutation detected in tumor tissue and/or blood. jPatients who have stable disease

compared to baseline measurements at week 13 or later during treatment with single agent adagrasib are eligible to cross over to adagrasib + cetuximab combination cohort. ClinicalTrials.gov. NCT03785249.
Presented at the European Society for Medical Oncology (ESMO) Congress, 18 September 2021
Adagrasib in advanced CRC: Best Overall Response
Adagrasib alone; N=45 KRYSTAL-1: Adagrasib (MRTX849) KRAS G12C Inhibitor ± Cetuximab in CRC
Adagrasib plus cetuximab; N=28
Adagrasib in Patients W ith Advanced CRC: Best O verall Response KRYSTAL-1: Adagrasib (MRTX849) KRAS G12C Inhibitor ± Cetuximab

Best Tumor Change From Baseline (n=45)a,b A dagrasib + Cetu xim ab in Patients W ith A dvanced CRC: Best O verall Resp onse
Maximum % Change From Baseline

40 PD PD Best Tumor Change From Baseline (n=28)a,b

PD

Maximum % Change From Baseline

20 20
SD
SD SD
PD SD SD
SD SD SD SDc 0
0
SD
SD SD SD SD SD SD
PD SD SD SD SD SD
-20 SD SD SD
SD SD
-20 SD SD SD SD
SD SD
SD SD SD SD
SD SD SD
SD
SD SD SD SD
-40 PRc PRc
-40 PD PR PRd PR PR
PR PR PR
PR PR PR
-60 PR SD PR
PRc PR PR PR
-60 PR PR
PR
-80

-80
-100
PR

Evaluable Patients
Evaluable Patients
• Response rate was 22% (10/45), including 1 unconfirmed PR
• Response rate was 43% (12/28), including 2 unconfirmed PRs
• SD was observed in 64% (29/45) of patients • SD was observed in 57% (16/28) of patients
• Clinical benefit (DCR) was observed in 87% (39/45) of patients • Clinical benefit (DCR) was observed in 100% (28/28) of patients
• No apparent association between response rate and molecular status was shown in an exploratory analysise • No apparent association between response rate and molecular status was shown in an exploratory analysise
aAll
results are based on investigator assessments. bEvaluable population (n=45) excludes 1 patient who withdrew consent prior to the first scan. cPhase 1/1b. dAt the time of the 25 May 2021 data cutoff, the patient had uPR.
eMolecular aAll
results are based on investigator assessments. b Evaluable population (n=28) excludes 4 patients who withdrew consent prior to the first scan. cAt the time of the 9 July 2021 data cutoff, 2 patients had uPRs.
status (BRAF V600E mutation, MSI-H or dMMR, EGFR amplification, TP53 mutation, PIK3CA mutation) includes patients with conclusively evaluable test results.
eMolecular status (BRAF V600E mutation, MSI-H or dMMR, EGFR amplification, TP53 mutation, PIK3CA mutation) includes patients with conclusively evaluable test results.
Data as of 25 May 2021 for monotherapy (median follow-up: 8.9 months).
Data as of 9 July 2021 (median follow-up: 7 months).
Presented at the European Society for Medical Oncology (ESMO) Congress, 18 September 2021
Presented at the European Society for Medical Oncology (ESMO) Congress, 18 Septembe

Weiss et al, ESMO 2021; LBA #6

Adagrasib in advanced CRC: Best Overall Response
Adagrasib alone; N=45 Adagrasib plus cetuximab; N=28

KRYSTAL-1: Adagrasib (MRTX849) KRAS G12C Inhibitor ± Cetuximab in CRC

Adagrasib in Patients W ith Advanced CRC: D uration of Treatm ent

Duration of Treatment (n=45)a
SD
SD
PR
PR
SD Progression
SD
SD First Response
SD
SD Treatment Ongoing
PR b
PR Death
PR c
SD c
SD
SD
SD
SD
Evaluable Patients

SD c
PR c
SD
SD
SD
PD
SD
PR d
PR
PR
PR
SD
SD
SD c
SD
SD
SD • Median DOR was 4.2 months (2.3, 6.9)e
PD
SD
SD
• Median time to response was 1.4 months
SD c
SD d • At time of analysis, 40% (18/45) of patients
SD

PD
SD remain on treatment
PD
PD
PD

0 2 4 6 8 10 12 14 16
Time, months
aAll
results are based on investigator assessments. bAt the time of the 25 May 2021 data cutoff, the patient had uPR. cPatients who crossed over to receive adagrasib + cetuximab. dPhase 1/1b. eMedian duration of response is
based on 9 confirmed responses.
Data as of 25 May 2021 for monotherapy (median follow-up: 8.9 months). Presented at the European Society for Medical Oncology (ESMO) Congress, XX September 2021

Weiss et al, ESMO 2021; LBA #6

 Adagrasib in advanced CRC: Efficacy and TRAE
Adagrasib alone; N=45
KRYSTAL-1: Adagrasib (MRTX849) KRAS G12C Inhibitor ± Cetuximab in CRC

Adagrasib in Patients With Advanced CRC: Progression-Free Survival

Progression-Free Survival (n=46)
100

90

80 Median PFS: 5.6 months (95% CI: 4.1, 8.3)

Progression-Free Survival, %

70

60

50
42%
40

30

20

10
censored
0
0 2 4 6 8 10 12 14
Time, months
Patients at risk: 46 39 31 13 8 3 1 0

Data as of 25 May 2021 for monotherapy (median follow-up: 8.9 months).

Presented at the European Society for Medical Oncology (ESMO) Congress, 18 September 2021

Weiss et al, ESMO 2021; LBA #6

Targeting the MAPK pathway: Downstream inhibition
 Colorectal cancer PDX models

Pancreatic cancer PDX models

SOS1i + MEKi combination

Hofmann et al., AACR 2021 #CT210

 SOS1i + KRAS G12Ci Combination in KRAS G12Cmut CRC PDX models

Hofmann et al., AACR 2021 #CT210

RAS- and TP53 mutations as checkpoint failure promoters

Seligman et al, Oral Abstract Session, ESMO 2021

Courtesy of Pierre Laurent-Puig, Oral Abstract Session, ESMO 2021
Seligman et al, ESMO 2021 #382O
Adavosertib as maintenance tx. in RAS and TP53 mut mCRC

PFS OS

Seligman et al, ESMO 2021 #382O

Adavosertib as maintenance tx. in RAS and TP53 mut mCRC

Seligman et al, ESMO 2021 #382O

Adavosertib in other tumour entities

Courtesy of Pierre Laurent-Puig, Oral Abstract Session, ESMO 2021

 Sensitizing MSS mCRC for immunotherapy

Pietrantonio et al., ESMO 2021 #383O; Cremolini et al., ESMO 2021 # LBS20
Pietrantonio et al., ESMO 2021 #383O
Pietrantonio et al., ESMO 2021 #383O
 TMZ → TMZ/Nivo/Ipi in MSS and MGMT silenenced mCRC

Pietrantonio et al., ESMO 2021 #383O

 TMZ → TMZ/Nivo/Ipi in MSS and MGMT silenenced mCRC

Pietrantonio et al., ESMO 2021 #383O

 TMZ → TMZ/Nivo/Ipi in MSS and MGMT silenenced mCRC

Pietrantonio et al., ESMO 2021 #383O

ATEZO-TRIBE: Sensitizing by increasing chemotherapy efficacy

Cremolini et al., ESMO 2021 # LBS20

Atezo-TRIBE trial: Primary endpoint improved: PFS

Cremolini et al., ESMO 2021 # LBS20

Atezo-TRIBE trial: Subgroups

MSS

MSI

Cremolini et al., ESMO 2021 # LBS20

Summary
• EPOCH trial: PFS improved. TARE is alive. But: More endpoint results needed
• Lessons in applied tumour biology

Trial Preclinical / hypothesis Clinical considerations

Adagrasib Active as single agent and more in Phase I/II, strong signal and good rationale.
in G12c mut up-/downstream combo But small group
Adavosertib „active“ in the given definition Phase II, signal. Relevant subgroup.
in RAS mut/PT53 mut But: maintenance setting only proven
TMZ/Nivo/Ipi Immunoactivation (partly) shown Signal. Small sample here, to be confirmed
in MSS (MGMT silenced)
Atezo-TRIBE Activation of immunogenecity in Can we believe this….?
MSS shown But: randomized data…
Trastuzumab/Deruxtecan Most relevant, likely
in HER2