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SABCS 2023 +
Timothy J. Pluard, MD
Saint Luke’s Koontz Center for Advanced Breast Cancer
PALOMA-2 MONALEESA-2 MONALEESA-7 MONARCH-3
Regimen Letrozole +/- palbociclib
(2:1)
Letrozole +/- ribociclib
(1:1)
Goserelin + AI or tamoxifen
+/- ribociclib (1:1)
AI +/- abemaciclib (2:1)
Eligibility Postmenopausal,
untreated advanced
HR+/HER2- BC
Postmenopausal,
untreated advanced
HR+/HER2- BC
Pre/perimenopausal,
untreated advanced
HR+/HER2- BC
Postmenopausal,
untreated advanced
HR+/HER2- BC
Sample size 666 668 672 493
De novo MBC 38% 34% 41% 20%
Median PFS
(CDK vs. placebo)
27.6 vs. 14.5 months
(HR 0.56; 0.46-0.69)
25.3 vs. 16 months
(HR 0.57; 0.45-0.60)
23.8 vs. 13 months
(HR 0.55; 0.44-069)
29 vs. 14.8
(HR 0.53; 0.42-0.66)
Median OS
(CDK vs. placebo)
53.9 vs. 51.2 months
2.7
(HR 0.96; 0.77-1.17)*
63.9 vs. 51.4 months
12.4
(HR 0.76, 0.63-0.93)
58.7 vs. 48 months
10.7
(HR 0.76; 0.60-0.95)
66.8 vs 53.7 months
0.804 (0.637-1.015)
Toxicities of interest Neutropenia, leukopenia,
fatigue
Neutropenia, leukopenia,
fatigue, QTc prolongation,
transaminitis
Neutropenia, leukopenia,
fatigue, nausea, QTc
prolongation, transaminitis
Neutropenia, fatigue,
diarrhea, nausea, anemia,
abdominal pain
Randomized phase III trials of CDK4/6 inhibitors in the first line setting
Final OS SABCS 2023
ER + MBC 1L
Endocrine Resistance
• Primary Resistance
• Relapse on adjuvant endocrine therapy(ET) in first 2 years
• Progression with first 6 months on 1L ET therapy for MBC
• Secondary Resistance
• Relapse on adjuvant ET after 2 years or within 12 mos of completing adj ET
• Progression > 6 after starting 1L ET for MBC
HR+ 2L Treatment after ET + CDK 4/6i
• Fulvestrant alone after 1L AI+ CDK 4/6 limited benefit (3-5 mos)
• Switching ET and continuing CDK4/6:
• MAINTAIN: 2L: Fulvestrant(83%) or everolimus(17%) +/- ribociclib
• 84% of patients had AI + Palbociclib 1L
• 67% of patients had 1L CDK > 12 months
• mPFS ET+CDK 5.3 vs 2.8 mos
Precision Oncology in 2L HR+ MBC
Alteration Frequency Therapy Comments
ESR1 Mutation ~40% Elacestrant Acquired (after AI)
PIK3CA 30-40% Alpelisib,
Capivasertib
Inavolisib
Inavolisib not yet
approved
AKT mutation ~ 3-4% Capivasetib
PTEN LOF ~4-5% Capivasetib
BRCA1, BRCA2, PALB2 Olaparib,
Talozoparib
Germline or
somatic
HER2 Kinase Mutant ~4% Neratinib/Herceptin 6-7% in ILC
PI3K Pathway in Breast Cancer
everolimus
alpelisib
x
x
Targeting The Pi3k Pathway in HR+ MBC
SOLAR 1: PFS in PI3K-mutated breast cancer
Andre et al N Engl J Med 2019
This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute
11.0 mos
5.7 mos
SOLAR 1: Alpelisib Toxicity
• Hyperglycemia
• 2/3 of patients; 1/3 G3/4
• Rash
• 58%
• Diarrhea
• 58%
• Discontinuation d/t toxicity
• 25%
PI3K Pathway in Breast Cancer
everolimus
alpelisib
x
x
capivasertib
x
This presentation is the intellectual property of the author/presenter. Contact them at
This presentation is the intellectual property of the author/presenter. Contact them at permission to reprint and/or
distribute
Dual-primary endpoint
Turner, SABCS 2022
San Antonio Breast Cancer Symposium – December 5-9, 2023
PFS in overall population
This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute.
PFS in altered population
TNBC
San Antonio Breast Cancer Symposium – December 5-9, 2023
BEGONIA Arm 7: Dato-DXd + Durvalumab
Kaplan-Meier analysis was performed. Circles indicate censored observations.
CI, confidence interval; Dato-DXd, datopotamab deruxtecan; DoR, duration of response; NC, not calculable; PFS, progression-free survival.
Number of patients at risk
Durva +
Dato-DXd
62 61 56 55 54 52 45 40 37 32 24 23 18 18 14 13 13 2 2 0
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
Probability
of
progression-free
survival
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Time from first dose date (months)
Durva + Dato-DXd (N=62)
Durva + Dato-DXd (N=62)
Number of patients at risk
Durva +
Dato-DXd
49 49 49 47 46 42 35 30 28 21 18 17 17 13 13 12 1 1 0
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
Duration
and
onset
of
objective
response
This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute.
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Time from first dose date (months)
Schmid, et al. ESMO 2023
San Antonio Breast Cancer Symposium – December 5-9, 2023
Antitumour Responses in 1L a/mTNBC
(n=62)
Confirmed ORR was 79% (49/62; 95% CI, 66.8–88.3) with 6 CR and 43
PR Antitumor responses were observed regardless of PD-L1 expression
level as assessed by 2 separate PD-L1 assays and scoring methods
Median PFS was 13.8 months (95% CI, 11.0–NC) Median DoR was 15.5 months (95% CI, 9.92–NC)
HER2-Positive
San Antonio Breast Cancer Symposium – December 5-9, 2023
HER2 Targeted Drugs
Trastuzumab
Pertuzumab
Margetuximab TDM1
T-Deruxtecan
This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute.
Lapatinib
Neratinib
Tucatinib
San Antonio Breast Cancer Symposium – December 5-9, 2023
Primary Results From a Phase 2a Study of Zanidatamab in
Combination With Palbociclib Plus Fulvestrant in HER2+ HR+
Metastatic Breast Cancer
Santiago Escrivá-de-Romani,1,* Juan M. Cejalvo,2 Emilio Alba,3,4 Jennifer Friedmann,5 Álvaro Rodríguez Lescure,6 Marie-France Savard,7
Rossanna C. Pezo,8 Maria Gion,9 Manuel Ruiz-Borrego,10 Erika Hamilton,11 Timothy Pluard,12 Marc Webster,13 Muralidhar Beeram,14 Hannah Linden,15 Cristina Saura,1
Diana Shpektor,16 Bob Salim,17 Phoebe Harvey,17 Sara Hurvitz15
*Primary/Presenting Author
1Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain; 2Hospital Clínico Universitario de Valencia, Valencia, Spain; 3Hospital Regional Universitario y Virgen de la Victoria, Málaga, Andalucía, Spain;
4Centro de Investigación Biomédica en Red de Oncología, CIBERONC, Madrid, Spain; 5Jewish General Hospital, Montreal, QC, Canada; 6Hospital General Universitario de Elche, Elche, Alicante, Spain; 7The Ottawa Hospital Cancer Centre, Ottawa,
ON, Canada; 8Sunnybrook Health Sciences Centre, Toronto, ON, Canada; 9Hospital Ruber Internacional, Madrid, Spain, Hospital Universitario Ramón y Cajal, Madrid, Spain; 10Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain;
11Sarah Cannon Research Institute (SCRI)/Tennessee Oncology, Nashville, TN, USA; 12Saint Luke’s Cancer Institute, University of Missouri, Kansas City, MO, USA; 13Tom Baker Cancer Centre, Calgary, AB, Canada; 14South Texas Accelerated
Research Therapeutics (START), San Antonio, TX, USA; 15University of Washington, Fred Hutchinson Cancer Center, Seattle, WA, USA; 16Zymeworks Inc, Vancouver, BC, Canada; 17Jazz Pharmaceuticals, Palo Alto, CA, USA.
This presentation is the intellectual property of the author/presenter. Contact them at sescriva@vhio.net for permission to reprint and/or distribute
Background and Objective
This presentation is the intellectual property of the author/presenter. Contact them at sescriva@vhio.net for permission to reprint and/or distribute
 Prior studies with a HER2-targeting agent combined with an ER
antagonist with or without a CDK 4/6 inhibitor have shown
clinical benefit in patients with HER2+ HR+ mBC1,2
 Zanidatamab is a bispecific antibody that simultaneously binds
two non-overlapping extracellular domains of HER2 (biparatopic
binding) leading to3:
• Receptor crosslinking, clustering, internalization, and
downregulation
• Inhibition of tumor cell signaling and proliferation by
preventing HER2 dimerization
• Immune-mediated antitumor effects including
antibody-dependent cellular cytotoxicity and phagocytosis,
and complement-dependent cytotoxicity
1. Tolaney SM, et al. Lancet Oncol. 2020;21(6):763-775. 2. Ciruelos E, et al. Clin Cancer Res. 2020;26(22):5820-5829. 3. Weisser NE, et al. Nat Commun. 2023;14(1):1394.
Objective: To evaluate the safety and efficacy of zanidatamab in combination with palbociclib
(CDK4/6 inhibitor) plus fulvestrant (ER antagonist) in HER2+ HR+ mBC
Zanidatamab binding to HER23
This presentation is the intellectual property of the author/presenter. Contact them at sescriva@vhio.net for permission to reprint and/or distribute
*Indicates patients with unconfirmed partial responses. Dotted lines indicate -30% and +20% change in tumor size.
aAll patients received prior trastuzumab and taxane.
San Antonio Breast Cancer Symposium®, December 5-9, 2023
Efficacy of Treatment by Best Overall Response (All Patients)
* * * *
*
Best Overall Response:
cPR SD
cCR PD
Percent
change
from
baseline
in
sum
of
diameters
60
40
20
0
-20
-40
-60
-80
-100
Central IHC
PAM50
Prior HER2
Trta
1+
-
DP
X
3+
+
LB
DPC
X
-
1+
DP
+
2+
HE
DPC
+
2+
HE
DPC
X
+
2+
DPC
X
HE
1+
DPC
+
2+
DP
L
+
2+
LB
PC
LN
-
2+
LB
DP DP
1+
HE
DL
X
-
2+
DP
+
2+
DPC
+
3+
DL
-
0
DP
L
+
1+
DP
+
2+
HE
DPC
2+
DL
+
3+
HE
DP
-
1+
LB
DPC
-
1+
LB
DP
-
2+
HE
DP
+
2+
DPC
N
+
3+
HE
DP
L
-
0
HE
DPX
+
3+
HE
DPC
+
3+
HE
DPC
M
-
2+
LB
DPX
+
2+
LB
DL
+
3+
DP
+
3+
DP
+
3+
HE
DP
L
+
2+
HE
DL
X
2+
LB
D
-
2+
DP
-
3+
DP
+
3+
DP
+
3+
DP
+
2+
DP
+
2+
HE
DP
+
3+
LB
DX
+
3+
D
+
3+
D
+
3+
DP
+
2+
HE
DP
Prior HER2 trta:C, tucatinib; D, T-DM1; L, lapatinib; M, margetuximab; N, neratinib; P, pertuzumab; X, T-DXd.
PAM50 subtype: HE, HER2-enriched; LB, luminal B.
*
Central FISH
LB
Prior fulv Y Y Y Y Y Y Y Y Y
HER2CLIMB-02: Primary Analysis of a Randomized, Double-blind
Phase 3 Trial of Tucatinib and Trastuzumab Emtansine for
Previously Treated HER2-positive Metastatic Breast Cancer
Sara A. Hurvitz, MD
Fred Hutchinson Cancer Center, Seattle, WA, USA
Sherene Loi, Joyce O’Shaughnessy, Alicia F. C. Okines, Sara M. Tolaney, Joohyuk Sohn, Cristina Saura, Xiaofu Zhu, David Cameron, Thomas Bachelot,
Erika P. Hamilton, Giuseppe Curigliano, Antonio C. Wolff, Nadia Harbeck, Norikazu Masuda, Linda Vahdat, Khalil Zaman, Frances Valdes-Albini, Margaret Block,
Timothy Pluard, Tira J. Tan, Chelsea D. Gawryletz, Arlene Chan, Philippe L. Bedard, Rinat Yerushalmi, Binghe Xu, Konstantinos Tryfonidis, Michael Schmitt, Diqiong
Xie, Virginia F. Borges
This presentation is the intellectual property of the author/presenter. Contact them at shurvitz@fredhutch.org for permission to reprint and/or distribute
HER2CLIMB-02 Study Design
NCT03975647. https://www.clinicaltrials.gov/study/NCT03975647. Accessed Oct 5, 2023.
a Patients who received prior tucatinib, afatinib, T-DXd, or any investigational anti-HER2, anti-EGFR, or HER2 TKIs were not eligible. Patients who received lapatinib and neratinib were not eligible if the drugs were received within 12 months of starting study
treatment, and patients who received pyrotinib for recurrent or metastatic breast cancer were not eligible. These patients were eligible if the drugs were given for ≤21 days and were discontinued for reasons other than disease progression or severe toxicity. b
Subsequent OS analyses are planned upon 80% and 100% of required events for the final OS analysis.
1L, first-line; BID, twice daily; cORR, confirmed objective response rate; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenously; LA/MBC, locally advanced or metastatic breast cancer; OS, overall survival; PFS, progression-
free survival; PO, orally; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; TKIs, tyrosine kinase inhibitors.
Date of data cutoff: Jun 29, 2023. Patients were enrolled from Oct 8, 2019, to Jun 16, 2022.
The primary analysis for PFS was planned after ≈331 PFS events to provide 90% power for hazard ratio of 0.7 at two-sided alpha level of 0.05.
The first of two interim analysis for OS was planned at the time of the primary PFS analysis, if the PFS result was significantly positive.b
• HER2+ LA/MBC
with progression after
trastuzumab and
taxane in any
settinga
• ECOG PS ≤1
• Previously treated
stable, progressing,
or untreated brain
metastases not
requiring immediate
local therapy
T-DM1 + Tucatinib
T-DM1 3.6 mg/kg IV and tucatinib 300
mg PO BID
T-DM1 + Placebo
T-DM1 3.6 mg/kg IV and Placebo PO
BID
Outcomes
Primary
•PFS by investigator assessment per
RECIST v1.1
Key Secondary (hierarchical)
•OS
•PFS in patients with brain
metastases
•cORR per RECIST v1.1
•OS in patients with brain metastases
N≈460 R
1:1
Hurvitz S, et al. SABCS 2023
This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute.
Stratification factors:
• Line of treatment for
metastatic disease (1L vs
other)
• Hormone receptor status
(positive vs negative)
• Presence or history of brain
metastases (yes vs no)
• ECOG PS (0 vs 1)
San Antonio Breast Cancer Symposium – December 5-9, 2023
Progression-Free Survival
HR, hazard ratio; PFS, progression-free survival; T-DM1, trastuzumab
emtansine. Date of data cutoff: Jun 29, 2023.
T-DM1 + Tucatinib
(N=228)
T-DM1 + Placebo
(N=235)
# of events 151 182
Median PFS (95% CI)
9.5 months (7.4, 10.9) 7.4 months (5.6, 8.1)
HR (95% CI): 0.76 (0.61, 0.95)
P=0.0163
Confirmed Objective
Response 42% vs 36.1%
San Antonio Breast Cancer Symposium – December 5-9, 2023
T-DM1 + Tucatinib
(N=99)
T-DM1 + Placebo
(N=105)
# of events 70 85
Median PFS (95%
CI)
7.8 months (6.7, 10.0) 5.7 months (4.6, 7.5)
HR (95% CI)a: 0.64 (0.46, 0.89)
Hurvitz S, et al. SABCS 2023
This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute.
PFS in Patients with Brain Metastases
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight on the Latest in MBC
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight on the Latest in MBC

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Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight on the Latest in MBC

  • 1. SABCS 2023 + Timothy J. Pluard, MD Saint Luke’s Koontz Center for Advanced Breast Cancer
  • 2. PALOMA-2 MONALEESA-2 MONALEESA-7 MONARCH-3 Regimen Letrozole +/- palbociclib (2:1) Letrozole +/- ribociclib (1:1) Goserelin + AI or tamoxifen +/- ribociclib (1:1) AI +/- abemaciclib (2:1) Eligibility Postmenopausal, untreated advanced HR+/HER2- BC Postmenopausal, untreated advanced HR+/HER2- BC Pre/perimenopausal, untreated advanced HR+/HER2- BC Postmenopausal, untreated advanced HR+/HER2- BC Sample size 666 668 672 493 De novo MBC 38% 34% 41% 20% Median PFS (CDK vs. placebo) 27.6 vs. 14.5 months (HR 0.56; 0.46-0.69) 25.3 vs. 16 months (HR 0.57; 0.45-0.60) 23.8 vs. 13 months (HR 0.55; 0.44-069) 29 vs. 14.8 (HR 0.53; 0.42-0.66) Median OS (CDK vs. placebo) 53.9 vs. 51.2 months 2.7 (HR 0.96; 0.77-1.17)* 63.9 vs. 51.4 months 12.4 (HR 0.76, 0.63-0.93) 58.7 vs. 48 months 10.7 (HR 0.76; 0.60-0.95) 66.8 vs 53.7 months 0.804 (0.637-1.015) Toxicities of interest Neutropenia, leukopenia, fatigue Neutropenia, leukopenia, fatigue, QTc prolongation, transaminitis Neutropenia, leukopenia, fatigue, nausea, QTc prolongation, transaminitis Neutropenia, fatigue, diarrhea, nausea, anemia, abdominal pain Randomized phase III trials of CDK4/6 inhibitors in the first line setting Final OS SABCS 2023 ER + MBC 1L
  • 3. Endocrine Resistance • Primary Resistance • Relapse on adjuvant endocrine therapy(ET) in first 2 years • Progression with first 6 months on 1L ET therapy for MBC • Secondary Resistance • Relapse on adjuvant ET after 2 years or within 12 mos of completing adj ET • Progression > 6 after starting 1L ET for MBC
  • 4. HR+ 2L Treatment after ET + CDK 4/6i • Fulvestrant alone after 1L AI+ CDK 4/6 limited benefit (3-5 mos) • Switching ET and continuing CDK4/6: • MAINTAIN: 2L: Fulvestrant(83%) or everolimus(17%) +/- ribociclib • 84% of patients had AI + Palbociclib 1L • 67% of patients had 1L CDK > 12 months • mPFS ET+CDK 5.3 vs 2.8 mos
  • 5. Precision Oncology in 2L HR+ MBC Alteration Frequency Therapy Comments ESR1 Mutation ~40% Elacestrant Acquired (after AI) PIK3CA 30-40% Alpelisib, Capivasertib Inavolisib Inavolisib not yet approved AKT mutation ~ 3-4% Capivasetib PTEN LOF ~4-5% Capivasetib BRCA1, BRCA2, PALB2 Olaparib, Talozoparib Germline or somatic HER2 Kinase Mutant ~4% Neratinib/Herceptin 6-7% in ILC
  • 6. PI3K Pathway in Breast Cancer everolimus alpelisib x x
  • 7. Targeting The Pi3k Pathway in HR+ MBC
  • 8. SOLAR 1: PFS in PI3K-mutated breast cancer Andre et al N Engl J Med 2019 This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute 11.0 mos 5.7 mos
  • 9. SOLAR 1: Alpelisib Toxicity • Hyperglycemia • 2/3 of patients; 1/3 G3/4 • Rash • 58% • Diarrhea • 58% • Discontinuation d/t toxicity • 25%
  • 10. PI3K Pathway in Breast Cancer everolimus alpelisib x x capivasertib x
  • 11. This presentation is the intellectual property of the author/presenter. Contact them at This presentation is the intellectual property of the author/presenter. Contact them at permission to reprint and/or distribute
  • 12. Dual-primary endpoint Turner, SABCS 2022 San Antonio Breast Cancer Symposium – December 5-9, 2023 PFS in overall population This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute. PFS in altered population
  • 13. TNBC San Antonio Breast Cancer Symposium – December 5-9, 2023
  • 14. BEGONIA Arm 7: Dato-DXd + Durvalumab Kaplan-Meier analysis was performed. Circles indicate censored observations. CI, confidence interval; Dato-DXd, datopotamab deruxtecan; DoR, duration of response; NC, not calculable; PFS, progression-free survival. Number of patients at risk Durva + Dato-DXd 62 61 56 55 54 52 45 40 37 32 24 23 18 18 14 13 13 2 2 0 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 Probability of progression-free survival 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Time from first dose date (months) Durva + Dato-DXd (N=62) Durva + Dato-DXd (N=62) Number of patients at risk Durva + Dato-DXd 49 49 49 47 46 42 35 30 28 21 18 17 17 13 13 12 1 1 0 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 Duration and onset of objective response This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute. 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Time from first dose date (months) Schmid, et al. ESMO 2023 San Antonio Breast Cancer Symposium – December 5-9, 2023 Antitumour Responses in 1L a/mTNBC (n=62) Confirmed ORR was 79% (49/62; 95% CI, 66.8–88.3) with 6 CR and 43 PR Antitumor responses were observed regardless of PD-L1 expression level as assessed by 2 separate PD-L1 assays and scoring methods Median PFS was 13.8 months (95% CI, 11.0–NC) Median DoR was 15.5 months (95% CI, 9.92–NC)
  • 15. HER2-Positive San Antonio Breast Cancer Symposium – December 5-9, 2023
  • 16. HER2 Targeted Drugs Trastuzumab Pertuzumab Margetuximab TDM1 T-Deruxtecan This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute. Lapatinib Neratinib Tucatinib San Antonio Breast Cancer Symposium – December 5-9, 2023
  • 17. Primary Results From a Phase 2a Study of Zanidatamab in Combination With Palbociclib Plus Fulvestrant in HER2+ HR+ Metastatic Breast Cancer Santiago Escrivá-de-Romani,1,* Juan M. Cejalvo,2 Emilio Alba,3,4 Jennifer Friedmann,5 Álvaro Rodríguez Lescure,6 Marie-France Savard,7 Rossanna C. Pezo,8 Maria Gion,9 Manuel Ruiz-Borrego,10 Erika Hamilton,11 Timothy Pluard,12 Marc Webster,13 Muralidhar Beeram,14 Hannah Linden,15 Cristina Saura,1 Diana Shpektor,16 Bob Salim,17 Phoebe Harvey,17 Sara Hurvitz15 *Primary/Presenting Author 1Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain; 2Hospital Clínico Universitario de Valencia, Valencia, Spain; 3Hospital Regional Universitario y Virgen de la Victoria, Málaga, Andalucía, Spain; 4Centro de Investigación Biomédica en Red de Oncología, CIBERONC, Madrid, Spain; 5Jewish General Hospital, Montreal, QC, Canada; 6Hospital General Universitario de Elche, Elche, Alicante, Spain; 7The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; 8Sunnybrook Health Sciences Centre, Toronto, ON, Canada; 9Hospital Ruber Internacional, Madrid, Spain, Hospital Universitario Ramón y Cajal, Madrid, Spain; 10Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain; 11Sarah Cannon Research Institute (SCRI)/Tennessee Oncology, Nashville, TN, USA; 12Saint Luke’s Cancer Institute, University of Missouri, Kansas City, MO, USA; 13Tom Baker Cancer Centre, Calgary, AB, Canada; 14South Texas Accelerated Research Therapeutics (START), San Antonio, TX, USA; 15University of Washington, Fred Hutchinson Cancer Center, Seattle, WA, USA; 16Zymeworks Inc, Vancouver, BC, Canada; 17Jazz Pharmaceuticals, Palo Alto, CA, USA. This presentation is the intellectual property of the author/presenter. Contact them at sescriva@vhio.net for permission to reprint and/or distribute
  • 18. Background and Objective This presentation is the intellectual property of the author/presenter. Contact them at sescriva@vhio.net for permission to reprint and/or distribute  Prior studies with a HER2-targeting agent combined with an ER antagonist with or without a CDK 4/6 inhibitor have shown clinical benefit in patients with HER2+ HR+ mBC1,2  Zanidatamab is a bispecific antibody that simultaneously binds two non-overlapping extracellular domains of HER2 (biparatopic binding) leading to3: • Receptor crosslinking, clustering, internalization, and downregulation • Inhibition of tumor cell signaling and proliferation by preventing HER2 dimerization • Immune-mediated antitumor effects including antibody-dependent cellular cytotoxicity and phagocytosis, and complement-dependent cytotoxicity 1. Tolaney SM, et al. Lancet Oncol. 2020;21(6):763-775. 2. Ciruelos E, et al. Clin Cancer Res. 2020;26(22):5820-5829. 3. Weisser NE, et al. Nat Commun. 2023;14(1):1394. Objective: To evaluate the safety and efficacy of zanidatamab in combination with palbociclib (CDK4/6 inhibitor) plus fulvestrant (ER antagonist) in HER2+ HR+ mBC Zanidatamab binding to HER23
  • 19. This presentation is the intellectual property of the author/presenter. Contact them at sescriva@vhio.net for permission to reprint and/or distribute *Indicates patients with unconfirmed partial responses. Dotted lines indicate -30% and +20% change in tumor size. aAll patients received prior trastuzumab and taxane. San Antonio Breast Cancer Symposium®, December 5-9, 2023 Efficacy of Treatment by Best Overall Response (All Patients) * * * * * Best Overall Response: cPR SD cCR PD Percent change from baseline in sum of diameters 60 40 20 0 -20 -40 -60 -80 -100 Central IHC PAM50 Prior HER2 Trta 1+ - DP X 3+ + LB DPC X - 1+ DP + 2+ HE DPC + 2+ HE DPC X + 2+ DPC X HE 1+ DPC + 2+ DP L + 2+ LB PC LN - 2+ LB DP DP 1+ HE DL X - 2+ DP + 2+ DPC + 3+ DL - 0 DP L + 1+ DP + 2+ HE DPC 2+ DL + 3+ HE DP - 1+ LB DPC - 1+ LB DP - 2+ HE DP + 2+ DPC N + 3+ HE DP L - 0 HE DPX + 3+ HE DPC + 3+ HE DPC M - 2+ LB DPX + 2+ LB DL + 3+ DP + 3+ DP + 3+ HE DP L + 2+ HE DL X 2+ LB D - 2+ DP - 3+ DP + 3+ DP + 3+ DP + 2+ DP + 2+ HE DP + 3+ LB DX + 3+ D + 3+ D + 3+ DP + 2+ HE DP Prior HER2 trta:C, tucatinib; D, T-DM1; L, lapatinib; M, margetuximab; N, neratinib; P, pertuzumab; X, T-DXd. PAM50 subtype: HE, HER2-enriched; LB, luminal B. * Central FISH LB Prior fulv Y Y Y Y Y Y Y Y Y
  • 20. HER2CLIMB-02: Primary Analysis of a Randomized, Double-blind Phase 3 Trial of Tucatinib and Trastuzumab Emtansine for Previously Treated HER2-positive Metastatic Breast Cancer Sara A. Hurvitz, MD Fred Hutchinson Cancer Center, Seattle, WA, USA Sherene Loi, Joyce O’Shaughnessy, Alicia F. C. Okines, Sara M. Tolaney, Joohyuk Sohn, Cristina Saura, Xiaofu Zhu, David Cameron, Thomas Bachelot, Erika P. Hamilton, Giuseppe Curigliano, Antonio C. Wolff, Nadia Harbeck, Norikazu Masuda, Linda Vahdat, Khalil Zaman, Frances Valdes-Albini, Margaret Block, Timothy Pluard, Tira J. Tan, Chelsea D. Gawryletz, Arlene Chan, Philippe L. Bedard, Rinat Yerushalmi, Binghe Xu, Konstantinos Tryfonidis, Michael Schmitt, Diqiong Xie, Virginia F. Borges This presentation is the intellectual property of the author/presenter. Contact them at shurvitz@fredhutch.org for permission to reprint and/or distribute
  • 21. HER2CLIMB-02 Study Design NCT03975647. https://www.clinicaltrials.gov/study/NCT03975647. Accessed Oct 5, 2023. a Patients who received prior tucatinib, afatinib, T-DXd, or any investigational anti-HER2, anti-EGFR, or HER2 TKIs were not eligible. Patients who received lapatinib and neratinib were not eligible if the drugs were received within 12 months of starting study treatment, and patients who received pyrotinib for recurrent or metastatic breast cancer were not eligible. These patients were eligible if the drugs were given for ≤21 days and were discontinued for reasons other than disease progression or severe toxicity. b Subsequent OS analyses are planned upon 80% and 100% of required events for the final OS analysis. 1L, first-line; BID, twice daily; cORR, confirmed objective response rate; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenously; LA/MBC, locally advanced or metastatic breast cancer; OS, overall survival; PFS, progression- free survival; PO, orally; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; TKIs, tyrosine kinase inhibitors. Date of data cutoff: Jun 29, 2023. Patients were enrolled from Oct 8, 2019, to Jun 16, 2022. The primary analysis for PFS was planned after ≈331 PFS events to provide 90% power for hazard ratio of 0.7 at two-sided alpha level of 0.05. The first of two interim analysis for OS was planned at the time of the primary PFS analysis, if the PFS result was significantly positive.b • HER2+ LA/MBC with progression after trastuzumab and taxane in any settinga • ECOG PS ≤1 • Previously treated stable, progressing, or untreated brain metastases not requiring immediate local therapy T-DM1 + Tucatinib T-DM1 3.6 mg/kg IV and tucatinib 300 mg PO BID T-DM1 + Placebo T-DM1 3.6 mg/kg IV and Placebo PO BID Outcomes Primary •PFS by investigator assessment per RECIST v1.1 Key Secondary (hierarchical) •OS •PFS in patients with brain metastases •cORR per RECIST v1.1 •OS in patients with brain metastases N≈460 R 1:1 Hurvitz S, et al. SABCS 2023 This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute. Stratification factors: • Line of treatment for metastatic disease (1L vs other) • Hormone receptor status (positive vs negative) • Presence or history of brain metastases (yes vs no) • ECOG PS (0 vs 1) San Antonio Breast Cancer Symposium – December 5-9, 2023
  • 22. Progression-Free Survival HR, hazard ratio; PFS, progression-free survival; T-DM1, trastuzumab emtansine. Date of data cutoff: Jun 29, 2023. T-DM1 + Tucatinib (N=228) T-DM1 + Placebo (N=235) # of events 151 182 Median PFS (95% CI) 9.5 months (7.4, 10.9) 7.4 months (5.6, 8.1) HR (95% CI): 0.76 (0.61, 0.95) P=0.0163 Confirmed Objective Response 42% vs 36.1% San Antonio Breast Cancer Symposium – December 5-9, 2023 T-DM1 + Tucatinib (N=99) T-DM1 + Placebo (N=105) # of events 70 85 Median PFS (95% CI) 7.8 months (6.7, 10.0) 5.7 months (4.6, 7.5) HR (95% CI)a: 0.64 (0.46, 0.89) Hurvitz S, et al. SABCS 2023 This presentation is the intellectual property of the presenter. Contact mchavez1@mdanderson.org for permission to reprint and/or distribute. PFS in Patients with Brain Metastases

Editor's Notes

  1. Abbreviations: CDK, cyclin-dependent kinase; ER, estrogen receptor; HER2+, human epidermal growth factor receptor 2-positive; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mBC, metastatic breast cancer.
  2. Abbreviations: C, tucatinib; cCR, confirmed complete response; D, T-DM1; Fulv, fulvestrant; HE, HER2-enriched; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; FISH, fluorescence in situ hybridization; L, lapatinib; LB, luminal B; M, margetuximab; N, neratinib; P, pertuzumab; PAM50, Prediction Analysis of Microarray 50; cPR, confirmed partial response; PD, progressive disease; SD, stable disease; T-DM1, ado-trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; Trt, treatment; X, T-DXd; Y, yes.