Report Back from San Antonio Breast Cancer Symposium: Spotlight on MBC

Report Back from San
Antonio Breast Cancer
Symposium: Spotlight on
MBC
Virginia Kaklamani, MD DSc
Professor of Medicine
Leader, Breast Oncology Program
Associate Director Clinical Research

Topics
• HR positive breast cancer
– CDK4/6 inhibitors
– Oral SERDs
• New chemotherapy agents
• HER2 positive breast cancer
– Novel agents

CDK4/6 inhibitors in MBC
OS
benefit

San Antonio Breast Cancer Symposium®, December 10-14, 2019
This presentation is the intellectual property of the author/presenter. Contact them at secretaria-cientifica@geicam.org for permission to reprint and/or distribute
Study Design (Cohort 1, initial design)
Treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent
Exemestane 25 mg daily +
Palbociclib 125 mg 3 weeks on/1 week off, q
28-days
N=300
*NSAI: Non-Steroidal Aromatase Inhibitor
R
A
N
D
O
M
I
Z
A
T
I
O
N
Stratification:
visceral vs non visceral
metastases
prior sensitivity to
hormonal treatment (yes
vs no)
prior chemotherapy for
MBC (yes vs no)
 country
1:1
Capecitabine 1250 mg/m2 (1000 mg/m2 in
patients >70 years old) twice daily
2 weeks on/1 week off, q 21-days
HR+/HER2- MBC
recurrence on or within 12m
of completed adjuvant NSAIs
or progression while on or
within 1m of completing
NSAIs for advanced disease
one line of chemo for MBC
allowed
no prior capecitabine or
exemestane for MBC

Study Design (Cohort 2)
Treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent
Fulvestrant 500 mg (days 1 & 15 of cycle 1
and then once every 28 days) +
Palbociclib 125 mg 3 weeks on/1 week off, q
28-days
patients aged >70 years) twice daily for 2
weeks followed by 1 week off, in 21-day
cycles
patients >70 years old) twice daily
2 weeks on/1 week off, q 21-days
1:1
R
A
N
D
O
M
I
Z
A
T
I
O
N
HR+/HER2- MBC
recurrence on or within 12m
of completed adjuvant AIs
or progression while on or
within 1m of completing AIs
for advanced disease
one line of chemo for MBC
allowed
no prior capecitabine or
fulvestrant for MBC
N=300
Stratification:
visceral vs non visceral
metastases
prior sensitivity to
hormonal treatment (yes
vs no)
prior chemotherapy for
MBC (yes vs no)
 country

Median follow-up 17.64 months
ET + PAL CAP
N=302 N=299
Events, n (%) 236 (78.1) 203 (67.9)
Censored, n (%) 66 (21.9) 96 (32.1)
Median PFS, months (95% CI) 7.4 (5.9, 9.3) 9.4 (7.5, 11.3)
Adjusted Hazard Ratio (95% CI) 1.09 (0.90, 1.31)
Adjusted p-value (Cox) 0.380
The adjusted hazard ratio was obtained using a stratified Cox proportional hazard model with treatment arm and the stratification factors as covariates
Secondary Objective: PFS Cohort 1 + Cohort 2 (N=601)

Safety
EXE + PAL FUL + PAL CAP
N=150 N = 149 N=289
Adverse Events, n (%) 147 (98.0) 148 (99.3) 286 (99.0)
Related 133 (88.7) 128 (85.9) 275 (95.2)
Leading to Study Drug Discontinuation 3 (2.0) 8 (5.4) 37 (12.8)
Most frequent related adverse events of grade ≥ 3 according to NCI-CTCAE vs 4.0
Neutrophil count decreased 86 (57.3) 83 (55.7) 16 (5.5)
Febrile neutropenia 2 (1.3) 1 (0.7) 4 (1.4)
Palmar-plantar erythrodysesthesia syndrome 0 0 68 (23.5)
Diarrhea 2 (1.3) 2 (1.3) 22 (7.6)
Fatigue 2 (1.3) 1 (0.7) 16 (5.5)
Anemia 1 (0.7) 3 (2.0) 10 (3.5)
Serious Adverse Events, n (%) 24 (16.0) 19 (12.8) 63 (21.8)
Related 6 (4.0) 5 (3.4) 30 (10.4)
Leading to Study Drug Discontinuation 5 (3.3) 2 (1.3) 12 (4.2)
On study treatment deaths*, n (%) 2 (1.3) 5 (3.4) 5 (1.7)
Related 0 0 3 (1.0)
*Deaths within 30 days of last dose

Conclusions
• Hormone therapy combination as good as
chemotherapy
• With very rare exceptions women with ER+
MBC should be receiving CDK4/6 inhibitor
before they receive chemotherapy
Footer

Final analysis of phase 1 study of elacestrant
(RAD1901), a novel selective estrogen receptor
degrader (SERD), in estrogen receptor positive
(ER+), human epidermal growth factor receptor 2
negative (HER2-) advanced breast cancer
Virginia Kaklamani1, Aditya Bardia2, Sharon Wilks3, Amy Weise4, Donald Richards5, Wael
Harb6, Cynthia Osborne7, Robert Wesolowski8, Meghan Karuturi9, Paul Conkling10, Rebecca
G. Bagley11, JungAh Jung11, Teeru Bihani11, Maureen G. Conlan11, Peter Kabos12
1University of Texas Health Sciences Center, Houston, TX; 2Massachusetts General Hospital Cancer Center, Boston, MA;
3Texas Oncology-San Antonio, US Oncology Research, San Antonio, TX; 4Barbara Ann Karmanos Cancer Center, Detroit, MI;
5Texas Oncology-Tyler, US Oncology Research, Tyler, TX; 6Horizon Oncology Center, Lafayette, IN; 7Texas Oncology-Baylor
Charles A. Sammons Cancer Center; Dallas, TX; 8Ohio State University Comprehensive Cancer Center, Columbus, OH; 9MD
Anderson Cancer Center, Houston, TX; 10Virginia Oncology Associates, US Oncology Research, Norfolk, VA;
11Radius Health, Inc., Waltham, MA; 12University of Colorado, Aurora, CO

Conclusions
• New class of agents which you may be seeing
in clinic in the next 2 years
Footer

This presentation is the intellectual property of the presenter. Contact Dr. Gerardo Umanzor at gerardumanzor@gmail.com for permission to reprint and/or distribute.
13
*360 Evaluable Patients
OPE (n=240)
IV Paclitaxel (n=120)
80% power, 15% difference
in confirmed RR (P=0.045)
1-3 4-6 7-9 10-12 13-15 16-18 19a 20,21 22 23,24 25+
Study Design
aIf first response at week 19, then week 22 scan obtained; bDefined as last patient, last scan; bComputer-generated algorithm assigning overall response.
CR, complete response; mITT, modified intent-to-treat; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST v1.1, Response Evaluation Criteria
in Solid Tumors version 1.1; RR, response rate.
OPE
OPE:IV Paclitaxel,
2:1 randomization
Evaluable
N=360*
Baseline
IV P
Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6
Treatment Period
(weeks)
Extension Period
(weeks)
Imaginga
(optional)
Primary Endpoint
Final Analysisb
Cycle 7 Cycle 8 Cycle 9+
Primary Objectives
• Efficacy Endpoint (Prespecified mITT Population)
Confirmed tumor response by week 19a
• 2 consecutive scans of PR/CR using RECIST v1.1
• Blinded and adjudicated central independent reviewc
• Safety and Tolerability (Safety Population)
Secondary Objectives
• PFS
• OS

14
Primary Endpoint in Prespecified mITT Population (Final Analysis):
OPE Increased Confirmed RR Compared to IV Paclitaxel
Tumor Evaluations OPE
IV
Paclitaxel
Stable disease, % 23.8 39.2
Progressive disease, % 16.2 21.6
aITT analysis of the primary endpoint is also significant.
Confirmed Response Ratea
P =0.005
Δ=14.8%
ConfirmedResponseRate,%
40.4%
25.6%
OPE (n=235)
IV Paclitaxel (n=125)
PR: 39.1%
CR: 1.3%
10%
20%
30%
40%
50%
60%
CR: 0.8%
PR: 24.8%
0

15
Ongoing Analysis PFS in Prespecified mITTa Population
HR=0.760 (95% CI: 0.551,1.049)
CumulativeProgression-FreeSurvival
Months (Relative to Randomization)
OPE
IV Paclitaxel
Numbers of Subjects at Risk
OPE 235 219 208 174 154 130 119 87 84 55 49 27 23 20 15 13 12 6 6 4 3 2 1 1 1 0
IV
Paclitaxel
125 118 116 102 87 68 63 38 34 20 19 11 10 10 7 7 7 5 5 4 1 1 0
aIn the ITT analysis, a nonsignificant numerical trend was seen for the median PFS favoring the OPE median.
bEvent is defined as radiological disease progression by central review or death collected in eDC within 90 days of the last tumor assessment.
CI, confidence interval; HR, hazard ratio.
Log-rank test P=0.0773
PFS, mITT
(N=360)
OPE
(n =235)
IV
paclitaxel
(n=125)
Median estimate,
months
9.3 8.3
Censored summary, % 58.3 48.0
Patients with eventb, % 41.7 52.0
Patients discontinued with
no eventb (censored), %
40.4 36.8
Patients ongoing with no
eventb (censored), %
17.9 11.2

16
Ongoing Analysis OS in Prespecified mITT Population
Log-Rank Test P=0.0353
CumulativeOverallSurvival
OPE
IV Paclitaxel
Months (Relative to Randomization)
Numbers of Subjects at Risk
OPE 235 229 218 190 162 130 107 84 66 48 42 31 27 23 18 10 7 4 2 0
IV
Paclitaxel
125 121 114 99 85 65 47 40 33 24 17 14 12 11 5 4 3 1 1
HR=0.684 (95% CI: 0.475, 0.985)
OS, mITT
(N=360)
OPE
(n =235)
IV
paclitaxel
(n=125)
Median estimate,
months
27.9 16.9
Censored summary, % 68.9 58.4
Patient deaths (events), % 31.1 41.6
Discontinued patients and
survival status unknown
(censored), %
17.9 18.4
Patients ongoing or being
followed up (censored), %
51.1 40.0
ITT results: Median estimate (months),
OPE (27.7), IV Paclitaxel (16.9); Log-rank test P =0.114
HR=0.762 (95% CI: 0.540,1.077)

17
Estimate
Neuropathyb with
CTCAE grade ≥2
-0.235
Alopecia with CTCAE grade 2 -0.194
Neutropenia with CTCAE grade ≥3 0.018
Diarrhea with CTCAE grade ≥3 0.038
Vomiting or nausea with
CTCAE grade ≥3c 0.061
0 10 20 30 40 50 60
% Population
Treatment-emergent Adverse Events of Interest:
Safety Population (N=399)
aIncidence rate difference is calculated as the rate from the OPE group minus the rate from the IV Paclitaxel group; bIncludes burning sensation, dysesthesia,
hypoesthesia, hyporeflexia, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy
c. The protocol initially did not allow patients in the OPE arm to receive prophylactic antiemetic therapy. With the introduction of appropriate prophylaxis of nausea, the
rates and severity of these adverse events decreased.
-0.5 -0.4 -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5
Response Rate Differencea
OPE Better IV Paclitaxel Better
7.6%
31.1%
28.8%
48.1%
29.9%
28.1%
5.3%
1.5%
6.8%
0.7%
OPE (n=264) IV Paclitaxel (n=135)

Conclusions
• First oral taxane shows promise
• Several other taxanes in clinical trials
• Should see them in clinic soon
Footer

This presentation is the intellectual property of the author/presenter. Contact them at ikrop@partners.org for permission to reprint and/or distribute.
DS-8201 Was Designed With 7 Key Attributesa
to Deliver an Optimal Antitumor Effect1-4
aThe clinical relevance of these features is under investigation.
MOA, mechanism of action.
1. Nakada T, et al. Chem Pharm Bull (Tokyo). 2019;67(3):173-185. 2. Ogitani Y, et al. Clin Cancer Res. 2016;22(20):5097-5108. 3. Trail PA, et al. Pharmacol Ther. 2018;181:126-142. 4. Ogitani Y, et al. Cancer Sci. 2016;107(7):1039-1046.
Payload MOA:
topoisomerase I inhibitor
High potency of payload
Tumor-selective cleavable linker
High drug to antibody ratio ≈ 8
Stable linker-payload
Payload with short systemic half-life
Membrane-permeable payload
3
7
4
5
6
2
1
• A humanized anti-HER2 IgG1 mAb with the same
amino acid sequence as trastuzumab, covalently linked to
• A topoisomerase I inhibitor, an exatecan derivative, via
• A tetrapeptide-based cleavable linker
DS-8201 is an ADC composed of 3 components:
Humanized anti-HER2
IgG1 mAb1-3
Deruxtecan1,2
Topoisomerase I Inhibitor
(DXd)
Tetrapeptide-Based Cleavable Linker
19

R
1:1:1
PART 2
DESTINY-Breast01 Study Design:
An Open-Label Multicenter Phase 2 Study
Population
• ≥18 years of age
• Unresectable and/or
metastatic BC
• HER2-positive (centrally
confirmed on archival
tissue)
• Prior T-DM1
• Stable, treated brain
metastases were
allowed
PK Stage
(n=65)
Dose-Finding Stage
(n=54)
Continuation Stage
(n=134)
PART 1
T-DM1
Resistant/Refractory
(n=249)
T-DM1
Intolerant
(n=4)
6.4 mg/kg
(n=22)
7.4 mg/kg
(n=21)
R
1:1
PART 2a
5.4 mg/kg
(n=130)
PART 2b
5.4 mg/kg
(n=4)
5.4 mg/kg
(n=22)
5.4 mg/kg
(n=28)
6.4 mg/kg
(n=26)
Data Cutoff: August 1, 2019
• 184 patients enrolled at 5.4 mg/kg
• 79 patients (42.9%) are ongoing
• 105 patients (57.1%) discontinued, primarily for progressive disease (28.8%)
20
PART 2a
5.4 mg/kg
(n=130)
PART 2b
5.4 mg/kg
(n=4)
5.4 mg/kg
(n=22)
5.4 mg/kg
(n=28)
<<slide animated>>

Best Tumor Size Response
Best change from baseline in sum of the longest diameters
of measurable tumors by independent central review (n=168)
100
80
60
40
20
-20
0
-40
-60
-80
-100
Best%ChangeFromBaselineinSumofDiametrics
11/168 CRs
The line at 20% indicates progressive disease; the line at −30% indicates partial response.
a Includes all patients who received T-DXd 5.4 mg/kg (intent-to-treat analysis; N=184).
21
Confirmed ORR: 60.9%a
(95% CI, 53.4%–68.0%)

Progression-Free and Overall Survival
aPatients who received T-DXd 5.4 mg/kg.
CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression-free survival; T-DXd, trastuzumab deruxtecan.
Progression-Free Survivala
Median: 16.4 months (95% CI, 12.7-NE)
Overall Survivala
Median: Not reached (95% CI, NE-NE)
Median follow-up, 11.1 months (range, 0.7-19.9 months)
22
Censored: 86.4%
Events: 13.6%
ProbabilityofProgression-FreeSurvival
Months
1.0
0.8
0.6
0.4
0.2
0.0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 2016 17 18 19
184 182 174 155 153 135 121 107 103 94 69 54 38 17 11 10 09 4 3 1No. at risk:
65%
Estimated 1-year PFS
(95% CI, 56%-72%)
Censored: 68.5%
Events: 31.5%
86%
Estimated 1-year OS
(95% CI, 80%-91%)
ProbabilityofSurvival
Months
1.0
0.8
0.6
0.4
0.2
0.0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 2016 17 18 19
184 183 182 179 174 171 167 161 155147 133 101 66 36 21 16 012 9 8 4No. at risk:

Treatment-emergent Adverse Events in >15% of Patientsa
aPatients who received T-DXd 5.4 mg/kg.
bEach of the following TEAE was associated with a fatal outcome: respiratory failure, acute respiratory failure, disease progression, general physical health deterioration, lymphangitis, pneumonia, pneumonitis, shock hemorrhagic; 1
patient had two TEAEs associated with death: acute kidney injury and acute hepatic failure.
0 10 20 30 40 50 60 70 80 90 100
Cough
Headache
Thrombocytopenia
Decreased WBC Count
Diarrhea
Anemia
Decreased Appetite
Neutropenia
Constipation
Vomiting
Alopecia
Fatigue
Nausea
Any TEAE
Grade 1 or 2
Grade ≥3
• Serious TEAEs, 22.8% (drug related, 12.5%)
• TEAEs associated with discontinuation, 15.2%
(drug related, 14.7%); the majority were due
to pneumonitis/ILD (8.7%)
• There were 9 (4.9%) TEAE-associated deathsb
23

Patients who received T-DXd 5.4 mg/kg (N=184)
Preferred Term,
n (%)
Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Any
Grade/
Total
Interstitial
lung diseasea 5 (2.7) 15 (8.2) 1 (0.5) 0 4 (2.2) 25 (13.6)
Adverse Events of Special Interest: Interstitial Lung Disease
aDrug related; ILD was determined by the Independent ILD Adjudication Committee based on 44 preferred terms.
ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan.
ILD events were actively managed by patient monitoring, dose modification, and
adherence to the ILD management guidelines
Median time from the first infusion of T-DXd to onset of ILD was 27.6 weeks (range, 6-76 weeks)
24

Conclusions
• This medication is now approved!
• We still have large clinical trials taking place
• Concern about pneumonitis
Footer

26
This presentation is the intellectual property of the author/presenter. Contact them at rmurthy1@mdanderson.org for permission to reprint and/or distribute.
HER2CLIMB Trial Design
https://clinicaltrials.gov/ct2/show/NCT02614794
Tucatinib + Trastuzumab + Capecitabine
(21-day cycle)
Tucatinib 300 mg PO BID
+
Trastuzumab 6 mg/kg Q3W (loading dose 8 mg/kg C1D1)
+
Capecitabine 1000 mg/m2 PO BID (Days 1-14)
Key Eligibility Criteria
• HER2+ metastatic breast cancer
• Prior treatment with trastuzumab,
pertuzumab, and T-DM1
• ECOG performance status 0 or 1
• Brain MRI at baseline
• Previously treated stable brain
metastases
• Untreated brain metastases not needing
immediate local therapy
• Previously treated progressing brain
metastases not needing immediate local
therapy
• No evidence of brain metastases
Placebo + Trastuzumab + Capecitabine
(21-day cycle)
Placebo
+
Trastuzumab 6 mg/kg Q3W (loading dose 8 mg/kg C1D1)
+
Capecitabine 1000 mg/m2 PO BID (Days 1-14)
N=410
N=202
*Stratification factors: presence of brain metastases
(yes/no), ECOG status (0 or 1), and region (US or
Canada or rest of world)
R*
(2:1)

27
Progression-Free Survival in the Primary Endpoint Population
Prespecified efficacy boundary for PFS: P=0.05
Data cut off: Sep 4, 2019
Risk of progression or death was
reduced by 46% in the primary
endpoint population
One-year PFS (95% CI):
TUC+Tras+Cape
33%
(27, 40)
Pbo+Tras+Cape
12%
(6, 21)
Median PFS (95% CI):
7.8 months
(7.5, 9.6)
5.6 months
(4.2, 7.1)
Events,
N=480
HR
(95% CI) P Value
TUC+Tras+Cape 178/320 0.54
(0.42, 0.71)
<0.00001
Pbo+Tras+Cape 97/160
Median
63%
33%
46%
12%

28
Overall Survival in the Total Study Population
Events
N=612
HR
(95% CI) P Value
(0.50, 0.88)
0.00480
Pbo+Tras+Cape 85/202
Prespecified efficacy boundary for OS (P=0.0074)
was met at the first interim analysis.
Risk of death was reduced by 34%
in the total population
Two-year OS (95% CI):
TUC+Tras+Cape
45%
(37, 53)
Pbo+Tras+Cape
27%
(16, 39)
Median OS (95% CI):
21.9 months
(18.3, 31.0)
17.4 months
(13.6, 19.9)
76%
Median
45%
62%
27%

29
Progression-Free Survival for Patients with Brain Metastases
Events
N=291
HR
(95% CI) P Value
(0.34, 0.69)
<0.00001
Pbo+Tras+Cape 51/93
Prespecified efficacy boundary for PFSBrainMets
(P=0.0080) was met at the first interim analysis.
Risk of progression or death in
patients with brain metastases was
reduced by 52% in the total population
One-year PFS (95% CI):
TUC+Tras+Cape
25%
(17, 34)
Pbo+Tras+Cape
0%
Median PFS (95% CI):
7.6 months
(6.2, 9.5)
5.4 months
(4.1, 5.7)
60%
25%
34%
0%
Median

30
0
10
20
30
40
50
60
70
80
90
100Frequency
Most Common Adverse Events (≥20% in the Tucatinib Arm)
PPE: palmar-plantar erythrodysesthesia, AST: aspartate transaminase, ALT: alanine transaminase
Grade
1
Grade
≥3
TUC + Tras + Cape
Pbo + Tras + Cape
Grade
2

Conclusions
• Very promising medication
• Very efficacious for patients with brain
metastases
• Expect it approved soon
Footer

New set of trials base treatment on genomic
changes of cancer

This presentation is the intellectual property of the presenter. Contact them at nicholas.turner@icr.ac.uk for permission to reprint and/or distribute.
plasmaMATCH
study outline
Primary objective
• Response rate of therapies
matched to mutations in ctDNA
Secondary objective
• Frequency of targetable
mutations
• Accuracy of ctDNA testing
• Proportion of patients entering
a cohort
• Activity in clonally dominant vs
sub-clonal ESR1 mutations
Advanced breast cancer with measurable disease
Progressed on prior therapy for ABC or relapsed
within 12m adjuvant chemotherapy
Up to 2 prior lines chemotherapy for ABC
Consent for treatment cohort
Cohort A
ESR1 mutation
Extended-dose
fulvestrant
Cohort B
HER2 mutation
Neratinib (plus
fulvestrant in
ER+ BC)
Cohort C
AKT1 mutation
(ER+ BC)
Capivasertib
and fulvestrant
Cohort E*
TNBC with no
mutation
Olaparib and
AZD6738
Actionable mutation identified
+ Prospective from part way through recruitment (n=364), retrospective in remaining patients (n=436) *Cohort E to be reported separately
Cohort D
AKT basket
AKT1 (ER- BC)
PTEN mutation
Capivasertib
External tumour sequencing
Cohort D only
ctDNA testing
Droplet Digital PCR
Sequencing – Guardant 360 +

San Antonio Breast Cancer Symposium, December 10-14, 2019
Pre-treated primary tumors and paired metastasis (23pts) Post-treatment primary tumors and paired metastasis (15pts)
PAM50 subtype
Primary Tumors and Metastases
~10% subtype switch rate in Basal-like cases (typically with normal-like)
~30% subtype switching rate in Luminal-type cases (LumA, LumB, HER2-enriched)
This presentation is the intellectual property of AURORA. Contact tking7@bwh.harvard.edu for permission to reprint and/or distribute.
Basal
Her2
LumA
LumB

Genomic Heterogeneity During Evolution
Copy number changes
associated with HER2E subtype,
TCGA, Nature, 2012
HER2E
Primary
Post-Treatment
Right Liver
Met
Left Liver
Met

Key Point
When treating and/or studying metastatic
disease, whenever possible,
biopsy and perform molecular assays
on the metastatic site(s)

Conclusions
HR positive breast cancer
• CDK4/6 inhibitors offer survival benefit in MBC
• Oral SERDs may be easier better drugs
Oral Taxanes show promise
HER2 positive breast cancer
• DS8201 now approved
• Tucatinib shows promise especially in patients with brain mets
Tumors Evolve and frequent pathologic evaluation is key

Report Back from San Antonio Breast Cancer Symposium: Spotlight on MBC

Report Back from San Antonio Breast Cancer Symposium: Spotlight on MBC

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