Roche Pharmaceutical Development and Sales Overview
Roche
Giredestrant: Early data support continued development in ER+ BC
Ph III (persevERA) interim results in 1L ER+ BC expected for 2024
Ph II (acelERA) results in 2/3L ER+/HER- BC
Ph II (coopERA) results in neoadjuvant ER+/HER- BC
PFS-INV: ESR1m subgroup
100+
90-
80-
70-
PFS-INV, %
60-
50
40-
30-
20-
10-
0-
0
2
4
6
8
10
12
14
Months
No. at risk
giredestrant
51
36
26
12
9
4
PCET
39
20
9
1
congress
PARIS
2022
ESMO
HR (95% CI)
p-value (log-rank)
mPFS, months
giredestrant
(n = 51)
PCET
(n = 39)
0.60 (0.35, 1.03)
0.0610
5.3
3.5
Ki67 response at wk 2 and at surgery
Relative reduction in Ki67% from baseline
OHNWAG
Baseline to week 2
Giredestrant
(n=107)
-75%
Anastrazole
(n=94)
-67%
Baseline to surgery
G+P
(n = 93)
-81%
A+P
(n=91)
-74%
2022 ASCO
ANNUAL MEETING
。%%
0.00
-0.25-
-0.50-
-0.75-
-1.00-
•
•
.
PFS benefit was more pronounced in patients with ESR1 mutations (HR of
0.81 in all-comers vs HR of 0.60 in patients with ESR1 mutations)
In 2L/3L setting patients have received multiple cycles of ET
The activity observed in patients whose tumours still depend on estrogen
receptor activity for viability is encouraging for earlier lines, where nearly
all ER+ tumours are dependent on ER activity
.
G+P, Giredestrant + Palbociclib; A+P, Anastrozole + Palbociclib
First randomized study to show superior activity of an oral SERD
(giredestrant) over an aromatase inhibitor (anastrozole) in ER+/HER2- eBC
Final analysis confirmed greater suppression of Ki67 and rates of complete
cell cycle arrest with giredestrant vs. anastrazole at time of surgery
Ki67 is a biomarker of proliferation associated with improved long-term
efficacy outcomes in early stage disease
Safety data consistent with known safety profile
Fasching P et al., ASCO 2022; Martin M et al., ESMO 2022; Clinical cutoff: 18 Feb 2022; median follow-up 7.89 months; SERD-Selective estrogen receptor degrader; BC-Breast cancer; ER=estrogen receptor; ESR1-estrogen
receptor 1; ET-estrogen therapy; PFS-INV-progression-free survival by investigator assessment; HR-hazard ratio; PCET=physician's choice of endocrine therapy; HER2-Human epidermal growth factor receptor 2
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