INAVO120 Trial

[Slide 1]
A Overall Survival in the Full Analysis Population
100
96.8
HI
Median
H
87.0
Overall
90.1
74.3
No. of
Survival
75
76.7
Deaths (%)
(95% CI)
65.8
Overall Survival (%)
mo
67.2
56.5
Inavolisib
50
56.3
72 (44.7)
34.0 (28.4-44.8)
(N=161)
Inavolisib
46.3
Placebo
82 (50.0)
27.0 (22.8-38.7)
(N=164)
25
Placebo
Stratified hazard ratio for death,
0.67 (95% CI, 0.48-0.94)
P=0.02
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
51
Months
No. at Risk
Inavolisib
161
155
149
142
131
114
99
88
78
67
54
43
34
22
19
13
7
1
Placebo
164
155
142
127
119
104
90
77
63
48
42
36
32
18
10
4
2
1
B Analysis of Overall Survival in Key Subgroups
Subgroup
No. of Patients
Median Overall Survival
Hazard Ratio for Death (95% CI)
Inavolisib
Placebo
Inavolisib
Placebo
mo
All patients
161
164
34.0
27.0
0.76 (0.55-1.04)
Age
<65 yr
136
130
36.0
26.8
0.65 (0.46-0.92)
>65 yr
25
34
14.4
NR
1.65 (0.77-3.51)
Geographic region
Asia
58
62
32.7
27.0
0.78 (0.45-1.34)
North America or western Europe
63
64
30.2
29.3
0.95 (0.56-1.59)
Other
40
38
36.0
16.6
0.53 (0.28-0.98)
ECOG performance-status score at baseline
0
100
106
39.2
36.0
0.69 (0.45-1.05)
1
60
58
27.1
26.8
0.85 (0.52-1.38)
Menopausal status at randomization
Premenopausal
52
52
32.7
23.9
0.67 (0.38-1.19)
Postmenopausal
104
111
34.0
28.0
0.81 (0.55-1.19)
Visceral disease
No
29
36
38.0
40.7
1.06 (0.46-2.46)
Yes
132
128
33.0
24.1
0.70 (0.50-0.99)
Liver metastases at enrollment
No
84
73
38.0
36.0
0.87 (0.53-1.44)
Yes
77
91
28.8
21.9
0.72 (0.48-1.10)
No. of organs with metastases at enrollment
1
21
32
NR
31.9
0.77 (0.28-2.10)
2
58
46
44.8
24.1
0.51 (0.28-0.90)
>3
82
86
28.8
24.2
0.86 (0.57-1.30)
Resistance to endocrine therapy
Primary
54
58
25.9
22.8
0.69 (0.42-1.14)
Secondary
107
105
37.7
34.3
0.77 (0.51-1.16)
Hormone receptor status
ER-positive, PR-negative
45
45
25.9
38.7
1.16 (0.65-2.08)
ER-positive, PR-positive
113
113
39.2
24.5
0.60 (0.41-0.88)
Previous endocrine therapy
Aromatase inhibitor and tamoxifen
18
19
NR
NR
1.15 (0.38-3.44)
Aromatase inhibitor only
60
71
26.3
24.2
0.89 (0.56-1.41)
Tamoxifen only
82
73
44.8
36.0
0.68 (0.42-1.11)
0.10
0.67 1.00
10.00
Inavolisib Better
Placebo Better

[Slide 1]
San Antonio Breast Cancer Symposium®, December 5-9, 2023
4
INAVO120 study design
Key eligibility criteria
Enrolment period: December 2019 to September 2023
Enrichment of patients with poor prognosis:
N=325
PIK3CA-mutated, HR+, HER2- ABC by central
Inavolisib (9 mg QD PO)
+ palbociclib (125 mg PO QD D1-D21)
ctDNA* or local tissue/ctDNA test
fulvestrant (500 mg C1D1/15 and Q4W)**
Measurable disease
R
Until PD
Progression during/within 12 months of
1:1
or toxicity
adjuvant ET completion
Placebo (PO QD)
SURVIVAL
FOLLOW-UP
+ palbociclib (125 mg PO QD D1-D21)
+
No prior therapy for ABC
fulvestrant (500 mg C1D1/15 and Q4W)**
Fasting glucose <126 mg/dL and HbA1c <6.0%
Stratification factors:
Endpoints
Visceral Disease (Yes vs. No)
Primary: PFS by Investigator
Endocrine Resistance (Primary VS. Secondary)
Secondary: OSF, ORR, BOR, CBR, DOR, PROs
Region (North America/Western Europe; Asia; Other)
.
Central testing for PIK3CA mutations was done on ctDNA using FoundationOneLiquid (Foundation Medicine). In China, the central ctDNA test was the PredicineCARE NGS assay (Huidu). : Defined per 4th
European School of Oncology (ESO)-European Society for Medical Oncology (ESMO) International Consensus Guidelines for Advanced Breast Cancer.1 Primary: relapse while on the first 2 years of adjuvant ET;
Secondary: relapse while on adjuvant ET after at least 2 years or relapse within 12 months of completing adjuvant ET. : OS testing only if PFS is positive; interim OS analysis at primary PFS analysis;
.. Pre-menopausal women received ovarian suppression. ctDNA, circulating tumor DNA; R, randomized. 1. Cardoso F, et al. Ann Oncol 2018;29:1634-1657
This presentation is the intellectual property of the authors. Contact jhaverik@mskcc.org for permission to reprint and/or distribute

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[Slide 2]
San Antonio Breast Cancer Symposium®, December 5-9. 2023
9
Primary endpoint: PFS (investigator-assessed)
6-month
12-month
18-month
Inavo+Palbo+Fulv Pbo+Palbo+Fulv
100
(n=161)
(n=164)
82.9%
No. of events, n (%)
82 (50.9)
113 (68.9)
Median (95% CI), mo
15.0 (11.3,20.5)
7.3 (5.6,9.3)
75
Stratified hazard ratio (95% CI)
0.43 (0.32, 0.59)
55.9%
55.9%
p<0.0001
46.2%
50
32.6%
Inavo+Palbo+Fulv
21.1%
25
Pbo+Palbo+Fulv
Censored
0
0
3
6
9
12
15
18
21
24
27
30
33
36
Time (mo)
Patients at risk:
Inavo+Palbo+Fulv
161
134
111
92
66
48
41
Median follow-up:
31
22
13
11
5
1
Pbo+Palbo+Fulv
164
113
77
59
40
23
19
16
12
6
3
3
1
21.3 months
CCOD: 29th September 2023
CI, confidence interval; Fulv. fulvestrant; Inavo, inavolisib; mo, months: Palbo, palbociclib; Pbo. placebo; PFS, progression-free survival.
This presentation is the intellectual property of the authors. Contact jhaverik@mskcc.org for permission to reprint and/or distribute

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[Slide 3]
San Antonio Breast Cancer Symposium®, December 5-9, 2023
12
Key secondary endpoint: Overall survival (interim analysis)
Inavo+Palbo
Pbo+Palbo
6-month
12-month
18-month
+Fulv (n=161)
+Fulv (n=164)
No. of events, n (%)
42 (26.1)
55 (33.5)
97.3%
100
85.9%
Median (95% CI), mo
NE (27.3, NE)
31.1 (22.3, NE)
Stratified Hazard
0.64 (0.43, 0.97)
73.7%
Ratio (95% CI)
p=0.0338
75
89.9%
74.9%
67.5%
50
25
Inavo+Palbo+Fulv
Pbo+Palbo+Fulv
Censored
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
Time (mo)
Patients at risk:
Inavo+Palbo+Fulv
161
143
127
114
101
85
69
56
38
26
17
8
4
1
1
Median follow-up:
Pbo+Palbo+Fulv
164
139
120
98
87
72
61
52
33
19
11
5
3
1
0
21.3 months
The pre-specified boundary for os (p of 0.0098 or HR of 0.592) was not crossed at this interim analysis
CI, confidence interval: Fulv. fulvestrant; Inavo, inavolisib; mo, months: NE, not estimable; OS, overall survival; Palbo, palbociclib; Pbo, placebo.
This presentation is the intellectual property of the authors. Contact jhaverik@mskcc.org for permission to reprint and/or distribute

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[Slide 4]
San Antonio Breast Cancer Symposium®, December 5-9, 2023
15
Adverse events with any grade AEs >20% incidence in either
treatment group
Adverse Events
Inavo+Palbo+Fulv
Pbo+Palbo+Fulv
(N=162)
(N=162)
All Grades
Grade 3-4
All Grades
Grade 3-4
Neutropenia
144 (88.9%)
130 (80.2%)
147 (90.7%)
127 (78.4%)
Thrombocytopenia
78 (48.1%)
23 (14.2%)
73 (45.1%)
7 (4.3%)
Stomatitis/Mucosal inflammation
83 (51.2%)
9 (5.6%)
43 (26.5%)
0
Anemia
60 (37.0%)
10 (6.2%)
59 (36.4%)
3 (1.9%)
Hyperglycemia
95 (58.6%)
9 (5.6%)
14 (8.6%)
0
Diarrhea
78 (48.1%)
6 (3.7%)
26 (16.0%)
0
Nausea
45 (27.8%)
1 (0.6%)
27 (16.7%)
0
Rash
41 (25.3%)
0
28 (17.3%)
0
Decreased Appetite
38 (23.5%)
<2%
14 (8.6%)
<2%
Fatigue
38 (23.5%)
<2%
21 (13.0%)
<2%
COVID-19
37 (22.8%)
<2%
17 (10.5%)
<2%
Headache
34 (21.0%)
<2%
22 (13.6%)
<2%
Leukopenia
28 (17.3%)
11 (6.8%)
40 (24.7%)
17 (10.5%)
Ocular Toxicities
36 (22.2%)
0
21 (13.0%)
0
Key AEs are shown in bold. AES were assessed per CTCAE V5. Neutropenia, thrombocytopenia, stomatitis/mucosal inflammation, anemia, hyperglycemia, diarrhea, nausea and rash
were assessed as medical concepts using grouped terms
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Fulv, fulvestrant; Inavo, inavolisib; Palbo, palbociclib; Pbo, placebo.
This presentation is the intellectual property of the authors. Contact jhaverik@mskcc.org for permission to reprint and/or distribute

[Slide 1]
2025 ASCO®
ANNUAL MEETING

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[Slide 2]
INAVO120: A Phase III, randomized, double-blind,
placebo-controlled study¹,²
Key eligibility criteria
Enrollment period: January 2020 to September 2023
Enrichment of patients with poor prognosis:
N 325
Inavolisib (9 mg PO QD)
PIK3CA-mutated, HR+, HER2- aBC by central
+ palbociclib (125 mg PO QD D1-D21)
ctDNA* or local tissue/ctDNA test
+ fulvestrant (500 mg C1D1/15 and Q4W)+
R
Until PD
Measurable disease
1:1
or toxicity
Placebo (PO QD)
SURVIVAL
FOLLOW-UP
Progression during/within 12 months of
+ palbociclib (125 mg PO QD D1-D21)
adjuvant ET completion
+ fulvestrant (500 mg C1D1/15 and Q4W)t
No prior therapy for aBC
Stratification factors:
Fasting glucose <126 mg/dL and HbA1c <6.0%
Visceral disease (yes vs. no)
Endocrine resistance (primary vs. secondary):
Region (North America/Western Europe VS. Asia vs. Other)
Primary endpoint: Investigator-assessed PFS
Secondary endpoints included: OS; investigator-assessed ORR, BOR, CBR, and DoR; PROs
ClinicalTrials gov number, NCT04191499
Adapted from Jhaven KJ, of al. SABCS 2023 (Abstract GS03-13). Central testing for PIK3CA mutations was done on CIDNA using FoundationOneLiquid (Foundation Medicine, Inc.). In China, the central ctDNA test was the PredicineCARE NGS assay
(Huidu); Pre-menopausal women received ovarian suppression; Defined per 4th European School of Oncology (ESO)-European Society for Medical Oncology (ESMO) International Consensus Guidelines for Advanced Breast Cancer.3
Primary: Relapse while on the first 2 years of adjuvant ET; secondary: Relapse while on adjuvant ET after at least 2 years or misses within 12 months of completing adjuvant ET.
aBC, advanced breast cancer; BOR, best overall response; C, cycle; CBR, clinical benefit rate; ctDNA, circulating tumor DNA D, day: DoR duration of response; ET, endocrine therapy: HbAse glycated hemoglobin; HER2-, HER2-negative;
QD, daily; R, randomization
HR+, hormone receptor-positive; NGS, next-generation sequencing: ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PO, by mouth; PRO, patient-reported outcome; Q4W, every 4 weeks;
1. Turner NC, of at. N Engl J Med 2024; 391:1584-1596 2. Jhaven KJ, of al. SABCS 2023 (Abstract GS03-13); 3. Cardoso F, or at Ann Oncol 2018; 29:1634-1657
2025 ASCO
#ASCO25
PRESENTED BY: Nicholas Turner, MD, PhD
ASCO
AMERICAN SOCIETY OF
ANNUAL MEETING
CLINICAL ONCOLOGY
Presentation is property of the author and ASCO. Permission required for reuse, contact -.og
KNOWLEDGE CONQUERS CANCER

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[Slide 3]
INAVO120 updated PFS
Events, n (%)
Median, months (95% CI)
Inavolisib (n = 161)
103 (64.0)
17.2 (11.6-22.2)
Placebo (n = 164)
141 (86.0)
7.3 (5.9-9.2)
100
83.4
Stratified hazard ratio, 0.42
(95% CI = 0.32-0.55)
75
58.0
PFS (%)
49.7
50
41.8
57.9
Inavolisib
25
31.3
20.5
16.7
Placebo
0
Median follow-up:
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
51
34.2 months
Months
No. at risk
Inavolisib
161
146
129
112
89
73
65
57
46
32
25
19
15
11
10
7
3
1
Placebo
164
125
95
74
50
34
30
24
21
14
11
10
8
4
2
1
1
1
The improvement in PFS was maintained during longer follow-up
Data cutoff: November 15, 2024.
CI, confidence interval; PFS, progression-free survival. © Copyright 2025.
2025 ASCO
PRESENTED BY: Nicholas Turner, MD, PhD
ASCO
AMERICAN SOCIETY OF
#ASCO25
CLINICAL ONCOLOGY
ANNUAL MEETING
Presentation is property of the author and ASCO. Permission required for reuse, contact permissions@asco.org
KNOWLEDGE CONQUERS CANCER

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[Slide 4]
INAVO120 key secondary endpoint: os
Deaths, n (%)
Median, months (95% CI)
Inavolisib (n = 161)
72 (44.7)
34.0 (28.4-44.8)
Placebo (n = 164)
82 (50.0)
27.0 (22.8-38.7)
96.8
100
87.0
Stratified hazard ratio, 0.67
74.3
(95% CI = 0.48-0.94)
65.8
75
P = 0.0190
90.1
56.5
OS (%)
76.7
50
67.2
Inavolisib
56.3
46.3
25
Placebo
0
Median follow-up:
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
51
34.2 months
Months
No. at risk
Inavolisib
161
155
149
142
131
114
99
88
78
67
54
43
34
22
19
13
7
1
Placebo
164
155
142
127
119
104
90
77
63
48
42
36
32
18
10
4
2
1
Improvement in median OS: 7 months. The prespecified boundary for statistical significance (p < 0.0469) was crossed
Data cutoff: November 15, 2024.
CI, confidence interval; OS, overall survival. © Copyright 2025.
2025 ASCO
PRESENTED BY: Nicholas Turner, MD, PhD
#ASCO25
ASCO
AMERICAN SOCIETY OF
CLINICAL ONCOLOGY
ANNUAL MEETING
Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco.org
KNOWLEDGE CONQUERS CANCER

[Slide 1]
Background:
INAVO, a highly potent and selective PI3Ka
inhibitor that also promotes mutated p110a
degradation, is FDA-approved in combination with
PALBO + FULV for PIK3CA-mutated, HR+, HER2-,
endocrine-resistant aBC, based on the primary
analysis of INAV0120 (NCT04191499), which
showed a statistically significant and clinically
meaningful investigator-assessed progression-
free survival (INV-PFS) benefit in the INAVO arm
vs. the PBO arm (hazard ratio 0.43; 95%
confidence interval [CI] = 0.32-0.59; p < 0.0001).
At that analysis, interim OS results were immature.
Here we report the final OS analysis, including
updated efficacy and safety.

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[Slide 2]
Methods:
Pts received INAVO (9 mg orally once daily [PO
QD]; Days 1-28 of each 28-day cycle)/PBO +
PALBO (125 mg PO QD; Days 1-21 of each cycle)
+ FULV (500 mg intramuscularly; Cycle 1 Days 1
and 15 then every ~4 weeks). OS and objective
response rate (ORR) were formally tested; updated
INV-PFS and safety analyses are descriptive.

---

[Slide 3]
Results:
Data cut-off was Nov 15, 2024, at 34.2 months
(mo) of median follow-up. Median OS was 34.0
mo (95% CI = 28.4-44.8) in the INAVO arm and
27.0 mo (95% CI = 22.8-38.7) in the PBO arm
(stratified hazard ratio 0.67; 95% CI = 0.48-0.94; p
= 0.0190 [boundary = 0.0469]). The os benefit was
consistent across key subgroups. The survival
probability at 6, 12, 18, 24, and 30 mo was 96.8%,
87.0%, 74.3%, 65.8%, and 56.5% in the INAVO arm
and 90.1%, 76.7%, 67.2%, 56.3%, and 46.3% in the
PBO arm. ORR was 62.7% (95% CI = 54.8-70.2)
and 28.0% (95% CI = 21.3-35.6), respectively (p <
0.0001). Median time to chemotherapy (TTC) was
35.6 mo (95% CI = 25.4-not reached) in the INAVO
arm and 12.6 mo (95% CI = 10.4-16.1) in the PBO
arm (stratified hazard ratio 0.43; 95% CI = 0.30-
0.60). Updated median INV-PFS was 17.2 mo (95%
CI = 11.6-22.2) in the INAVO arm and 7.3 mo (95%
CI = 5.9-9.2) in the PBO arm (stratified hazard
ratio 0.42; 95% CI = 0.32-0.55), with landmark

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[Slide 4]
analyses supporting durable benefit. 90.7% of pts
in the INAVO arm and 84.7% in the PBO arm had
grade 3/4 adverse events (AEs); there were no
new grade 5 AEs; 63.4% and 13.5% experienced
any-grade hyperglycemia (grouped term); and AEs
led to INAVO and PBO discontinuation in 6.8% and
0.6% of pts, respectively.
Conclusions:
INAVO + PALBO + FULV demonstrated a
statistically significant and clinically meaningful
os benefit compared with PBO + PALBO + FULV.
Improvement in INV-PFS was maintained during
longer follow-up, along with a substantial and
statistically significant improvement in ORR. TTC
was also substantially delayed (by ~2 years) by
the addition of INAVO to PALBO + FULV. With
longer exposure to INAVO, no new safety signals,
nor changes in the safety profile, were noted,
supporting good tolerability (reflected in low
discontinuation due to AEs).

[Slide 1]
Table S1. Key Post-progression Therapies.
Patients — no. (%)
Inavolisib
Placebo
Second line
Third line
Second line
Third line
or later
or later
Discontinued
111/161 (68.9)
144/164 (87.8)
treatment
No subsequent
17/161 (10.6)
22/164 (13.4)
therapy — death
Received
109/144
subsequent
83/111 (74.8)
48/111 (43.2)
56/144 (38.9)
(75.7)
therapy*
Chemotherapy (any)
46/83 (55.4)
41/48 (85.4)
79/109 (72.5)
49/56 (87.5)
Capecitabine
26/83 (31.3)
14/48 (29.2)
37/109 (33.9)
24/56 (42.9)
Paclitaxel
12/83 (14.5)
17/48 (35.4)
20/109 (18.3)
16/56 (28.6)
Eribulin
1/83 (1.2)
11/48 (22.9)
6/109 (5.5)
17/56 (30.4)
Antibody-drug
1/83 (1.2)
8/48 (16.7)
1/109 (0.9)
20/56 (35.7)
conjugate (any)
Trastuzumab
0
6/48 (12.5)
1/109 (0.9)
16/56 (28.6)
deruxtecan
Sacituzumab
0
2/48 (4.2)
0
8/56 (14.3)
govitecan
PI3K inhibitor (any)
5/83 (6.0)
2/48 (4.2)
11/109 (10.1)
3/56 (5.4)
Alpelisib
5/83 (6.0)
2/48 (4.2)
9/109 (8.3)
2/56 (3.6)
mTOR kinase
inhibitor
8/83 (9.6)
4/48 (8.3)
10/109 (9.2)
9/56 (16.1)
(everolimus)
8
Original Article
CDK4/6 inhibitor
8/83 (9.6)
3/48 (6.2)
5/109 (4.6)
3/56 (5.4)
(any)
Ribociclib
1/83 (1.2)
1/48 (2.1)
5/109 (4.6)
0
Abemaciclib
2/83 (2.4)
2/48 (4.2)
0
2/56 (3.6)
Other (any)
6/83 (7.2)
0
3/109 (2.8)
5/56 (8.9)

[Slide 1]
The NEW ENGLAND JOURNAL of MEDICINE
ORIGINAL ARTICLE
Inavolisib-Based Therapy in PIK3CA-Mutated
Advanced Breast Cancer
N.C. Turner, S.-A. Im, C. Saura, D. Juric, S. Loibl, K. Kalinsky, P. Schmid,
S. Loi, P. Sunpaweravong, A. Musolino, H. Li, Q. Zhang, Z. Nowecki, R. Leung,
E. Thanopoulou, N. Shankar, G. Lei, T.J. Stout, K.E. Hutchinson, J.L. Schutzman,
C. Song, and K.L. Jhaveri
A Progression-free Survival in the Full Analysis Population
100
82.9
Progression-free Survival (%)
75
55.9
50
46.2
55.9
Inavolisib
25
32.6
21.1
Placebo
0
0
3
6
9
12
15
18
21
24
27
30
33
36
Months
No. at Risk
Inavolisib
161
134
111
92
66
48
41
31
22
13
11
5
1
Placebo
164
113
77
59
40
23
19
16
12
6
3
3
1

2026
ESMO BREAST CANCER
Annual Congress
420RO: Efficacy of inavolisib (INAVO) + palbociclib (PALBO)
+ fulvestrant (FULV) in patients (pts) with PIK3CA-mutated,
hormone receptor-positive, HER2-negative (HER2-),
endocrine-resistant advanced breast cancer (aBC) with and
without hyperglycaemia (HG) in the Phase III INAVO120 trial
Presenting author: Prof. Dr. med. Sibylle Loibl
Universitätsklinikum Frankfurt am Main, Frankfurt am Main, Germany
8 May 2026
This medicinal product is subject to additional monitoring
ESMO
 INAVO120: Background and study design
Key eligibility criteria
Enrolment period: January 2020 to September 2023
Enrichment of patients with poor prognosis:
N 325
INAVO (9 mg PO QD)
PIK3CA-mutated. hormone receptor-positive,
PALBO (125 mg PO QD D1-D21)
HER2-negative aBC by central ctDNA* or local
FULV (500 mg C1D1/15 and Q4W)+
tissue/ctDNA test
R
Until PD
1:1
or toxicity
Measurable disease
PBO (PO QD)
SURVIVAL
FOLLOW-UP
Progression during/within 12 months of
PALBO (125 mg PO QD D1-D21)
adjuvant ET completion
FULV (500 mg C1D1/15 and Q4W)+
No prior therapy for aBC
Stratification factors:
Visceral disease (yes vs. no)
Fasting glucose <126 mg/dL and HbA1c <%6.0
Endocrine resistance (primary vs. secondary)
Region (North America/Western Europe vs. Asia vs. Other)
Primary endpoint: Investigator-assessed PFS
Secondary endpoints included: OS; investigator-assessed ORR, BOR, CBR and DoR; PROs
INAVO120 (NCT04191499) demonstrated statistically significant investigator-assessed PFS and OS benefit for INAVO + PALBO + FULV compared with
PBO
+
PALBO + FULV in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant aBC¹²
Hyperglycaemia (an on-target toxicity with PI3K inhibitors) was recorded in 63.4% VS 13.5% of patients in the INAVO VS placebo arms at the final analysis2
We report efficacy (investigator-assessed PFS, ORR, DoR and OS) in patients with and without INAVO-associated hyperglycaemia
- Hyperglycaemia was defined as any reported hyperglycaemia adverse event per CTCAE v5, regardless of grade, duration or treatment received
Adapted from Jhaven KJ. et at SABCS 2023 (Abstract GS03-13) Please see side notes for footnotes and abbreviations
1. Turner NC of of N Engl J Med 2024 391:1584-1 1596 2 Jhavori KL of of N Engi , Med 2025 393:151-161 3 Cardoso F. of of Ann Oncol 2018 29:1634-1657
Presenting author: Prof. Dr. med. Sibylle Loibl
Content of this presentation IS copyright and responsibility of the author Permission is required for to use
ESMO
 INAVO120: Investigator-assessed PFS by hyperglycaemia status
100
PBO arm
INAVO arm with hyperglycaemia
INAVO arm without hyperglycaemia
75
+
Investigator-assessed PFS (%)
Censored
50
25
0-
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
51
Time
(months)
Patients at risk
PBO arm
164
125
95
74
50
34
30
24
21
14
11
10
8
4
2
1
1
1
INAVO arm with hyperglycaemia
102
95
86
75
60
50
44
42
34
23
18
14
11
8
7
4
2
0
INAVO arm without hyperglycaemia
59
51
43
37
29
23
21
15
12
9
7
5
4
3
3
3
1
1
INAVO arm with hyperglycaemia
INAVO arm without hyperglycaemia
PBO arm
Patients with event, n (%)
63 (61.8)
40 (67.8)
141 (86.0)
Median investigator-assessed PFS, months (95% CI)
21.0(13.4-26.6)
12.8 (9.1-20.5)
7.3(5.9-9.2)
Stratified HR vs. PBO arm (95% CI)
0.38 (0.27-0.52)*
0.51 (0.35-0.74)*
-
Investigator-assessed PFS was consistently improved in the INAVO arm
compared with the PBO arm for all patients
Data cut-off date 15 November 2024 Updated HR for investigator-assessed PFS for all patients in the INAVO arm vs the PBO arm at the final analysis 0.42 (95% C1032-055)
CI, confidence interval, HR, hazard ratio INAVO. inavolisib PBO. placebo, PFS. progression free survival
1 Jhaveri KL, of of N Engl Med 2025, 393:151-161
Presenting author: Prof. Dr. med. Sibylle Loibl
Content of this presentation IS copyright and responsibility of the author Permission IS required for re use
ESMO
 INAVO120: Response by hyperglycaemia status
INAVO arm
INAVO arm
All PBO
with hyperglycaemia
without hyperglycaemia
arm patients
(n 102)
(n 59)
(n 164)
BOR, n (%)
Complete response
4 (3.9)
2 (3.4)
1 (0.6)
Partial response
62 (60.8)
33 (55.9)
45 (27.4)
Stable disease
29 (28.4)
15 (25.4)
81 (49.4)
Progressive disease
6 (5.9)
3 (5.1)
35 (21.3)
Missing
1 (1.0)
6 (10.2)
2 (1.2)
ORR, n (%)
66 (64.7)
35 (59.3)
46 (28.0)
Median TTR, months (95% CI)
3.7 (2.1-7.5)
3.6 (2.0-12.9)
NR (NE)
Median DoR, months (95% CI)
20.3 (12.2-40.2)
18.2 (9.6-25.8)
11.1 (8.5-20.2)1
[Stratified HR vs. PBO (95% CI)]
[0.57 (0.32-0.98)]
[0.62 (0.32-1.17)]
Data cut-off date 15 November 2024
BOR best overall response, CI, confidence interval, DoR duration of response HR, hazard ratio, INAVO, inavolisib NE not estimable NR. not reached ORR objective response rate; PBO, placebo, TTR time to response
1 Jhaveri KI., of at N Engl J Med 2025 393:151-161
Presenting author: Prof. Dr. med. Sibylle Loibl
Content of this presentation IS copyright and responsibility of the author Permission IS required for re use
ESMO