SABCS 2022 Takeaways - 10

10 CLINICAL TRIALS UPDATES
Novel Agents: SERDs (continued)
SERENA-2 (GS3-02)
According to Mafalda Oliveira, MD, PhD, presenter, SERENA-2 met its primary
objective in that camizestrant at both doses improves progression-free survival in
postmenopausal women with ER+/HER2- advanced breast cancer.
San Antonio Breast Cancer Symposium®, December 6-10, 2022
PFS by blinded independent central review
1.0
0.8
0.6
0.4
0.2
0.0
C 75
C 150
F
74
73
73
Events [n (%)]
Median PFS,
months (90% CI)
Adjusted HR
(90% CI)a
P value
C 75 (n=74) C 150 (n=73)
39 (52.7)
7.4
(4.5-10.9)
0.56
(0.39-0.80)
0.0079*
33 (45.2)
12.7
(9.3-18.4)
0.47
(0.33-0.68)
0.0004*
F (n=73)
53 (72.6)
3.7
(2.0-3.8)
-
-
Camizestrant 75 mg
Camizestrant 150 mg
Fulvestrant 500 mg
Mafalda Oliveira, MD, PhD
3
46
45
32
6
27
33
20
9
21
29
15
12
Time (months)
15
21
10
10
8
5
4
4
4
3
1
1
* BICR assessment conducted as a sensitivity analysis shows a statistically significant benefit in PFS at both doses
of camizestrant over fulvestrant, consistent with the investigator assessment
* The camizestrant 150 mg group showed a higher degree of investigator versus BICR discordance than the camizestrant 75 mg
and fulvestrant groups, where investigator PD was called more often than BICR PD, 31.5% discordance for 150 versus 18.9%
and 15.1% for 75 and F, respectively
*Statistically significant; aHRs adjusted for prior use of CDK4/6i and liver/lung metastases
BICR: blinded independent central review; CI: confidence interval; HR: hazard ratio; PFS: progression-free survival
This presentation is the intellectual property of the author/presenter. Contact them at moliveira@vhio.net for permission to reprint and/or distribute.
15
18
21
24
27
At 24 weeks, objective response and clinical benefit rates favored camizestrant
at both the 75 mg and 150 mg doses vs. fulvestrant, with the clinical benefit rate at
approximately 50% for both camizestrant doses.
Two phase III studies of camizestrant in advanced breast cancer, SERENA-4 and
SERENA-6, are enrolling.
Andrea De Censi, MD, PhD, on 10-year Results of Low-dose
Tamoxifen vs. Placebo for High-risk Lesions
ON RISK OF RECURRENCE...
" There was a significant 42% reduction
in recurrence for women with
high-risk lesions, including atypical
ductal hyperplasia, lobular carcinoma
in situ, and ductal carcinoma in situ
(DCIS), when receiving 3 years of
low-dose (5 mg) tamoxifen compared
with placebo. This is true even 7 years
after treatment cessation, indicating a
carryover effect of low-dose tamoxifen.
The benefit was seen across all
patient subgroups and was significant in postmenopausal women,
obese women, women undergoing mastectomy, and those
with DCIS-in which there was a remarkable 50% reduction of
recurrence with low-dose tamoxifen for 3 years, which provides
a new standard of care in this cohort. "
ON STANDARD OF CARE...
" The low risk of death at 10 years (0.6%) supports use of the
reduced dose for women with DCIS. "
ON DOSE...
" Although there is not a 5 mg tablet currently on the market,
10 mg every-other day is reasonable. We had shown in our
presurgical trial on Ki67 that in addition to 5 mg even 1 mg
per day was noninferior to 20 mg. We didn't have the courage
to de-escalate to this point, so what is the minimum effective
dose of tamoxifen is still an open question. "
ON COST OF CARE AND CLINICAL TRIAL FUNDING...
" This was an academic nonprofit trial that aimed to attain a
safe, equitable, and affordable treatment which costs $2-3 per
month, and the comparison of this cost with those of modern
treatments is merciless and embarrassing. "
2022 SABCS TAKEAWAYS EDITION
Probability of PFS

SABCS 2022 Takeaways

Table of Contents for the Digital Edition of SABCS 2022 Takeaways

SABCS 2022 Takeaways - A
SABCS 2022 Takeaways - 1
SABCS 2022 Takeaways - 2
SABCS 2022 Takeaways - 3
SABCS 2022 Takeaways - 4
SABCS 2022 Takeaways - 5
SABCS 2022 Takeaways - 6
SABCS 2022 Takeaways - 7
SABCS 2022 Takeaways - 8
SABCS 2022 Takeaways - 9
SABCS 2022 Takeaways - 10
SABCS 2022 Takeaways - 11
SABCS 2022 Takeaways - 12
SABCS 2022 Takeaways - 13
SABCS 2022 Takeaways - 14
SABCS 2022 Takeaways - 15
SABCS 2022 Takeaways - 16
SABCS 2022 Takeaways - 17
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