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Report Back from SGO:
What’s New In Uterine
Cancer
Ebony R. Hoskins, MD
Gynecologic Oncology
Washington, DC
Objectives
 Review updated Phase 3 randomized clinical trial data
 Review Phase 2 clinical trial data
 Review what is in development for treatment
 Updated staging
 Questions/Discussions
Overall Survival Data-RUBY Trial-Part 1
 Phase 3 randomized trial for advanced or recurrent endometrial
cancer (including carcinosarcoma)
 Carboplatin/paclitaxel+dostarlimab vs.Carboplatin/paclitaxel+placebo
 Maintenance : dostarlimab vs. placebo q 6 weeks up to 3 years, until
dz progression
 7 month improvement in survival in dostarlimab group in pMMR
 Side effect profile safe
• Fatigue, hair loss, anemia, peripheral neuropathy, nausea (both
arms)
Statistically Significant OS Benefit in Overall Population
Primary endpoint
aMedian expected duration of follow-up; range 31.0–49.5 months.
CP, carboplatin-paclitaxel; HR, hazard ratio; NE, not estimable; OS, overall survival.
Dostarlimab + CP
Median (95% CI), mo Events, n/N (%)
Dostarlimab + CP
Placebo + CP
44.6 (32.6–NE)
28.2 (22.1–35.6)
109/245 (44.5%)
144/249 (57.8%)
70.1%
54.9%
54.3%
42.9%
Placebo + CP
HR, 0.69
(95% CI, 0.54–0.89)
P=0.002
Median duration of
follow-up, 37.2 monthsa
100
80
60
40
20
0
Time since randomization, mo
Probability
of
survival,
%
No. at risk(events)
Dostarlimab + CP 245(0) 239(3) 232(9) 223(16) 211(27) 201(37) 198(40) 188(48) 184(51) 181(54) 175(60) 168(67) 164(71) 154(80) 146(86) 137(93) 118(98) 95(102) 70(104) 52(107) 37(107) 17(108) 6(108) 2(109) 0(109)
Placebo + CP 249(0) 244(3) 239(8) 228(18) 223(23) 210(36) 197(47) 181(63) 168(74) 156(84) 143(97) 135(105) 127(111) 122(116) 117(120) 112(123) 96(127) 78(131) 53(134) 39(139) 22(142) 13(143) 4(144) 2(144) 0(144)
OS maturity 253/494 (51.2%) Censored
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48
Scan for slides
38.2% of patients in the placebo + CP arm
received subsequent immunotherapy
Substantial OS Benefit in dMMR/MSI-H Populationa
aOverall survival in the dMMR/MSI-H and MMRp/MSS populations was a prespecified exploratory endpoint. bMedian expected duration of follow-up; range 31.0–48.7 months.
CP, carboplatin-paclitaxel; dMMR, mismatch repair deficient; HR, hazard ratio; MSI-H, microsatellite instability high; NE, not estimable; OS, overall survival.
53(0)
65(0)
52(1)
63(2)
50(3)
62(3)
48(5)
59(6)
46(6)
56(9)
45(7)
55(10)
45(7)
51(13)
44(7)
48(16)
44(7)
43(20)
34(10)
23(32)
28(11)
19(33)
19(11)
12(33)
14(12)
11(33)
8(12)
7(34)
6(12)
6(34)
2(12)
1(35)
1(12)
0(35)
0(12)
Dostarlimab + CP
No. at risk(events)
Dostarlimab + CP
Placebo + CP
Probability
of
survival,
%
82.8%
78.0%
57.5%
46.0%
Placebo + CP
HR, 0.32
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48
Time since randomization, mo
44(7) 44(7) 43(8) 42(9) 41(9) 41(9) 41(9)
41(21) 39(23) 37(25) 34(27) 33(28) 31(29) 31(29)
100
80
60
40
20
0
Censored
Scan for slides
Median (95% CI), mo Events, n/N (%)
Dostarlimab + CP
Placebo + CP
NE (NE–NE)
31.4 (20.3–NE)
12/53 (22.6%)
35/65 (53.8%)
OS maturity 47/118 (39.8%)
(95% CI, 0.17–0.63)
nominal P=0.0002
Median duration of
follow-up, 36.6 monthsb
41.5% of patients in the placebo + CP arm
received subsequent immunotherapy
Clinically Meaningful OS Difference in MMRp/MSS
Populationa
187(2) 182(6) 175(11) 165(21) 156(30) 153(33) 144(41) 140(44) 137(47) 131(53) 125(59) 122(62) 113(71) 105(77) 96(84) 84(88) 67(91)
181(1) 177(5) 169(12) 167(14) 155(26) 146(34) 133(47) 125(54) 115(63) 104(74) 98(80) 93(84) 89(88) 86(91) 81(94) 73(95) 59(98)
51(93) 38(95) 29(95) 11(96)
41(101) 28(106) 15(108) 7(109)
4(96)
3(109)
1(97)
2(109)
0(97)
0(109)
Dostarlimab + CP
No. at risk(events)
Dostarlimab + CP 192(0)
Placebo + CP 184(0)
66.5%
48.6%
53.2%
41.9%
Placebo + CP
aOverall survival in the dMMR/MSI-H and MMRp/MSS populations was a prespecified exploratory endpoint. bMedian expected duration of follow-up; range 31.2–49.5 months.
CP, carboplatin-paclitaxel; HR, hazard ratio; MMRp, mismatch repair proficient; MSS, microsatellite stable; NE, not estimable; OS, overall survival.
Probability
of
survival,
%
Time since randomization, mo
100
80
60
40
20
0
Scan for slides
HR, 0.79
(95% CI, 0.60–1.04)
nominal P=0.0493
Median duration of
follow-up, 37.5 monthsb
Median (95% CI), mo Events, n/N (%)
Dostarlimab + CP
Placebo + CP
34.0 (28.6–NE)
27.0 (21.5–35.6)
97/192 (50.5%)
109/184 (59.2%)
OS maturity 206/376 (54.8%) Censored
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48
37.0% of patients in the placebo + CP arm
received subsequent immunotherapy
Overall survival and Progression free survival
by PD-L1 Status- NRG-GY018 Trial
 Phase 3 randomized trial for advanced or recurrent endometrial cancer
(EXCLUDING carcinosarcoma)
 Carboplatin/paclitaxel+pembrolizumab vs.Carboplatin/paclitaxel+placebo
 Maintenance : pembrolizumab vs. placebo q 6 weeks up to 14 cycles (84
weeks), until dz progression
 OS and PFS in dMMR and pMMR and impace of PD-L1 expression
 Data is still maturing
 Suggests a benefit of adding pembrolizumab to chemotherapy for advanced or
recurrent endometrial cancer
Database cutoff: Dec 6, 2022.
Pembrolizumab Improved PFS Regardless
of PD-L1 Status
pMMR Population
Events,
n/N
Median PFS
(95% CI), mo
HR (95% CI)
Pembro + CT 21/80 15.1 (11.1–NR)
0.44 (0.26–0.75)
Placebo + CT 37/83 11.0 (8.3–11.4)
Events,
n/N
Median PFS
(95% CI), mo
HR (95% CI)
Pembro + CT 71/208 13.1 (9.1–19.8)
0.59 (0.43–0.80)
Placebo + CT 100/205 8.5 (8.0–10.7)
PD-L1 CPS ≥1 PD-L1 CPS <1
Pembrolizumab Improved PFS Regardless
of PD-L1 Status
dMMR Population
Database cutoff: Dec 16, 2022.
Events,
n/N
Median PFS
(95% CI), mo
HR (95% CI)
Pembro + CT 10/22 12.0 (6.5–NR)
0.30 (0.11–0.83)
Placebo + CT 9/14 4.9 (4.2–9.9)
Events,
n/N
Median PFS
(95% CI), mo
HR (95% CI)
Pembro + CT 18/86 NR (NR–NR)
0.27 (0.16–0.47)
Placebo + CT 51/97 8.3 (6.5–14.1)
PD-L1 CPS ≥1 PD-L1 CPS <1
Dostarlimab
(500 mg IV
Q3W)
+
CPd (Q3W)
Placebo IV
(Q3W)
+
CPd (Q3W)
Dostarlimab
1000 mg IV Q6W up to 3 yearse
+
Niraparib
200 or 300 mgf QD up to 3 yearse
Placebo IV
Q6W up to 3 yearse
Placebo PO
QD up to 3 yearse
Follow-
up
R 2:1
Eligible patients
• Stage III/IV disease or first
recurrent ECa
• All histologies except
sarcomasb
• Naive to systemic
anticancer therapy or had
a recurrence or PD ≥6
months after completing
systemic anticancer therapy
• Naive to PARP inhibitor
therapy
Stratification
• MMR/MSI statusc
• 25% dMMR/MSI-H
• 75% MMRp/MSS
• Prior external pelvic
radiotherapy
• Disease status
On-study imaging assessments were performed Q6W (±7 days) from the randomization date until week 25 (cycle 8), followed by Q9W (±7 days) until week 52. Subsequent tumor imaging was performed every 12 weeks (±7 days) until radiographic PD was documented by investigator assessment per
RECIST v1.1 followed by 1 additional imaging 4–6 weeks later, or subsequent anticancer therapy was started, whichever occurred first. Thereafter, scans were performed per standard of care.
aHistologically/cytologically proven advanced or recurrent EC; stage III/IV disease or first recurrent EC with low potential for cure by radiation therapy or surgery alone or in combination. bCarcinosarcoma, clear cell, serous, or mixed histology permitted (mixed histology containing ≥10% carcinosarcoma,
clear cell, or serous histology). cPatients were randomized based on either local or central MMR/MSI testing results. Central testing was used with local results were not available. For local determination of MMR/MSI status, IHC, next-generation sequencing, and polymerase chain reaction assays were
accepted. For central determination of MMR/MSI status IHC per Ventana MMR RxDx panel was used. dCarboplatin AUC 5 mg/mL/min and paclitaxel 175 mg/m2. eTreatment ends after 3 years, PD, toxicity, withdrawal of consent, investigator’s decision, or death, whichever occurs first. Continued treatment
with dostarlimab or placebo beyond 3 years may be considered following discussion between the sponsor and the investigator. fDose of 300 mg in patients with body weight ≥77 kg and platelet count ≥150,000/µL and 200 mg in patients with body weight <77 kg or platelet count <150,000/µL or both. AUC,
area under the plasma or serum concentration-time curve; BICR, blinded independent central review; BOR, best overall response; CP, carboplatin-paclitaxel; CR, complete response; DCR, disease control rate; dMMR, MMR deficient; DOR, duration of response; EC, endometrial cancer; HRQOL, health-
related quality of life; IHC, immunohistochemistry; INV, investigator assessment; MMR, mismatch repair; MMRp, MMR proficient; MSI, microsatellite instability; MSI-H, MSI high; MSS, microsatellite stable; ORR, objective response rate; OS, overall survival; PARP, poly(ADP-ribose) polymerase; PD,
progressive disease; PFS, progression-free survival; PK, pharmacokinetic; PO, by mouth; PR, partial response; PRO, patient-reported outcome; Q3W,every 3 weeks; Q6W,every 6 weeks; Q9W,every 9 weeks; QD, once daily; R, randomization; RECIST v1.1, Response Evaluation Criteria in Solid
Tumors version 1.1; SD, stable disease.
Primary endpoint
• PFS by INV
per RECIST v1.1
• Overall
• MMRp/MSS
Secondary endpoints
• OS
• PFS by BICR
• ORR
• DOR
• DCR (BOR of CR,
PR, or SD)
• PFS2
• HRQOL/PRO
• PK
(6 cycles)
(6 cycles)
N=192
N=99
ENGOT-EN6-NSGO/GOG-3031/RUBY Part 2
Scan for slides
49.5% of patients in the dostarlimab + niraparib + CP arm and 69.7% of patients in the placebos + CP arm had experienced progression or death as of the data cutoff date.
CP, carboplatin-paclitaxel; dostar, dostarlimab; HR, hazard ratio; nira, niraparib; PFS, progression-free survival.
No. at risk (events)
Dostarlimab + niraparib +CP 192(0) 169(7) 155(15) 131(32) 104(51) 91(63) 84(69) 79(73) 68(84) 43(92) 37(92) 16(94) 6(94) 3(95) 2(95) 0(95)
Placebo IV + placebo oral + CP 99(0) 96(1) 86(9) 66(25) 43(45) 31(56) 27(59) 26(59) 19(66) 14(68) 10(68) 6(69) 2(69) 1(69) 0(69)
HR, 0.60
(95% CI, 0.43–0.82)
P=0.0007
57.0%
33.7%
Dostar +
nira + CP
Placebo IV +
placebo oral + CP
Probability
of
PFS,
%
Median expected duration of follow-up, 19.0 months
Dostar + nira + CP
Placebos + CP
0 2 4
Chemotherapy period
Median (95%CI), mo
14.5 (11.8–17.4)
8.3 (7.6–9.8)
8 10
100
80
60
40
20
0
12 14 16 18 20 22 24 26 28 30
6
Statistically Significant PFS Benefit in Overall Population
Primary endpoint
Time since randomization, mo
PFS maturity: 56.4%
Scan for slides
 Niraparib is a PARP inhibitor which is used as a maintenance drug,
currently in ovarian cancer.
 PARP inhibitor inhibit cancer cells from repairing itself cell death
 Study limited in the lack of arm with dostarlimab only
 Side effects
ENGOT-EN6-NSGO/GOG-3031/RUBY Part 2
0
20
40
60
80
100
TEAEs in ≥25% of Patients in Either Arm
Any grade
Grade ≥3
Any grade
Grade ≥3
0 20 40 60
Patients, % Patients, %
CP, carboplatin-paclitaxel; dostar, dostarlimab; nira, niraparib; TEAE, treatment-emergent adverse event.
80 100
Dostar + CP followed by dostar + nira (N=191) Placebo + CP followed by placebo (N=96)
Nausea
Fatigue
Anemia
Alopecia
Peripheral
neuropathy
Arthralgia
59.7 3.1
52.4 2.6 2.1 42.7
49.7 22.5 13.5 47.9
43.5 0.5 0
0 50.0
36.5
35.1 0 Constipation 0 30.2
33.0 32.3
2.1 1.0
0.5 0
29.3 29.2
28.8
26.7
28.1
14.6
3.7
3.7 Vomiting 1.0
Diarrhea 2.1
Scan for slides
New Drugs on the Horizon
Phase 2
Antibody Drug Conjugate (ADC)
 Antibody Drug Conjugate (ADC): monoclonal antibody toward a SPECIFIC
target on a cancer cell (less likely normal cells) which is attached to a drug
and a linker (also known as a conjugate)
 Lots of new drugs on horizon are ADC’s
 The Ideal ADC:
1. Targets a specific cancer antigen while not harming healthy cells
2. A strong small drug with high toxicity to a cancer cell which results in death
once internalized in the tumor cell
3. A stable linker (conjugate) that can release the drug in
4. Monoclonal antibodies linked to small cytotoxic preparations that focus on the
specific cancer cell to reduce side effects
Pettinato MC. Introduction to Antibody-Drug Conjugates. Antibodies (Basel). 2021 Oct 27;10(4):42.
doi: 10.3390/antib10040042. PMID: 34842621; PMCID: PMC8628511.
DESTINY-PanTumor02
 T-Dxd (trastuzumab deruxtecan) HER 2 target; FDA approved in breast cancer
 The DESTINY-PanTumor02 looked in endometrial, ovarian and cervical cancer
tumors which express Her2Neu
 Endometrial cancer tumors which express Her2 (+2 or +3)
100 0 100 0
0 20 40
ORR in all patients, and by central IHC status and
number of prior regimens
20/31 (64.5%)
60 80
Error bars represent 95% confidence intervals
*In patients with IHC 1+/0/unknown by central testing, responses were observed in 4/10 patients with endometrial cancer, 6/12 patients with
cervical cancer, and 4/10 patients with ovarian cancer; †one patient with endometrial cancer was reported to have received no prior regimens
IHC, immunohistochemistry; INV, investigator; ORR, objective response rate
All patients
≤1 prior
regimen†
≥2 prior
regimens
Central
IHC 3+*
Central
IHC 2+*
20 80 100
3/9 (33.3%)
18/40 (45.0%)
5/8 (62.5%)
20/40 (50.0%)
4/6 (66.7%)
16/34 (47.1%)
20 40 60 80
Confirmed ORR by INV (%)
11/13 (84.6%) 6/8 (75.0%) 7/11 (63.6%)
8/17 (47.1%) 8/20 (40.0%) 7/19 (36.8%)
13/32 (40.6%)
40 60
Endometrial cancer Cervical cancer Ovarian cancer
23/40 (57.5%)
Safety summary: gynecological cohorts
Analyses were performed in patients who received ≥1 dose of T-DXd (N=120); median total treatment duration was
9.0, 6.0, and 5.9 months in the endometrial, cervical, and ovarian cohorts, respectively
*Included pneumonia (n=1) and organizing pneumonia (n=1); †category includes the preferred terms fatigue, asthenia, and malaise;
‡category includes the preferred terms neutrophil count decreased and neutropenia; §category includes the preferred terms platelet count
decreased and thrombocytopenia;¶all ILD/pneumonitis cases were reviewed by an Adjudication Committee
ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event
11.7
15.0
18.3
6.7
Most common drug-related TEAEs (>10%) in gynecological cohorts
4.2 64.2
6.7 44.2
5.0 32.5
13.3 30.8
19.2 28.3
0.8 27.5
3.3 19.2
0 10 20 30 40 50 60 70 80
n (%)
Gynecological
cohorts N=120
Any drug-related TEAEs 106 (88.3)
Drug-related TEAEs Grade ≥3 54 (45.0)
Serious drug-related TEAEs 18 (15.0)
Drug-related TEAEs associated
with dose discontinuations
7 (5.8)
Drug-related TEAEs associated
with dose interruptions
24 (20.0)
Drug-related TEAEs associated
with dose reductions
35 (29.2)
Drug-related TEAEs associated
with deaths
2 (1.7)*
ILD/pneumonitis adjudicated
as T-DXd related¶, n (%)
Grade 1 Grade 2 Grade 3 Grade 4 Grade 5
Any
grade
Gynecological cohorts N=120 4 (3.3) 8 (6.7) 0 0 1 (0.8) 13 (10.8)
Nausea
Fatigue†
Diarrhea
Anemia
Neutropenia‡
Vomiting
Decreased appetite
Alopecia
Thrombocytopenia§
Transaminases
increased
Grade ≥3
Any grade
New Drugs on the Horizon
Pre-clinical
Tirzepatide
 ~65-70% endometrial cancer is associated with obesity
 Dual-acting GLP-1 (think Ozempic)/GIP receptor agonists (tirzepatide)
Tirzepatide in endometrial cancer mice
model
Tirzepatide Treatment Results
 Drug treatment resulted in less weight overall and tumor weight
 Decreased proliferation of cancer cells (Ki-67) in the mice tumors
 Pro-apoptosis markers were noted in endometrial cancer mice tissue
 Suggestive an innovative strategy in treatment of obesity-related endometrial
cancer
Endometrial Cancer Staging
2009 FIGO Staging
Adjuvant Therapy
- Stage
- Tumor histology
- Tumor grade
- Lymphovascular invasion
- Age
Singh et al Obstetrics and Gynecology International 2013
2023 FIGO Staging
Berek et al Int J Gyncol Obstet 2023
Summary of Major Changes
 Introduction of non-anatomical parameters (stages
I/II) histologic type/grade, LVI, molecular
subgroup
 Subdivision of stage II/IV categories according to
location and size of disease
 Creation of a stage for “synchronous” low grade
endometrioid tumors of endometrium and ovary
Comparison of
2009 and 2023
FIGO Staging
McCluggage et al Int J Gyncol Obstet 2023
Diversity in Clinical Trials
1,437,423
3,886,830
4,500,000
4,000,000
3,500,000
3,000,000
2,500,000
2,000,000
1,500,000
1,000,000
500,000
0
Gynecologic Breast
Breast vs. Gynecologic Cancer Survivors
Findings and Key T
akeaways
• Breast cancer survivorship predominates grant fundings vs.
all gynecologic cancers combined (148 vs. 11 grants)
• Higher total cost per study and survivor for breast cancer
vs. gynecologic cancer
• Unmet need:
Gynecologic cancer survivorship research and support
Clinical Trial Diversity and Inclusion
• Marginalized individuals have highest cancer incidence and
mortality rate
• 2-3% of underrepresented racial and ethnic groups are involved in
clinical trials
• Only 9% of cancer patients are informed of clinical trial
• Up to 2/3 of patients are willing to enroll in trials but are never
offered this option- including black patients (unexpected findings)
• Structural barriers account for 77% of lack of participation in
clinical trials
Pothuri, Gynecol Oncol, 2023
Arias, National Academies Press, 2022
Importance of Diversity in Clinical Trials
• Improve scientific rigor
• Enhance generalizability of data
• Opportunity to receive standard of care/ cutting edge treatment
for minority groups
• Innovation
• Equitable access to research
• Improved patient trust
Questions/Comments/Discussion

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  • 2. Objectives  Review updated Phase 3 randomized clinical trial data  Review Phase 2 clinical trial data  Review what is in development for treatment  Updated staging  Questions/Discussions
  • 3. Overall Survival Data-RUBY Trial-Part 1  Phase 3 randomized trial for advanced or recurrent endometrial cancer (including carcinosarcoma)  Carboplatin/paclitaxel+dostarlimab vs.Carboplatin/paclitaxel+placebo  Maintenance : dostarlimab vs. placebo q 6 weeks up to 3 years, until dz progression  7 month improvement in survival in dostarlimab group in pMMR  Side effect profile safe • Fatigue, hair loss, anemia, peripheral neuropathy, nausea (both arms)
  • 4. Statistically Significant OS Benefit in Overall Population Primary endpoint aMedian expected duration of follow-up; range 31.0–49.5 months. CP, carboplatin-paclitaxel; HR, hazard ratio; NE, not estimable; OS, overall survival. Dostarlimab + CP Median (95% CI), mo Events, n/N (%) Dostarlimab + CP Placebo + CP 44.6 (32.6–NE) 28.2 (22.1–35.6) 109/245 (44.5%) 144/249 (57.8%) 70.1% 54.9% 54.3% 42.9% Placebo + CP HR, 0.69 (95% CI, 0.54–0.89) P=0.002 Median duration of follow-up, 37.2 monthsa 100 80 60 40 20 0 Time since randomization, mo Probability of survival, % No. at risk(events) Dostarlimab + CP 245(0) 239(3) 232(9) 223(16) 211(27) 201(37) 198(40) 188(48) 184(51) 181(54) 175(60) 168(67) 164(71) 154(80) 146(86) 137(93) 118(98) 95(102) 70(104) 52(107) 37(107) 17(108) 6(108) 2(109) 0(109) Placebo + CP 249(0) 244(3) 239(8) 228(18) 223(23) 210(36) 197(47) 181(63) 168(74) 156(84) 143(97) 135(105) 127(111) 122(116) 117(120) 112(123) 96(127) 78(131) 53(134) 39(139) 22(142) 13(143) 4(144) 2(144) 0(144) OS maturity 253/494 (51.2%) Censored 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 Scan for slides 38.2% of patients in the placebo + CP arm received subsequent immunotherapy
  • 5. Substantial OS Benefit in dMMR/MSI-H Populationa aOverall survival in the dMMR/MSI-H and MMRp/MSS populations was a prespecified exploratory endpoint. bMedian expected duration of follow-up; range 31.0–48.7 months. CP, carboplatin-paclitaxel; dMMR, mismatch repair deficient; HR, hazard ratio; MSI-H, microsatellite instability high; NE, not estimable; OS, overall survival. 53(0) 65(0) 52(1) 63(2) 50(3) 62(3) 48(5) 59(6) 46(6) 56(9) 45(7) 55(10) 45(7) 51(13) 44(7) 48(16) 44(7) 43(20) 34(10) 23(32) 28(11) 19(33) 19(11) 12(33) 14(12) 11(33) 8(12) 7(34) 6(12) 6(34) 2(12) 1(35) 1(12) 0(35) 0(12) Dostarlimab + CP No. at risk(events) Dostarlimab + CP Placebo + CP Probability of survival, % 82.8% 78.0% 57.5% 46.0% Placebo + CP HR, 0.32 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 Time since randomization, mo 44(7) 44(7) 43(8) 42(9) 41(9) 41(9) 41(9) 41(21) 39(23) 37(25) 34(27) 33(28) 31(29) 31(29) 100 80 60 40 20 0 Censored Scan for slides Median (95% CI), mo Events, n/N (%) Dostarlimab + CP Placebo + CP NE (NE–NE) 31.4 (20.3–NE) 12/53 (22.6%) 35/65 (53.8%) OS maturity 47/118 (39.8%) (95% CI, 0.17–0.63) nominal P=0.0002 Median duration of follow-up, 36.6 monthsb 41.5% of patients in the placebo + CP arm received subsequent immunotherapy
  • 6. Clinically Meaningful OS Difference in MMRp/MSS Populationa 187(2) 182(6) 175(11) 165(21) 156(30) 153(33) 144(41) 140(44) 137(47) 131(53) 125(59) 122(62) 113(71) 105(77) 96(84) 84(88) 67(91) 181(1) 177(5) 169(12) 167(14) 155(26) 146(34) 133(47) 125(54) 115(63) 104(74) 98(80) 93(84) 89(88) 86(91) 81(94) 73(95) 59(98) 51(93) 38(95) 29(95) 11(96) 41(101) 28(106) 15(108) 7(109) 4(96) 3(109) 1(97) 2(109) 0(97) 0(109) Dostarlimab + CP No. at risk(events) Dostarlimab + CP 192(0) Placebo + CP 184(0) 66.5% 48.6% 53.2% 41.9% Placebo + CP aOverall survival in the dMMR/MSI-H and MMRp/MSS populations was a prespecified exploratory endpoint. bMedian expected duration of follow-up; range 31.2–49.5 months. CP, carboplatin-paclitaxel; HR, hazard ratio; MMRp, mismatch repair proficient; MSS, microsatellite stable; NE, not estimable; OS, overall survival. Probability of survival, % Time since randomization, mo 100 80 60 40 20 0 Scan for slides HR, 0.79 (95% CI, 0.60–1.04) nominal P=0.0493 Median duration of follow-up, 37.5 monthsb Median (95% CI), mo Events, n/N (%) Dostarlimab + CP Placebo + CP 34.0 (28.6–NE) 27.0 (21.5–35.6) 97/192 (50.5%) 109/184 (59.2%) OS maturity 206/376 (54.8%) Censored 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 37.0% of patients in the placebo + CP arm received subsequent immunotherapy
  • 7. Overall survival and Progression free survival by PD-L1 Status- NRG-GY018 Trial  Phase 3 randomized trial for advanced or recurrent endometrial cancer (EXCLUDING carcinosarcoma)  Carboplatin/paclitaxel+pembrolizumab vs.Carboplatin/paclitaxel+placebo  Maintenance : pembrolizumab vs. placebo q 6 weeks up to 14 cycles (84 weeks), until dz progression  OS and PFS in dMMR and pMMR and impace of PD-L1 expression  Data is still maturing  Suggests a benefit of adding pembrolizumab to chemotherapy for advanced or recurrent endometrial cancer
  • 8. Database cutoff: Dec 6, 2022. Pembrolizumab Improved PFS Regardless of PD-L1 Status pMMR Population Events, n/N Median PFS (95% CI), mo HR (95% CI) Pembro + CT 21/80 15.1 (11.1–NR) 0.44 (0.26–0.75) Placebo + CT 37/83 11.0 (8.3–11.4) Events, n/N Median PFS (95% CI), mo HR (95% CI) Pembro + CT 71/208 13.1 (9.1–19.8) 0.59 (0.43–0.80) Placebo + CT 100/205 8.5 (8.0–10.7) PD-L1 CPS ≥1 PD-L1 CPS <1
  • 9. Pembrolizumab Improved PFS Regardless of PD-L1 Status dMMR Population Database cutoff: Dec 16, 2022. Events, n/N Median PFS (95% CI), mo HR (95% CI) Pembro + CT 10/22 12.0 (6.5–NR) 0.30 (0.11–0.83) Placebo + CT 9/14 4.9 (4.2–9.9) Events, n/N Median PFS (95% CI), mo HR (95% CI) Pembro + CT 18/86 NR (NR–NR) 0.27 (0.16–0.47) Placebo + CT 51/97 8.3 (6.5–14.1) PD-L1 CPS ≥1 PD-L1 CPS <1
  • 10. Dostarlimab (500 mg IV Q3W) + CPd (Q3W) Placebo IV (Q3W) + CPd (Q3W) Dostarlimab 1000 mg IV Q6W up to 3 yearse + Niraparib 200 or 300 mgf QD up to 3 yearse Placebo IV Q6W up to 3 yearse Placebo PO QD up to 3 yearse Follow- up R 2:1 Eligible patients • Stage III/IV disease or first recurrent ECa • All histologies except sarcomasb • Naive to systemic anticancer therapy or had a recurrence or PD ≥6 months after completing systemic anticancer therapy • Naive to PARP inhibitor therapy Stratification • MMR/MSI statusc • 25% dMMR/MSI-H • 75% MMRp/MSS • Prior external pelvic radiotherapy • Disease status On-study imaging assessments were performed Q6W (±7 days) from the randomization date until week 25 (cycle 8), followed by Q9W (±7 days) until week 52. Subsequent tumor imaging was performed every 12 weeks (±7 days) until radiographic PD was documented by investigator assessment per RECIST v1.1 followed by 1 additional imaging 4–6 weeks later, or subsequent anticancer therapy was started, whichever occurred first. Thereafter, scans were performed per standard of care. aHistologically/cytologically proven advanced or recurrent EC; stage III/IV disease or first recurrent EC with low potential for cure by radiation therapy or surgery alone or in combination. bCarcinosarcoma, clear cell, serous, or mixed histology permitted (mixed histology containing ≥10% carcinosarcoma, clear cell, or serous histology). cPatients were randomized based on either local or central MMR/MSI testing results. Central testing was used with local results were not available. For local determination of MMR/MSI status, IHC, next-generation sequencing, and polymerase chain reaction assays were accepted. For central determination of MMR/MSI status IHC per Ventana MMR RxDx panel was used. dCarboplatin AUC 5 mg/mL/min and paclitaxel 175 mg/m2. eTreatment ends after 3 years, PD, toxicity, withdrawal of consent, investigator’s decision, or death, whichever occurs first. Continued treatment with dostarlimab or placebo beyond 3 years may be considered following discussion between the sponsor and the investigator. fDose of 300 mg in patients with body weight ≥77 kg and platelet count ≥150,000/µL and 200 mg in patients with body weight <77 kg or platelet count <150,000/µL or both. AUC, area under the plasma or serum concentration-time curve; BICR, blinded independent central review; BOR, best overall response; CP, carboplatin-paclitaxel; CR, complete response; DCR, disease control rate; dMMR, MMR deficient; DOR, duration of response; EC, endometrial cancer; HRQOL, health- related quality of life; IHC, immunohistochemistry; INV, investigator assessment; MMR, mismatch repair; MMRp, MMR proficient; MSI, microsatellite instability; MSI-H, MSI high; MSS, microsatellite stable; ORR, objective response rate; OS, overall survival; PARP, poly(ADP-ribose) polymerase; PD, progressive disease; PFS, progression-free survival; PK, pharmacokinetic; PO, by mouth; PR, partial response; PRO, patient-reported outcome; Q3W,every 3 weeks; Q6W,every 6 weeks; Q9W,every 9 weeks; QD, once daily; R, randomization; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease. Primary endpoint • PFS by INV per RECIST v1.1 • Overall • MMRp/MSS Secondary endpoints • OS • PFS by BICR • ORR • DOR • DCR (BOR of CR, PR, or SD) • PFS2 • HRQOL/PRO • PK (6 cycles) (6 cycles) N=192 N=99 ENGOT-EN6-NSGO/GOG-3031/RUBY Part 2 Scan for slides
  • 11. 49.5% of patients in the dostarlimab + niraparib + CP arm and 69.7% of patients in the placebos + CP arm had experienced progression or death as of the data cutoff date. CP, carboplatin-paclitaxel; dostar, dostarlimab; HR, hazard ratio; nira, niraparib; PFS, progression-free survival. No. at risk (events) Dostarlimab + niraparib +CP 192(0) 169(7) 155(15) 131(32) 104(51) 91(63) 84(69) 79(73) 68(84) 43(92) 37(92) 16(94) 6(94) 3(95) 2(95) 0(95) Placebo IV + placebo oral + CP 99(0) 96(1) 86(9) 66(25) 43(45) 31(56) 27(59) 26(59) 19(66) 14(68) 10(68) 6(69) 2(69) 1(69) 0(69) HR, 0.60 (95% CI, 0.43–0.82) P=0.0007 57.0% 33.7% Dostar + nira + CP Placebo IV + placebo oral + CP Probability of PFS, % Median expected duration of follow-up, 19.0 months Dostar + nira + CP Placebos + CP 0 2 4 Chemotherapy period Median (95%CI), mo 14.5 (11.8–17.4) 8.3 (7.6–9.8) 8 10 100 80 60 40 20 0 12 14 16 18 20 22 24 26 28 30 6 Statistically Significant PFS Benefit in Overall Population Primary endpoint Time since randomization, mo PFS maturity: 56.4% Scan for slides
  • 12.  Niraparib is a PARP inhibitor which is used as a maintenance drug, currently in ovarian cancer.  PARP inhibitor inhibit cancer cells from repairing itself cell death  Study limited in the lack of arm with dostarlimab only  Side effects ENGOT-EN6-NSGO/GOG-3031/RUBY Part 2
  • 13. 0 20 40 60 80 100 TEAEs in ≥25% of Patients in Either Arm Any grade Grade ≥3 Any grade Grade ≥3 0 20 40 60 Patients, % Patients, % CP, carboplatin-paclitaxel; dostar, dostarlimab; nira, niraparib; TEAE, treatment-emergent adverse event. 80 100 Dostar + CP followed by dostar + nira (N=191) Placebo + CP followed by placebo (N=96) Nausea Fatigue Anemia Alopecia Peripheral neuropathy Arthralgia 59.7 3.1 52.4 2.6 2.1 42.7 49.7 22.5 13.5 47.9 43.5 0.5 0 0 50.0 36.5 35.1 0 Constipation 0 30.2 33.0 32.3 2.1 1.0 0.5 0 29.3 29.2 28.8 26.7 28.1 14.6 3.7 3.7 Vomiting 1.0 Diarrhea 2.1 Scan for slides
  • 14. New Drugs on the Horizon Phase 2
  • 15. Antibody Drug Conjugate (ADC)  Antibody Drug Conjugate (ADC): monoclonal antibody toward a SPECIFIC target on a cancer cell (less likely normal cells) which is attached to a drug and a linker (also known as a conjugate)  Lots of new drugs on horizon are ADC’s  The Ideal ADC: 1. Targets a specific cancer antigen while not harming healthy cells 2. A strong small drug with high toxicity to a cancer cell which results in death once internalized in the tumor cell 3. A stable linker (conjugate) that can release the drug in 4. Monoclonal antibodies linked to small cytotoxic preparations that focus on the specific cancer cell to reduce side effects Pettinato MC. Introduction to Antibody-Drug Conjugates. Antibodies (Basel). 2021 Oct 27;10(4):42. doi: 10.3390/antib10040042. PMID: 34842621; PMCID: PMC8628511.
  • 16. DESTINY-PanTumor02  T-Dxd (trastuzumab deruxtecan) HER 2 target; FDA approved in breast cancer  The DESTINY-PanTumor02 looked in endometrial, ovarian and cervical cancer tumors which express Her2Neu  Endometrial cancer tumors which express Her2 (+2 or +3)
  • 17. 100 0 100 0 0 20 40 ORR in all patients, and by central IHC status and number of prior regimens 20/31 (64.5%) 60 80 Error bars represent 95% confidence intervals *In patients with IHC 1+/0/unknown by central testing, responses were observed in 4/10 patients with endometrial cancer, 6/12 patients with cervical cancer, and 4/10 patients with ovarian cancer; †one patient with endometrial cancer was reported to have received no prior regimens IHC, immunohistochemistry; INV, investigator; ORR, objective response rate All patients ≤1 prior regimen† ≥2 prior regimens Central IHC 3+* Central IHC 2+* 20 80 100 3/9 (33.3%) 18/40 (45.0%) 5/8 (62.5%) 20/40 (50.0%) 4/6 (66.7%) 16/34 (47.1%) 20 40 60 80 Confirmed ORR by INV (%) 11/13 (84.6%) 6/8 (75.0%) 7/11 (63.6%) 8/17 (47.1%) 8/20 (40.0%) 7/19 (36.8%) 13/32 (40.6%) 40 60 Endometrial cancer Cervical cancer Ovarian cancer 23/40 (57.5%)
  • 18. Safety summary: gynecological cohorts Analyses were performed in patients who received ≥1 dose of T-DXd (N=120); median total treatment duration was 9.0, 6.0, and 5.9 months in the endometrial, cervical, and ovarian cohorts, respectively *Included pneumonia (n=1) and organizing pneumonia (n=1); †category includes the preferred terms fatigue, asthenia, and malaise; ‡category includes the preferred terms neutrophil count decreased and neutropenia; §category includes the preferred terms platelet count decreased and thrombocytopenia;¶all ILD/pneumonitis cases were reviewed by an Adjudication Committee ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event 11.7 15.0 18.3 6.7 Most common drug-related TEAEs (>10%) in gynecological cohorts 4.2 64.2 6.7 44.2 5.0 32.5 13.3 30.8 19.2 28.3 0.8 27.5 3.3 19.2 0 10 20 30 40 50 60 70 80 n (%) Gynecological cohorts N=120 Any drug-related TEAEs 106 (88.3) Drug-related TEAEs Grade ≥3 54 (45.0) Serious drug-related TEAEs 18 (15.0) Drug-related TEAEs associated with dose discontinuations 7 (5.8) Drug-related TEAEs associated with dose interruptions 24 (20.0) Drug-related TEAEs associated with dose reductions 35 (29.2) Drug-related TEAEs associated with deaths 2 (1.7)* ILD/pneumonitis adjudicated as T-DXd related¶, n (%) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Any grade Gynecological cohorts N=120 4 (3.3) 8 (6.7) 0 0 1 (0.8) 13 (10.8) Nausea Fatigue† Diarrhea Anemia Neutropenia‡ Vomiting Decreased appetite Alopecia Thrombocytopenia§ Transaminases increased Grade ≥3 Any grade
  • 19. New Drugs on the Horizon Pre-clinical
  • 20. Tirzepatide  ~65-70% endometrial cancer is associated with obesity  Dual-acting GLP-1 (think Ozempic)/GIP receptor agonists (tirzepatide)
  • 21. Tirzepatide in endometrial cancer mice model
  • 22. Tirzepatide Treatment Results  Drug treatment resulted in less weight overall and tumor weight  Decreased proliferation of cancer cells (Ki-67) in the mice tumors  Pro-apoptosis markers were noted in endometrial cancer mice tissue  Suggestive an innovative strategy in treatment of obesity-related endometrial cancer
  • 24. 2009 FIGO Staging Adjuvant Therapy - Stage - Tumor histology - Tumor grade - Lymphovascular invasion - Age Singh et al Obstetrics and Gynecology International 2013
  • 25. 2023 FIGO Staging Berek et al Int J Gyncol Obstet 2023 Summary of Major Changes  Introduction of non-anatomical parameters (stages I/II) histologic type/grade, LVI, molecular subgroup  Subdivision of stage II/IV categories according to location and size of disease  Creation of a stage for “synchronous” low grade endometrioid tumors of endometrium and ovary
  • 26. Comparison of 2009 and 2023 FIGO Staging McCluggage et al Int J Gyncol Obstet 2023
  • 29. Findings and Key T akeaways • Breast cancer survivorship predominates grant fundings vs. all gynecologic cancers combined (148 vs. 11 grants) • Higher total cost per study and survivor for breast cancer vs. gynecologic cancer • Unmet need: Gynecologic cancer survivorship research and support
  • 30. Clinical Trial Diversity and Inclusion • Marginalized individuals have highest cancer incidence and mortality rate • 2-3% of underrepresented racial and ethnic groups are involved in clinical trials • Only 9% of cancer patients are informed of clinical trial • Up to 2/3 of patients are willing to enroll in trials but are never offered this option- including black patients (unexpected findings) • Structural barriers account for 77% of lack of participation in clinical trials Pothuri, Gynecol Oncol, 2023 Arias, National Academies Press, 2022
  • 31. Importance of Diversity in Clinical Trials • Improve scientific rigor • Enhance generalizability of data • Opportunity to receive standard of care/ cutting edge treatment for minority groups • Innovation • Equitable access to research • Improved patient trust

Editor's Notes

  1. Dostarlimab= Immunotherapy -Binds PD-1 (Blocking interaction of PDL1 and PDL2 on T cells)
  2. Pembro binds PD-1 and block PD-L1