GYN Studies and PIs

Question 1

Adjuvant Ovary Treatment

Answer 1

Platinum chemo +/- Bev

Question 2

Maintenance Ovary Treatment

Answer 2

1) Obsv
2) Single agent bev
3) Single agent PARP
4) PARP + bev

Question 3

Hou et al key takeaways

Answer 3

1) 69 pts
2) 100% sens/spec - all + pts relapsed, all serially neg pts were disease free
3) CA-125 not prognostic for relapse

Question 4

PARP Poster key takeaways

Answer 4

1) 45 pts
2) ctDNA was predictive of PARP response
3) all pts with rising ctDNA progressed and those serially neg had clinical benefit
4) CA-125 not associated with PFS

Question 5

PAOLA-1

Answer 5

1) ENGOT study, PI Isabelle Ray-Coquard (France)
2) Maintenance escalation
3) Olaparib+bev vs bev

Question 6

PRIMA

Answer 6

1) GOG/ENGOT study, PIs Antonio Martin (GEICO, Spain), Brad Monk (FL Cancer), Bhavna and Floor also authors
2) Maintenance escalation
3) Niraparib vs placebo

Question 7

MONSTAR-ov

Answer 7

1) Japanese trial enrolling
2) Chemo/maintenance escalation
3) Adding bev to chemo and bev to niraparib for ctDNA+ pts

Question 8

DUO-O

Answer 8

1) GOG/ENGOT study, PIs Carol Aghajanian (MSK), Philip Harter (Germany), pharma sponsor AZ
2) Chemo/Maintenance escalation
3) Adding Durva and olaparib to chemo/maintenance

Question 9

GY-036

Answer 9

1) NRG study, PIs Rob Coleman (prev TX Oncology, CMO Vaniam Group), Tom Herzog (UCinncinati), Kathleen Moore (OK)
2) PARP duration 1 vs 2 yrs
3) Study discussion at ASCO GOG - need to discuss further

Question 10

NeoPembrOV

Answer 10

1) ENGOT study, PI Isabelle Ray-Coquard (France)
2) Add Pembro to NAC, ACT and maintenance

Question 11

MK-4830-002

Answer 11

1) Merck study, Lillian Siu (PMCC)
2) Add novel drug 4830 to NAC and ACT

Question 12

Ovary Areas of interest

Answer 12

1) Maintenance escalation and descalation
2) Surveillance and TOMR
3) Maintenance treatment monitoring and discontinuation

Question 13

Stg I Endo ACT

Answer 13

1) HIR/HR go / no-go
2) XRT
3) XRT + chemo

Question 14

Endo surveillance

Answer 14

1) Based on physical exam
2) Limited CA-125/imaging
3) Most recurrences are local to pelvis and curable with XRT
4) Limits scope of TOMR

Question 15

Advanced/Metastatic Endo Treatment

Answer 15

1) Chemo
2) IO
3) IO + PARP +/- TKI

Question 16

Recio Early Endo Paper Take Aways

Answer 16

1) 101 pts
2) 100% NPV - all serially neg remained relapse free
3) 52% PPV for anytime + (median f/u ONLY 3 months!!)

Question 17

GY-020

Answer 17

1) NRG study, PI Floor Backes (OSU)
2) Stg I HIR dMMR EC
3) XRT vs XRT + Pembro
4) Emily contracting with NRG for samples

Question 18

EMERGE-C

Answer 18

1) Pothuri NYU
2) HIR p53wt endo
3) ctDNA neg randomized to obsv vs XRT
4) Working on schema together

Question 19

KN-B21

Answer 19

1) Merck/GOG study; PI Brian Slomovitz (UMiami)
2) High risk endo
3) Adjuvant escalation
4) Adding Pembro to ACT
5) Negative study announced in May 2024
6) Can Signatera help find pts who will benefit (Imvigor)?

Question 20

DUO-E

Answer 20

1) AZ + GOG ; PI Shannon Westin (MDACC)
2) Advanced/recurrent endo
3) Maintenance escalation
4) Obsv vs Durva vs Durva+olaparib
5) Positive readout - now SOC for pMMR

Question 21

RUBY

Answer 21

1) GSK + GOG; PI Mansoor Mirza (Copenhagen University Hospital, Denmark)
2) Advanced/recurrent endo
3) Maintenance escalation
4) Obsv vs dostarlimab - now SOC for dMMR

Question 22

AtTEnd

Answer 22

1)ENGOT; PI Nicoletta Colombo (University of Milan-Bicocca)
2) Advanced/recurrent endo
3) Maintenance escalation
4) Add Atezo to chemo/maintenance - now SOC

Question 23

GY-018

Answer 23

1)NRG ; PI Ramez Eskander (UCSD)
2) Advanced/recurrent endo
3) Maintenance escalation
4) Add Pembro to chemo/maintenance - now SOC
5) Confirmed does not have tps we would need

Question 24

SIENDO

Answer 24

1) ENGOT study, PI Vikki Maker (MSK)
2) Advanced/recurrent endo
3) Maintenance escalation
4) Add Selinexor to maintenance

Question 25

LEAP-001

Answer 25

1) PI Vikki Maker (MSK) 2) Advanced/recurrent endo 3) Maintenance escalation 4) Lenvatinib + Pembro for maintenance 5) failed trial

Question 26

Endo Areas of Interest

Answer 26

1) Adjuvant therapy selection for early EC 2) Advanced/recurrent adjuvant/maintenance therapy escalation 3) Maintenance treatment monitoring and duration 4) Scan on MRD to identify local recurrences sooner?

Question 27

Locally advanced cervical treatment

Answer 27

1) Chemo + XRT 2) Questions on induction chemo before or consolidation chemo after 3) Add Pembro for advanced disease

Question 28

Cervical surveillance

Answer 28

1) one scan 2-4 mns post treatment then wait for clinical symptoms

Question 29

Metastatic cervical treatment

Answer 29

1) Chemo + either bev or IO (Atezo/Pembro)

Question 30

KN-A18

Answer 30

1) GOG/ENGOT study 2) Adding Pembro to CRT

Question 31

INTERLACE

Answer 31

1) GCIG study, PI 2) Adding induction chemo before chemo/xrt

Question 32

Cervical Areas of Interest

Answer 32

1) Is consolidation chemo after CRT needed? 2) Surveillance - frequently symptomatic at recurrence, can we avoid this? 3) IO treatment monitoring and switch non-responders

Question 33

Brad Monk

Answer 33

FL Cancer PI: PRIMA

Question 34

Carol Aghajanian

Answer 34

MSK PI: DUO-O

Question 35

Rob Coleman

Answer 35

Prev TX Oncology, CMO Vaniam Group PI: GY-036

Question 36

Tom Herzog

Answer 36

U Cinncinati PI: GY-036

Question 37

Isabelle Ray-Coquard

Answer 37

France PI: PRIMA, NeoPembrOV

Question 38

Brian Slomovitz

Answer 38

U Miami PI: KN-B21

Question 39

Shannon Westin

Answer 39

MDACC PI: DUO-E

Question 40

Nicoletta Colombo

Answer 40

University of Milan-Bicocca PI: AtTEnd

Question 41

Ramez Eskander

Answer 41

UCSD PI: GY-018

Question 42

Vikki Maker

Answer 42

MSK PI: SIENDO, LEAP-001

Question 43

Questions to Ask Providers

Answer 43

1) Have you seen recent data published in ctDNA? 2) Where do you see the most potential utility for ctDNA? 3) Did you hear about the recent Medicare approval in ovarian cancer? 4) Where would you like to see additional research for ctDNA in GYN malignancies? 5) Any biobanks or opportunity for RWE?

Question 44

Conference Schpeal!

Answer 44

1) So much excitement! Recently received Medicare coverage for ovary and planning to submit for endo. 2) Published papers in ovary and early endo, presented data on PARP and IO monitoring at SGO and working on publishing that 3) Working towards finding biobanks and sample sets to further validate in various settings 4) Interested in Maintenance decision making, monitoring and duration for both ovary and endo, go/no-go ACT decisions in early endo, surveillance, and metastatic treatment monitoring 5) Would love to talk in more detail about any of the above. What areas for ctDNA utility are you most interested in clinically and for research?