Drug Class: Hormonal Therapy

Aromatase Inhibitors

Treatment given for recurrence occurring at any time after last platinum-based treatment

Objective Response Rate (%)

Percentage of patients whose tumors shrink or go away after treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

1 Prior Therapy 3 Prior Therapies

GR Antagonists

Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during last platinum-based treatment

Objective Response Rate (%)

Percentage of patients whose tumors shrink or go away after treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

2.5 Prior Therapies 3 Prior Therapies Prior Therapies Not Reported

Aromatase Inhibitors

First-line treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
Retrospective Study: Adjuvant Hormone Therapy in LGSC Two sites Letrozole, Tamoxifen, Anastrozole Primary cytoreductive surgery and adjuvant hormone therapy in women with advanced low-grade serous carcinoma: Reducing overtreatment without compromising survival?

Promising PFS and OS in Low Grade Serous Cancer patients treated with letrozole, anastrozole, or tamoxifen following cytoreductive surgery

PFS: Not Reached (41 months follow up)
OS: Not Reached (41 months follow up)

Pub 2017

Maintenance after first-line therapy: Treatment to prevent relapse after complete or partial response to therapy

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in NCCN Guidelines
Retrospective Study: Hormonal Maintenance in LGSC II Anastrozole, Letrozole, Tamoxifen Retrospective analysis of Hormonal Maintenance Therapy for Patients With LGS Ovarian Cancer

Significantly longer PFS with hormonal maintenance therapy (HMT) vs. observation (OBS) in Low Grade Serous OC patients

HMT vs OBS:

PFS: 64.9 vs 26.4 months*
OS: 115.7 vs 102.7 months

pub 2017
Drugs in Clinical Development
Letrozole University Hospital Basel Single-site Letrozole Letrozole may be a valuable maintenance treatment in high-grade serous ovarian cancer patients

Promising activity with minimal toxicity of letrozole maintenance in ER-positive patients

Let vs Placebo:

All patients:
RFS: Not Reached vs 13.2 months*

Patients w/o residual disease:
RFS: Not Reached vs 20.8 months

Patients w/ residual disease:
RFS: 21.6 (n=7) vs 8.8 (n=6) months*

pub 2018
*Statistically significant result

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02283658 II Everolimus, Letrozole A Phase 2 Trial of Letrozole and Everolimus in Relapsed Hormone Receptor Positive Ovarian, Fallopian Tube or Primary Peritoneal Carcinomas

Letrozole+everolimus combination shows promising results in ER-positive ovarian cancer

PFS: 3.9 months
OS: 13.0 months

pub 2017
NCT02657928 II Letrozole, Ribociclib A Phase 2 Trial of Ribociclib (LEE011) and Letrozole in ER Positive Relapsed Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinomas, and Endometrial Cancers.

Letrozole+ribociclib is active in ER+ OC with 25% achieving PFS for 23 weeks or longer, but greatest benefit is seen in LGSOC

ORR (HGSOC): 0%
ORR (LGSOC): 100% (n=3)
PFS ≥ 23 weeks: 25%

abs May 2019 and presentation
NCT03673124 II Letrozole, Ribociclib A Phase II Trial of Ribociclib (LEE011) Plus Letrozole in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum

The combination of letrozole plus ribociclib demonstrates promising activity in women with recurrent LGSOC

ORR: 23%
DCR: 79%
DoR: 19.1 months
PFS: 19.1 months

abs Mar 2023 and presentation

Anti-Estrogens

First-line treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
Retrospective Study: Adjuvant Hormone Therapy in LGSC Two sites Anastrozole, Letrozole, Tamoxifen Primary cytoreductive surgery and adjuvant hormone therapy in women with advanced low-grade serous carcinoma: Reducing overtreatment without compromising survival?

Promising PFS and OS in Low Grade Serous Cancer patients treated with hormone therapy following cytoreductive surgery

PFS: Not Reached (41 months follow up)
OS: Not Reached (41 months follow up)

Pub 2017

Maintenance after first-line therapy: Treatment to prevent relapse after complete or partial response to therapy

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in NCCN Guidelines
Retrospective Study: Hormonal Maintenance in LGSC II Anastrozole, Letrozole, Tamoxifen Retrospective analysis of Hormonal Maintenance Therapy for Patients With LGS Ovarian Cancer

Significantly longer PFS with hormonal maintenance therapy (HMT) vs. observation (OBS) in Low Grade Serous OC patients

HMT vs OBS:

PFS: 64.9 vs 26.4 months*
OS: 115.7 vs 102.7 months

pub 2017
*Statistically significant result

ER Antagonists

Neo adjuvant (before surgery) and first-line treatment with/without extended (maintenance) treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT03531645 II Abemaciclib, Fulvestrant A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Neoadjuvant treatment with fulvestrant and abemaciclib is tolerable and demonstrates unprecedented response and complete gross resection rates in Low Grade Serous OC

ORR: 60% (n=15)
DCR: 100%

7 patients w/ IDS:
100% achieved optimal cytoreduction at IDS
(71% R0, 29% R1)

abs Jun 2022 and poster

GR Antagonists

Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT03776812 II nab-Paclitaxel, Relacorilant A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Intermittent relacorilant+nab-paclitaxel improves PFS, DoR and OS and has a favorable safety profile in recurrent platinum resistant ovarian cancer patients who have received prior bevacizumab

Intermittent Rel+Nab vs Nab:

ORR: 35.7 vs 35.8%
PFS: 5.6 vs 3.8 months
DoR: 5.6 vs 3.6 months*
OS: 13.9 vs 12. 2 months

Subgroup of patients similar to patient in ROSELLA Phase III:
 ORR: 40.7 vs 33.3%
PFS: 7.2 vs 3.7 months*
DoR: 5.6 vs 3.4 months*
OS: 17.9 vs 12. 6 months*

pub 2023, abs Mar 2024
*Statistically significant result

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