Clinical Situation: Platinum-Resistant/Refractory Recurrence

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

1 Prior Therapy 2 Prior Therapies 2.5 Prior Therapies 3 Prior Therapies 4 Prior Therapies 5 Prior Therapies 6 Prior Therapies Prior Therapies Not Reported

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.

Drug Class Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Standard of Care Chemotherapy
Chemotherapy NCT00191607 III Gemcitabine, Liposomal doxorubicin A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy

Comparable efficacy for liposomal doxorubicin and gemcitabine with different toxicity profiles

PLD vs Gem:

ORR: 8.3 vs 6.1%
PFS: 3.1 vs 3.6 months

pub 2007

Chemotherapy Study 30-49; Trial 4 III Liposomal doxorubicin, Topotecan Prescribing Information Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan

Liposomal doxorubicin and topotecan have similar efficacy, but very different toxicity profiles

PLD vs Top:

ORR: 12.3 vs 6.5%
PFS: 2.3 vs 3.4 months

pub 2001

Chemotherapy NCT00023907 II Paclitaxel A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Weekly paclitaxel shows promising activity in Pt-R and Pt-Rf patients

ORR: 20.9%

pub 2006

Standard of Care Targeted Drugs
Angiogenesis Inhibitors: VEGF NCT00976911; AURELIA III Liposomal doxorubicin, Paclitaxel, Topotecan, Bevacizumab Prescribing Information AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Improved ORR and PFS with addition of bevacizumab to liposomal doxorubicin, paclitaxel or topotecan (most evident with paclitaxel), but no OS benefit

Pac/PLD/Top+Bev vs Pac/PLD/Top:

ORR: 28.2 vs 12.5%*
PFS: 6.7 vs 3.4 months*

pub 2014; 2015

Angiogenesis Inhibitors: VEGF UMIN000017247; JGOG3023 II Gemcitabine, Liposomal doxorubicin, Paclitaxel, Topotecan, Bevacizumab An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial-

Retreatment with bevacizumab is effective and AEs are manageable for platinum resistant recurrent ovarian cancer previously treated with bevacizumab for front-line or platinum sensitive recurrence

Gem/Pac/PLD/Top+Bev vs Gem/Pac/PLD/Top:

ORR: 25.0 vs 13.7%
PFS: 4.0 vs 3.1 months*
OS: 15.3 vs 11.3 months

pub 2022

Antibody Drug Conjugates: FRalpha NCT04209855; MIRASOL III Liposomal doxorubicin, Mirvetuximab soravtansine, Paclitaxel, Topotecan MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Mirvetuximab soravtansine is the first treatment to demonstrate a PFS and OS benefit in Pt-R OC compared to single agent chemotherapy

ORR: 42 vs 16%*
PFS: 5.62 vs 3.98 months*
OS: 16.46 vs 12.75 months*

pub 2023

Antibody Drug Conjugates: FRalpha NCT04296890; SORAYA III Mirvetuximab soravtansine Prescribing Information SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Mirvetuximab shows impressive activity and tolerability in FRα-high platinum resistant ovarian cancer

ORR: 32.4%
DoR: 6.9 months
PFS: 4.3 months

pub 2023, abs Mar 2023 and presentation

Drugs in NCCN Guidelines
Chemotherapy Rose (2003) CisPt+Gem II Cisplatin, Gemcitabine Phase II study of cisplatin plus gemcitabine in platinum-resistant and platinum-refractory ovarian cancer

Cisplatin+gemcitabine is active in Pt-R and Pt-Rf patients

ORR: 42.9%
PFS: 6 months

pub 2003

Chemotherapy NCT03093155 II Bevacizumab, Ixabepilone A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

Ixabepilone+bevacizumab is a well-tolerated, effective combination for treatment of platinum/taxane resistant ovarian cancer that extends both PFS/OS relative to ixabepilone monotherapy and prior receipt of bevacizumab should not preclude use of ixabepilone+bevacizumab

Ixa+Bev vs Ixa:
ORR: 33 vs 8%*
PFS: 5.5 vs 2.2 months*
OS: 10.0 vs 6.0 months*

pub 2022

Antibody Drug Conjugates: FRalpha NCT02606305; FORWARD II Ib/II Bevacizumab, Mirvetuximab soravtansine A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

The mirvetuximab soravtansine plus bevacizumab doublet is an active and well-tolerated regimen in patients with FRα-expressing platinum-resistant ovarian cancer. Promising activity is observed for patients regardless of level of FRα expression or prior bevacizumab

ORR: 44%
PFS: 8.2 months

pub 2023

Chemotherapy NCT00002478 II Etoposide Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer

Prolonged etoposide regimen shows activity, but has hematologic toxicity

ORR: 26.8%
PFS: 5.7 months

pub 1998

Chemotherapy NCT00004037 II Docetaxel Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma

Docetaxel shows activity, but with significant hematologic toxicity

ORR: 22.4%
PFS: 2.1 months

pub 2003

Chemotherapy NCT00087087 II Pemetrexed A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma

Pemetrexed has favorable antitumor activity with mild and non-cumulative toxicity

ORR: 21.4%
PFS: 2.9 months

pub 2009

Chemotherapy Retrospective Study: Metronomic Oral Cyclophosphamide (MOC) II Cyclophosphamide Metronomic oral cyclophosphamide (MOC) in the salvage therapy of heavily treated recurrent ovarian cancer patients: a retrospective, multicenter study

Metronomic oral cyclophosphamide may provide a valid alternative for the palliative treatment of heavily pretreated recurrent ovarian cancer

ORR: 15%
DCR: 45%
PFS: 4 months

pub 2014

Antibody Drug Conjugates: HER2 NCT04482309; DESTINY-PanTumor02 II Trastuzumab deruxtecan A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

Trastuzumab Deruxtecan (T-DXd) has a manageable safety profile and shows encouraging ORR and durable clinical benefit in OC, particularly in patients with IHC 3+ expression

ORR: 45%
DoR: 11.3 months
PFS: 5.9 months

HER2 IHC3+: (n=11)
ORR: 63.6%
PFS: 12.5 months

HER2 IHC2+:
ORR: 36.8%
PFS: 4.1 months

abs Oct 2023, pub 2024

Angiogenesis Inhibitors: VEGF NCT00097019 II Bevacizumab A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects With Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed

Bevacizumab has single-agent activity, but risk of GI-related adverse events

ORR: 15.9%
PFS: 4.4 months
OS: 10.7 months

pub 2007

Angiogenesis Inhibitors: VEGF NCT02853318 II Bevacizumab, Cyclophosphamide, Pembrolizumab A Phase II Evaluation of Pembrolizumab in Combination With IV Bevacizumab and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Bevacizumab+pembrolizumab+cyclophosphamide is well tolerated and demonstrates clinical benefit and durable treatment responses

ORR: 43.3%
DCR: 95%
PFS: 7.6 months

pub 2020

Angiogenesis Inhibitors: VEGF Retrospective Study: Bevacizumab and Cyclophosphamide II Cyclophosphamide, Bevacizumab The combination of intravenous bevacizumab and metronomic oral cyclophosphamide is an effective regimen for platinum-resistant recurrent ovarian cancer

Cyclophosphamide+bevacizumab is an effective, well-tolerated combination in heavily pretreated patients

ORR: 42.4%
PFS: 3 months

pub 2013

Angiogenesis Inhibitors: VEGF UMIN000016619 II Bevacizumab, Gemcitabine A Feasibility Study of Gemcitabin and Bevacizumab in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The combination chemotherapy with gemcitabine and bevacizumab is feasible, effective and safe

ORR: 42%
DCR: 84%
PFS: 5.1 months
OS: 21.3 months

pub 2020

Angiogenesis Inhibitors: Multi-targeted RTK NCT01047891 II Sorafenib, Topotecan A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer

Sorafenib given with topotecan (5-day schedule) and continued as maintenance therapy results in a significant improvement in ORR, PFS and OS

ORR: 31 vs 12%*
PFS: 6.7 vs 4.4 months*
OS: 17.1 vs 10.1 months*

pub 2018

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors: PARP NCT03699449 II Cediranib, Olaparib An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)

Olaparib+cediranib shows promising activity in BRCA MUT patients

ORR: 50%

abs Jun 2021 and poster, pub 2022

DNA Damage Repair Pathway Inhibitors: PARP NCT02889900; CONCERTO II Cediranib, Olaparib A Single Arm, Open-label, Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women With Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer Who do Not Carry a Deleterious or Suspected Deleterious Germline BRCA Mutation

Olaparib+cediranib has manageable toxicity and shows evidence of anti-tumor activity in heavily pretreated platinum resistant non-gBRCA MUT patients

ORR: 15.6%
PFS: 5.1 months

pub 2022

DNA Damage Repair Pathway Inhibitors: PARP NCT03574779 II Dostarlimab, Bevacizumab, Niraparib A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL)

Triplet therapy with niraparib, dostarlimab, and bevacizumab is tolerable and demonstrates clinical activity in patients with BRCA WT Pt-R OC without HRR gene mutations

ORR: 17.9%
DCR: 76.9%
PFS: 7.6 months

w/ prior Bev: ORR: 6%
w/o prior Bev: ORR: 27%

abs Mar 2021

DNA Damage Repair Pathway Inhibitors: PARP NCT02657889; TOPACIO I/II Pembrolizumab, Niraparib Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer (TOPACIO)

Promising activity of niraparib+pembrolizumab in platinum resistant patients independent of BRCA status, HRD status and PD-L1 expression

ORR: 21%

pub 2019

DNA Damage Repair Pathway Inhibitors: ATR NCT02595892 II Berzosertib, Gemcitabine Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer

Addition of berzosertib to gemcitabine increases PFS without additional toxicity, the benefit was observed mainly in patients with platinum-free interval less than 3 months

Ber+Gem vs Gem:

PFS: 5.7 vs 3.7 months*

pub 2020, pub 2021

Antibody Drug Conjugates: FRalpha NCT03386942 I Farletuzumab ecteribulin A Phase 1 Study of MORAb-202 in Subjects With Solid Tumors

Anti-tumor activity is seen with both the farletuzumab ecteribulin (MORAb-202) 0.9 mg/kg and 1.2 mg/kg doses and efficacy is observed irrespective of FRalpha-expression levels

0.9 mg/kg (n=24):

ORR: 25%
DoR: 10.6 months
PFS: 6.7 months
OS: 10.5 months

1.2 mg/kg (n=21)

ORR: 52.4%
DoR: 7.6 months
PFS: 8.2 months
OS: NR

Abs Jun 2022 and posters

Antibody Drug Conjugates: FRalpha NCT03748186 I Luveltamab tazevibulin A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody-Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers

Luveltamab tazevibulin (STRO-002) is well tolerated with evidence of anti-tumor activity in heavily pretreated patients across a broad range of FRα expression levels. No ocular toxicity signals have been observed.

All patients:
ORR: 31.7%
PFS: 4.3 months

FR alpha TPS > 25%:
ORR: 37.5%
PFS: 6.1 months

abs Jun 2021 and poster, abs Jun 2023 and presentation

Antibody Drug Conjugates: CLDN6 NCT05103683 I TORL-1-23 A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

TORL-1-23 has a favorable safety/tolerability profile with encouraging preliminary anti-tumor activity in heavily-pretreated CLDN6-expressing ovarian cancer

ORR: 33.3%

Doses of 2.4 mg/kg or 3.0 mg/kg: (n=12)
ORR: 58%

abs Oct 2023 and poster, press release Jan 2024

Antibody Drug Conjugates: CDH6 NCT04707248 I Raludotatug deruxtecan Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

Raludotatug deruxtecan (DS-6000a) is generally well tolerated and demonstrates encouraging clinical activity in heavily pretreated Pt-R OC without CDH6 preselection

ORR: 46%
DCR: 98%
DoR: 11.2 months
PFS: 7.9 months

abs Oct 2023 and presentation

Antibody Drug Conjugates: B7H4 NCT05194072 I SGN-B7H4V A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

SGN-B7H4V shows a manageable safety profile and durable responses are observed in high grade serous OC

ORR: 20%

abs Oct 2023 and presentation

Angiogenesis Inhibitors: VEGF NCT02873962 II Nivolumab, Bevacizumab A Phase II Study With a Safety lead-in of Nivolumab in Combination With Bevacizumab or in Combination With Bevacizumab and Rucaparib for the Treatment of Relapsed Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Bevacizumab+nivolumab shows activity in Pt-R patients, independent of PD-L1 expression

ORR: 16.7%
CBR: 33.3%
PFS: 7.7 months

pub 2019

Angiogenesis Inhibitors: VEGF/DLL4 NCT03030287 Ib Navicixizumab, Paclitaxel A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Promising activity of navicixizumab+paclitaxel in heavily pretreated patients

ORR: 43.2%
PFS: 7.2 months

pub 2022

Angiogenesis Inhibitors: Multi-targeted RTK NCT03797326 II Lenvatinib, Pembrolizumab A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

Lenvatinib+pembrolizumab demonstrates encouraging efficacy and manageable safety in patients with heavily pretreated OC, including those with prior platinum failure and those with previous bevacizumab exposure

ORR: 24%

abs Sep 2020

Angiogenesis Inhibitors: Multi-targeted RTK NCT02584478 Ia/II/III Anlotinib, Liposomal doxorubicin, Paclitaxel, Topotecan A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma

Anlotinib demonstrates positive combined synergic efficacy with chemotherapy in platinum resistant ovarian cancer

Anl+Pac, PLD or Top:
ORR: 43%
PFS: 6.3 months

abs Oct 2022

Angiogenesis Inhibitors: Multi-targeted RTK NCT02788708 I Lenvatinib, Paclitaxel Phase I Evaluation of Lenvatinib and Weekly Paclitaxel in Patients With Recurrent Endometrial, Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lenvatinib+weekly paclitaxel is tolerable with manageable side effects and shows promising response rates in Pt-R OC, also in patients with rare histologies

ORR: 71% (incl. 1 LGS, 2 OCCC, 1 carcinosarcoma)
PFS: 7.2 months

pub 2021

Hormonal Therapy: GR 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

poster Oct 2022, pub 2023

Signaling Pathway Inhibitors: PI3K-AKT-mTOR/PI3Kalpha NCT01623349 I Alpelisib, Olaparib Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer

Encouraging activity of alpelisib+olaparib combination, also in BRCA WT patients

ORR: 34.6%
PFS: 7.2 months

gBRCA WT: ORR: 31.3%
gBRCA MUT: ORR: 33.3% (n=9)
BRCA WT: ORR: 33.3% (n=12)
BRCA MUT: ORR: 30.8% (n=13)

pub 2019

Cell Cycle Inhibitors: CHK1/2 NCT03414047 II ACR-368 A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

ACR-368 (prexasertib) demonstrates durable single agent activity in a subset of patients with platinum resistant HGSOC regardless of clinical characteristics or prior therapy

ORR: 12.1%
DCR: 37.1%

pub 2022

Cell Cycle Inhibitors: Wee1 NCT01164995 II Adavosertib, Carboplatin Phase II Pharmacological Study With Wee-1 Inhibitor MK-1775 Combined With Carboplatin in Patients With p53 Mutated Epithelial Ovarian Cancer and Early Relapse (< 3 Months) or Progression During Standard First Line Treatment

Promising activity of adavosertib+carboplatin combination in TP53-mutated primary platinum resistant and platinum refractory ovarian cancer; a large proportion of responding patient had CCNE1 AMP

ORR: 41%
PFS: 5.6 months

pub 2016, pub 2023

Cell Cycle Inhibitors: Wee1 NCT04516447 I Azenosertib, Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel A Phase 1b Study of ZN-c3 in Combination With Chemotherapy in Patients With Platinum-Resistant Ovarian, Peritoneal or Fallopian Tube Cancer

Azenosertib (ZN-c3), combined with chemotherapy, is well-tolerated and demonstrates clinical activity in patients with Pt-R or Pt-Rf OC

Aze+CarboPt:
ORR: 35.7%; DoR: 11.4 months; PFS: 10.4 months

Aze+Pac:
ORR: 50%; DoR: 5.6 months; PFS: 7.4 months

Aze+Gem: (n=13)
ORR: 38.5%; DoR: 6.2 months; PFS: 8.3 months

Aze+PLD:
ORR: 19.4%; DoR: 7.3 months; PFS: 6.3 months

abs Jun 2023 and poster

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT02440425 II Paclitaxel, Pembrolizumab Phase 2 Trial of Dose Dense (Weekly) Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Recurrent Ovarian Cancer

Pembrolizumab+paclitaxel shows improved ORR and PFS compared to historical results with paclitaxel

ORR: 51.4%
PFS: 6.7 months
OS: 13.4 months

Press release Feb 2020

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT02608684 II Cisplatin, Gemcitabine, Pembrolizumab A Phase II Study of Pembrolizumab With Cisplatin and Gemcitabine Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer

Adding pembrolizumab to cisplatin+gemcitabine and continuing as maintenance treatment results in promising response rates, however the median duration of response is modest and the addition of pembrolizumab does not appear to provide benefit beyond the use of chemotherapy alone in most patients

ORR: 61.1%
PFS: 6.2 months

pub 2021

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT02865811 II Liposomal doxorubicin, Pembrolizumab A Phase II Study of Pembrolizumab Combined With Pegylated Liposomal Doxorubicin (PLD) For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer

Encouraging anti-tumor activity of pembrolizumab+liposomal doxorubicin with acceptable safety profile

ORR: 26.1%
CBR: 52.2%

pub 2020

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT02799095; ARTISTRY-1 I/II Nemvaleukin alfa, Pembrolizumab A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1

Pembrolizumab with Nemvaleukin alfa (ALKS 4230) is well tolerated with encouraging clinical benefit

ORR: 28.6% (n=14)
DoR: 12.3 months

abs Jun 2021 and poster, abs Mar 2022, abs Jun 2022 and presentation

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT03029598 I/II Carboplatin, Pembrolizumab Anti-PD-1 Therapy in Combination With Platinum Chemotherapy for Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Pembrolizumab+carboplatin is well-tolerated and active in recurrent Pt-R OC. A ratio of peripheral T-cell exhaustion to radiographic tumor burden may identify patients more likely to benefit from this chemoimmunotherapy

ORR: 10.3%; DCR: 63%
PFS: 4.6 months
All 7 PD-L1+ patients achieved PR or SD

pub 2021

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT03596281; PEMBOV I Liposomal doxorubicin, Pembrolizumab, Bevacizumab An Open-label Phase 1 of Pembrolizumab in Combination With Bevacizumab and Pegylated Liposomal Doxorubicin in Patients With Platinum Resistant Epithelial Ovarian Cancer

Pembrolizumab+bevacizumab with or without liposomal doxorubicin is well tolerated and demonstrate durable responses in Pt-R OC patients

Bev+Pem:
ORR: 26.3%
PFS: 4.7 months

Bev+PLD+Pem:
ORR: 31.6%
PFS: 4.8 months

abs Nov 2021, abs Jun 2022 and poster

Immunotherapy: Checkpoint Inhibitors/PD-L1 NCT02431559 II Durvalumab, Liposomal doxorubicin Phase 1/2 Study of Chemoimmunotherapy With Toll-like Receptor 8 Agonist Motolimod (VTX-2337) + Anti-PD-L1 Antibody MEDI4736 in Subjects With Recurrent, Platinum-Resistant Ovarian Cancer for Whom Pegylated Liposomal Doxorubicin is Indicated

Durvalumab+liposomal doxorubicin has a tolerable safety profile and promising efficacy

ORR: 22.5%
PFS: 5.5 months
OS: 17.6 months

abs Mar 2020

Immunotherapy: Checkpoint Inhibitors/CTLA-4 NCT04140526 Ia/Ib Gotistobart Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)

ONC-392 as monotherapy shows encouraging anti-tumor activity in ovarian cancer

ORR: 21%
DCR: 50%

abs Nov 2022 and poster

Immunotherapy: Checkpoint Inhibitors/CTLA-4 NCT03860272 I Balstilimab, Botensilimab A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer

Botenlisimab alone or in combination with balstilimab demonstrates clinical activity in platinum resistant OC. Activity is seen both in patients with the low and high affinity FcγRIIIA alleles, unlike first generation anti-CTLA-4 molecules that generally benefit only those patients who express the high affinity allele

Bot:
ORR: 11.1%

Bot+Bal:
ORR: 33%

abs Nov 2022 and slide from presentation, abs Mar 2023 and presentation

Immunotherapy: Checkpoint Inhibitors/PVRIG NCT04570839 I/II BMS-986207, COM701, Nivolumab A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

The combination of COM701 + BMS-986207 + nivolumab is well tolerated and has encouraging durable anti-tumor activity with immune activation in patients with platinum resistant HGSOC and OCCC

ORR: 20%
DCR: 45%

abs Nov 2023 and poster

Immunotherapy: Immune Cell Stimulators/IL-2R NCT02799095; ARTISTRY-1 I/II Nemvaleukin alfa, Pembrolizumab A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1

Nemvaleukin alfa (ALKS 4230) with pembrolizumab is well tolerated with encouraging clinical benefit

ORR: 28.6% (n=14)
DoR: 12.3 months

abs Jun 2021 and poster, abs Mar 2022, abs Jun 2022 and presentation

Oncolytic Viruses NCT02759588; VIRO-15 Ib/II Bevacizumab, Carboplatin, Docetaxel, Gemcitabine, Liposomal doxorubicin, Olvimulogene nanivacirepvec, Paclitaxel Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15)

Patients treated with IP Olvi-Vec-primed immunochemotherapy combined with standard carboplatinum based therapy shows ORR and PFS exceeding historical comparisons and patients’ own last prior therapy. The majority of patients benefit from apparent reversal of platinum resistance

ORR: 54%
PFS: 11.0 months
PFS (6 months): 77%
OS: 15.7 months

pub 2023

Oncolytic Viruses NCT00408590 I MV-NIS Phase I Trial of Intraperitoneal Administration of a) a CEA-Expressing Derivative, and b) a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer

Intraperitoneal administration of MV-NIS is safe with early evidence of antitumor activity and treatment with MV-NIS augments endogenous immunity against tumor antigens

DCR: 81.3%
OS: 26.5 months

pub 2015

*Statistically significant result

< Return to Clinical Situation

< Return to Clinical Trial Results Homepage