Drug Class: Antibody Targeted Drug Conjugates

Antibody Drug Conjugates (ADC): FRalpha

Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more 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 2.5 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

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 Prior Therapies 3 Prior Therapies Prior Therapies Not Reported

Antibody Drug Conjugates (ADC): HER2

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

3 Prior Therapies

Antibody Drug Conjugates (ADC): CLDN6

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

4 Prior Therapies

Antibody Drug Conjugates (ADC): CDH6

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

4 Prior Therapies

Antibody Drug Conjugates (ADC): B7H4

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

Prior Therapies Not Reported

Antibody Drug Conjugates (ADC): FRalpha

Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more 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
NCT02606305; FORWARD II Ib/II Bevacizumab, Carboplatin, 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

Encouraging activity of mirvetuximab soravtansine combinations in FRalpha+ patients

Mir+CarboPt:

ORR: 71%
PFS: 15 months

Mir+CarboPt+Bev:

1-2 prior therapies:
ORR: 81%
PFS: 12.0 months

1 prior therapy:
ORR: 90%
PFS: 11.9 months

pub 2018, abs Oct 2020

NCT02606305; FORWARD II Ib/II Carboplatin, 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 combination of carboplatin and mirvetuximab shows encouraging activity in FRalpha+ platinum sensitive patients

ORR: 71%
PFS: 15 months

pub 2018, abs Oct 2020

NCT02606305; FORWARD II-2 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 combination of mirvetuximab soravtansine with bevacizumab demonstrates an encouraging ORR in platinum sensitive patients with high FRalpha expression

ORR: 69%
PFS: 13.3 months

abs Jun 2021 and presentation, Sep 2022 presentation

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
Standard of Care Targeted Drugs
NCT04209855; MIRASOL III Liposomal doxorubicin, Mirvetuximab soravtansine, Paclitaxel, Topotecan Prescribing Information 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

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
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

Drugs in Clinical Development
NCT02631876; FORWARD I III Liposomal doxorubicin, Paclitaxel, Topotecan, Mirvetuximab soravtansine FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Mirvetuximab soravtansine has favorable tolerability and benefit-risk profile compared to chemotherapy in FRalpha high patients

Mir vs TPC (PLD, Pac, Top):

FRalpha high (10X scoring method):

ORR: 24 vs 10%*
PFS: 4.8 vs 3.3 months*

FRalpha high (PS2+ scoring method):

ORR: 26 vs 6%*
PFS: 5.6 vs 3.2 months*
OS: 16.4 vs 11.4 months*

pub 2021

NCT02606305; FORWARD II Ib/II Liposomal doxorubicin, Pembrolizumab, 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

Encouraging activity of mirvetuximab soravtansine with bevacizumab, liposomal doxorubicin or pembrolizumab in FRalpha+ patients

Mir+Bev:
ORR: 39%
PFS: 6.9 months
Mir+PLD:
ORR: 13%
PFS: 7.0 months
Mir+Pem:
ORR: 30%
PFS: 4.2 months

abs May 2017, abs Apr 2018, pub 2020

NCT01609556 I Mirvetuximab soravtansine A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

Mirvetuximab soravtansine shows promising activity in platinum-resistant FRalpha+ patients who had ≤3 prior therapies

≤3 prior therapies vs >3 prior therapies:

ORR: 39 vs 13%
PFS: 6.7 vs 3.9 months

pub 2017; abs Jun 2017

NCT02996825 I Gemcitabine, Mirvetuximab soravtansine A Phase I Dose-Escalation Safety and Tolerability Study of MirvetuximabSoravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC)

Mirvetuximab soravtansine and gemcitabine demonstrate promising activity in platinum resistant ovarian cancer, but with frequent hematologic toxicities

ORR: 40.9%
PFS: 7.5 months

abs Jun 2021 and poster, pub 2024

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

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

*Statistically significant result

Antibody Drug Conjugates (ADC): HER2

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
Standard of Care Targeted Drugs
NCT04482309; DESTINY-PanTumor02 II Trastuzumab deruxtecan Prescribing Information 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 patients with HER2 IHC 3+ expression

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

abs Oct 2023, pub 2024

Drugs in NCCN Guidelines
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 activity in OC patients with HER2 IHC 2+

ORR: 36.8%
PFS: 4.1 months

abs Oct 2023, pub 2024

Antibody Drug Conjugates (ADC): CLDN6

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
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 (ADC): CDH6

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
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 (ADC): B7H4

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
NCT05194072 I Felmetatug vedotin A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

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

ORR: 20%

abs Oct 2023 and presentation

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