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 6 Prior Therapies Prior Therapies Not Reported

Antibody Drug Conjugates (ADC): CD166

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): Mesothelin

Partially Pt-Sensitive/Resistant: Treatment given for recurrence occurring 6-12 months or less than 6 months 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

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

Prior Therapies Not Reported

Antibody Drug Conjugates: MUC16 (CA125)

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: NaPi2b

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: Tissue Factor

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

4 Prior Therapies

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-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

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
NCT02631876; FORWARD I III Liposomal doxorubicin, Mirvetuximab soravtansine, Paclitaxel, Topotecan 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

NCT04296890; SORAYA III Mirvetuximab soravtansine 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%

press release Nov 2021

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

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

Encouraging activity of mirvetuximab soravtansine+bevacizumab in FRalpha+ patients

ORR: 39%
PFS: 6.9 months

pub 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 resistant patients with high FRalpha expression

ORR: 59%
PFS: 9.7 months

abs Jun 2021 and presentation

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+gemcitabine can be combined at clinically relevant doses with promising efficacy, particularly in FRalpha med/high tumors

ORR: 40.9%
PFS: 7.5 months

abs Jun 2021 and poster

NCT03748186 I STRO-002 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

STRO-002 is well tolerated with evidence of anti-tumor activity in heavily pretreated patients. No ocular toxicity signals have been observed. Durable responses and anti-tumor activity have been demonstrated across a broad range of FRα expression levels

Results from dose escalation, doses 2.9 mg/kg and above:

ORR: 32%
CBR: 55%
PFS: 7.2 months

abs Jun 2021 and poster

*Statistically significant result

Antibody Drug Conjugates (ADC): Axl

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
NCT02988817 I/II Enapotamab vedotin First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients With Solid Tumors

Enapotamab Vedotin has a manageable safety profile and encouraging anti-tumor activity in heavily pretreated ovarian cancer patients

ORR: 13% (n=15)

abs Jun 2019

Antibody Drug Conjugates (ADC): CD166

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
NCT03149549 I/II Praluzatamab ravtansine A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

CX-2009 is well tolerated with early evidence of biological activity in Pt-R/Pt-Rf ovarian cancer

ORR: 11.1% (2PR)
DCR: 66.7% (2PR, 10SD)

abs May 2020 and poster

Antibody Drug Conjugates (ADC): Mesothelin

Partially Pt-Sensitive/Resistant: Treatment given for recurrence occurring 6-12 months or less than 6 months 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
NCT01439152 I Anetumab ravtansine An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose of the Anti-mesothelin Antibody Drug Conjugate BAY94-9343 in Subjects With Advanced Solid Tumors

Anetumab ravtansine shows preliminary activity and reversible adverse events in ovarian cancer, particularly in mesothelin+ patients

21 ovarian at 2.2 mg/kg qw:
ORR: 9.5%
DCR: 66.7%
PFS: 2.8 months

pub 2020

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
NCT02751918 Ib Anetumab ravtansine, Liposomal doxorubicin An Open-label Phase Ib Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Maximum Tolerated Dose of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin 30 mg/m2 Given Every 3 Weeks in Subjects With Mesothelin-expressing Platinum-resistant Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Anetumab ravtansine+liposomal doxorubicin shows promising activity in mesothelin-positive patients

ORR: 28%
PFS: 5.1 months

abs sept 2020

Antibody Drug Conjugates: MUC16 (CA125)

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
NCT02146313 I DMUC4064A A Phase I, Open-Label, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of DMUC4064A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer

DMUC4064A shows anti-tumor activity with acceptable safety profile

ORR: 24.6%
PFS: 3.9 months

pub 2021

Antibody Drug Conjugates: NaPi2b

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
NCT03319628 Ib/II Upifitamab rilsodotin A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b

UpRi (XMT-1536) is well tolerated and shows promising signs of anti-tumor activity in platinum resistant ovarian cancer

ORR: 23%
DCR: 72%

NaPi2b High (TPS≥75):
ORR: 34%
DCR: 87%

abs Oct 2020 and presentation, press release Jan 2021, press release Nov 2021

Antibody Drug Conjugates: Tissue Factor

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
NCT02001623 I/II Tisotumab vedotin First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

Promising activity of tisotumab vedotin in heavily pretreated ovarian cancer patients

33 evaluable ovarian:
ORR: 15.2%

pub 2019

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