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

Trial ID # NCT02751918
Phase Ib
Drug Class Antibody Drug Conjugates: Mesothelin
Drug Name Anetumab ravtansine
Alternate Drug Names BAY 94-9343, Anti-mesothelin Antibody-Drug Conjugate BAY 94-9343
Drugs in Trial Anetumab ravtansine, Liposomal doxorubicin
Eligible Participant

Mesothelin-positive platinum-resistant cancer

Patients Enrolled

21; median 3 prior therapies (1-10)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, PFS, RP2D, evaluated per RECIST

Biomarkers

Mesothelin protein

Efficacy

RP2D: 6.5mg/kg Ane IV and 30 mg/m2 PLD IV once every three weeks
ORR: 52% (11PR, n=21)
DCR: 86% (11PR, 7SD, n=21)
PFS: 5.5 months

Clinically Significant Adverse Events

Serious AE: any (33%), sudden death not otherwise specified (14%)
Grade 3-4 AE: any (57%), fatigue (24%), decreased neutrophil count (24%), anemia (10%), decreased platelet counts (10%), decreased white blood cell counts (10%)

Conclusion

Promising activity in platinum-resistant mesothelin-positive patients

Reference

Bulat L et al. Phase Ib study of anti-mesothelin antibody drug conjugate anetumab ravtansine in combination with pegylated liposomal doxorubicin in platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. J Clin Oncol (2018) 36 (suppl; abstr 5571)
https://meetinglibrary.asco.org/record/161700/abstract