Solid Tumor - BAY 94-9343 - MSLN expression

Association details:

Biomarker:	MSLN expression
Cancer:	Solid Tumor
Drug:	anetumab ravtansine (BAY 94-9343) (Microtubule inhibitor, Mesothelin-targeted antibody-drug conjugate)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.

Excerpt:

...- Mesothelin expression in the tumor tissue from archival or fresh biopsy samples defined as the membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on at least 30% of tumor cells....

Trial ID:

NCT01439152

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

Excerpt:

...Tumor response based on RECIST (Response Evaluation Criteria in Solid Tumors)`Level of mesothelin expression using IHC (Immunohistochemistry) staining for the tumor tissue obtained from fresh or archival tumor tissue`Plasma levels of soluble mesothelin`Immunogenicity evaluation based on anti-BAY94-9343 antibody count...

Trial ID:

NCT02485119

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

Excerpt:

...- Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis...

Trial ID:

ARCS-Multi

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer

Excerpt:

...- Availability of archival or fresh tissue for testing of mesothelin expression level....

Trial ID:

NCT03023722

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase I Study of Anetumab Ravtansine in Hepatic or Renal Impairment

Excerpt:

...- Histologically or cytologically confirmed, locally advanced or metastatic solid cancers known to express mesothelin on the tumor cell surface (e.g....

Trial ID:

NCT02696642

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

Excerpt:

...- Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin...

Trial ID:

NCT02610140

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma

Excerpt:

...Subjects must have histologically or cytologically confirmed previously treated unresectable mesothelin expressing advanced lung adenocarcinoma (stage IIIB or IV) as confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) Subjects must have positive mesothelin expression in the archival tumor tissue, defined as the mesothelin membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on the membrane of greater than or equal to 10% of tumor cells....

Trial ID:

NCT02839681

Evidence Level:

Sensitive: C3 – Early Trials

Source:

J Clin Oncol

Title:

First-in-Human, Multicenter, Phase I Dose-Escalation and Expansion Study of Anti-Mesothelin Antibody–Drug Conjugate Anetumab Ravtansine in Advanced or Metastatic Solid Tumors

Excerpt:

Among 148 patients with mesothelioma or ovarian, pancreatic, non–small-cell lung, and breast cancers, 1 had a complete response, 11 had partial responses, and 66 had stable disease….Anetumab ravtansine exhibited a manageable safety and favorable pharmacokinetic profile with encouraging preliminary antitumor activity in heavily pretreated patients with mesothelin-expressing solid tumors.

DOI:

10.1200/JCO.19.02085

Trial ID:

NCT01439152