Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anetumab ravtansine · 5 trials · 4 indications
Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.
During SLI, patients with cholangiocarcinoma received anetumab ravtansine in combination with cisplatin and patients with pancreatic adenocarcinoma received anetumab ravtansine in combination with gemcitabine. The highest dose of anetumab ravtansine that can be given so that not more than 1 out of 6 patients experiences a dose-limiting toxicity (DLT) during the DLT evaluation period were declared as the MTD for anetumab ravtansine in combination with cisplatin or with gemcitabine.
A patient is a responder if the patient has a best response compared to baseline of complete response (CR) or partial response (PR) among all post-baseline tumor assessments, as determined per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma)
A patient experiences durable disease control if the patient has a tumor response compared to baseline of CR, PR or stable disease (SD) among the post-baseline tumor assessments made at least 180 days from first treatment, without prior disease progression
ECG evaluation
ECG evaluation
ECG evaluation
ECG evaluation
ECG evaluation
ECG evaluation
ECG evaluation
MTD is defined as the highest dose of anetumab ravtansine administered in combination with pegylated liposomal doxorubicin that can be given such that not more than 1 of 6 subjects at a given dose level experiences a dose-limiting toxicity (DLT).
| Arm | Type | Description |
|---|---|---|
| BAY94-9343 | EXPERIMENTAL | Drug Anetumab ravtansine given Intravenously (IV) |
| Vinorelbine | ACTIVE_COMPARATOR | Drug Vinorelbine given Intravenously |
| Cholangiocarcinoma | EXPERIMENTAL | Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with cisplatin. Please note the study is no longer recruiting for the cholangiocarcinoma safety lead-in phase. During the main study phase anetumab ravtansine will be administered at the determined MTD in combination with cisplatin. Please note the main study phase for cholangiocarcinoma will no longer be going ahead. |
| Adenocarcinoma of the pancreas | EXPERIMENTAL | Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with gemcitabine During the main study phase, anetumab ravtansine will be administered at the determined MTD in combination with gemcitabine |
| Other solid tumors | EXPERIMENTAL | (Non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), Adenocarcinoma of the breast - triple negative (TNBC), Gastric adenocarcinoma including gastroesophageal junction (GEJ Cancer, Thymic carcinoma) During the main study phase, anetumab ravtansine will be administered at dose of 6.5 mg/kg in solid tumors |
| Anetumab ravtansine | EXPERIMENTAL | The evaluation of multiple ECG parameters and the drug-drug interaction (DDI) potential of anetumab ravtansine parameters when administered alone and together with itraconazole 100 mg oral capsules will be conducted in 2 sequential parts. On Cycle 1 Day 1, anetumab ravtansine will be given alone at a dose of 6.5 mg/kg in Part 1 and Part 2. On Cycle 2 Day 1, anetumab ravtansine will be given together with itraconazole at a dose of 0.6 mg/kg in Part 1, and at a dose of 6.5 mg/kg (planned) in Part 2. |
| Control group | EXPERIMENTAL | Anetumab ravtansine was given at 6.5 mg/kg body weight (BW) as a 1 hour intravenous (IV) infusion once every 3 weeks (Q3W) for subjects with adequate hepatic and renal function. |
| mild HI group | EXPERIMENTAL | Anetumab ravtansine was given at 6.5 mg/kg BW as a 1 hour IV infusion Q3W for subjects with mild hepatic impairment (HI). |
| moderate HI group | EXPERIMENTAL | Anetumab ravtansine was given at 6.5 mg/kg BW as a 1 hour IV infusion Q3W for subjects with moderate hepatic impairment (HI). |
| moderate RI group | EXPERIMENTAL | Anetumab ravtansine was given at 6.5 mg/kg BW as a 1 hour IV infusion Q3W for subjects with moderate renal impairment (RI). |
| Name | Type | Description |
|---|---|---|
| Anetumab ravtansine (BAY94-9343) | DRUG | Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted. |
| Vinorelbine | DRUG | Starting dose: 30mg/m\^2 administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise. |
| Cisplatin | DRUG | Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle |
| Itraconazole | DRUG | Itraconazole 100 mg oral capsules given by mouth Cycle 1 (Day 18): 200 mg twice daily (BID) (Days 19 - 21): 200 mg once daily (QD) Cycle 2 (Days 1-8): 200 mg QD 12 days in total (Part 1 or Part 2) |
| Pegylated Liposomal Doxorubicin | DRUG | Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle. |
Inclusion Criteria: * Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin * Unresectable locally advanced or metastatic MPM after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed. * Patients must have measurabl...
Anetumab ravtansine is an investigational oncology drug being studied for the treatment of mesothelin-expressing cancers, including malignant pleural mesothelioma, ovarian neoplasms, and other advanced solid tumors. It is a small molecule in Phase 1 and Phase 2 clinical development for these indications.
Anetumab ravtansine is being developed by Bayer AG, which trades under the ticker BAYRY. The drug is an investigational small molecule oncology therapy that has been evaluated in clinical trials for mesothelioma and other mesothelin-expressing tumors.
Anetumab ravtansine is in Phase 1 and Phase 2 clinical development. It has completed Phase 1 studies in hepatic or renal impairment and in combination with pegylated liposomal doxorubicin, as well as a Phase 1b multi-indication study. A Phase 2 trial as second-line treatment for malignant pleural mesothelioma has also been completed.
Anetumab ravtansine has been studied in four completed trials. NCT02610140 was a Phase 2 trial in mesothelioma with 248 participants. NCT02696642 was a Phase 1 study in hepatic or renal impairment with 54 participants. NCT02751918 was a Phase 1b combination trial in ovarian neoplasms with 65 participants. NCT03102320 was a Phase 1b multi-indication study in advanced solid tumors with 173 participants.
Anetumab ravtansine is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development. No approval status has been established for this agent.