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Also known as Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine · 6 trials · 5 indications
Primary efficacy will be assessed based on radiological tumor evaluation by contrast-enhanced computed tomography (CT) or contrast-enhanced magnetic resonance imaging (MRI) of chest/abdomen/pelvis. Contrast enhanced RECIST 1.1 scan will be done at Prescreening. Said pre-screen scan will be the baseline measure. RECIST 1.1 Scans will be done every 6 weeks for the first 6 months after the start of treatment, or more frequently if clinically indicated, every 9 weeks until the end of year 2 and every 12 weeks thereafter until disease progression or end of study, whichever comes first.
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 |
|---|---|---|
| All Subjects | EXPERIMENTAL | Patients with advanced metastatic pancreatic cancer who have measurable disease |
| 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 | DRUG | Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle |
| 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: Eligibility criteria for prescreening * Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant or adjuvant chemotherapy would not be counted as a line of therapy). If prior radiation, measurable lesion outside radiation po...
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Anetumab ravtansine is an investigational antibody-drug conjugate being studied in mesothelin-expressing advanced solid tumors, including mesothelioma, ovarian neoplasms, pancreatic cancer, and other neoplasms. It is not approved for any indication and remains in clinical development. Trials have enrolled patients with recurrent platinum-resistant ovarian cancer and pre-treated mesothelin-expressing pancreatic cancer.
Anetumab ravtansine targets mesothelin on tumor cells and delivers a tubulin inhibitor payload that binds tubulin subunits including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. By inhibiting tubulin polymerization, the payload disrupts microtubule dynamics and leads to cell cycle arrest and apoptosis in mesothelin-expressing cancer cells.
Anetumab ravtansine is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer has sponsored the clinical trials evaluating the agent in mesothelin-expressing solid tumors, including studies in mesothelioma, ovarian cancer, and pancreatic cancer.
Anetumab ravtansine is in Phase 1 development overall, though individual trials have been conducted in Phase 1b and Phase 2. It is investigational and has not been approved by the FDA for any indication. The completed studies include a Phase 1b multi-indication trial and a Phase 2 pancreatic cancer trial.
Anetumab ravtansine has been evaluated in completed trials including NCT03102320, a Phase 1b multi-indication study in mesothelin-expressing advanced solid tumors; NCT03023722, a Phase 2 study in pre-treated mesothelin-expressing pancreatic cancer; NCT02824042, a Phase 1 ECG and drug interaction study; and NCT02751918, a Phase 1b study in recurrent mesothelin-expressing platinum-resistant ovarian cancer.
Yes, anetumab ravtansine is also known as BAY94-9343. BAY94-9343 is the internal Bayer development code for the same antibody-drug conjugate. Both names refer to the identical investigational agent targeting mesothelin, and searches for either name refer to the same molecule.