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Also known as RO7198457 intravenous (IV), RO7198457
Autogene cevumeran · 5 trials · 13 indications
DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first: * Locoregional recurrence or distant metastases as determined by an independent central radiology assessment. * Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment. * Death from any cause. * Loss to follow-up is censored.
PFS was defined as the time from randomization to the first documented PD as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (KM) method was used to estimate median PFS.
| Arm | Type | Description |
|---|---|---|
| Autogene Cevumeran + Nivolumab | EXPERIMENTAL | Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints. |
| Nivolumab | ACTIVE_COMPARATOR | Participants will receive 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year. |
| Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX | EXPERIMENTAL | Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX. |
| Arm 2: mFOLFIRINOX | ACTIVE_COMPARATOR | Participants will receive mFOLFIRINOX. |
| RO7198457 | EXPERIMENTAL | Participants will receive a recommended dose of RO7198457. |
| Observational Group | OTHER | Observational group will undergo watchful waiting, which is the standard of care in this setting. |
| Biomarker Cohort | EXPERIMENTAL | - |
| Exploratory Cohort | EXPERIMENTAL | - |
| Colorectal Liver Metastasis (CLM) Cohort | EXPERIMENTAL | - |
| Safety Run-in Period: Autogene Cevumeran + Pembrolizumab | EXPERIMENTAL | Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran. |
| Randomized Period: Arm A: Pembrolizumab | ACTIVE_COMPARATOR | Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression. |
| Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab | EXPERIMENTAL | Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran. |
| Phase 1a Flat Dose Escalation: Autogene Cevumeran | EXPERIMENTAL | Participants will receive autogene cevumeran at escalated dosages. |
| Phase 1b Flat Dose Escalation: Autogene Cevumeran + Atezolizumab | EXPERIMENTAL | Participants will receive autogene cevumeran at escalated dosages along with atezolizumab at a fixed dose of 1200 milligrams (mg) |
| Phase Ib: Dose Exploration: Autogene Cevumeran + Atezolizumab | EXPERIMENTAL | Non-small cell lung cancer (NSCLC) or melanoma cancer immunotherapy (CIT)-treated participants will receive autogene cevumeran (at dosage lower than maximum tolerated dose \[MTD\] based on available safety data) along with atezolizumab at a fixed dose of 1200 mg. |
| Phase 1b Expansion: Autogene Cevumeran + Atezolizumab | EXPERIMENTAL | Participants with different indications as per inclusion criteria will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a fixed dose of 1200 mg. |
| Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy) | EXPERIMENTAL | CIT-naive patients with selected tumor types who consent to optional serial biopsies will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a dixed dose of 1200 mg. |
| Name | Type | Description |
|---|---|---|
| Autogene Cevumeran | DRUG | Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm. |
| Nivolumab | DRUG | Nivolumab will be administered as an IV infusion per the schedule specified in the arm. |
| Atezolizumab | DRUG | Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints. |
| mFOLFIRINOX | DRUG | mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints. |
| RO7198457 intravenous (IV) | DRUG | RO7198457 administered as an IV injection at protocol-specified intervals over 12 months. |
| Observational group (no intervention) | OTHER | watchful waiting |
| Pembrolizumab | DRUG | Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. |
Inclusion Criteria: * Participants must have the capacity to participate/enroll in the study and to provide informed consent * Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or upper urinary tract * Tumor-node-metastasis (TNM ) classific...
Autogene cevumeran is an investigational RNA therapy being studied in oncology for several tumor types. These include resected pancreatic ductal adenocarcinoma, high-risk muscle-invasive urothelial carcinoma, ctDNA-positive resected stage II or stage III colorectal cancer, and previously untreated advanced melanoma. It is not yet approved for any indication.
Autogene cevumeran is being developed by BioNTech SE, which trades on Nasdaq under the ticker BNTX. BioNTech is running the clinical program, including trials that pair the agent with checkpoint inhibitors such as nivolumab, atezolizumab, and pembrolizumab, or with chemotherapy regimens like mFOLFIRINOX.
Autogene cevumeran is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory agency. The Phase 2 program spans pancreatic ductal adenocarcinoma, muscle-invasive urothelial carcinoma, colorectal cancer, and advanced melanoma.
Autogene cevumeran is being studied in several Phase 2 trials. NCT06534983 tests it with nivolumab versus nivolumab alone in high-risk muscle-invasive urothelial carcinoma. NCT05968326 evaluates adjuvant autogene cevumeran plus atezolizumab and mFOLFIRINOX in resected pancreatic ductal adenocarcinoma. NCT04486378 compares it with watchful waiting in ctDNA-positive resected colorectal cancer, and NCT03815058 studied it with pembrolizumab in advanced melanoma.
Yes. Autogene cevumeran is also known as RO7198457, and the intravenous form is referred to as RO7198457 intravenous (IV). The RO7198457 designation appears in earlier trial records, including NCT04486378 and NCT03815058, while autogene cevumeran is the current name used across the development program.
Autogene cevumeran is an RNA therapy that falls into the -vec/-gene target class, meaning it is designed as a gene-based therapeutic approach. It is being developed in oncology, where it is studied both as a single agent and in combination with checkpoint inhibitors or chemotherapy across multiple solid tumor settings.