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Autogene Cevumeran · 4 trials · 11 indications
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. |
| 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. |
| 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 cancer therapy being studied for the treatment of advanced melanoma, muscle-invasive urothelial carcinoma, and resected pancreatic ductal adenocarcinoma. It is also being evaluated in combination with checkpoint inhibitors such as atezolizumab, pembrolizumab, and nivolumab in clinical trials.
Autogene Cevumeran is a gene therapy that targets tumor-specific mutations by encoding personalized neoantigens. It is designed to stimulate the immune system to recognize and attack cancer cells bearing these mutations. The therapy is being tested across multiple solid tumor types.
Autogene Cevumeran is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials of the therapy in various cancer indications.
Autogene Cevumeran is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in several cancer types.
Autogene Cevumeran is being studied in multiple trials, including NCT03289962 (Phase 1, completed), NCT03815058 (Phase 2, completed), NCT05968326 (Phase 2, recruiting), and NCT06534983 (Phase 2, active). These trials evaluate the drug alone or in combination with other therapies.
Yes, Autogene Cevumeran is also known as RO7198457. This alternative name appears in clinical trial records and is used interchangeably with Autogene Cevumeran in research and regulatory documents.