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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...
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Autogene Cevumeran is an investigational cancer therapy being studied for advanced melanoma, pancreatic ductal adenocarcinoma, and muscle-invasive urothelial carcinoma. It is also being evaluated in combination with other agents for these and other solid tumors. It is currently in Phase 2 clinical development and is not yet approved.
Autogene Cevumeran is a gene therapy that works by delivering genetic material to encode tumor antigens, potentially stimulating the immune system to recognize and attack cancer cells. It is being studied in combination with checkpoint inhibitors like atezolizumab, pembrolizumab, and nivolumab to enhance anti-tumor immune responses.
Autogene Cevumeran is being developed by BioNTech SE (ticker: BNTX). The company is conducting multiple clinical trials evaluating the drug as a single agent and in combination with other therapies for various cancer indications.
Autogene Cevumeran is currently in Phase 2 clinical development. It has completed a Phase 1 trial and is being evaluated in three Phase 2 trials for advanced melanoma, pancreatic ductal adenocarcinoma, and muscle-invasive urothelial carcinoma. It is investigational and not yet approved.
Autogene Cevumeran is being studied in several trials: NCT03289962 (Phase 1, completed), NCT03815058 (Phase 2, completed, advanced melanoma), NCT05968326 (Phase 2, recruiting, pancreatic cancer), and NCT06534983 (Phase 2, recruiting, urothelial carcinoma). These trials evaluate the drug alone or with checkpoint inhibitors.
Yes, Autogene Cevumeran is also known as RO7198457. This alternative name appears in clinical trial titles and is used interchangeably in research contexts. Both names refer to the same investigational gene therapy being developed by BioNTech.