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Also known as Intismeran, mRNA-4157, V940, Individualized neoantigen therapy
Intismeran autogene · 7 trials · 8 indications
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.
RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
OS, defined as the time from randomization to death due to any cause. OS will be presented.
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigator assessment or death due to any cause, whichever occurs first. Progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 as assessed by investigator will be presented.
EFS is defined as the time from randomization to any of the following events, as determined by blinded independent central review (BICR): High-grade (HG) non-invasive papillary carcinoma (Ta) or carcinoma in situ (CIS) in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of urothelial carcinoma (UC); High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant metastasis of UC including non-regional lymph nodes (stage M1)\]; Or death due to any cause. The EFS for BCG-treated participants will be presented.
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa | EXPERIMENTAL | Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection. |
| Arm B: Intismeran | EXPERIMENTAL | Participants will receive intismeran 1 mg via IM injection. |
| Arm C: Placebo | PLACEBO_COMPARATOR | Participants will receive dose-matched placebo via IM injection. |
| Intismeran autogene + Pembrolizumab | EXPERIMENTAL | Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner. |
| Placebo + Pembrolizumab | ACTIVE_COMPARATOR | Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner. |
| Intismeran Autogene + Pembrolizumab + Chemo | EXPERIMENTAL | Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m\^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Intismeran Autogene 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance. |
| Placebo + Pembrolizumab + Chemo | EXPERIMENTAL | Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m\^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance. |
| Intismeran autogene + BCG | EXPERIMENTAL | Participants in Cohort A receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75. |
| BCG | ACTIVE_COMPARATOR | Participants in Cohort A receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75 |
| Intismeran autogene | EXPERIMENTAL | Participants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. |
| Name | Type | Description |
|---|---|---|
| Intismeran | BIOLOGICAL | IM injection |
| Pembrolizumab coformulated with berahyaluronidase alfa | BIOLOGICAL | SC injection |
| Placebo | OTHER | IM injection |
| Intismeran autogene | BIOLOGICAL | IM injection |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Carboplatin | DRUG | Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion |
| Paclitaxel | DRUG | 200 or 175 mg/m\^2 IV Infusion |
| Nab-paclitaxel | DRUG | 100 mg/m\^2 IV Infusion |
| BCG | BIOLOGICAL | Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk ...
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Intismeran autogene is an investigational RNA therapy being studied in oncology for malignant melanoma, non-small cell lung cancer, squamous non-small cell lung cancer, renal cell carcinoma, and urinary bladder neoplasms. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development. It is not yet approved for any indication.
Intismeran autogene is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is running the clinical development program for the drug across multiple cancer types, including melanoma, non-small cell lung cancer, and bladder cancer.
Intismeran autogene is in Phase 2 clinical development. It is an investigational RNA therapy and has not been approved by the FDA. Two active trials are ongoing, and no completed trials have been reported. The program includes both Phase 2 and Phase 3 studies.
Intismeran autogene is being studied in several recruiting trials. These include NCT07513376 in high-risk Stage I non-small cell lung cancer, NCT07221474 in metastatic squamous non-small cell lung cancer, NCT06961006 in melanoma, and NCT06833073 in bladder cancer. All are currently recruiting participants.
Yes, intismeran autogene is also known as intismeran. The two names refer to the same investigational RNA therapy developed by Merck & Company, Inc. (MRK). It is also referred to by the code V940 in clinical trial listings.
Intismeran autogene is being studied in malignant melanoma, non-small cell lung cancer, squamous non-small cell lung cancer, renal cell carcinoma, and urinary bladder neoplasms. The trials are active-controlled and double-blind, with a total planned enrollment of 1,744 participants across the studies.