Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-986545, BNT327, PM8002
Pumitamig · 8 trials · 8 indications
Phase 2
Phase 3
Phase 1
Phase 1
Phase 1
Phase 1
Phase 1
Phase 2
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | ACTIVE_COMPARATOR | - |
| Arm A: Pumitamig | EXPERIMENTAL | - |
| Arm B: Pembrolizumab | ACTIVE_COMPARATOR | - |
| Cohort A: Pumitamig | EXPERIMENTAL | - |
| Cohort B: Pumitamig | EXPERIMENTAL | - |
| Arm A: Pumitamig + Imzokitug + Histology-based PDCT | EXPERIMENTAL | - |
| Arm B: Pumitamig + Imzokitug + Histology-based PDCT | EXPERIMENTAL | - |
| Arm C: Pumitamig + Imzokitug + Histology-based PDCT | EXPERIMENTAL | - |
| Arm D: Pumitamig + Histology-based PDCT | EXPERIMENTAL | - |
| Arm A1 | EXPERIMENTAL | - |
| Arm A2 | EXPERIMENTAL | - |
| Arm C | EXPERIMENTAL | - |
| Arm D | EXPERIMENTAL | - |
| Part 1A: 1A-1 Pumitamig + Ipilimumab | EXPERIMENTAL | - |
| Part 1A: 1A-2 Pumitamig + Ipilimumab | EXPERIMENTAL | - |
| Part 1B: 1B-1 Pumitamig + Cabozantinib | EXPERIMENTAL | - |
| Part 1B: 1B-2 Pumitamig + Cabozantinib | EXPERIMENTAL | - |
| Part 2A: 2A-1 Pumitamig + Ipilimumab | EXPERIMENTAL | - |
| Part 2A: 2A-2 Pumitamig + Ipilimumab | EXPERIMENTAL | - |
| Part 2B: 2B-1 Pumitamig + Cabozantinib | EXPERIMENTAL | - |
| Part 2B: 2B-2 Pumitamig + Cabozantinib | EXPERIMENTAL | - |
| Part 2C: 2C-1 Pumitamig | EXPERIMENTAL | - |
| Part 2D: 2D-1 Pumitamig + Casdatifan | EXPERIMENTAL | - |
| Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan | EXPERIMENTAL | - |
| Cohort 1A | EXPERIMENTAL | - |
| Cohort 1B | EXPERIMENTAL | - |
| Cohort 2A | EXPERIMENTAL | - |
| Cohort 2B | EXPERIMENTAL | - |
| Cohort 2C | EXPERIMENTAL | - |
| Cohort 1A2 | EXPERIMENTAL | - |
| Cohort 1B2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pumitamig | DRUG | Specified dose on specified days |
| Durvalumab | DRUG | Specified dose on specified days |
| Pembrolizumab | DRUG | Specified dose on specified days |
| Carboplatin | DRUG | Specified dose on specified days |
| Cisplatin | DRUG | Specified dose on specified days |
| Paclitaxel | DRUG | Specified dose on specified days |
| Pemetrexed | DRUG | Specified dose on specified days |
| Imzokitug | DRUG | Specified dose on specified days |
| Folfox | DRUG | Specified dose on specified days |
| Capox | DRUG | Specified dose on specified days |
| Nivolumab | DRUG | Specified dose on specified days |
| FOLFIRI | DRUG | Specified dose on specified days |
| Bevacizumab | DRUG | Specified dose on specified days |
| Ipilimumab | DRUG | Specified dose on specified days |
| Cabozantinib | DRUG | Specified dose on specified days |
| Casdatifan | DRUG | Specified dose on specified days |
Inclusion Criteria * Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease. * Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation...
Pumitamig is an investigational small molecule oncology drug being developed by Bristol-Myers Squibb Company (ticker: BMY). It is being studied in multiple cancer types, including non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, and gastric, gastroesophageal junction, or esophageal adenocarcinoma. It has not been approved by the FDA and remains in clinical development.
Pumitamig is being evaluated for several non-small cell lung cancer settings: early-stage disease before surgery, locally advanced or metastatic disease as first-line treatment, previously untreated advanced disease with PD-L1 of 50 percent or higher, and unresectable stage III disease after concurrent chemoradiation therapy. It is investigational and not approved for any use.
Pumitamig is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating Pumitamig across multiple cancer indications.
Pumitamig is in clinical development and is being evaluated in Phase 2 and Phase 3 trials. The Phase 3 trials include ROSETTA Lung-201 and ROSETTA Lung-202. Pumitamig is investigational and has not been approved by the FDA.
Pumitamig is being studied in four registered trials: NCT07871214 (ROSETTA Lung-220, Phase 2, early-stage NSCLC before surgery), NCT07680764 (Phase 2, locally advanced or metastatic NSCLC, first-line), NCT07361510 (ROSETTA Lung-202, Phase 3, previously untreated advanced NSCLC with PD-L1 of 50 percent or higher), and NCT07361497 (ROSETTA Lung-201, Phase 3, unresectable stage III NSCLC after chemoradiation).
No, Pumitamig is not FDA approved. It is an investigational drug still in clinical development, with Phase 2 and Phase 3 trials ongoing. Bristol-Myers Squibb is evaluating Pumitamig across several cancer types, including non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, and gastric or esophageal adenocarcinoma.