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| Molecular Profile | RB1 loss |
| Therapy | Alisertib + Pembrolizumab |
| Indication/Tumor Type | head and neck squamous cell carcinoma |
| Response Type | unknown |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| RB1 loss | head and neck squamous cell carcinoma | unknown | Alisertib + Pembrolizumab | Phase Ib/II | Actionable | In a Phase I/II trial, treatment with Alisertib (MLN8237) plus Keytruda (pembrolizumab) was well tolerated but did not meet the primary efficacy endpoint in Phase II in patients with immunotherapy-refractory, Rb1-deficient head and neck squamous cell carcinoma, with no objective responses, a median overall survival of 16.8 months, median progression-free survival of 1.4 months, and stable disease (SD) in 8 of 15 patients, but did include some with prolonged SD (PMID: 39589337; NCT04555837). | 39589337 |
| PubMed Id | Reference Title | Details |
|---|---|---|
| (39589337) | Phase I/II Study of the Aurora Kinase A Inhibitor Alisertib and Pembrolizumab in Refractory, Rb-Deficient Head and Neck Squamous Cell Carcinomas. | Full reference... |