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| Ref Type | Journal Article | ||||||||||||
| PMID | (38401247) | ||||||||||||
| Authors | Di Giacomo AM, Schenker M, Medioni J, Mandziuk S, Majem M, Gravis G, Cornfeld M, Ranganathan S, Lou S, Csoszi T | ||||||||||||
| Title | A phase II study of retifanlimab, a humanized anti-PD-1 monoclonal antibody, in patients with solid tumors (POD1UM-203). | ||||||||||||
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| Abstract Text | POD1UM-203, an open-label, multicenter, phase II study, evaluated retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1) in patients with selected solid tumors where immune checkpoint inhibitor therapies have previously shown efficacy.Eligible patients (≥18 years) had measurable disease and included unresectable or metastatic melanoma, treatment-naive metastatic non-small-cell lung cancer (NSCLC) with high programmed death-ligand 1 (PD-L1) expression (tumor proportion score ≥50%), cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (UC) with PD-L1 expression (combined positive score ≥10%), or treatment-naive locally advanced/metastatic clear-cell renal cell carcinoma (RCC). Retifanlimab 500 mg was administered intravenously every 4 weeks as a 30-min infusion. The primary endpoint was investigator-assessed overall response rate.Overall, 121 patients (35 melanoma, 23 NSCLC, 29 UC, 34 RCC) were enrolled and treated. The overall response rate [95% confidence interval (CI)] was 40.0% (23.9-57.9) in the melanoma cohort, 34.8% (16.4-57.3) in the NSCLC cohort, 37.9% (20.7-57.7) in the UC cohort, and 23.5% (10.7-41.2) in the RCC cohort. Median duration of response was 11.5 months (95% CI 2.2-not reached) in the UC cohort, and was not reached in the other cohorts. Retifanlimab safety was consistent with previous experience for PD-(L)1 inhibitors.Retifanlimab demonstrated durable antitumor activity in patients with melanoma, NSCLC, UC, or RCC. The efficacy and safety of retifanlimab were as expected for a PD-(L)1 inhibitor. These data support further study of retifanlimab in solid tumors. | ||||||||||||
| Molecular Profile | Treatment Approach |
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| Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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| Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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| Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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| CD274 positive | transitional cell carcinoma | predicted - sensitive | Retifanlimab | Phase II | Actionable | In a Phase II trial (POD1UM-203), Zynyz (retifanlimab) treatment was well tolerated and demonstrated antitumor activity in patients with CD274 (PD-L1)-positive (CPS >/= 10%) urothelial carcinoma, resulting in an overall response rate of 37.9% (11/29, 1 complete and 10 partial responses), disease control rate of 55.2%, median progression-free survival of 5.7 months, median duration or response of 11.5 months, and median overall survival of 15.2 months (PMID: 38401247; NCT03679767). | 38401247 |
| CD274 over exp | lung non-small cell carcinoma | predicted - sensitive | Retifanlimab | Phase II | Actionable | In a Phase II trial (POD1UM-203), Zynyz (retifanlimab) treatment was well tolerated and demonstrated antitumor activity in non-small cell lung cancer patients with high CD274 (PD-L1) expression (TPS >/= 50%), resulting in an overall response rate of 34.8% (8/23, 8 partial responses), disease control rate of 65.2%, median progression-free survival of 4.4 months, and median duration of response and median overall survival were not reached (PMID: 38401247; NCT03679767). | 38401247 |