(Melanoma) Is Imfinzi + Ceralasertib Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On October 25, 2021, R. Kim and colleagues from Samsung Medical Center published results in Annals of Oncology from a Phase II clinical trial evaluating the anti-PD-L1 antibody Imfinzi (durvalumab) plus the oral ATR inhibitor ceralasertib in metastatic malignant melanoma patients who had progressed on prior anti-PD-1 antibody therapy.
This Phase II trial enrolled 30 patients with metastatic malignant melanoma who had progressed on prior anti-PD-1 antibody therapy. Patients received Imfinzi (1500 mg) plus ceralasertib (240 mg twice daily on Days 15–28) in 4-week treatment cycles. The primary endpoint was objective response rate (ORR). Prior anti-PD-1 therapies received included Keytruda, Opdivo, and chemotherapy, with a maximum of 3 prior lines of treatment.
Results:
- Primary endpoint ORR: 31.0%
- Disease control rate: 63.3%
- Median duration of treatment: 8.8 months
- Median progression-free survival: 7.1 months
- Median overall survival: 14.2 months
Safety:
All-grade adverse events: anemia 76.7%, anorexia 66.7%, thrombocytopenia 63.3%, nausea 56.7%. Grade ≥3 hematologic adverse events occurred in 53.3%: anemia 33.3%, thrombocytopenia 23.4%, neutropenia 16.7%.
Based on the Phase II trial results, R. Kim and colleagues concluded that durvalumab (Imfinzi) plus ceralasertib demonstrated favorable antitumor activity in metastatic malignant melanoma patients who had progressed on prior anti-PD-1 antibody therapy.
Source: https://www.annalsofoncology.org/article/S0923-7534(21)04545-2/fulltext
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