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Soo Park, MD
Soo Park, MD
Posted: Thursday, April 4, 2024
Chuanliang Cui, MD, of Peking University Cancer Hospital and Institute, Beijing, and colleagues aimed to assess the safety, tolerability, and efficacy of combining the tyrosine kinase inhibitor sitravatinib with the anti–PD-1 antibody tislelizumab in patients with unresectable, advanced, or metastatic melanoma who had experienced disease progression after prior first-line anti–PD-L1 monotherapy. The combination therapy demonstrated an objective response rate of 36%, indicating antitumor activity, with a median progression-free survival estimated at 6.7 months.
“The results from this phase Ib study support the further investigation of sitravatinib in combination with tislelizumab in larger cohorts of patients with refractory/resistant unresectable, advanced, or metastatic melanoma,” the investigators concluded.
The study included 25 patients enrolled in this open-label trial (ClinicalTrials.gov identifier NCT03666143) with unresectable, advanced, or metastatic melanoma who had experienced disease progression following prior first-line anti–PD-L1 monotherapy. Patients received sitravatinib once daily in combination with tislelizumab administered every 3 weeks.
Analysis of the data revealed that all patients reported treatment-emergent adverse events, 52% of which were of grade 3 or higher However, most treatment-emergent adverse events were mild or moderate, with none resulting in fatalities, according to the study authors. Furthermore, 12% of patients discontinued treatment because of treatment-emergent adverse events, suggesting the combination therapy was generally well tolerated.
In terms of efficacy, the combination of sitravatinib and tislelizumab demonstrated an objective response rate of 36. Additionally, the median progression-free survival was estimated to be 6.7 months, suggesting the combination therapy may effectively control disease progression for some members of this patient population.
The investigators acknowledged several study limitations. The sample size of the overall melanoma population was small, especially when assessing outcomes in patients with subtypes of melanoma. “The single-arm design of the study meant that it lacked a head-to-head arm to allow for comparison of safety and efficacy against other PD-1/PD-L1 inhibitors,” they noted.
Disclosures: Dr. Cui reported no conflicts of interest. For full disclosures of the other study authors, visit futuremedicine.com.
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