According to preliminary results from a phase II clinical trial presented at the 2006 meeting of the American Society of Clinical Oncology, first- or second-line treatment of metastatic renal cell cancer (RCC) with the combination of Nexavar® (sorafenib) and interferon-alpha 2b (IFN-α2b) produces promising response rates and is well tolerated.

Both Nexavar and IFN-α2b have shown activity in metastatic RCC, and it is possible that each agent will enhance the activity of the other. To explore the combination of Nexavar and IFN-α2b in the treatment of metastatic RCC, researchers conducted a phase II clinical trial. Thirty-nine of an anticipated 40 patients have been enrolled thus far. Patients with any subtype of RCC were allowed.as long as they had received no more than one prior treatment (excluding IFN-α2b). A majority of patients had clear cell RCC.

Treatment consisted of eight-week cycles of Nexavar 400 mg po bid plus IFN-α2b 10 MU sc tiw. Cycles were repeated until disease-progression with two-week breaks between cycles allowed. The primary study endpoint was response rate and tolerability.

Information about response rate was available for 29 patients, and information about toxicity was available for 33 patients.

• Overall response rate was 38% (35% PR and 3% CR). An additional 48% of patients experienced stable disease.
• Grade 3 or 4 adverse events included neutropenia (21%) and hypophosphatemia (33%). Smaller proportions of patients experienced severe fatigue (3%), rash (9%), and hand and foot syndrome (3%).

The researchers conclude that thus far, the combination of Nexavar and IFN-α2b is well tolerated and shows substantial antitumor activity in both untreated and IL-2-resistant metastatic RCC.  

One more patient will be enrolled into the study. Data regarding progression-free survival and response duration are still pending.

Reference: Gollob J, Richmond T, Jones J, et al. Phase II Trial of Sorafenib Plus Interferon-alpha 2b (IFN- α2b) as First- or Second-line Therapy in Patients with Metastatic Renal Cell Cancer (RCC). Proceedings from the annual meeting of the American Society of Clinical Oncology. Atlanta, Georgia. 2006. Abstract # 4538.

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