February 19, 2014
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Cixutumumab shows promise in thymic epithelial tumors

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Cixutumumab demonstrated activity and was well tolerated among patients with relapsed thymoma, according to phase 2 study results.

The analysis included 49 patients (37 patients with thymomas and 12 with thymic carcinomas) with an ECOG performance status of 0 or 1. All patients had progressed after at least one platinum-containing chemotherapy regimen.

Patients received 20 mg/kg IV cixutumumab (IMC-A12, Lilly) every 3 weeks for a median of eight cycles (range, 1-46).

Median follow-up was 24 months (interquartile range, 17.3-36.9).

Among patients with thymoma, five (14%; 95% CI, 5-29) achieved a partial response and 28 achieved stable disease.

No patients with thymic carcinoma (95% CI, 0-26) achieved a partial response, and five achieved stable disease.

Disease progression occurred in four patients with thymoma and seven patients with thymic carcinoma.

Among all patients, the most common adverse events were hyperglycemia (10%), lipase elevation (6%), weight loss (4%), tumor pain (4%) and hyperuricemia (4%).

Nine (24%) patients with thymoma developed an autoimmune condition during study treatment, the most common of which was pure red cell aplasia. Five of these were new-onset disorders.

One death occurred due to disease progression. A second death occurred due to disease-related complications, which researchers said “could have been precipitated by treatment with cixutumumab.”

“Cixutumumab monotherapy is well tolerated and active in relapsed thymoma,” the researchers concluded. “Development of autoimmunity during treatment needs further investigation.”

Disclosure: The study was partially funded by ImClone Systems. See the study for a full list of the researchers’ relevant financial disclosures.