Dalantercept Monotherapy Study Misses Endpoint
Treatment with single-agent dalantercept had favorable safety profile in recurrent or metastatic head and neck squamous cell carcinoma.
Treatment with single-agent dalantercept had modest activity and a favorable safety profile in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) refractory to platinum-based therapy, according to a study published in Cancer.1
For this phase 2 study (Clinicaltrials.gov Identifier: NCT01458392), investigators enrolled 40 patients and assigned them to receive 80 mg, 0.6 mg/kg, or 1.2 mg/kg of dalantercept subcutaneously every 3 weeks.
The overall response rate 5%, with 35% of patients achieving stable disease. Among patients who received 1.2 mg/kg and 0.6 mg/kg of dalantercept, 44% and 30.8% achieved disease control, respectively. No patients in the 0.6-mg/kg group had a partial response.
Patients with human papillomavirus (HPV)-positive disease had a disease control rate of 55%, versus 20% among those with HPV-negative disease (P = .0392)
Median progression-free survival was 1.4 months (95% CI, 1.3-2.2) and median overall survival was 7.1 months (95% CI, 5.5-11.1). The 1-year overall survival rate was 22.7%.
The most common treatment-related adverse events were anemia, fatigue, peripheral edema, headache, and hyponatremia. Thirteen patients had a serious adverse event; there were no treatment-related deaths.
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Given its limited antitumor activity and its manageable safety profile, future studies should evaluate the efficacy of dalantercept in combination with chemotherapy and/or radiotherapy as additional strategies for the treatment of recurrent or metastatic HNSCC.
- Jimeno A, Posner MR, Wirth LJ, et al. A phase 2 study of dalantercept, an activin receptor-like kinase-1 ligand trap, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer. 2016 Sep 20. doi: 10.1002/cncr.30317 [Epub ahead of print]