Durvalumab With or Without Tremelimumab in Subgroup of Resistant Head and Neck Cancer
Posted: Monday, December 3, 2018
According to results from the phase II CONDOR study, durvalumab monotherapy and durvalumab plus tremelimumab appear to provide clinical benefits and antitumor activity in some patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). Lillian L. Siu, MD, FRCPC, of the University of Toronto, Ontario, and colleagues observed no significant differences in efficacy or tolerance between the two treatments in patients who had either low or no PD-L1 tumor cell expression. The report was published in JAMA Oncology.
Patients who had recurrent or metastatic HNSCC and low or no PD-L1 tumor cell expression (n = 267) were randomly assigned to receive durvalumab plus tremelimumab (n = 133), durvalumab monotherapy (n = 67), or tremelimumab monotherapy (n = 67). This patient population came from 127 sites in North America, Europe, and Asia Pacific.
No significant differences in safety and efficacy were observed between patients who received durvalumab with or without tremelimumab. The objective response rate was 7.8% in the combination group, 9.2% in the durvalumab group, and 1.6% in the tremelimumab group. The median overall survival for patients who received the combination therapy was 7.6 months versus 6.0 and 5.6 months among those treated with durvalumab monotherapy and tremelimumab monotherapy, respectively.
Of the patients treated with the combination therapy, 15.8% (n = 21) experienced grade 3 and 4 adverse events compared with 12.3% (n = 8) of those treated with durvalumab alone and 16.9% (n = 11) of those treated with tremelimumab monotherapy. Immune-mediated adverse events occurred only among patients in the combination arm (n = 8).
A phase III study will assess the combination therapy as a second-line treatment in patients with HNSCC who have low and high PD-L1 tumor cell expression, the authors concluded.