Dynavax reports results from Phase 1b/2 study of SD-101 and Keytruda combination
Dynavax Technologies announced "increasingly favorable" results from the Phase 1b/2 SYNERGY-001 open-label, multicenter study of the combination of SD-101 and KEYTRUDA in advanced melanoma patients who are naive to anti-PD-1/PD-L1 treatment. The results were presented today in a poster session at the 2019 American Society of Clinical Oncology, or ASCO, Annual Meeting. The overall response rate, or ORR, in the SD-101 2 mg/lesion group of 76% was higher than in the SD-101 8 mg/lesion group at 49%. The median duration of response, or DOR, in both groups has not been reached, with the lower bound of the 95% confidence interval of at least 14 months. The 18-month progression free survival, or PFS, rate in the SD-101 2 mg/lesion group of 72% was higher than in the SD-101 8 mg/lesion group at 36%. Similar rates of responses occurred in patients with PD-L1 negative tumors and PD-L1 positive tumors. Tumor shrinkage has been observed in both injected and non-injected lesions, including visceral lesions such as the liver and lung. In addition, the company presented data from the Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy.