- Dynavax Technologies (NASDAQ:DVAX) is up 18% premarket on light volume on the heels of its announcement of preliminary data from its ongoing Phase 1b/2 clinical trial evaluating SD-101 combined with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) in patients with advanced melanoma naïve to anti-PD-1/L1 therapy. The results were presented at ESMO in Munich.
- The overall response rate (ORR) in the group receiving no more than 2 mg of SD-101 was 70% (n=33/47) while the ORR in the group receiving 8 mg of SD-101 was 48% (n=19/40).
- The six-month progression-free survival rate (PFS) in the less-than-or-equal-to 2 mg group was 85%. Suggested median PFS was 15.2 months.
- Response rates appeared similar regardless of PD-1 status.
- SD-101 is an intratumoral Toll-like receptor 9 (TLR9) agonist designed to modulate the tumor microenvironment and prime T cells to generate a systemic anti-tumor response.
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