Dynavax (DVAX) Presents Data from SD-101 + Keytruda Phase 1/2 in Metastatic Melanoma; One CR Noted

October 10, 2016 6:31 AM EDT

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Dynavax Technologies Corporation (Nasdaq: DVAX) announced the first presentation of findings from an ongoing Phase 1/2 study evaluating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with Keytruda (pembrolizumab), Merck's anti-PD-1 treatment. Early results evaluating five patients with metastatic melanoma for efficacy and 16 patients for safety were reported. In patients naïve to anti-PD-1 treatment objective responses were observed in three out of four (75%) including one complete response (CR) and two partial responses (PR's). One patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease (SD). These data were presented in a poster session on Sunday at the European Society of Medical Oncology (ESMO) Annual Congress 2016 in Copenhagen, Denmark.

SD-101 in combination with pembrolizumab was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. No immune-related adverse events were reported, and the most common treatment-emergent adverse events were grade 1-2 flu-like symptoms, including fever, chills and myalgia consistent with the engagement of TLR9 and production of interferon alpha. The study also included biomarker assessments suggesting that treatment with SD-101 and pembrolizumab resulted in elevation of gene signatures consistent with an increase in immune cell types and multiple immune functions.



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