Dynavax Technologies Presents Positive Responses in Study of SD-101 With Keytrudaa

Dynavax Technologies (DVAX) said it presented findings in patients with metastatic melanoma in the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDAA, an anti-PD-1 therapy developed by Merck (MRK), known as MSD outside the United States and Canada.

The data showed a 100% overall response rate, with a complete response (CR) rate of 29%, which it said is a meaningful increase over use of KEYTRUDA alone, which has already shown a 33% ORR, with a 6% CR. In 12 patients with advanced (stage IIIc/IV) melanoma who had previously failed on anti-PD-1 treatment, introduction of SD-101 resulted in tumor shrinkage in 42% of patients, with 17% having a partial response (PR), indicating an anti-tumor immune response generated by SD-101.

SD-101 in combination with KEYTRUDA generally was well-tolerated.

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