Another day, another onco-immunology tie-up, and this time it’s Merck & Co and Dynavax unveiling a new collaboration to investigate combinations of their investigational drugs.
The firms have signed two clinical trial collaboration pacts to look at the potential synergistic effect of marrying Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) and investigational anti-interleukin-10 immunomodulator MK-1966 with Dynavax’s investigational toll-like receptor 9 (TLR9) agonist SD-101.
Under the plans, the safety and efficacy of combining SD-101 with Keytruda in patients with advanced melanoma will be assessed in a Phase Ib/II, multicenter, open-label study, pencilled in for the second half of 2015, while a regimen of SD-101 and MK-1966 will be tested in patients with solid or haematological malignancies in a Phase I trial also due to kick off later this year.
Dynavax will sponsor and fund the SD-101 and Keytruda study and Merck will sponsor and fund the SD-101/MK-1966 trial. Both agreements include the potential to extend the collaboration into Phase III, but further details weren’t released.
US priority review for Keytruda filing
Meanwhile, Merck said US regulators have assigned a priority review to Keytruda for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumour aberrations, if present.
The filing was based on data from the KEYNOTE-001 trial, which showed an overall response rate of 45.2% in patients with greater than or equal to 50% of tumour cells expressing PD-L1.
Given that the US Food and Drug Administration has granted a priority and accelerated review, Merck should have a decision by October 2.