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Merck, Plexxikon to evaluate immuno-oncology combination regimen

Merck and Plexxikon, a member of Daiichi Sankyo Group, have entered into a collaboration agreement for a combination study to evaluate an investigational immuno-oncology regimen.

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Under the deal, a Phase I/II trial will be conducted to evaluate the combination of Plexxikon’s investigational CSF-1R inhibitor, PLX3397, and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), which provides the potential for a double blockade of cancer-induced immune suppression.

By mid-year, patients with advanced melanoma and multiple other solid tumors will be enrolled in the trial, which will evaluate the safety and tolerability of the combination therapy.

Plexxikon chief executive officer Gideon Bollag said: "We are excited to evaluate PLX3397 in combination with Keytruda, as each agent is designed to attack cancer cells in different ways.

"Cancer cells use multiple tactics to evade host immune responses, and the combination of these two agents is being investigated to re-activate anti-tumor immunity using distinct and complementary mechanisms.

"Importantly, both PLX3397 and Keytruda have potential application in multiple types of cancer."

PLX3397 is a new oral small molecule that potently and selectively inhibits CSF-1R, KIT, and mutant FLT3 kinases.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2.

By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Merck Research Laboratories oncology early-stage development therapeutic area head Dr Eric Rubin said: "We are at an important juncture in the advancement of immuno-oncology, and this is why Merck is focused on this area of breakthrough science.

"Given the promising data observed with Keytruda and PLX3397, we are eager to see how combining these medicines may be complementary in increasing the immune response."

Currently, PLX3397 is also being evaluated in several other clinical indications, including tenosynovial giant cell tumor (TGCT), historically called pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), breast cancer and glioblastoma.

Image: The clinical study will evaluate Merck’s anti-PD-1 therapy, Keytruda in combination with Plexxikon’s PLX3397. Photo: courtesy of Baitong333/