Phase II study of ruxolitinib with regorafenib for relapsed/refractory (r/r) metastatic colorectal cancer (mCRC).

TPS3623 Background: Therapeutic options are limited after patients (pts) with mCRC progress following treatment with current standards of care. As with pancreatic cancer (PC), CRC induces a systemic inflammatory response, possibly from inflammatory cytokine production by colorectal tumor cells themselves or by the local inflammatory milieu. Elevated levels of inflammatory cytokines are associated with more advanced disease and reduced survival. In the phase II RECAP study, treatment with the JAK1/JAK2 inhibitor ruxolitinib + capecitabine showed improved overall survival (OS) relative to placebo + capecitabine in pts with metastatic PC who had evidence of systemic inflammation as demonstrated by elevated C-reactive protein levels (Hurwitz et al. ASCO 2014. abs 4000). Given the evidence supporting a role for the JAK-STAT pathway in the systemic inflammatory response in CRC, ruxolitinib may be an effective therapeutic strategy in pts with r/r mCRC. Methods: Eligible pts are aged ≥ 18 years with histologicall...