Curis Reports Clinical Activity Of CUDC-907

(RTTNews) - Curis Inc. (CRIS) presented data from the completed dose escalation and ongoing expansion stages of the Phase 1 trial of CUDC-907, an oral dual inhibitor of histone deacetylase or HDAC and phosphoinositide 3-kinase or PI3K enzymes.

The data demonstrated that treatment with CUDC-907 resulted in complete or CRs and partial responses or PRs in heavily pretreated patients with relapsed/ refractory diffuse large B cell lymphoma (RR-DLBCL), including those harboring alterations of the MYC oncogene, a poor performing sub-group for which there are no approved targeted therapies.

In preclinical studies, CUDC-907 treatment of DLBCL cell lines was shown to result in complete suppression of MYC protein levels in a rapid and dose dependent manner. Additionally, anti-tumor activity was observed in multiple in vivo MYC-altered DLBCL models.

Based on promising clinical activity observed in patients with RR-DLBCL, particularly those with cancers harboring MYC alterations, Curis expects to initiate a Phase 2 trial to examine CUDC-907 in patients with MYC-altered DLBCL.

In this trial, approximately 120 patients with relapsed/refractory disease will be randomly assigned to receive CUDC-907 as monotherapy or CUDC-907 with the standard dose of rituximab. Patients will remain on treatment until progression of disease, discontinuation for safety reasons, or other reasons for treatment discontinuation.

The primary endpoint of the trial is objective response rate with secondary endpoints that include progression free survival, overall survival and duration of response. Positive results with CUDC-907 monotherapy will lead to an expansion of patient enrollment and discussion with the FDA regarding potential registration strategy in this patient population.

The rituximab combination treatment arm of the Phase 2 trial is intended to inform the design of a confirmatory, randomized trial of CUDC-907 in combination with rituximab as compared to rituximab in combination with standard of care chemotherapy.