Iovance says patient dosing continues in C-145-04 study
Iovance Biotherapeutics said in today's earnings release, "Patient dosing continues in the C-145-04 study for cervical carcinoma. The company recently dosed its first patient in Europe. This study design is based on a Simon's two-stage design. The first stage has been completed and enrollment in the study continues with target enrollment of 47. Preliminary data for 15 patients yielded an ORR of 27% with an early look at the DOR ranging from 2.4 to 2.5+ months. Patients in the study had a median of five prior therapies. The safety findings from this study remain consistent with previous reports. The protocol for this study has been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. Iovance anticipates providing an update on this study at an upcoming medical meeting in 2019. In the C-145-03 study for head and neck cancer, to date, preliminary data for 13 patients has yielded an ORR of 31% with the DOR ranging from 2.8 to 7.6 months. The safety findings from this study is also consistent with previous reports. Patients in the study had a median of three prior therapies. For the study in NSCLC, IOV-LUN-201, in collaboration with MedImmune, the company amended the protocol to eliminate the TIL monotherapy cohort and patients will now be enrolled for treatment with LN-145 and durvalumab. There are currently nine sites active for this trial. The study in PD-1 naive melanoma and head and neck patients with TIL in combination with pembrolizumab, and LN-145 as monotherapy in NSCLC patients (IOV-COM-202) is open to enrollment with two sites active."