Ignyta confirms completion of enrollment of the efficacy data sets for both the NTRK tissue-agnostic cohort and the ROS1 NSCLC cohort to support dual NDA submissions in 2018
- Ignyta has achieved enrollment of two registration-enabling efficacy data sets for lead candidate, entrectinib, to support dual NDA submissions in NTRK tissue-agnostic and ROS1 fusion-positive non-small cell lung cancer (NSCLC) indications in 2018.
- Updated entrectinib data in ROS1 NSCLC to be shared in oral presentation at the IASLC 18th World Conference on Lung Cancer on October 18, 2017
- New Phase 1b clinical data on RXDX-105 presented in late-breaking oral session at the European Society for Medical Oncology (ESMO) 2017 Congress.
- A total of 152 patients, with a range of solid tumors, have been treated in the Phase 1/1b clinical trial, including 74 patients treated at the recommended Phase 2 dose of 275mg daily in the fed state, and 43 patients treated at a dose of 350mg daily in the fed state.
- RXDX-105 continues to be well tolerated, with the most common treatment-related adverse events Grade 1 or 2 and reversible with dose modifications. The most common Grade 3 treatment-related adverse events (>5 percent) were rash (10 percent), hypophosphatemia (7 percent) and elevated ALT (7 percent).
- Ignyta will continue discussing RXDX-105 with potential partners and will provide an update on this program in the first half of 2018.
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