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Following positive Phase II results, the company plans to seek US and EU approval for the CAR T-cell therapy in relapsed or refractory follicular lymphoma in 2021.
The promising response rates seen in the SUMMIT trial may provide further reason to broadly test all advanced cervical cancer patients for precision medicine biomarkers.
The dose-finding study will now enroll up to 30 patients with sarcomas characterized by gene rearrangements similar to Ewing sarcoma.
Through the partnership, Strata will use its next-generation sequencing test to identify advanced cancer patients with mutations in the MAPK signaling pathway.
The Phase 0 trial will assess whether infigratinib can cross the blood-brain barrier to penetrate recurrent high-grade gliomas harboring FGFR genetic alterations.
The two companies will evaluate the efficacy of the combination in patients with ER-positive, HER2-negative, advanced breast cancer.
Within the partnership, Strata Oncology will use its StrataNGS test to identify patients with NRG1 gene fusions who may be eligible to enroll in a Phase II trial for the drug.
The Phase II trial in China will enroll 106 NSCLC patients with ROS1 fusions who have either never received a tyrosine kinase inhibitor or have received Xalkori.
A Phase II trial conducted in China also showed that the HER2-targeting TKI was safe and tolerable in patients with previously treated HER2-positive advanced NSCLC.
The Quantum Leap-sponsored I-SPY 2 trial will evaluate Byondis' antibody-drug conjugate SYD985 against standard of care for HER2-low, early-stage breast cancer.