Enrollment Completed in Global Multi-Center Ph 3 Clinical Trial of Trilaciclib in Patients with mTNBC

“TNBC tumors are aggressive and difficult to treat; and while chemotherapy with or without targeted therapy remains first line TNBC standard of care, there is a great need to improve survival beyond that expected from it – particularly without increasing toxicity,” said Raj Malik, M.D., G1’s Chief Medical Officer. “PRESERVE 2 is exciting as it is evaluating trilaciclib in mTNBC to build on the robust survival benefit observed in the Phase 2 program. Completion of enrollment is an important milestone for G1 and the patients we seek to treat, and we look forward to the interim analysis, which is expected to occur in the second half of 2023. This is a registrational trial for which we have been granted Fast Track designation by the U.S. Food and Drug Administration – and if the results are positive, we will work closely with the FDA to expedite our regulatory filing for approval in this indication.”
Share:
More News
“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not
Chris Ehrlich, CERo Therapeutics CEO added, “CBCI is a world-renowned cancer center, and we believe their participation in our AML trial is continued validation of the scientific work performed to date with CER-1236. We look forward to announcing enrollment and initial dosing in the near term for this trial and
“Treating the first patient in the GUARDIAN-101 trial marks a pivotal milestone in Clasp’s mission to transform patient outcomes through precision immunotherapy,” said Dr. Lauren Harshman, M.D., SVP of Clinical Development at Clasp Therapeutics. “Advancing CLSP-1025 into the clinic is an important step in validating the potential of our pHLAre
“AP402 targets p95HER2, a truncated form of HER2 present in 30-40% of HER2-positive cancers, which is associated with exceptionally poor prognosis, and not addressable by conventional anti-HER2 therapies,” said Dr. Jeng Her, Ph.D., Founder and Chief Executive Officer of AP Biosciences. “AP402 represents the only T-cell engager in human trials