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
Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: “We are building a broad pipeline of ADCs addressing novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “These
“Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options,” commented Doug Warner, Chief Medical Officer of TYRA. “We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect
“As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We look forward to partnering with Simcere Zaiming, to advance
