Terns Secures FDA Breakthrough Designation for TERN-701, Merck Deal to Accelerate Trials
FDA granted Breakthrough Therapy Designation to TERN-701 for Ph+ CML patients without T315I mutation after two or more TKIs, based on encouraging molecular responses in trials. This designation and Merck acquisition could accelerate pivotal trials and bolster Terns’ bid to position TERN-701 as a best-in-disease allosteric BCR::ABL1 inhibitor.
1. Breakthrough Therapy Designation
The FDA granted Breakthrough Therapy Designation to TERN-701 for adult patients with Philadelphia chromosome-positive CML in chronic phase without the T315I mutation who have failed two or more TKIs. This status is intended to expedite development and review of therapies offering substantial improvement over available treatments.
2. Phase 1/2 CARDINAL Trial Results
In the ongoing CARDINAL trial, TERN-701 demonstrated encouraging major molecular response and deep molecular response rates by week 24, including in patients with high baseline disease burden and prior allosteric TKI exposure. Most treatment-emergent adverse events were low grade with minimal severe events or discontinuations.
3. Merck Acquisition and Next Steps
Terns recently agreed to be acquired by Merck, a move expected to accelerate initiation of pivotal trials for TERN-701. The combined resources aim to advance TERN-701 toward registration studies, with the goal of establishing it as a best-in-disease oral allosteric BCR::ABL1 inhibitor with an improved safety profile.