Terns Pharmaceuticals stock surged 81.6% in morning trading on Monday after the clinical-stage oncology company reported promising data from its ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor for chronic myeloid leukemia (CML).
The data, selected for oral presentation at the upcoming 67th American Society of Hematology Annual Meeting in December, showed a 75% overall major molecular response (MMR) rate by 24 weeks among 32 efficacy-evaluable patients with previously treated CML.
The company highlighted strong efficacy in difficult-to-treat patient subgroups, with 69% MMR rates in patients who lacked efficacy to their last tyrosine kinase inhibitor (TKI) and 60% in those with prior asciminib treatment. No patients had lost MMR at the time of the data cutoff.
"The 24 weeks MMR achievement rate with TERN-701 is unprecedented, trending at least two times higher than the rates reported in other Phase 1 studies of CML therapies that are approved or in development," said Amy Burroughs, chief executive officer of Terns.
The trial enrolled heavily pretreated patients with a median of three prior TKIs, with 35% having received four or more prior treatments. Despite this challenging population, the drug demonstrated an encouraging safety profile with mostly low-grade adverse events.
The most common side effects were diarrhea (22%), headache (18%), and nausea (16%), all Grade 1 or 2. Higher-grade adverse events occurred in less than 10% of patients, primarily neutropenia (7%) and thrombocytopenia (4%).
The company plans to present expanded and updated data from the CARDINAL trial at the ASH Annual Meeting in December, followed by an investor conference call.