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Terns’ TERN-701 Shows Strong CML Responses in CARDINAL, Setting 320 mg and 500 mg Phase 2 Doses

The ASH update positions Terns to advance the program toward Phase 3 plans.

Overview

  • Updated CARDINAL results presented at ASH reported a 74% cumulative MMR by 24 weeks among 38 efficacy‑evaluable patients, with 29% achieving DMR.
  • Activity was seen in heavily pre-treated CML patients, including those with prior lack of efficacy on asciminib and ponatinib.
  • Terns reported no dose‑limiting toxicities, no maximum tolerated dose reached, and 87% of 63 enrolled patients remaining on treatment at the September 13 cutoff.
  • Based on efficacy and safety, the company selected 320 mg and 500 mg once daily as recommended phase 2 doses, with a 36% DMR rate by 24 weeks observed in that range.
  • Shares hit a record and closed up about 37% after the update, Oppenheimer raised its price target to $58 with an outperform rating, and reports indicate roughly $400 million in new funding to support pivotal studies.