Terns Drug Challenges Scemblix Dominance with Unprecedented Leukemia Data
- Dec 10
- 2 min read
Terns Pharmaceuticals has captured the attention of the biopharma industry following the presentation of "unprecedented" efficacy data for its chronic myeloid leukemia (CML) therapy, TERN-701, at the American Society of Hematology (ASH) annual meeting. The early-stage results suggest the investigational agent is poised to challenge the market dominance of Novartis’ blockbuster CML treatment, Scemblix.
The positive results, which were revealed on Monday, showed TERN-701 achieved a double whammy of improvement over Novartis’ approved STAMP inhibitor, Scemblix. Data from the Phase I CARDINAL trial, which involved 38 efficacy-evaluable participants previously treated for CML, showed that Terns’ allosteric BCR/ABL1 inhibitor achieved a 75% overall major molecular response (MMR) rate at week 24. Furthermore, 64% of patients who were not previously in MMR achieved that status after treatment.
Analysts quickly noted the exceptional nature of these findings, as TERN-701 more than doubled the response rate of the rival therapy. For comparison, Scemblix and a similar investigational CML asset achieved MMR rates ranging from 24% to 32% in their respective trials, with Scemblix specifically achieving a 25% MMR rate at 24 weeks in a similar study population.
Beyond efficacy, analysts from William Blair highlighted the drug’s potential to improve the standard of care, noting its "unequivocal improvement in both clinical efficacy and safety" combined with the convenience of daily dosing that has no food effect. The data also demonstrated TERN-701’s ability to salvage responses in patients who had previously received and relapsed on Scemblix.
The market reacted swiftly to the readout, with Terns Pharmaceuticals shares climbing 10% as markets opened Tuesday, having already soared as high as 55% during pre-market trading. Analysts project that TERN-701 could eventually bring in peak annual sales of $3.4 billion. To fund development, Terns immediately moved to raise cash, offering $400 million worth of shares in a public offering. The positive data follows Terns’ decision earlier this year to refocus from metabolic diseases, such as obesity, to cancer.
Terns is preparing to release more data next year and intends to meet with regulators to plan a registrational trial for use in front-line and second-line CML. Analysts are optimistic that the best-in-disease results seen in Phase I will be successfully replicated in the pivotal setting.
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Keywords: Terns drug challenges Scemblix dominance
Terns drug challenges Scemblix dominance
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