By Christy Santhosh
Oct 28 (Reuters) – Geron said on Wednesday it would halt a late-stage trial of its blood cancer treatment, marking a setback for the company’s only commercial product, sending its shares plunging 20% in early trading.
The drug, branded as Rytelo, was being evaluated as a treatment for myelofibrosis, a rare type of blood cancer in which scar tissue gradually builds up in the bone marrow.
Geron said it made the decision following an independent data monitoring committee’s recommendation that the trial, named IMpactMF, was unlikely to achieve its main goal of overall survival, compared with the best available therapy.
Rytelo received US approval in 2024 for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS), a group of blood cancers.
The trial was disappointing, but no new safety concerns were seen despite higher and more frequent dosing than in LR-MDS, supporting confidence in the ongoing Rytelo launch, said TD Cowen analyst Tara Bancroft.
Geron said a detailed analysis of the data would be conducted, and study findings would be shared at a future date.
The trial enrolled 327 patients with high-risk myelofibrosis whose disease had returned or failed to respond after treatment with a JAK inhibitor, a type of drug used to manage symptoms and reduce spleen enlargement.
“We do not believe this outcome meaningfully alters physician perception of Rytelo in LR-MDS as the compound’s approved indication and the anchor of the commercial story,” said Wedbush analyst Robert Driscoll.
Rytelo competes with Bristol Myers Squibb’s Reblozyl. It generated $57.5 million in second-quarter revenue, and the company expects full-year sales of $220 million to $240 million.
(Reporting by Christy Santhosh in Bengaluru; Editing by Maju Samuel)
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