Serputinib/Serpatinib (Reto) linked to long-term survival in thyroid cancer

Selpercatinib is a new type of targeted drug that belongs to the first class of potent RET kinase inhibitors. In recent years, with in-depth research on the importance of RET gene mutations and fusions in tumorigenesis, the efficacy of seputinib as a treatment for RET fusion-positive tumors, especially in patients with thyroid cancer, has attracted much attention. According to the latest data from the LIBRETTO-001 trial, seputinib showed a significant improvement in long-term survival rate in patients with thyroid cancer, which provides new hope for the clinical treatment of such patients.

In this pivotal trial, researchers followed a group of patients with RET fusion-positive thyroid cancer treated with radioactive iodine for five years to evaluate the efficacy and safety of seputinib. The design of the trial is divided into two phases, the first is a dose escalation trial in Phase 1, and the second is a dose expansion phase in Phase 2. In the Phase 1 trial, participants received varying doses of seputinib, ranging from 20 mg once daily to 240 mg twice daily. The final recommended dose was 160 mg twice daily.

In terms of the basic characteristics of the participants, the median age was 60.5 years old, and 58.3% of the patients were male. The Eastern Cooperative Oncology Group (ECOG) performance status score showed that 58% of the patients scored 0, indicating that their daily activities were not affected, while 37% of the patients scored 1, indicating a mild impact, which provides a good basis for evaluating the efficacy of the drug.

The primary endpoint of the trial is objective response rate (ORR) as assessed by RECIST 1.1 criteria. The results showed that seputinib achieved an ORR of 95.8% in the treatment of thyroid cancer patients, of which 20.8% of patients achieved complete response, 75% of patients achieved partial response, and only 4.2% of patients remained stable, with no patient experiencing disease progression. These results indicate that septinib is not only effective in controlling the disease but also able to achieve complete tumor regression in a significant proportion of patients.

During the 5-year follow-up, the researchers also evaluated important indicators such as duration of response (DoR) and progression-free survival (PFS). The results showed that the estimated DoR at 5 years was as high as 63.5%, and the median follow-up time was 54.8 months. At the same time, the 5-year progression-free survival rate (PFS) was 70.7%, and the overall survival rate (OS) reached 75.7%. These data demonstrate that the efficacy of seputinib in patients with RET fusion-positive thyroid cancer is durable and can provide patients with a long-term survival advantage.

Of note, in terms of safety, no patients discontinued treatment due to adverse effects, although most patients required dose adjustments during treatment. This shows that seputinib has a relatively good safety profile and can be tolerated by the vast majority of patients. This provides clinicians with greater confidence when using the drug.

With the extension of follow-up time, the sustained response and strong 5-year PFS and OS rates of seprotinib in patients with RET fusion-positive thyroid cancer further established the standard status of seprotinib as the first-line treatment in this patient population. She noted that these results not only support early and comprehensive genomic testing but also highlight the potential of seputinib as a first-line treatment for patients with RET-driven cancers.

In summary, the application of serpatinib/serpatinib in patients with thyroid cancer brings new options and hope for clinical treatment. With the deepening of more research, it is expected to provide more evidence support for the treatment of RET fusion-positive tumors, promote the process of personalized treatment, and benefit more patients.

References:https://www.medscape.com/viewarticle/selpercatinib-linked-long-term-survival-thyroid-cancer-2025a1000pza