Tarlatamab designated as an orphan drug for SCLC

Korean research team, led by Professor Ahn Myung Ju, has confirmed the optimal dosage of Tarlatmab

Presented dosage testing results, including 10 mg, and the research was published in the NEJM

Amgen’s drug candidate ‘Tarlatamab,’ intended for treating small cell lung cancer (SCLC), has received orphan drug designation in Korea.

 

The Ministry of Food and Drug Safety (MFDS) announced this decision through its first orphan drug designation posting of the New Year.

 

The approved indication is for treating adult patients with progressive SCLC whose cancer had progressed after previous second-line treatments.

 

The research team led by Professor Ahn Myung Ju, from the Division of Hematology-oncology in the Department of Medicine at Samsung Medical Center, has confirmed Tarlatamab as a potential treatment for second-line treatment in SCLC.

 

Their research article was published in the New England Journal of Medicine (NEJM).

 

The research team demonstrated the treatment potential of bispecific T-cell engagers like Tarlatamab.

 

Tarlatamab is a novel bispecific T-cell engager drug that recognizes antigens present on both cancer cells and immune cells.

 

Even when cancer cells manage to evade immune cells, Tarlatamab can engage immune T-cells, directing them to closely target cancer cells and initiate an attack.

 

Professor Ahn’s research team conducted this research with the goal of identifying a novel therapeutic strategy that could maximize the effects of Tarlatamab while ensuring the safety of patients.

 

They conducted a study enrolling 220 patients who had not responded to the first-line treatment for SCLC, from 56 institutions across 17 countries and randomly assigned to clinical groups for evaluation.

 

According to the U.S.

 

Food and Drug Administration (FDA), the research team administered two different doses of Tarlatamab, 10mg and 100mg, to patients and assessed various prognosis such as treatment reactions and drug-related side effects.

 

As a result, the optimal dosage for the drug was determined to be 10mg of Tarlatamab administered every 2 weeks, which led to clinical improvements in prognosis and a reduction in side effects.

 

According to the research group, patients who received 10 mg showed an objective response rate of 40%, which was higher than the 32% response rate observed in those who received a 100 mg dose.

 

The median progression-free survival in the 10-mg group was 4.9 months, higher than the 3.9 months in the 100-mg group.

 

The overall survival, measured at nine months following the treatments, was 68% for the 10-mg group and 66% for the 100-mg group.

 

The 10-mg dose demonstrated a higher treatment effect with fewer side effects.

 

Since Tarlatamab is a T-cell activating therapy, the most common side effect is ‘cytokine release syndrome.’ In the 10-mg group, 51% of the patients experienced cytokine release syndrome, whereas, in the 100-mg group, 61% did.

 

“SCLC, classified into limited and extended stages, is characterized by its rapid progression without clear incremental stages.

 

For most patients, metastasis to other lungs or organs presents treatment challenges.

 

Currently, treatment options remain limited.

 

Consequently, I hope that ongoing research will contribute to alleviating the suffering of patients,” Professor Ahn said.