① On Thursday (May 17), the US FDA approved a method for treating widespread small-cell lung cancer by Amgen; ② The drug is generically named Tarlatamab and will be launched under the name Imdelltra; ③ Phase II trial results showed that after taking a specific dose of Tarlatamab, patients' cancer tumors shrunk by an average of 40%, increasing the average lifespan by one year.
Financial Services, May 17 (Editor Zhou Ziyi) The US Food and Drug Administration (FDA) approved Amgen (Amgen)'s treatment for lung cancer on Thursday (May 17).
Tarlatamab is a bispecific T-cell conjugate (BiTE) antibody developed by Amgen in the United States, targeting DLL3 and CD3 as a second-line treatment or late-stage treatment for patients with extensive small cell lung cancer (ES-SCLC). The drug will be launched under the name Imdelltra.
In clinical trials, the drug has been shown to shrink tumors and help patients with small cell lung cancer live significantly longer.
small cell lung cancer
Small cell lung cancer usually starts in the airways of the lungs, grows rapidly, forms a large tumor, and spreads throughout the body. Symptoms include bloody phlegm, cough, chest pain, and shortness of breath.
Amgen said that of the more than 2.2 million patients diagnosed with lung cancer worldwide every year, small cell lung cancer accounts for 15%, or 330,000 cases. According to a study published in the “Journal of Cancer (Journal of Cancer)”, about 80% to 85% of patients with small cell lung cancer were diagnosed with advanced lung cancer.
Amgen's Chief Scientific Officer Dr. Jay Bradner said there are approximately 35,000 patients with small cell lung cancer in the US.
According to data from the American Cancer Association, when small cell lung cancer spreads to other parts of the body, only 3% of patients can live for five years; while all patients with this disease, regardless of whether the cancer spreads or not, the five-year survival rate is 7%.
Bradner also notes that patients with small cell lung cancer usually only live for four to five months.
Extend life
Tarlatamab is known as a bispecific T-cell conjugate (BiTE) and is designed to redirect the immune system's T cells to recognize and kill cancer cells.
Based on the results of a phase II trial conducted on more than 200 patients with small cell lung cancer, it was found that the cancer tumors shrunk by an average of 40% after taking 10 mg of Tarlatamab every 2 weeks.
Notably, after starting the 10 mg dose of Amgen, patients had a median survival time of 14.3 months, and 40% of patients responded to Tarlatamab treatment. In contrast, according to data from the US National Cancer Institute, the average survival time for patients under current treatment methods is about 6 to 12 months.
Dr. Bradner of Amgen said, “The treatment gave these patients, who usually only live four to five months, almost an extra year.”
Amgen is currently continuing to study several Imdelltra trials, some of which will test the drug as an early treatment for small cell lung cancer.
Furthermore, Amgen is also planning to launch another phase III study to use this drug as a first-line treatment for patients with advanced small cell lung cancer.
Bradner notes, “When you develop cancer drugs, if they work in advanced stages of the disease, then they work better when you move them to first-line treatment.”
Dr. Bradner also said there are currently “quite few” treatment options for the disease, “It's one of the most terrible cancers, so we need a new solution.”