May 26,BeOne Medicines announced its collaboration with AmgenThe Phase 2 clinical study DeLLphi-307 of tarlatamab for injection, jointly conducted in China, has achieved positive results.。DeLLphi-307 (NCT06502977) study aims to evaluate taladotin forTreatment for Chinese patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least two prior lines of therapy (including platinum-based chemotherapy)The efficacy, safety, and tolerability, with the primary endpoint being the objective response rate (ORR).Detailed data will be announced at the upcoming medical conference.Extensive-Stage Small Cell Lung Cancer (ES-SCLC) is an aggressive type of lung cancer that has spread to other parts of the body, typically considered advanced cancer with a generally poor prognosis and a lack of effective treatment options.
Currently, the first-line treatment for SCLC patients is still mainly platinum-based chemotherapy.Platinum-based chemotherapy drugs, including cisplatin and carboplatin, are commonly used to treat various types of cancer, including small cell lung cancer (SCLC). However, the majority of patients experience disease progression within 6 months, and treatment options after recurrence are very limited, with a median survival time of only 8-10 months. In recent years, breakthroughs in immunotherapy in the SCLC field have provided new options for patients.
On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tarlatamab for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has progressed after platinum-based chemotherapy.Tarlatamab Becomes an Approved Second-Line Treatment Drug for Small Cell Lung Cancer.Tarlatamab, brand name Imdelltra, Chinese name Taladotamab, is a DLL3/CD3 bispecific antibody drug developed by Amgen, Inc.，Capable of simultaneously binding to DLL3 protein on tumor cells and CD3 protein on T cells, which then activates T cells to kill tumor cells expressing the DLL3 protein. Up to 96% of SCLC patients have tumor cells that express DLL3 protein on their surface, but normal cells hardly express DLL3 protein, making DLL3 a highly attractive therapeutic target.Mechanism of Action of Tarlatamab | Source: Amgen Official WebsiteBased on the positive data from the overall response rate and duration of response (DoR) in the previous DeLLphi-301 study, taladotin has received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2024 for the treatment of adult patients with ES-SCLC who have failed platinum-based chemotherapy.The study results showed that treatment with tarlatamab (10 mg administered every two weeks, N=99)ORR was up to 40% (95% Confidence Interval [CI]: 31, 51), with a median DoR of 9.7 months (CI: 2.7, 20.7+).`, Median Overall Survival`(mOS) was 14.3 months, and the final complete survival data are not yet mature.Recently,Taladotinib's First Global Phase 3 Study DeLLphi-304 Also Met Preset Primary Endpoint in the Planned Interim Analysis.TheThe study aims to evaluate its efficacy for second-line treatment of SCLC.The results showed that, compared with the standard chemotherapy regimen (SOC), tarlatumab achieved a statistically and clinically significant improvement in overall survival (OS). Its safety profile was consistent with previous trials, demonstrating a significant survival advantage in SCLC patients who had failed first-line platinum-based chemotherapy.Based on the positive results obtained from the DeLLphi-301, DeLLphi-304, and DeLLphi-307 studies, tarlatamab is expected to provide a new treatment option for second-line, third-line, and later-line therapy for patients with SCLC in China.Currently, the drug has been included in the treatment recommendations of the "Expert Consensus on Immunotherapy for Small Cell Lung Cancer (2025 Edition)." BeOne Medicines has reached a global oncology strategic cooperation with Amgen, which includes jointly advancing the development and commercialization of Tarlatamab in China.Plan to submit the marketing application for the relevant indications within the year.
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