The month of May that has just passed was absolutely a fortunate month for Amgen.
On May 28, the FDA approved Bkemv for two rare diseases. This is as an interchangeable biosimilar to the originator product Soliris (eculizumab).On May 16, FDA granted accelerated approval to tarlatamab-dlle (Imdelltra) for the treatment of patients whose disease progressed during or after platinum-based chemotherapy.Extensive-Stage Small Cell Lung Cancer。This is the world's first and currently the only approved treatment for major solid tumors.Bispecific T Cell Engager Therapy (DLL3/CD3). Approximately85%-96%SCLC patients express DLL3, making it an ideal target for treating SCLC. Patients are not required to undergo DLL3 level testing before medication.As a DLL3/CD3 bispecific antibody, tarlatamab targets the DLL3 antigen after entering the body, while simultaneously binding to the patient's own T cells via the CD3 antigen. This is followed by the formation of a synapse between T cells and DLL3-expressing cells, triggering T-cell activation, which leads to the release of inflammatory cytokines and the lysis of DLL3-expressing cells, thereby achieving its effect.Activate patients' own T cells to attack cancer cells expressing DLL3The mechanism of action. This product is also the first SCLC treatment drug with a highly selective mechanism of action.In a Phase 2 clinical trial (DeLLphi-301p),The overall response rate reached 40%, with a median duration of response of 9.7 months and a median overall survival of 14.3 months.Based on this, the FDA made the decision to grant accelerated approval, while also leaving Amgen with numerous tasks to further refine tarlatamab.Efficacy, Safety, and CMC。The first priority, of course, is to initiate Phase 3 clinical trials.The FDA is requiring Amgen to conduct a multicenter randomized clinical trial to confirm the clinical benefit of tarlatamab in patients with extensive-stage small cell lung cancer, as the previous Phase 2 clinical trial only provided preliminary data on a small scale, which is far from sufficient for full approval.In this regard, Amgen has been proactive. On May 6, just days before the approval, the final protocol for the Phase 3 clinical trial (Dellphi-304) was submitted as early as December 2022. This trial is currently underway, with an expected completion date in April 2026, and the final clinical report is anticipated to be submitted by August 2026.This accelerated approval is only for second-line treatment, and Amgen is clearly not satisfied with this.Amgen has launched new clinical trials aimed at becoming a first-line therapy., including Dellphi-305 as maintenance therapy in combination with PD-L1 therapy, and Dellphi-306 as consolidation therapy alone for limited-stage SCLC. If these two clinical trials are successful, SCLC can be fully addressed.Secondly, the FDA requires the submission of a complete safety analysis report, enhanced pharmacovigilance monitoring, and collectionData from Minority Ethnic Patients and Comprehensive Analysis。It is considered insufficient to assess Amgen's plan to submit a post-marketing spontaneous adverse event analysis report.Cytokine Release Syndrome (CRS)、Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)As well as the serious risk of neurotoxicity, Amgen must conduct a comprehensive safety analysis to determine the long-term incidence, severity, and outcomes. The final report is due in August 2026.Given that the accelerated approval prescribing information includes CRS and ICANS in the black box warning, the FDA has required Amgen to enhance pharmacovigilance monitoring, specifically mandating the reporting of all CRS and ICANS cases within 15 days, particularly within the first three years post-approval.In addition, Amgen should also collect data from representative minority patients with SCLC in the United States and conduct a comprehensive analysis. The final report is due on April 2027.In addition to the above-mentioned requirements for efficacy and safety,The FDA also issued a CMC requirement., which is actually related to safety. The FDA requires Amgen to developMonocyte Activation Test (MAT)Can be reliably measuredIntravenous Solution Stabilizer (IV Solution Stabilizer, IVSS)Endotoxin in. The results of the feasibility study for method development need to be submitted by January 2025. If the method feasibility study is approved, the next step will be to conduct a method validation study with three batches of IVSS, and submit the method validation report by January 2026. If the MAT method proves unfeasible, Amgen commits to developing an alternative method for endotoxin detection that is not affected by low endotoxin recovery.So-called IVSS, a sterile, preservative-free, colorless to pale yellow clear solution. Each vial of IVSS contains citric acid monohydrate (36.75 mg), lysine hydrochloride (1598.8 mg), polysorbate 80 (7 mg), sodium hydroxide to adjust pH to 7.0, and water for injection. The purpose of IVSS is to rinse the inside of the infusion bag with IVSS before adding tarlatamab into the infusion bag to prevent tarlatamab from adsorbing onto the inner walls of the infusion bag and tubing. BiG 10th Anniversary Preview
June 26-29, Suzhou, BiG Ten-Year Anniversary Celebration to Be Held, This ConferenceDivided into domestic and international chapters for the first time，Starting from original scientific research and clinical needs, DiscussionInnovative technology platforms and therapies (PROTAC/molecular glue, bispecific antibodies/ADC, siRNA/ASO, CGT, AI drug discovery)Significant advancements and development prospects,A Decade of Drug Development: A Glimmer of Hope Emerges, Only Through the Trials of Time Comes True Gold!
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