Amgen's Breakthrough BiTE Therapy Imdelltra Receives FDA Accelerated Approval for Extensive-Stage Small Cell Lung Cancer

On May 16 local time, Amgen announced that the U.S. FDA had granted accelerated approval to its bispecific T-cell engager (BiTE) Imdelltra (tarlatamab-dlle) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has progressed during or after platinum-based chemotherapy.）Adult patients.The press release noted that Imdelltra is the first approved BiTE therapy for the treatment of solid tumors.。

SCLC is one of the most aggressive solid tumors, with a median overall survival of only about 12 months after first-line treatment and a 5-year survival rate of approximately 7%. In the United States alone, around 35,000 patients are diagnosed with SCLC each year.

The approval of Tarlatamab is based on the results of the global phase 2 clinical trial, DeLLphi-301. The trial results showed that tarlatamab demonstrated durable anti-tumor activity in patients with advanced SCLC whose disease progressed during or after platinum-based chemotherapy. Data published last year in the New England Journal of Medicine (NEJM) showed that, with a median follow-up time of 10.6 months, an intent-to-treat analysis of 100 patients receiving the selected 10 mg dose of tarlatamab indicatedObjective Response Rate (ORR) was 40%(97.5% CI: 29, 52). The median progression-free survival (mPFS) in this patient population was 4.9 months (95% CI: 2.9, 6.7).Median overall survival was 14.3 months (95% CI: 10.8, NE)Of the patients who responded to the 10 mg dose of tarlatamab, 58% maintained their response for at least 6 months as of the data cutoff.

In terms of safety, no new safety signals were observed compared to Phase 1 clinical trials. Discontinuation due to treatment-related adverse events (TRAE) was uncommon (4%).

Tarlatamab is a bispecific T-cell engager (BiTE) designed by Amgen researchers. By simultaneously binding to CD3 on T cells and DLL3 on SCLC cells, it brings the patient's own T cells into close proximity with SCLC cells. This leads to the formation of an immune synapse and the lysis of cancer cells. DLL3 is an exciting target for treating SCLC because approximately 85% to 94% of SCLC patients express DLL3 on the surface of their cancer cells, while it is minimally expressed in normal cells. Amgen, Inc.Plan to launch two Phase 3 clinical trials, dividedDo not test tarlatamab as a first-line therapy for ES-SCLC and for limited-stage small cell lung cancer (LS-SCLC).

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Immune Cell Engagers Enter Boom Period, Multiple BiTEs Launched, NK/CAR-T/M Cell Engagers Follow Suit

BiTE Technology: A Targeted Immunooncology PlatformImdelltraAlready obtainedApproved, it has demonstrated powerful efficacy in solid tumors. Amgen remains committed to developing multiple BiTE molecules across a wide range of hematologic and solid tumor malignancies, paving the way for other applications in more tumor types.

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