▎WuXiEdited by Kant Content Team

Recently, Amgen announced the latest data on its "first-in-class" bispecific T-cell engager (BiTE) Imdelltra (tarlatamab) at the 2024 World Conference on Lung Cancer (WCLC). The analysis shows,Imdelltra in combination with PD-L1 inhibitors as first-line maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC) demonstrates controllable safety, sustained disease control, and positive survival outcomes, with a disease control rate (DCR) of 62.5%.

The DeLLphi-303 study, which was recently published, is a Phase 1b multicenter open-label trial designed to evaluate the safety and efficacy of Imdelltra in combination with standard chemotherapeutic immunotherapy as a first-line treatment, followed by Imdelltra in combination with a PD-L1 inhibitor, in patients with ES-SCLC.The main results of the analysis include:

Imdelltra Plus PD-L1 Inhibitor:Showed positive benefits with no new or unexpected safety findings.

Imdelltra plus Imfinzi (durvalumab):The patient's DCR was 62.5%.(95% CI: 45.8-77.3), the median duration of disease control (DoDC) could not be estimated (95% CI: 3.9-NE). The median progression-free survival (mPFS) for patients was 5.3 months (95% CI: 3.5-NE),The overall survival rate at 9 months was 91.8% (95% CI: 76.6-97.3).

Imdelltra in combination with Tecentriq (atezolizumab):Patient'sDCR is 62.5%(95% CI: 47.4-76.0), median DoDC was 7.2 months (95% CI: 5.6-NE). The mPFS for patients was 5.6 months (95% CI: 3.5-8.5),The overall survival rate at 9 months was 86.7% (95% CI: 70.3-94.4).

In patients receiving Imdelltra plus Imfinzi, 15% discontinued treatment due to treatment-related adverse events (TRAEs), and 8% discontinued the medication. In the Imdelltra plus Tecentriq treatment group, 17% of patients interrupted treatment due to TRAEs, and 4% discontinued the medication.

Amgen also announced extended follow-up data from the DeLLphi-301 Phase 2 clinical trial. The analysis showed that Imdelltra demonstrated sustained anti-cancer activity and manageable safety in patients with ES-SCLC who had previously received platinum-based chemotherapy.

In 100 patients receiving 10 mg of Imdelltra every two weeks,The objective response rate (ORR) was 40%, with nearly half of the responders still maintaining their response at the data cutoff.Thirty percent of patients had stable disease, with a median duration of disease control of 6.9 months (95% CI: 5.4-8.6) and a median OS of 15.2 months. Imdelltra demonstrated good long-term tolerability, with no new safety issues identified. These findings support the continued use of Imdelltra in this patient population.

Imdelltra is a bispecific antibody (bsAbs) designed by Amgen researchers, which brings patients' own T cells into close proximity with SCLC cells by simultaneously binding to CD3 on T cells and DLL3 on SCLC cells.This leads to the formation of immune synapses and lysis of cancer cells. DLL3 is an innovative target for the treatment of SCLC becauseApproximately 85% to 94% of SCLC patients have cancer cells that express DLL3 on their surface, which is minimally expressed in normal cells.Imdelltra received U.S. FDA approval in May this yearAccelerated ApprovalFor the treatment of adult patients with ES-SCLC whose disease has progressed during or after chemotherapy. A previous press release from Amgen stated,Imdelltra is the first approved BiTE therapy for the treatment of solid tumors.