Amgen announced that its Imdelltra (tarlatamab-dlle) significantly improves overall survival in patients with small cell lung cancer (SCLC) whose disease progressed after chemotherapy.
The announcement is based on DeLLphi-304, a global, randomised, controlled, open-label Phase 3 clinical trial assessing the efficacy and safety of Imdelltra in SCLC patients.
Imdelltra is an immunotherapy that targets DLL3 on tumour cells and CD3 on T cells, activating T cells to destroy DLL3-expressing SCLC cells.
DLL3 is a protein expressed on the surface of SCLC cells in the majority of patients with SCLC, however, it is minimally expressed in healthy cells.
In the Phase 3 study, participants were assigned to receive either Imdelltra or local standard-of-care chemotherapy, with overall survival as the primary outcome.
The chemotherapy included topotecan, lurbinectedin, or amrubicin, based on the country.
Imdelltra showed a statistically significant and clinically meaningful improvement in overall survival compared to local standard-of-care chemotherapy.
The drug showed a safety profile that was consistent with previous findings.
Amgen Research and Development executive vice president Jay Bradner said: “Small cell lung cancer is one of the most aggressive malignancies, with a high unmet need for more effective therapies.
“The topline results from DeLLphi-304 demonstrate an overwhelming clinical benefit for people living with this devastating disease and affirm Imdelltra as the standard of care.
“We look forward to sharing these results with the scientific community and health authorities as we continue our efforts to bring Imdelltra to patients worldwide.”
In May last year, the U.S. Food and Drug Administration (FDA) approved Imdelltra, based on results from the Phase 2 DeLLphi-301 clinical trial.
The drug was indicated for adults with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after platinum-based chemotherapy.
Imdelltra received accelerated approval in this indication, based on the overall response rate and duration of response, with continued approval contingent on confirmatory trials.
Recently, Amgen secured FDA approval for Uplizna, a humanised monoclonal antibody (mAb), to treat adults with Immunoglobulin G4-related disease (IgG4-RD).
