Glossary:
Antibody drug conjugate: a substance consisting of a monoclonal antibody that is linked to a drug. The antibody binds to receptors or proteins found on cancer cells, and then the linked drug enters the cells and kills them while leaving surrounding cells intact.
Progression-free survival: the time during and after treatment when a patient with cancer lives without the disease worsening.
Overall survival: the time when a patient with cancer is still alive.
Overall response rate: the percentage of patients who have a partial response or a complete response to treatment.
In particular, TROPION-Lung10 is focusing on Dato-DXd plus rilvegostomig or rilvegostomig plus Keytruda (pembrolizumab) in patients with previously untreated, locally advanced or metastatic nonsquamous non-small cell lung cancer with a high PD-L1 expression and without actionable genomic alterations.
In TROPION-Lung14, patients with previously untreated, locally advanced or metastatic EGFR-mutated nonsquamous non-small cell lung cancer will be treated with either Dato-DXd plus Tagrisso (osimertinib) or Tagrisso alone.
Lastly, TROPION-Lung15 will aim to assess Dato-DXd with or without Tagrisso compared with a platinum-based doublet chemotherapy in locally advanced or metastatic nonsquamous, EGFR-mutated non-small cell lung cancer with disease progression on prior Tagrisso treatment.
“Clinical research suggests that combining an antibody drug conjugate with a targeted treatment or a bispecific immunotherapy may drive stronger and more durable tumor responses in patients with a variety of cancers including lung cancer,” Dr. Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer at AstraZeneca, said in the release. “The initiation of these additional three phase 3 trials of datopotamab deruxtecan in combination with our agents, [Tagrisso] and rilvegostomig, illustrates our commitment to exploring potential synergies within our oncology pipeline, as well as the full potential and combinability of this TROP2-directed antibody drug conjugate across multiple segments and settings of non-small cell lung cancer.”
TROPION-Lung10
In the TROPION-Lung10 trial, researchers will aim to enroll an estimated 675 patients with previously untreated, locally advanced or metastatic nonsquamous non-small cell lung cancer. Patients will be randomly assigned to receive Dato-DXd plus rilvegostomig, rilvegostomig alone or Keytruda alone. Researchers will focus on several areas of interest including progression-free survival and overall survival, in addition to objective response rate, duration of response, safety and tolerability.
The TROPION-Lung14 trial will enroll an estimated 580 patients with previously untreated, locally advanced or metastatic nonsquamous non-small cell lung cancer with an EGFR mutation, particularly exon 19 deletion and/or L858R, according to the release. Patients will be randomly assigned to treatment with Dato-DXd plus Tagrisso or Tagrisso alone. The areas of interest in this trial include progression-free survival, central nervous system progression-free survival, overall response rate, overall survival and safety.
In the TROPION-Lung15 trial, an estimated 630 patients will be randomly assigned to receive either Dato-DXdeither alone or with Tagrisso, or platinum-based doublet chemotherapy. Patients in this trial will have locally advanced or metastatic nonsquamous non-small cell lung cancer with at least one EGFR mutation, particularly G719X, exon 19 deletion, S768I, L858R and/or L861Q, and whose disease progressed after treatment with Tagrisso. The endpoints of interest include progression-free survival, central nervous system progression-free survival, overall response rate, overall survival, safety and duration of response.
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