1. In patients with previously treated metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), treatment with sacituzumab tirumotecan (sac-TMT) resulted in improvements in objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) compared to docetaxel.
Evidence Rating Level: 1 (Excellent)
In patients with EGFR-mutated NSCLC, the first-line therapeutic option is typically EGFR tyrosine kinase inhibitors. Once disease progression occurs on both EGFR tyrosine kinase inhibitors and platinum-based chemotherapy, guidelines recommend the use of docetaxel. However, as the efficacy of docetaxel remains suboptimal, there is a need for novel treatment options. This randomized controlled trial therefore sought to compare the efficacy of sac-TMT, a novel antibody-drug conjugate, against docetaxel in patients with previously treated advanced EGFR-mutated NSCLC. 137 patients (median age, 56 years; 44% male) between the ages of 18 and 75 across 48 centres in China with EGFR-mutated NSCLC previously treated with EGFR tyrosine kinase inhibitors and platinum-based chemotherapy were randomly assigned to receive either sac-TMT (n = 91) or docetaxel (n = 46). The blind independent review committee (BIRC)-assessed ORR for the sac-TMT was 45% while the BIRC-assessed ORR for the docetaxel group was 16%, with a difference of 29% (95% CI 15% to 43%; one sided P<0.001). Additionally, the sac-TMT group had a 70% reduction in risk of disease progression or death compared to the docetaxel group (hazard ratio 0.30, 95% CI 0.20 to 0.46; one sided P<0.001). The 12 month OS for the sac-TMT group was 73% (95% CI, 62% to 81%) compared to 54% (95% CI, 39% to 67%) in the docetaxel group. Overall, this study found that use of sac-TMT in patients with previously treated advanced EGFR-mutated NSCLC resulted in benefits in ORR, PFS and OS compared to docetaxel.
Click to read the study in BMJ
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