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Sacituzumab tirumotecan plus pembrolizumab improved PFS as first-line treatment in PD-L1–positive advanced NSCLC.
Sacituzumab tirumotecan (sac-TMT; SKB264/MK-2870) in combination with pembrolizumab (Keytruda) produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs pembrolizumab alone in patients with PD-L1–positive advanced non–small cell lung cancer (NSCLC), meeting the primary end point of the phase 3 OptiTROP-Lung05 trial (NCT06448312).1
The study’s independent data monitoring committee reported that the regimen also demonstrated a positive trend in overall survival. This result marks the first phase 3 study to demonstrate an antibody-drug conjugate (ADC) combined with an immune checkpoint inhibitor met a primary end point in the first-line NSCLC setting, according to an announcement from Sichuan Kelun-Biotech Biopharmaceutical.
Based on these findings, the company plans to engage with the Center for Drug Evaluation of the National Medical Products Administration in China regarding a supplemental new drug application seeking the approval of sac-TMT in this indication.
OptiTROP-Lung05 was a randomized, open-label, multicenter phase 3 study designed to evaluate the efficacy and safety of sac-TMT in combination with pembrolizumab compared with pembrolizumab monotherapy in the first-line treatment of patients with PD-L1–positive, locally advanced or metastatic NSCLC. Eligible patients needed to be 18 to 75 years of age with histologically or cytologically confirmed stage IIIB/C or IV NSCLC not amenable to radical surgery and/or radical radiotherapy, regardless of concurrent chemotherapy.2 No prior systemic therapy in the locally advanced or metastatic setting was permitted. Patients were required to have a PD-L1 tumor proportion score (TPS) of 1% or higher, and other key inclusion criteria comprised at least 1 measurable lesion per RECIST 1.1 criteria, an ECOG performance status of 0 or 1, a life expectancy of at least 12 weeks, and adequate organ/bone marrow function.
The study randomly assigned patients to receive sac-TMT on days 1, 15, and 29 of each 6-week cycle plus pembrolizumab on day 1 of each cycle; or pembrolizumab alone on the same schedule.
Along with the primary end point of PFS, secondary end points included OS, objective response rate, disease control rate, duration of response, and time to response.
What are the current approved indications for sac-TMT in China?
To date, sac-TMT has received three regulatory approvals in China across distinct solid tumor populations. Based on findings from the phase 3 OptiTROP-Breast01 study (NCT05347134), the agent is approved for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least 2 prior systemic therapies, including at least one regimen administered in the advanced or metastatic setting.3 It is also approved for patients with EGFR-mutated, locally advanced or metastatic nonsquamous NSCLC whose disease has progressed following EGFR TKI therapy and platinum-based chemotherapy, as well as for those with EGFR-mutant locally advanced or metastatic nonsquamous NSCLC whose disease has progressed after prior EGFR TKI therapy.1,4
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