Kelun-Biotech and Merck & Co.’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) has achieved a positive result in the Phase 3 OptiTROP-Lung06 trial, marking a development in the treatment of PD-L1-negative nonsquamous non-small cell lung cancer (NSCLC).
Kelun announced that the study met its primary endpoint in a first-line treatment setting. The trial evaluated sac-TMT in combination with Merck’s Keytruda against Keytruda combined with pemetrexed and platinum-based chemotherapy. According to the company, an interim analysis showed that the sac-TMT and Keytruda regimen produced a statistically significant and clinically meaningful improvement in progression-free survival. A favorable trend in overall survival was also observed.
The result is notable because it is the first Phase 3 study of an antibody-drug conjugate combined with an immune checkpoint inhibitor to achieve its primary endpoint in first-line PD-L1-negative nonsquamous NSCLC. Analysts at Leerink Partners said the findings provide the first direct proof-of-concept that an antibody-drug conjugate could replace platinum-based chemotherapy in a first-line standard-of-care regimen for NSCLC.
The OptiTROP-Lung06 outcome follows earlier results from the Phase 3 OptiTROP-Lung05 study, which evaluated sac-TMT and Keytruda in PD-L1-positive NSCLC. While some observers had noted that Keytruda alone is typically used as standard treatment only in patients with high PD-L1 expression, the latest findings extend evidence for the combination into a PD-L1-negative population. Jefferies analysts wrote that the new data support the possibility that sac-TMT and Keytruda may outperform standard treatment regardless of PD-L1 expression, while noting that the trial was conducted only in China.
The study also addresses an area not currently covered by Merck’s global Phase 3 development program for sac-TMT. The company is already conducting registrational studies involving the drug in other first-line NSCLC settings, including maintenance treatment in squamous disease and treatment of PD-L1-high nonsquamous tumors. Analysts suggested that the Lung06 results could encourage consideration of a similar global study in PD-L1-negative patients, who account for about one-third of the first-line nonsquamous NSCLC population.
Speaking previously about the development strategy for sac-TMT, Marjorie Green, M.D., head of oncology clinical development at Merck, indicated that the company does not expect to simply replicate earlier broad lung cancer studies because the treatment landscape has become increasingly segmented. She also cautioned against adding multiple therapies together without considering the possibility of overlapping toxicities.
During a Merck investor event at the 2026 American Society of Clinical Oncology meeting, Green said, “But I do think that it is important for us to look at our portfolio and look at our OptiTROP data and think about, it’s very consistent across every subgroup. It’s consistent across histologies and there’s still opportunity there. And we have lots of things we can combine with in our portfolio.”
In a July 15 statement, a Merck spokesperson said the OptiTROP-Lung06 findings increased the company’s confidence in sac-TMT’s potential to improve treatment options in the first-line setting for patients with non-small cell lung cancer. Jefferies analysts also noted that Merck could potentially explore combining sac-TMT with its PD-1xVEGF bispecific candidate MK-2010 as an alternative development path.
The Lung06 outcome represents the second late-stage success reported for sac-TMT. Earlier in 2026, the antibody-drug conjugate met primary endpoints in a Phase 3 endometrial cancer study. Kelun plans to discuss the NSCLC results with Chinese regulators and present detailed Lung06 data at the European Society for Medical Oncology annual meeting in October.
Keytruda has shown encouraging results when combined with Sac-TMT in patients with PD-L1-negative non-small cell lung cancer (NSCLC). According to the latest clinical findings, the combination therapy significantly improved progression-free survival (PFS), offering new hope for patients who traditionally have fewer effective immunotherapy options.
The study highlights the growing potential of combination treatment strategies to improve outcomes in difficult-to-treat lung cancer populations.
Keytruda Combination Demonstrates Positive Results
The latest clinical trial evaluated Keytruda alongside Sac-TMT in patients with advanced PD-L1-negative NSCLC. Researchers reported a meaningful improvement in progression-free survival compared with standard treatment approaches, suggesting the combination may enhance anti-tumor activity.
These findings reinforce the role of Keytruda as a cornerstone immunotherapy while demonstrating the value of combining it with innovative targeted therapies.
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