Sichan Kelun-Biotech Biopharmaceutical’s sac-TMT (sacituzumab tirumotecan) has posted positive results in a late-stage trial in non-small cell lung cancer (NSCLC).
During the Phase III OptiTROP-Lung05, the antibody-drug conjugate (ADC) met its primary endpoint, offering statistically significant improvements in progression-free survival (PFS) when combined with MSD’s flagship oncology asset, Keytruda (pembrolizumab), when compared with Keytruda alone.
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Sac-TMT also demonstrated a trend towards improving overall survival (OS) in first-line patients with programmed death ligand 1 (PD-L1)-positive disease.
Sac-TMT acts by targeting the trophoblast cell surface antigen-2 (TROP2) protein, which is widely expressed across a variety of solid tumours and is often associated with poor patient prognosis.
While the OptiTROP-Lung05 trial was conducted entirely in China, its findings bode well for MSD, which holds the commercialisation rights to sac-TMT outside of greater China. The drug previously received breakthrough therapy designation from the US Food and Drug Administration (FDA) for pretreated, advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) mutations.
Earlier this month, MSD signed a funding agreement with Blackstone Life Sciences for the development of sac-TMT, which saw the latter put $700m on the table in exchange for “low-to-mid single-digit royalties” on net sales of the drug across MSD’s marketing territories.
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By GlobalDataSac-TMT’s future in NSCLC
Following this positive topline readout, Kelun plans to discuss the results with China’s National Medical Products Administration (NMPA) in the hopes of garnering sac-TMT’s approval in the frontline NSCLC setting.
Currently, the standard of care (SoC) in first-line NSCLC is Keytruda plus platinum chemotherapy; however, there is a recent push towards phasing out chemotherapy in favour of more targeted and tolerable treatment options – with ADCs emerging as a key power in this shift.
If the NMPA were to approve the Keytruda-Sac-TMT combination, Biswajit Podder, oncology and haematology analyst at GlobalData, noted that the regimen could have the potential to become the local SoC.
“If the magnitude of PFS and eventually OS benefit is clearly better than Keytruda monotherapy with a manageable safety profile, I would expect it to become a new SOC for PD-L1 positive patients who are suitable for an ADC and either wish to avoid or delay platinum chemotherapy,” said Podder.
However, on a global scale, Podder caveats that more data is needed from Kelun-Biotech’s global sac-TMT commercialisation partner, MSD, which is currently running late-stage clinical trials involving the drug worldwide.
Podder stated: “For Sac-TMT plus Keytruda to become a true worldwide standard, we will need to see data from the MSD-led global Phase III programmes that test this combination in populations more representative of wide practice and ideally against chemo immunotherapy comparators.”
Sac-TMT’s first-line uptake not yet clear
Despite his view that the Phase III OptiTROP Lung05 trial readout is “very encouraging”, Podder notes that the study has not yet proved that sac-TMT plus Keytruda is superior, or even non-inferior to the SoC chemo-immunotherapy combination.
However, he believes a chemotherapy-free option will be attractive to patients concerned about cumulative toxicity accrued from the use of platinum doublets.
In the immediate future, Podder mentioned that Sac-TMT plus Keytruda’s uptake across China will likely be strongest in “tertiary centres that already have experience with ADCs and Sac-TMT in later lines”.
Outside of China, he does not expect widespread first line use in the immediate future, as the combination has not yet obtained approval in any solid tumour setting.
Podder commented: “Without global Phase III data versus current SoC, most regulators, clinicians and guideline bodies will see the drug as investigational.
“At this stage, I would frame the OptiTROP Lung05 trial result as an important regional step forward and a strong proof of concept rather than an immediate global practice-changing result.”
Moving forward, analysts at GlobalData forecast that sac-TMT will bring in $3.37bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
