Kolon Biotech’s phase III lung cancer data: progression-free survival extended, with the efficacy advantage driven by more durable disease control
OptiTROP-Lung06 showed that sac-TMT plus pembrolizumab achieved median progression-free survival of 15.0 months in first-line treatment of PD-L1-negative advanced non-squamous non-small cell lung cancer, versus 5.7 months in the control group. JPMorgan is optimistic about its first-line treatment opportunity, but overall survival data remain immature, and median progression-free survival may fluctuate as the data mature.
Original source：J.P. MorganFirst published on Unhidea：Original source date：
Key takeaway
The efficacy and safety data from Lung06 support JPMorgan’s assessment of the first-line lung cancer opportunity for Kolon Biotech’s sac-TMT, with the efficacy advantage mainly reflected in more durable disease control.
How large was the efficacy gap in the new trial?
Among 455 previously untreated patients with advanced non-squamous non-small cell lung cancer, PD-L1 expression below 1%, and no EGFR or ALK alterations, median progression-free survival was 15.0 months with sac-TMT plus pembrolizumab and 5.7 months with chemotherapy plus pembrolizumab; the hazard ratio for disease progression or death was 0.49.
At a median follow-up of 9.4 months, the objective response rates were similar in the two groups, at 50.2% and 47.3%, respectively; median duration of response was 13.6 months and 6.8 months, respectively. The advantage came mainly from responses lasting longer, rather than a substantially higher initial response rate.
Overall survival data remain immature, with the current hazard ratio of 0.58 directionally favoring the sac-TMT group. Management noted that the confidence interval for median progression-free survival at the interim analysis was wide and that the figure could fluctuate subsequently; JPMorgan believes the trial’s sample size and hazard ratio support the durability of the efficacy signal.
What does the safety profile mean for first-line treatment?
The incidence of grade 3 or higher treatment-emergent adverse events was 47.6% in the sac-TMT combination group, lower than the 60.6% in the chemotherapy combination group. JPMorgan considers the safety profile manageable, strengthening the case for first-line use.
Severe reductions in blood cell counts were also less frequent: grade 3 or higher anemia occurred in 6.1% of patients, versus 20.4% in the control group; the corresponding rates of decreased platelet counts were 3.9% and 14.6%. Grade 3 or higher stomatitis occurred in 2.2% of the sac-TMT group.
Why did another trial of a drug in the same class prompt discussion?
The overall EVOKE-03 trial result was negative, but in a post hoc regional analysis, the overall survival hazard ratio for the Trodelvy regimen was 0.73 in East Asian patients and 0.65 in Chinese patients; the confidence intervals for both populations crossed 1, prompting some investors to focus on the comparability of Chinese trial results when extrapolated globally.
JPMorgan believes the result should not be overinterpreted: the Chinese subgroup was small, the analysis was post hoc and unstratified, and the distribution of biomarkers such as PD-L1 across subgroups was unknown. The bank also noted that Kolon’s earlier Lung05 trial had a progression-free survival hazard ratio of 0.35 and an immature overall survival hazard ratio of 0.55; the strong efficacy supports the potential success of its global program.
How do these data affect the assessment of Kolon’s development and valuation?
JPMorgan believes Lung06 and the earlier Lung05 together support the opportunity for sac-TMT in broader first-line lung cancer treatment, particularly among patients with low PD-L1 expression; PD-1 monotherapy is generally less effective in this population.
Management said Merck, which has acquired the rights to sac-TMT outside China, may directly initiate a trial in 2027 of its PD-1/VEGF drug combined with sac-TMT for non-small cell lung cancer, potentially skipping a new phase III trial of pembrolizumab plus sac-TMT.
JPMorgan forecasts that sac-TMT’s peak sales in China could exceed 9 billion yuan and reach 6 billion US dollars outside China; it maintains its Overweight rating on Kolon Biotech and its December 2026 price target of 677 Hong Kong dollars.
