Mixed happiness and sorrow! K-drug small cell lung cancer in phase III clinical PFS end point missed OS end point

Fan Dongdong recently published the results of phase III clinical keynote-604 trial of its checkpoint inhibitor keytruda (pembrolizumab) combined with chemotherapy (etoposide + platinum drugs) in the treatment of extensive small cell lung cancer (es-sclc) The results showed that keytruda chemotherapy combination significantly improved the primary end point of PFS (HR = 0.75, 95% CI, 0.61-0.91), but missed the primary end point of OS (HR = 0.80, 95% CI, 0.64-0.98) Keynote-604 is a randomized, double-blind, placebo-controlled phase III study in which 453 patients with SCLC who have not yet used systemic therapy were recruited to evaluate the therapeutic effect of keytruda combined chemotherapy on newly diagnosed patients with extensive small cell lung cancer compared with chemotherapy The double endpoints of the study were OS and PFS, and the secondary endpoints were objective response rate (ORR), duration of response (DOR), safety and quality of life The same as Pd - (L) 1 therapy, can not avoid being compared In the impower133 study, the risk of death was reduced by 30% in the Roche tecentriq group and 27% in the Caspian study in the AstraZeneca imfinzi group, both higher than keytruda's 20% Although the study failed to reach the primary end point of OS, the figure of reducing the risk of cancer progression or death by 25% is more competitive than the other two PD-L1 drugs Tecentriq reduced the risk of disease progression or death by 23%; imfinzi reduced the risk by 22% Dr Roy Baynes, chief medical officer, senior vice president and global head of moshadong research laboratory, said, "the results of keynote-604 prove that keytruda combined with chemotherapy has the potential to improve the disease progression of newly diagnosed patients with extensive small cell lung cancer and the prognosis of patients with highly invasive malignant tumors." This alone is not enough to support clinical approval, svbleerink analyst Daina graybosch said in an investor report, especially at a time when tecentriq and imfinzi have already won overall survival in the field Graybosch also said that if keynote-604 can succeed in the indication, sales of the drug in the United States could increase by another $269 million to $429 million in 2024 Mosadon said the mixed results of the study will be discussed with regulators and the progress will be announced at the upcoming medical conference Adorable adorable