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Pym monotherapy is a standard first-line treatment for metastasis non-small cell lung cancer (NSCLC) with a programmed death ligation ≥ 1 (PD-L1) tumor ratio score (TPS) of 50% and inoperable drive gene mutations.
it is not clear whether the addition of Ipi monoantigen to the treatment of Pym monoantigen can further improve the treatment effectiveness of such patients.
study was a randomized, double-blind Phase III trial (KEYNOTE-598) that recruited previously untreated PD-L1 TPS≥50% and did not carry a metastasis NSCL with sensitive EGFR or APK variants In patients with C, random (1:1) was assigned to the Ipi monoantigen (1 mg/kg,6 weeks x 18 times) or placebo group; all patients received pym monoantigen (200 mg) every 3 weeks for a total of 35 doses.
end points of the project are total survival and progress-free survival.
OS recruited 568 patients, 284 each in each group.
total survival periods were 21.4 months and 21.9 months,21.9 months(HR 1.08, 95% CI 0.85-1.3, respectively) in the Paim monoanti-Ipi-placebo group 7,p=0.74), with a medium progress-free survival period of 8.2 months and 8.4 months (HR 1.06,95% CI 0.86-1.30, p=0.72), respectively).
62.4% and 50.2% of adverse reactions in the PFS Ipi monoantigroup and placebo group, respectively, and the mortality rate was 13.1% and 7.5%, respectively.
external data and safety monitoring committee recommended that the ineffective study be discontinued, and subjects were suspended with ipsants and placebos.
addition, the addition of Pym monoantitherapy to Ippi monotherapy does not further improve the therapeutic effect of PD-L1 TPS≥50%, targetless EGFR or ALC variant metastasis NSCLC patients on the basis of Pim monoantitherapy.
therefore, the study did not support the use of Pim monoantigen ipi monoantigen therapy in this class of patients.