Jun­shi and Co­herus plan to hus­tle the lat­est PD-1 to the FDA af­ter an up­beat PhI­II as­sess­ment

Four months af­ter its first up­beat in­ter­im analy­sis, Shang­hai’s Jun­shi Bio­sciences and Cal­i­for­nia biotech Co­herus Bio­Sciences are tout­ing a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival for pa­tients treat­ed with tori­pal­imab plus chemother­a­py as a treat­ment for ad­vanced squa­mous or non-squa­mous NSCLC.

The drug, an an­ti-PD-1 mAb al­ready ap­proved in Chi­na as Tuoyi, pre­vi­ous­ly beat place­bo as a first-line treat­ment when com­bined with chemother­a­py. Among 465 ad­vanced NSCLC pa­tients who have nev­er re­ceived ther­a­py (both squa­mous and non­squa­mous), in­ves­ti­ga­tors ob­served a “sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival.”

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