The NMPA has approved Puyouheng for patients with unresectable or MSI-H or dMMR advanced solid tumors incl. advanced colorectal cancers & other advanced solid tumors that have progressed prior to 1L therapy with no alternative treatment options
The approval was based on a P-II study to evaluate Puyouheng (200mg, IV, q3w) in 100 patients with histologically confirmed MSI-H/dMMR advanced solid tumors. The results showed ORR for the ITT population was 49.0% with 9 cases of CR & 40 of PR at a median follow-up duration was 22.5mos.
In the subgroup of patients with colorectal cancers who had failed prior triplet therapy, the ORR was 50.0% & was found to be safe & effective, patients also get benefit from the therapy
Ref: PRNewswire | Image: Lepu Biopharma
