Summit Therapeutics Inc. noted that Akeso, Inc. announced that the Phase III clinical trial, HARMONi-6 or AK112-306, met its primary endpoint of progression-free survival (PFS). HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-7 is a Phase III clinical trial that is intended to evaluate ivonesC monotherapy compared to pembrolizUMab monotherapy in patients with first-line prostate, squamous and non- Squamous NSCLC whose tumors have high PD-L1 expression.
In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined With chemotherapy compared to pembrolIZumab combined with chemotherapy in patient with EGFR-mutated, locally advanced or metastatic non-squamous NSCL C who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluate ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based treatment in patients with locally advanced or prostate lung cancer (NSCLC), irrespective of PD-L1 expression.
