New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.
Summit Therapeutics and Akeso’s upcoming PD-1/VEGF bispecific antibody has officially bested Merck’s mega-blockbuster Keytruda on both overall survival and progression free survival in a type of non-small cell lung cancer.
The latest results for the partners could establish a new paradigm in NSCLC treatment where ivonescimab becomes the regimen of choice among oncologists, analysts said.
But the new data from the Phase 3 HARMONi-2 trial comes from Chinese clinical trials. Summit still has to verify the results in Western patients to get the FDA on board for a clean regulatory review.
Akeso on Thursday announced interim results from the Phase 3 HARMONi-2 trial, which compared ivonescimab against Keytruda in patients with first-line NSCLC with tumors that express PD-L1. The drug is already approved in China for this type of cancer, as well as two others, but has yet to be cleared in the U.S. for any indication.
Ivonescimab met the key secondary goal of improving overall survival (OS). The companies previously announced the achievement of the main progression-free survival (PFS) endpoint in May 2024, earning the antibody the nickname Keytruda killer. The therapy achieved PFS of 11.14 months as compared to Keytruda’s 5.82 months.
“Akeso’s HARMONi-2 study has now demonstrated both PFS and OS superiority versus Keytruda in China, raising the possibility that future NSCLC regimens may increasingly be judged against ivonescimab rather than Keytruda,” Jefferies wrote in a Thursday morning note.
“While investors can reasonably debate whether China data will fully translate globally,” the analysts continued, “this latest OS readout strengthens the case for ivonescimab as a potential next-generation immunotherapy backbone in NSCLC.”
Summit’s shares rose over 7% to $15.65 in early morning trading Thursday.
Akeso did not reveal detailed data on the OS endpoint but promised to do so at a future medical meeting and in a peer-reviewed journal.
In the meantime, Summit is working on confirming these achievements in trials conducted elsewhere. A key test will be the outcome of the global Phase 3 HARMONi-3 trial, which is testing ivonescimab with chemotherapy against Keytruda in patients with first-line metastatic NSCLC.
After the drug was approved for this indication in China, the regulator there released additional data on the label that suggested a degradation of the PFS benefit. Analysts raised concerns that the HARMONi-3 trial may not show a sufficient benefit to warrant an accelerated approval from the FDA.
Summit is expected to reveal data from HARMONi-3 sometime this half. In May, an early interim analysis of PFS from HARMONI-3 failed to reach statistical significance, postponing Summit’s plans for a regulatory filing in this indication.
Summit is, however, currently awaiting a November FDA decision for the therapy in NSCLC with mutations in the gene for epidermal growth factor receptor (EGFR).
