Analysts at BMO Capital Markets expect Summit and Akeso’s HARMONi-6 readout to put some pressure on Merck and its blockbuster biologic Keytruda.
Summit Therapeutics and Akeso’s investigational bispecific antibody ivonescimab yields better progression-free survival outcomes than BeiGene’s PD-1 inhibitor Tevimbra in patients with non-small cell lung cancer.
Analysts at BMO Capital Markets wrote that these findings not only “further heat up competition” in the lung cancer arena but will also “reflect positively” on the emerging approach of targeting both PD-1 and VEGF in cancer. Summit’s data, which came from the Phase III HARMONi-6 trial, could in turn have “positive readthrough” to other companies in this space, including BioNTech.
BMO expects Merck’s stock to come under pressure as Summit and Akeso strengthen their case to “challenge Keytruda’s supremacy.” The readout from HARMONi-6 “adds to a growing battle in the space that may be a future concern,” they continued.
According to Wednesday’s release, an independent data monitoring committee found that treatment with ivonescimab and chemotherapy led to a “statistically significant and clinically meaningful improvement” in progression-free survival (PFS), as compared with Tevimbra plus chemotherapy, the standard of care for non-small cell lung cancer in China. Ivonescimab was able to maintain its PFS advantage even in patients whose tumors were positive or negative for PD-L1 expression.
Summit and Akeso did not provide specific data but promised to do so at a conference later this year.
Ivonescimab leads the emerging class of new cancer therapies that target both the PD-1 and VEGF pathways. Through this mechanism, ivonescimab, and other experimental assets like it, can prevent cancer cells from evading the immune system and limit the formation of blood vessels that would otherwise sustain the tumor.
In September 2024, Summit and Akeso shook the cancer space when they claimed victory for ivonescimab over Merck’s blockbuster Keytruda. Data released at the time came from a different Phase NSCLC III trial—dubbed HARMONi-2—which showed that median PFS in the ivonescimab arm was 11.14 months, versus Keytruda’s 5.82 months.
Comparing the two therapies, Summit and Akeso showed that invonescimab nearly halved the risk of disease progression or death as compared with Keytruda.
Analysts were optimistic, but still clearly skeptical. BMO Capital Markets at the time said that despite compelling data, ivonescimab was “not yet the Keytruda slayer.” Much of the ambivalence stemmed from the fact that HARMONi-2 was conducted entirely in China. “Results may or may not be generalizable beyond the China-focused patient population,” BMO noted.
Wednesday’s HARMONi-6 trial is also wholly being run in China, which could raise similar questions. However, Truist Securities sang a more optimistic tune in a Wednesday note to investors, saying that the findings of the China study could have “several positive read-throughs” to Summit’s HARMONi-3 trial, which could enable a U.S. approval application. Summit is currently enrolling the global trial, which is being conducted “with registrational intent” in the U.S.
“This reinforces our favorable expectations for HARMONi-3,” Truist analysts said. The firm expects an interim analysis from this trial in the fourth quarter of 2026, with a final readout in early 2028.
