Key Takeaways:
Akeso Inc.'s ivonescimab plus chemotherapy reduced the risk of death by 34% versus a standard PD-1 inhibitor regimen in patients with previously untreated advanced squamous non-small cell lung cancer, meeting statistical significance in a Phase 3 trial presented at the American Society of Clinical Oncology meeting in Chicago.
"The study provides a vital new path forward for patients with these difficult-to-treat cancers who have limited treatment options," David Spigel, president and chief medical officer at Sarah Cannon Research Institute, said during an ASCO press briefing.
The Harmoni-6 trial enrolled 532 patients in China and compared ivonescimab, a PD-1xVEGF bispecific antibody, plus chemotherapy against BeiOne Medicines' Tevimbra plus chemo. Median overall survival reached 27.9 months in the ivonescimab arm versus 23.7 months in the control group, a gain of 4.2 months. The p-value of 0.0017 crossed the prespecified boundary of 0.0049. The benefit appeared consistent across PD-L1-negative patients (36% risk reduction) and PD-L1-positive patients (32% risk reduction).
The result marks the first time a PD-1 inhibitor-based regimen has demonstrated an overall survival improvement over another PD-1 plus chemo combination in first-line squamous NSCLC. Previous standalone VEGF inhibitors like bevacizumab have been prohibited in squamous NSCLC due to bleeding risks. Grade 3 or above hemorrhages occurred in 2.6% of ivonescimab patients versus 0.8% in the control arm. Serious adverse events were reported in 69% of the ivonescimab group and 59% of the control group, with about 5% of patients in both arms discontinuing treatment due to side effects.
Akeso shares surged 9.2% on the Hong Kong exchange following the data release. Summit Therapeutics, which holds rights to ivonescimab in the U.S., Canada, Europe and Japan through a deal worth up to $5 billion, is running a separate global Phase 3 trial comparing the drug against Merck & Co.'s Keytruda, with interim data expected this year. The China-only data set is unlikely to support U.S. approval on its own, ASCO Chief Medical Officer Julie Gralow said, but positive results from the global study "will undoubtedly lead to an approval in the U.S."
The survival benefit signals that the bispecific approach can overcome historical limitations of VEGF inhibition in squamous NSCLC. Investors will watch for interim data from the global Harmoni study later this year, which will determine whether the results translate to a broader patient population.
This article is for informational purposes only and does not constitute investment advice.
