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Tanja Obradovic

Jun 1, 2025, 02:34

Tanja Obradovic: HARMONi Trial – Topline Results Reveal Positive PFS for Ivonescimab in NSCLC

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:

“High interest at ASCO2025 is around novel bi-specific antibodies but in contrast to ASCO2024 we may not hear at this meeting more updates from Summit Therapeutics, Inc. on ivonescimab beyond what has been just announced today.

Topline results from the global Phase III clinical trial, HARMONi, came today and study successfully met the progression-free survival (PFS) primary endpoint and showed a positive trend in the other primary endpoint, overall survival (OS). HARMONi is a multiregional, double-blinded, placebo-controlled, Phase III trial evaluating ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI).

Statistically significant and clinically meaningful improvement in progression-free survival (hazard ratio of 0.52) compared to placebo in combination with chemotherapy was observed in both Asian and ex-Asian sub-populations.
Positive trend in OS in the primary analysis without achieving a statistically significant benefit (hazard ratio of 0.79) was also found in both patient populations. The median follow-up time for western patients was less than the median overall survival at the time of the analysis so these patients continue to be followed for long-term outcomes and final evaluation of OS benefit is still pending that will influence timing of the BLA submission to FDA.

While Summit Therapeutics, Inc. has confidence in ivonescimab’s potential to benefit patients globally including in the US, investment community is cautious and company stock is lower (over 20%) today as demonstration of OS benefit remains critical for regulatory success.”

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