- The HARMONi-6 trial demonstrates a statistically significant improvement in progression-free survival (PFS) with ivonescimab plus chemotherapy over tislelizumab plus chemotherapy in squamous non-small cell lung cancer (NSCLC).
- This Phase III study is the first to achieve meaningful benefits over a PD-(L)1 inhibitor combined with chemotherapy in this context.
- Summit Therapeutics Inc. (SMMT, Financial) continues global enrollment for the HARMONi-3 trial evaluating ivonescimab combined with chemotherapy against pembrolizumab for metastatic NSCLC.
Summit Therapeutics Inc. (NASDAQ: SMMT) has announced that its partner Akeso, Inc. achieved a milestone in the Phase III HARMONi-6 clinical trial. Conducted in China, the trial met its primary endpoint, demonstrating that ivonescimab combined with platinum-based chemotherapy significantly improves progression-free survival (PFS) compared to tislelizumab plus chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.
The trial showed that the PFS improvement was statistically significant and clinically meaningful, with benefits observed in both PD-L1-positive and PD-L1-negative tumors. An Independent Data Monitoring Committee established these findings at a prespecified interim analysis. Importantly, no new safety signals have been identified in this Phase III study. The comprehensive data set from HARMONi-6 is scheduled to be presented at a major medical conference later this year.
This achievement marks the first Phase III clinical trial to show a statistically significant improvement over a PD-(L)1 inhibitor combined with chemotherapy in the treatment of NSCLC. Previously, Akeso's HARMONi-2 study demonstrated the effectiveness of ivonescimab monotherapy in PD-L1 positive tumors, making this the second instance where ivonescimab-based regimens have outperformed standard PD-(L)1 inhibitor therapies.
In light of these achievements, Summit Therapeutics is actively enrolling patients for the HARMONi-3 trial. This multi-regional Phase III study will evaluate the efficacy of ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic squamous and non-squamous NSCLC patients. This trial is ongoing globally, including within Summit's licensed territories.
Ivonescimab, known as SMT112 in Summit's territories, is a novel investigational bispecific antibody that combines the immune effects of PD-1 blockade with the anti-angiogenesis effects of VEGF blockade. Its unique tetravalent structure is designed to enhance target binding and focus on tumor tissues, potentially improving safety and efficacy in treating insidious solid tumors.
