[Breaking News] Summit Reaches Record High: ‘Evorpacept’ Combo Therapy Outperforms Standard Treatment

## Summit Therapeutics Shares Skyrocket Following Promising Lung Cancer Therapy Results Shares of Summit Therapeutics (SMMT) soared to a record high of $36.91 on the New York Stock Exchange on April 24, driven by transformative advancements related to its lung cancer drug candidate, ivonescimab. Developed in collaboration with China's Akeso (9926.HK), ivonescimab exhibited statistically significant progression-free survival (PFS) benefits over existing treatments in Phase 3 clinical trials targeting patients with squamous non-small cell lung cancer (NSCLC). ### Ivonescimab: A Revolutionary Dual-Action Cancer Treatment Summit’s premier drug candidate, ivonescimab, addresses NSCLC using an innovative dual-action approach. Unlike Merck's immunotherapy Keytruda (pembrolizumab), which targets only the PD-1 protein, ivonescimab blocks both PD-1 and VEGF (vascular endothelial growth factor). This combination disrupts tumor growth by allowing the immune system to attack cancer cells while simultaneously cutting off their blood supply. PD-1 is a protein that cancer cells utilize to evade the immune system by preventing T cells from attacking them. Ivonescimab removes this shield, enabling the immune system to recognize and combat tumors effectively. Additionally, VEGF inhibition halts the formation of new blood vessels, effectively starving the cancer cells. This groundbreaking mechanism positions ivonescimab as a next-generation oncology therapy, particularly as Keytruda’s patent is set to expire in 2028. ### Proven Efficacy and Safety in Clinical Trials The Phase 3 "HARMONi-6" study, announced on April 23, confirmed ivonescimab's superiority over other PD-1 inhibitors. The trial, which involved 532 patients with locally advanced or metastatic squamous NSCLC across 66 sites in China, showed an improved PFS rate compared to the combination of tislelizumab (Tevimbra by BeiGene (6160.HK; BGNE on Nasdaq; 688235.SH)) and chemotherapy. These benefits were consistent across patients regardless of their PD-L1 expression levels, with no new safety concerns arising. This study builds on findings from the earlier "HARMONi-2" Phase 3 trial, where ivonescimab monotherapy was tested against pembrolizumab in Chinese patients with PD-L1-positive locally advanced or metastatic NSCLC. Ivonescimab-treated patients had a median PFS of 11.14 months, compared to 5.82 months for those on pembrolizumab, representing a significant 49% reduction in the risk of disease progression or death. ### Ivonescimab Surpasses Industry Benchmarks Ivonescimab is now recognized as the first therapy to demonstrate statistically significant improvements in clinical trials directly comparing it with PD-(L)1 inhibitor-chemotherapy regimens for NSCLC. After outperforming pembrolizumab in monotherapy trials last year, ivonescimab again excelled over tislelizumab in combination therapy trials this year, further solidifying its clinical importance. Industry experts emphasized the uniqueness of ivonescimab's dual-action approach in meeting unmet medical needs in NSCLC treatments. However, additional trials are necessary to ensure regulatory approval outside China. ### Pathway to FDA Approval Although Akeso obtained approval for ivonescimab in China under the trade name "Aidengxu" in 2024, Summit must undertake multi-regional clinical trials to secure U.S. Food and Drug Administration (FDA) approval. To this end, Summit is actively recruiting patients for its global Phase 3 trial, "HARMONi-3" (NCT05899608), which assesses ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic squamous and non-squamous NSCLC patients. A separate trial, "HARMONi-7" (NCT06767514), focuses on ivonescimab monotherapy compared to pembrolizumab in PD-L1-positive, locally advanced, or metastatic NSCLC patients. Data from these trials are expected to support Summit's regulatory submissions in the U.S. and other licensed regions. Following the success of HARMONi-2, some industry observers criticized the drug's initial exclusion of a direct comparison to the widely used Keytruda-chemotherapy regimen. If ivonescimab produces similarly favorable outcomes against this standard, the path to regulatory approval will be significantly eased. As Summit progresses with its global clinical program, the biopharmaceutical industry eagerly anticipates the results, hoping for a groundbreaking advancement that could revolutionize NSCLC treatment paradigms.