The shares of Summit Therapeutics Inc. (NASDAQ: SMMT) surged 62.84% to $19.98 today in reaction to positive findings from a Phase III clinical trial. During the 2024 World Conference on Lung Cancer (WCLC 2024) of the International Association for the Study of Lung Cancer (IASLC), the business presented their results in San Diego, California.
What Summit Therapeutics has shared?
Summit Therapeutics announced data from the Phase III HARMONi-2 study, which investigated ivonescimab, a novel bispecific antibody with potential first-in-class status. Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 were randomized to receive either pembrolizumab monotherapy or ivonescimab monotherapy.
The experiment was funded by Akeso, Inc. and was carried out in China. Professor Caicun Zhou, MD, PhD, of Tongji University School of Medicine, presented the trial’s findings. Comparing ivonescimab monotherapy to pembrolizumab, the main analysis of HARMONi-2 showed a substantial improvement in progression-free survival (PFS).
This advantage was shown in a range of clinical subgroups, including as individuals with varying histologies, high-risk variables, and both high and low PD-L1 expression. Furthermore, ivonescimab outperformed pembrolizumab in terms of overall response rates (ORR) and disease control rates (DCR).
Safety Overview and Upcoming Events
Ivonescimab’s safety profile was judged to be controllable and acceptable, in line with other research. Compared to individuals on pembrolizumab, fewer people stopped taking ivonescimab because of treatment-related adverse events (TRAEs). Summit Therapeutics sees the HARMONi-2 results as a turning point in the treatment of cancer and as a possible change in the therapeutic choices available to patients with lung cancer.
Building on these findings, SMMT intends to launch the HARMONi-7 trial early in 2025, aiming to assess ivonescimab monotherapy in comparison to pembrolizumab in patients with high PD-L1 expression metastatic non-small cell lung cancer.
Future Data Showcase at ESMO 2024
After presenting the data at presentation at WCLC 2024, Summit Therapeutics (SMMT) is also in plans of presenting Phase II results on ivonescimab at the European Society of Medical Oncology (ESMO) Congress 2024 to be held in Barcelona, Spain this week. The potential of ivonescimab as a first-line therapy for these presentations will include head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), and triple-negative advanced breast cancer (TNBC).