Summit Therapeutics Inc. (NASDAQ: SMMT) has announced promising data for its investigational bispecific antibody, ivonescimab, at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic. The company revealed that ivonescimab alone or in combination with chemotherapy led to intracranial responses in 34% of patients with brain metastases at baseline, with 23% achieving a complete response.
In the phase II trial for ivonescimab plus chemotherapy in multiple non-small cell lung cancer (NSCLC) settings, including 1L squamous NSCLC, patients with asymptomatic brain metastases at baseline experienced a median intracranial progression-free survival of 19.3 months. Moreover, no cases of intracranial bleeding were observed in these patients.
The updated data from the trial also revealed that first-line advanced or metastatic squamous NSCLC patients experienced a median progression-free survival of 11.1 months, while non-squamous tumors patients experienced a median progression-free survival of 13.3 months. The median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months.
Summit highlighted that the frequency of treatment-emergent adverse events leading to the discontinuation of ivonescimab was 11.1% and 2.8% in patients with squamous and non-squamous tumors, respectively. The most frequent treatment-emergent adverse events were anemia and decreased neutrophil counts in squamous patients, and anemia and constipation in non-squamous patients.
Summit Therapeutics continues its clinical development of ivonescimab in two NSCLC indications: the Harmoni Phase III trial, and the Harmoni-3 Phase III trial. The former involves ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI, while the latter involves ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients.
Ivonescimab, which is known as SMT112 in Summit’s license territories, is an investigational, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with anti-angiogenesis effects associated with blocking VEGF into a single molecule. The company emphasized that ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.
As of now, ivonescimab is an investigational therapy that is not approved by any regulatory authority. Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of medicinal therapies intended to improve the quality and potential duration of life for patients with serious unmet medical needs.
The posters presented at ELCC 2024 featured detailed safety and anti-tumor activity updates from the phase II trial for ivonescimab plus chemotherapy in multiple NSCLC settings, as well as promising intracranial anti-tumor activity and safety data for ivonescimab in NSCLC patients with brain metastases. Dr. H. Jack West, Vice President of Clinical Development at Summit, expressed pleasure at the favorable intracranial response rates and median intracranial progression-free survival, as well as the promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC. Following these announcements, the company's shares moved -3.1%, and are now trading at a price of $3.44. If you want to know more, read the company's complete 8-K report here.
