On May 9, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that the first United States-based patient has been enrolled in the Phase III HARMONi study (Press release, Summit Therapeutics, MAY 9, 2023, View Source [SID1234631317]).
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HARMONi is a Phase III multiregional, randomized, double-blinded study. The study will evaluate the efficacy and safety of ivonescimab combined with 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 third-generation EGFR tyrosine kinase inhibitor (TKI) such as osimertinib. Specifically, the study will compare ivonescimab combined with pemetrexed and carboplatin chemotherapies against a placebo plus pemetrexed and carboplatin. The study, designed with registration intent, has two primary endpoints: overall survival (OS) and progression-free survival (PFS).
HARMONi, also referred to as AK112-301, will enroll patients from the United States, Canada, Europe, and China in conjunction with our high-achieving partner, Akeso Inc. (Akeso). Akeso is responsible for enrollment in China, which has previously commenced; Summit is responsible for enrollment in the United States, Canada, and Europe. Over 400 patients are planned to be enrolled in the study.
"Advanced or metastatic non-small cell lung cancer is such a devastating diagnosis for patients," said Ian Anderson, M.D., Medical Oncologist at Providence Medical Foundation, who treated the first patient in HARMONi. "While we are making great strides as a medical community to improve the quality and duration of patients’ lives, there remains significant room for improvement in the treatment options available for these patients. In particular, for patients with an EGFR-mutated tumor whose tumor has progressed after their initial TKI therapy, there are limited options. We are particularly excited to evaluate the potential of ivonescimab in the HARMONi study to make a meaningful impact on the lives of these patients facing this difficult disease."
Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.1 This tetravalent structure, the design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which are intended to improve side effects and safety concerns associated with these targets and have the potential to focus the antitumor activity of both targets. We look forward to continuing to share additional details regarding ivonescimab at upcoming medical conferences.
Over 750 patients have been treated with ivonescimab across multiple clinical studies in China and Australia.
"Team Summit is committed to our mission to improve the quality of lives and potential duration of lives of patients suffering from serious unmet medical needs, starting with lung cancer," stated Dr. Maky Zanganeh, Co-CEO & President of Summit. "The combined work of all involved in launching HARMONi, from the closing of deal with Akeso to in-license ivonescimab three and a half months ago, to ensuring alignment with the US FDA regarding study design, preparing clinical study sites to enroll patients, readying ivonescimab for US clinical trials, and all of the foundational work needed to launch a clinical study, including contracts, Institutional Review Boards’ approvals, and quality reviews, is significant. Our commitment and dedication is clear, and we cannot be more excited about the future of ivonescimab and its potential to help patients who can benefit from this novel therapy."
"I would like to sincerely thank the investigators, coordinators, and their teams who have joined or will be a part of our study: without your commitment, patients would not have the opportunity to benefit from highly innovative investigational therapies," added Robert W. Duggan, Chairman and Co-CEO of Summit. "Most importantly, I would like to both thank and truly appreciate the courage of each patient around the world who will enroll in HARMONi: your actions are the reason why each person facing a cancer diagnosis has improved odds with each day that passes."
Lung cancer is believed to impact approximately 238,0002 people in the United States each year and approximately 477,0003 in Europe. NSCLC is the most prevalent type of lung cancer and represents approximately 80% of all incidences. Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.4
Ivonescimab is an investigational product and is not approved for use by any health authority. Its efficacy and safety for the treatment of any indication have not been established.
More information on the HARMONi study (NCT05184712) is available at clinicaltrials.gov.