Ivonescimab is used to treat metastatic non-squamous non-small cell lung cancer. Credit: Librepath / commons.wikimedia.org.

Summit Therapeutics has treated the first US patient with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the Phase III HARMONi study of ivonescimab.

Designed with registration intent, the double-blinded, randomised, multiregional study will evaluate the safety and efficacy of ivonescimab, along with pemetrexed and carboplatin chemotherapies, against a placebo plus pemetrexed and carboplatin.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

It will enrol more than 400 patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic NSCLC who have progressed after receiving a third-generation EGFR tyrosine kinase inhibitor osimertinib.

Summit will enrol subjects from the US, Canada and Europe while its partner Akeso will be responsible for enrolment in China, which started earlier.

Two primary endpoints of the study are overall survival and progression-free survival.

Summit co-CEO and president Dr Maky Zanganeh said: “The combined work of all involved in launching HARMONi, from the closing of the 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 enrol 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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A novel, potential investigational bispecific antibody Ivonescimab is available as SMT112 in the US, Canada, Europe, and Japan, and as AK112 in China and Australia.

More than 750 patients received treatment with ivonescimab in multiple clinical trials in China and Australia.