Ivonescimab benefit for EGFR mutant NSCLC patients who failed TKI therapy

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Published: 1 Jun 2024
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Prof Li Zhang - Sun Yat-Sen University Cancer Center, Guangzhou, China

Dr Zhang talks to ecancer at ASCO 2024 about the HARMONi-A phase 3 study which looked at ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment.

Ivonescimab (AK112/SMT112) is a anti-PD-1/VEGF bispecific antibody. Previous phase I/II clinical studies have shown potential efficacy of ivonescimab in NSCLC patients with EGFR mutations who had failed prior EGFR-TKIs therapies. This phase 3 study aimed to evaluate and confirm the efficacy and safety of ivonescimab combined with chemotherapy versus chemotherapy alone in this population.

The study found that ivonescimab plus chemotherapy significantly improved PFS while maintaining a manageable safety profile in this specific set of patients.

Ivonescimab benefit for EGFR mutant NSCLC patients who failed TKI therapy

Prof Li Zhang - Sun Yat-Sen University Cancer Center, Guangzhou, China

At the ASCO meeting I presented ivonescimab plus chemotherapy for EGFR mutant non-small cell lung cancer patients who failed from EGFR TKI. For the EGFR mutant population, EGFR TKI was the main frontline treatment and early response is very impressive. However, acquired resistance always comes to the patients, this is a big challenge for our patients. So, based on that, we designed a study which is chemotherapy versus chemotherapy plus ivonescimab for the EGFR mutant population who failed on EGFR TKI.

What are the results?

The study met its primary endpoint. The PFS of the study arm was 7.1 months versus 4.8 months and the hazard ratio was 0.46 and p-value less than 0.001 which is very significant for PFS improvement.

What could be the impact of this research?

As we know, in the EGFR TKI resistant population usually we use chemotherapy as the second treatment for this population. Here, through our studies, you can hear we have a new treatment option which is chemotherapy plus ivonescimab which is the VEGF and PD-1 bispecific antibody. Through these combinations we can improve the PFS and also recently we have early overall survival analysis showing the trend of the benefit of this combination which is also very clinically meaningful for our patients.

Anything else you would like to add?

This trial has only got approval from the Chinese regulatory authority so right now it’s a standard of care for China patients. But also the study was expanded for enrolment in North America and Europe and hopefully in the near future this combination will be available globally. This is very important news, both for Europe and for the North American population.