Summit Pharma has revealed {that a} second pivotal trial of its Akeso-partnered PD-1xVEGF bispecific ivonescimab has failed to point out an enchancment in general survival in a lung most cancers trial.
New topline information from the section 3 HARMONi research demonstrated that ivonescimab together with chemotherapy decreased the danger of illness development or loss of life by 48% in comparison with chemo alone when used as a second-line or later remedy for EGFR-mutant non-small cell lung most cancers (NSCLC), however a 21% enchancment in survival didn’t meet the edge for statistical significance.
Final month, shares in Summit misplaced greater than a 3rd of their worth after Akeso revealed OS information from the Chinese language HARMONi-2 trial evaluating ivonescimab to MSD’s PD-1 inhibitor Keytruda (pembrolizumab), each given on high of chemo, which confirmed a 22% discount within the danger of loss of life that additionally didn’t cross the importance threshold.
Earlier outcomes from the research, together with a 49% enchancment in progression-free survival (PFS), have been reported ultimately yr’s WCLC congress and brought on Summit’s share value to surge to a close to 52-week excessive of just about $32.
This time, traders’ response was muted – at the least on the time of writing, when Summit’s inventory was solely down a degree or two at a bit of beneath $26 – maybe suggesting that nervousness over the survival information had already been factored in. In spite of everything, it is not unusual that an preliminary development in OS can translate to a major enchancment with longer follow-up.
In an announcement, Summit pointed to the consistency within the outcomes between the Chinese language and worldwide research, and famous that HARMONi focuses on a affected person inhabitants the place PD-1 inhibitors “have beforehand been unsuccessful” at exhibiting enchancment in each OS and PFS.
There aren’t any present FDA-approved regimens which have demonstrated a statistically important enchancment in OS in second-line or later EGFR-positive NSCLC, the corporate stated, including that it’s contemplating submitting for approval of ivonescimab on the energy of the information.
The timing of that submitting has but to be decided, nevertheless, and can possible rely upon discussions with the FDA, which has beforehand stated it could want a major OS enchancment to help a advertising and marketing software.
Co-chief govt Dr Maky Zanganeh stated: “Our conviction within the promise that this remedy holds for sufferers continues to be validated: we imagine that ivonescimab has the potential to make a significant distinction for the betterment of sufferers’ lives.”
Summit licensed rights to ivonescimab in a $5 billion deal – together with a whopping $500 million upfront – in 2022. The drug has already been accepted in China for EGFR-positive NSCLC that has progressed after remedy with an EGFR inhibitor.
