Poziotinib responds 100% to pts with lung cancer mutations

Partner Spectrum reveals clinical trials of G778 mutation ZENITH20, which is a subtype of HER2 Exxon20 mutation

For all 12 people, the duration of partial response is 5.5 months, and PFS is 7.8 months

Poziotinib, a new lung cancer drug exported by Hanmi Pharmaceutical, was found to have a significant effect on the G778 mutation, which is common in patients with HER2 Exxon20 insertion mutation.

 

As a result of ZENITH20 clinical subanalysis, 12 patients showed 100% response, and PFS was also longer than other HER2 Exxon20 mutants.

 

In particular, when Poziotinib was first used, the PFS reached 9.8 months.

 

ESMO pre-released a draft of clinical studies scheduled to be announced ahead of the opening of the academic conference on the 5th (local time).

 

Further analysis results of ZENITH20 clinical trials conducted by Hanmi Pharmaceutical partner Spectrum Pharmaceuticals were also published.

 

Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred technology to the spectrum in 2015.

 

Spectrum has taken over the right to develop and commercialize Poziotinib in countries around the world except Korea and China.

 

At the end of last year, Spectrum filed an application for Poziotinib's permission with the U.S.

 

Food and Drug Administration (FDA) based on the results of the cohort 2 study among the ZENITH20 Global Phase 2.

 

The official review process will begin in February and an advisory committee will be held this month.

 

The data released this time is the result of confirming the effect of Poziotinib in the patient group with the G778 mutation among subtypes of non-small cell lung cancer with HER2 Exxon20 insertion mutation.

 

According to the spectrum, the G778 mutation is one of the most common submutants found in 9-19% of patients with HER2 Exxon20 insertion mutation.

 

Of the 170 patients who participated in the ZENITH20 study, a total of 14 patients showed G778 mutations among non-small cell lung cancer patients with HER2 Exxon20 insertion mutations.

 

They were included in cohort 2 and cohort 4, respectively.

 

Cohort 2 is for patients with past treatment experience, and Poziotinib 16mg was administered (QD) per day.

 

Cohort 4 administered one pill a day of Poziotinib 16mg or two tablets a day (BID) of 8mg to patients with no history of treatment.

 

As a result of analyzing 12 people who can be evaluated out of 14, all of them (100%) showed PR, and the DoR median value was 5.5 months.

 

The median PFS was 7.8 months.

 

In particular, in the case of cohort 4 consisting of patients with no treatment experience, the median PFS value reached 9.8 months, which was superior to the group of patients without G778 mutation.

 

The PFS of the patient group without G778 mutation was 5.5 months in cohort and 45.6 months in cohort.

 

Side effect profiles were similar to existing TKI ratings.

 

Spectrum commented, "No treatment experience or Poziotinib was effective in G778."