Hanmi Pharmaceutical, “Poziotinib Shows a Significant Result for Cohort 2”


On the 21st, Hanmi Pharmaceutical announced that Spectrum, one of its partner companies, presented the cohort 2 research results of phase 2 global clinical trial and the result of clinical trial for compassionate use approval on Poziotinib, an anti-cancer drug in development, at European Society for Medical Oncology(ESMO)’s ‘Virtual Congress 2020’ on the 19th.

This year, the event was held online from the 19th to the 21st (local time) due to the worldwide spread of COVID-19.

This cohort 2 study, orally presented, was conducted in 90 patients with EGFR/HER2 exon 20 insertion mutations in non-small-cell lung cancer and a history of treatment. 16mg of Poziotinib was orally administered once a day.

According to Hanmi Pharmaceutical, the Objective Response Rate(ORR) was 27.8% in the Intention To Treat(ITT) analysis. Though the minimal ORR value of patients with treatment history was expected to be 17%, the actual value was 18.9%, which is significant.

Disease Control Rate (DCR) was 70%, and tumor reduction was confirmed in 67 patients, 74% of all patients. The median value of tumor reduction was 22%. From the 74 patients evaluable, ORR was 35.1% and DCR was 82.4%.

The median Duration of Response(mDoR) was 5.1 months, follow-up period was 8.3months, and the median Progression-Free Survival(mPFS) was 5.5months.

14% of all patients(13 patients) had severe side effects related to the drug, while 12%(11 patients) discontinued the treatment because of the side effects.

In addition, Spectrum presented the results of an Expanded Access Program(EAP) clinical study for patients with end-stage metastatic EGFR/HER2 exon 20 insertion mutations in non-small0cell lung cancer. EAP refers to an approval program for therapeutic use, a system that allows the administration of clinical-stage drugs to terminal patients without an appropriate treatment alternative.

In the clinical trial, 16mg of Poziotinib was administered to 29 patients once a day or the dosage was reduced depending on the toxicity. Treatment discontinuation and dose reduction due to toxicity affected PFS, ORR, and DCR. Considering the results, Spectrum plans to administer lower dose of Poziotinib and adjust the schedule in ZENITH20 clinical trial in progress.

Francois Lebel, the CMO of Spectrum, said: “This ESMO presentation firstly disclosed the result of global phase 2 cohort study on Poziotinib to the medical experts around the world. As there is no approved drug for HER2 Exon20 insertion mutant non-small cell lung cancer so far, we will use the study result to discuss the various methods for approval with the FDA.”

On the other hand, Spectrum is known to start the rapid approval procedure for Poziotinib, such as completing the meeting request for New Drug Application(NDA) to the US Food and Drug Administration (FDA).

Source: YoungDoctor