Hanmi’s poziotinib enters final phase for commercialization

Spectrum submitted NDA to FDA… expects approval by H1 next year

Interpretation of the clinical data and on-site inspection of manufacturing facilities in the US will be key to receiving approval

‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US.

 

The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities.

 

If these progress as planned, Hanmi Pharmaceuticals will be able to achieve its first global commercialization landmark with the new drug technology export earlier next year.

 

On the 6th (local time), the US company Spectrum Pharmaceuticals submitted a new drug application (NDA) for poziotinib.

 

It is indicated for the treatment of locally advanced and metastatic HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) in patients who have previous treatment experience.

 

Poziotinib received the fast-track designation in March from the FDA.

 

Drugs that receive the fast-track designation receive various support from the FDA in the stages of its development.

 

Also, when applying for marketing authorization, the drugs are allowed to submit data sequentially under a rolling review as soon as data is available and are allowed to be discussed for priority review, etc.

 

In particular, the priority review would shorten the FDA's marketing authorization review period from 10 months to 6 months.

 

Considering the circumstances, Spectrum expects poziotinib to be approved in the US by the first half of next year.

 

If poziotinib receives FDA approval, it would be a first for Hanmi to succeed in the global commercialization of a new drug that it had exported technology for.

 

The variables that remain to approval now are poziotinib’s clinical trial data and on-site investigation.

 

Spectrum submitted the NDA based on the cohort 2 results of the ‘ZENITH20’ clinical trial.

 

Trial results showed that the objective response rate (ORR) of patients with HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) with treatment experience was 27.8%, the median duration of response (mDOR) 5.1 months, and the median progression-free survival (PFS) 5.5 months.

 

However, the drug showed somewhat less encouraging results in a clinical trial that was independently conducted in Europe.

 

Professor Arsela Prelaj of the IRCCS National Cancer Institute Foundation in Italy compared data of 30 patients who were administered poziotinib to 28 that did not.

 

No significant difference was found, with the overall survival (OS) of the poziotinib-treated group being 19.2 months compared to the 18.2 months in the control group.

 

However, when matched by propensity score and calculated by Cox's proportional hazard regression model, the risk of death in patients who took ‘poziotinib’ was reduced by 34% at the most.

 

Although no significant OS improvement was demonstrated in the study, the study still had meaning as it identified the possibility that the drug can reduce the risk of death.

 

The results were announced at the ESMO virtual congress in September.

 

The study was an investigator-led study without sponsorship from Hanmi or Spectrum.

 

The other variable that remains is the on-site investigation.

 

In the case of ‘Rolontis,’ another one of Hanmi’s technology export new drugs that Spectrum applied marketing authorization for, the on-site investigation had deferred what was on the brink of approval.

 

The FDA determined that there were some problems with Hanmi’s factory in Pyeongtaek and sent a complete response letter (CRL) to Spectrum.

 

Although Rolontis was expected to be approved in October last year, the FDA’s CRL has pushed back the schedule by over a year.

 

Hanmi believes such an issue will not arise for poziotinib because the two drugs have different manufacturing facilities.

 

An official from Hanmi said, “Rolontis is manufactured at Hanmi’s Pyeongtaek plant, whereas poziotinib is manufactured in the US.

 

Also, most of the FDA’s requests for supplementation have been now addressed.” Therefore, the industry’s eyes are focused on whether Hanmi will be able to overcome its two previous failures and succeed in its third attempt.

 

The FDA had deferred approval of Hanmi’s two technology export new drugs ‘Oraxol’ and ‘Rolontis’ in March and August this year.

 

The company had licensed out the technology for its metastatic breast cancer drug Oraxol to Athenex but the FDA deferred its approval due to neutropenia concerns.