"Leclaza’s mOS data of 38.9 months is remarkable"

Professor Ji-Youn Han, Head of Center for Lung Cancer, National Cancer Center (Department of Hemato-oncology)

“Comparable to osimertinib’s results…low rate of adverse events an advantage”

“New methods of treatments pour in in the field of lung cancer… patients do not need to be discouraged”

“The fact that Leclaza (lasertinib) achieved an OS (overall survival) of over 3 years is remarkable.” New OS data on the homegrown novel lung cancer drug Leclaza that was presented at the AOS 2022 & KCA Annual Meeting 2022 that was held recently in Seoul drew the pharmaceutical industry's attention.

 

The results were from a trial that evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI that was conducted in 17 centers in Korea.

 

Analysis results on the 76 EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months

This updated data is being received with significance in the field.

 

The OS data is comparable to the results of the 3rd-generation EGFR mutation-positive NSCLC treatment ‘osimertinib (product name: Tagrisso),’ while owning the potential for its use as monotherapy.

 

Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “The most important index used to assess the efficacy of anticancer drugs in clinical trials ultimately comes down to the patients' OS improvement.

 

Long-term follow-up results of LASER201 trial showed that mOS of patients that received Leclaza reached 38.9 months.

 

This is remarkable performance.” ◆"Cannot make direct comparisons…but results are as good as Tagrisso’s” Han highly rated the fact that Leclaza showed comparable performance to existing targeted therapies, although a direct comparison cannot be made to its competitor, osimertinib.

 

Although various clinical trials are in progress for the first 3rd-generation EGFR targeted therapy.

 

osimertinib, due to varying clinical trial designs and characteristics of registered patients, it is difficult to individually compare each trial's results with Leclaza’s.

 

Also, Leclaza's trials are in their Phase I/II stage, but osimertinib's trials have progressed to Phase III.

 

However, according to the Phase III AURA trial, osimertinib’s representative trial, the mOS was around 26 to 28 months in general, with some differences between countries.

 

“Compared to osimertinib, which is used as the global standard of care, Leclaza is only available for use in Korea.

 

However, data shows that Leclaza’s results are as good as the standard of care.

 

Leclaza’s clinical data as demonstrated through LASER201 is being received without disagreement globally.” ◆" Leclaza has a low incidence of interstitial pneumonia·thrombocytopenia" Han also emphasized Leclaza’s safety.

 

Leclaza has a lower incidence of adverse events than even its competitor osimertinib as well as 1st- and 2nd-generation EGFR targeted therapies.

 

1st and 2nd generation EGFR targeted therapies had higher skin toxicity.

 

The drugs, although effective against lung cancer cells, also targeted normal skin cells, resulting in patients suffering from skin troubles such as rashes or itching.

 

On the other hand, 3rd generation-targeted therapies selectively target mutations and therefore is less toxic and more efficient.

 

This comes as a significant difference to the patients in terms of quality of life.

 

In particular, Han explained that the two 3rd generation targeted therapies – osimertinib and Leclaza -differ in the adverse events aspect.

 

With her experience prescribing Leclaza over the past year, Han explained that “long-term use of osimertinib may cause interstitial pneumonia or thrombocytopenia in the patients.

 

One aspect I found interesting while monitoring the long-term safety profile of Leclaza demonstrated through the Phase I/II trial was that it had a very low incidence of interstitial pneumonia or thrombocytopenia.

 

“ Han added, “From the patient’s perspective, Leclaza’s lower incidence of adverse events during the 3 years of intake may come as a great advantage.

 

Grade I or II level numbness has been found with the use of Leclaza, but was infrequent.”