Leclaza P3T results unveiled... mPFS 20 months

Abstract released at ESMO ASIA 2022...presented primary results of Leclaza monotherapy

Primary endpoint mPFS 20.6 months... 11-month improvement over the control group

DoR 19.4 months... increased the possibility of extending indication as first-line treatment

The abstract data from a global Phase III trial on ‘Leclaza (lazertinib),’ the 31st homegrown novel drug developed by Yuhan Corp, has been released.

 

In the trial, Leclaza improved progression-free survival (PFS) by 11 months compared to the existing treatment Iressa and met the primary endpoint.

 

The study results of LASER301 above that assessed the safety and efficacy of Leclaza as first-line treatment in EGFR (epidermal growth factor receptor) mutant-positive NSCLC were released with other major study results on the 1st at the ESMO ASIA Congress 2022.

 

LASER301 is a global Phase III trial that evaluated the efficacy and safety of Leclaza as first-line treatment in locally advanced or metastatic NSCLC patients with EGFR mutations.

 

The trial enrolled 393 patients in 13 countries and compared Leclaza with the existing treatment, ‘gefitinib (brand name: Iressa).’ The primary efficacy endpoint was progression-free survival (PFS).

 

The secondary endpoints were objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and overall survival (OS).

 

In terms of median PFS (mPFS), the primary efficacy endpoint, Leclaza’s mPFS was 20.6 months, a significant improvement over the 9.7 months in the control group.

 

The drug also reduced the risk of disease progression and death by 55%.

 

The PFS improvement was consistently observed in all predefined subgroups (Asians and non-Asians, Exon19del or L858R mutation, etc.).

 

Leclaza’s DoR was 19.4 months, significantly longer than the 8.3 months in the control group.

 

ORR was 76% in both treatment groups.

 

The OS data has not matured yet (maturity 29%).

 

At 18 months after administration, the lazertinib arm’s survival rate was 80%, higher than the 72% in the control group but did not reach statistical significance (p=0.116).

 

Regarding its safety, lazertinib and Iressa showed a consistent safety profile with those that had been previously reported.

 

The results of the LASER301 study will be presented at the ESMO ASIA Congress 2022 which will be held on the 3rd in Singapore.

 

Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year.

 

It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells.

 

It is currently approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs.

 

Yuhan Corp conducted the global Phase III trial to expand the drug’s indication to first-line treatment in EGFR mutated lung cancer.

 

The results greatly increased the possibility of the drug extending its indication to first-line in Korea.

 

In Korea, Leclaza’s cumulative sales exceeded KRW 10 billion in only 1 year since its release with insurance reimbursement.

 

If approved in the first line, its increase in sales is expected to accelerate further.

 

Trials on its combined use with other drugs are also actively underway.

 

Yuhan Corp had made a licensing deal with the global pharmaceutical company Janssen.

 

Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘Rybrevant (amivantamab).’