Yuhan’s Leclaza targets US mkt based on its clinical effect

Confirms positive data for Leclaza monotherapy in WCLC 2024

Reaffirmed efficacy of Leclaza... Expected to target the market with the ‘Ryvrevant+Leclaza’ combo

Positive OS trend compared with Tagrisso...at 31.1 months of follow-up, 44% of patients on Leclaza continued treatment

The non-small cell lung cancer drug Leclaza (lasertinib) in combination with Ryvrevant(amivantamab) has gained competitivity in the U.S., based on data presented at the World Congress on Lung Cancer (WCLC 2024).

 

Additional data on Leclaza monotherapy and Leclaza in combination with Ryvrevantare is expected to be presented to further increase the drug’s clinical value.

 

WCLC 2024 will be held from September 7 in San Diego, U.S.

According to industry sources on the 31st, results from a study comparing the efficacy and safety of Leclaza+Ryvrevant and Leclaza monotherapy to Tagrisso monotherapy will be presented at WCLC 2024, which will be held from September 7 in San Diego, U.S.

 

The data to be presented at WCLC 2024 are from the interim follow-up results of the study, which evaluated the clinical efficacy of Leclaza monotherapy (216 patients) versus Tagrisso monotherapy (429 patients) and Leclaza+Ryvrevant combination therapy (429 patients).

 

In the results that were first disclosed through its abstract, the study showed that Leclaza monotherapy achieved a median progression-free survival (PFS) of 18.5 months by a blinded independent centralized review (BICR) over a median follow-up of 22 months.

 

Also, the Leclaza monotherapy arm was associated with a 2% reduction in the risk of disease recurrence, progression, or death compared with the 16.6 months confirmed in the Tagrisso arm.

 

In addition, an analysis of a high-risk subgroup showed that Leclaza improved PFS even further compared with Tagrisso.

 

In patients with a history of brain metastases, the median PFS was 16.4 months with Leclaza versus 13.0 months with Tagrisso.

 

The median PFS of patients with circulating tumor DNA (ctDNA) was also superior with Leclaza (18.4 months) versus Tagrisso (14.8 months).

 

While more detailed results will be presented at WCLC 2024, experts believe that these results will support the drug settle in the U.S.

 

market.

 

“I think the argument for Janssen will be in providing a stronger rationale for why they chose Leclaza for combination therapy,” said Professor A, a hematologist-oncologist at a Big 5 hospital who asked for anonymity.

 

”The abstract shows that the efficacy was as expected and that Leclaza was better in terms of side effects, which is one reason why the company chose to use Leclaza as its partner.”

Pic of Leclaza

With the rising need to prescribe new treatments, the research presented at WCLC 2024 is expected to support the use of Leclaza.

 

The congress will also feature a follow-up of the MARIPOSA trial presented at the European Society of Clinical Medical Oncology Annual Congress (ESMO 2023) last year.

 

According to the abstract, at a median follow-up of 31.1 months, 44% (185/421) of patients in the Leclaza+Ryvrevant arm and 34% (145/428) in the Tagrisso arm were still on treatment.

 

Overall survival (OS) data at a median follow-up of 31.1 months were also presented.

 

At 24 months, 75% and 70% of patients were alive in the Leclaza+Ryvrevantand Tagrisso arms, respectively, and at 36 months, the corresponding figures were 61% and 53%, respectively.

 

the interim analysis of the OS results showed a positive trend in favor of the Leclaza+Ryvrevantarm over the Tagrisso monotherapy arm as in last year but showed no statistical significance.

 

On this, the researchers commented, “OS continues to show a trend toward improvement in the Leclaza+Ryvrevant arm compared to Tagrisso, reaffirming how the Leclaza+Ryvrevant combination is the standard first-line therapy for advanced EGFRm NSCLC.”