Global guidelines recommend Leclaza combination therapy

Demonstrated higher 3-year overall survival rate than Tagrisso monotherapy

The NCCN recommends Leclaza plus Rybrevant combination therapy as a first-line therapy

Leclaza plus Rybrevant combination therapy has been listed as a first-line therapy in global guidelines after demonstrating improvements in survival rates.

 

Leclaza plus Rybrevant combination therapy, which is the new treatment for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), received U.S.

 

Food and Drug Administration (FDA) approval as a first-line therapy last month.

 

This combination therapy showed statistically improved progression-free survival (PFS) and overall survival (OS) than Tagrisso monotherapy.

 

Leclaza plus Rybrevant combination therapy has been listed in the NCCN guideline…demonstrated clinical effectiveness

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Sources said on September 12th Leclaza plus Rybrevant combination therapy has been recommended by the National Comprehensive Cancer Network (NCCN) as a first-line therapy based on its recent clinical effectiveness.

 

As a result, the combination therapy now has an expert assessment that it can be used as a first-line therapy for treating NSCLC harboring mutations of EGFR in exon 19 and exon 21.

 

The NCCN provides guidelines recommending cancer diagnosis, treatment, and prognosis.

 

It is an alliance of 33 centers, including the U.S.

 

National Cancer Center and research centers.

 

Physicians worldwide use the NCCN as the primary cancer diagnosis and treatment guideline.

 

As the NCCN recommends Leclaza plus Rybrevant combination therapy, its presence as a first-line therapy is expected to be expanded.

 

Until now, the NCCN and other guidelines have recommended Tagrisso monotherapy, a third-generation tyrosine kinase inhibitor (TKI) targeting exon 19 and exon 21, for the treatment of NSCLC harboring EGFR mutations.

 

However, Leclaza, the third-generation TKI like Tagrisso, and Rybrevant, targeting mutation in EGFR exon 20, have shown more effective results than Tagrisso monotherapy.

 

This indicates a potential change to the major cancer treatment guidelines.

 

The OS results of Leclaza plus Rybrevant combination therapy are suggested to be the key to commercialization.

 

Moreover, inclusion in the NCCN guidelines is a significant achievement.

 

Leclaza plus Rybrevant combination therapy shows continual benefits…3-year OS follow-up data have been disclosed Leclaza plus Rybrevant combination therapy is listed in the NCCN due to its proven effectiveness results.

 

In terms of interim OS analysis, Leclaza plus Rybrevant combination therapy showed superior benefits than Tagrisso.

 

These clinical results were from the Phase 3 MARIPOSA study, which was disclosed during the European Society for Medical Oncology (ESMO) conference and the annual World Conference on Lung Cancer (WCLC) conference.

 

The clinical trial compared the effectiveness and safety of Leclaza plus Rybrevant combination therapy to Tagrisso monotherapy.

 

The patients were randomly assigned at a 1:1 ratio to either the Leclaza plus Rybrevant combination therapy group (429 individuals) or the Tagrisso group (429 individuals).

 

The clinical trial showed that 61% of the Leclaza plus Rybrevant combination therapy group had a three-year OS rate, which was higher than 53% of the Tagrisso monotherapy group.

 

75% of the Leclaza plus Rybrevant combination therapy group had a two-year OS rate, whereas 70% for the Tagrisso group.

 

Leclaza plus Rybrevant combination therapy shows continued benefits than Tagrisso monotherapy in terms of the overall survival (OS) rate.

 

The median follow-up of 31.1 months showed that 155 patients of the Leclaza plus Rybrevant combination therapy group had a disease progression and discontinued further treatment, whereas 233 patients of the Tagrisso group discontinued further treatment due to disease progression.

 

Then, the patients received follow-up therapies using chemotherapy, such as Alimta (pemetrexed) plus carboplatin.

 

The second PFS (PFS2) measurement showed that the Leclaza plus Rybrevant combination therapy group had a significantly longer median time between treatment discontinuance and follow-up therapy than the Tagrisso group.

 

Additionally, Leclaza plus Rybrevant combination therapy showed positive results for the intracranial PFS, which is an indicator for brain metastasis.

 

The results showed that the median PFS, which was set as the primary endpoint, for Leclaza plus Rybrevant combination therapy was 23.7 months.

 

The Leclaza monotherapy group had a median PFS of 18.5 months, longer than 16.6 months for the Tagrisso monotherapy group.

 

Leclaza plus Rybrevant combination therapy also reduced the disease progression and death risk by 30% compared to the Tagrisso group.

 

The PFS2 results showed that the Leclaza plus Rybrevant combination therapy group had a 25% lower disease progression and death risk than the Tagrisso monotherapy group.

 

Researchers stated, "Leclaza plus Rybrevant combination therapy is showing improvements in the outcomes of disease progression as well as OS than Tagrisso monotherapy," adding, "We have confirmed Leclaza plus Rybrevant combination therapy is a first-line standard therapy for EGFR-mutated advanced NSCLC."