The Key to Competitiveness is 'OS·Brain metastasis'

Lexraza + Libribant Positive

[ESMO 2023] Revealed Clinical Results of 'MARIPOSA' Efficacy Evaluation of Leclaza+Rybrevant

A 7-month improvement in PFS compared to co-use therapy, Tagrisso monotherapy.

The combination therapy of major EGFR variant lung cancer treatments has yielded results at the annual conference of the European Society of Oncology (ESMO 2023).

 

Combination therapy of Lexraza + Rybrevant has succeeded in improving major clinical evaluation indicators compared to Tagrisso monotherapy.

 

Lexraza is a lung cancer treatment that targets the EGFR variant Exxon 19 and Exxon 21 L858R developed by Yuhan.

 

We are confirming the possibility of a primary treatment for lung cancer in combination with Janssen's Exxon 20 target Rybrevant.

 

Tagrisso, in combination with platinum-based chemotherapy, has released clinical results in which encephalon has been effective in lung cancer patients.

 

Tagrisso is a third-generation tyrosine kinase inhibitor (TKI), such as Leclaza, which is used to treat primary and secondary lung cancer with EGFR mutations.

 

After the failure of third-generation TKI treatment, platinum-based chemotherapy, which is mainly used for secondary treatment, is being used in combination with Tagrisso to evaluate its effectiveness.

 

Published clinical results showed that one side did not show overwhelming results.

 

The overall survival (OS) data to be released at a later date and the effectiveness of brain transfer in patients have become important.

 

Leclaza+Rybrevant Improves key evaluation indicators for Tagrisso therapy.

 

At ESMO 2023 on the 23rd, the results of an interim analysis of the MARIPOSA Phase 3 clinical study evaluating the efficacy of Leclaza+Rybrevant combination therapy were released.

 

The clinical trial was conducted in 1074 patients with EGFR variant locally advanced or metaplastic non-small cell lung cancer.

 

The patient age (median) was 63 years old and Asian patients accounted for more than half (59%).

 

Among them, the rate of brain transfer was 41%.

 

Patients were randomly assigned to a 2:2:1 ratio for Leclaza+Rybrevant combination therapy, Tagrisso monotherapy, and Leclaza monotherapy.

 

The primary evaluation variables included no-progress survival (PFS), and the secondary evaluation variables included the OS, PFS (PFS2) after the first subsequent treatment, and ORR.

 

As a clinical result, the PFS (median) of the Leclaza+Rybrevant group was 23.7 months and the Lexa monotherapy group PFS was 18.5 months, which was longer than the 16.6 months recorded by the Tagrisso monotherapy group.

 

The Leclaza+Rybrevant group was found to have a 30% lower risk of disease progression and death than the Tagrisso group.

 

ORR showed similar numbers, with Leclaza+Rybrevant groups and Tagrisso monotherapy groups at 86% and 85%, respectively.

 

In the interim OS analysis, the Leclaza+Rybrevant group showed a favorable tendency over the Tagrisso monotherapy group.

 

PFS2 results show that the Leclaza+Rybrevant group had a 25% lower risk of disease progression or death compared to the Tagrisso monotherapy group.

 

In terms of safety, EGFR and MET-related adverse reactions have been more commonly reported in the Leclaza+Rybrevant group.

 

Level 3 adverse events were reported at 75% and 43% in the Leclaza+Rybrevant and Tagriso monotherapy groups, respectively, and serious adverse events were reported at 49% and 33%.

 

The adverse events that led to death were similar at 8% and 7%.

 

Presenters at Presidential Session 3 held on the 23rd.

 

Yonsei Cancer Hospital Professor Cho Byeong-cheol (left) introduced the results of the MARIPOSA phase 3 clinical trial.

 

Photo source = ESMO DAILY REPORT

Professor Cho Byung-cheol of Yonsei Cancer Hospital, who was in charge of the presentation on this day, said, "Recraza + Libribant combination therapy was effective regardless of race or race.

 

In particular, as favorable tendencies have been confirmed in the OS mid-analysis, Leclaza+Rybrevant has suggested the possibility of becoming a new standard treatment for the new EGFR variant primary treatment for non-small cell lung cancer.” In the case of Tagrisso, data from a follow-up study of the FLAURA2 clinic was released.

 

In the FLAURA2 clinical study, PFS of Tagriso+Platinum-based chemotherapy was recorded at 29.4 months.

 

In ESMO 2023, the results of a subgroup analysis of patients were released.

 

The results of a study released on the 21st showed that the combination of Tagrisso + chemotherapy for patients had a stronger inhibitory effect on intracranial progression compared to Tagrizo monotherapy.

 

The clinical trial included 557 patients with EGFR-positive metaplastic non-small cell lung cancer who had no previous experience in general therapy.

 

Among them, there were 222 patients with brain war.

 

Patients were assigned to the combination therapy group (279 people) and the monotherapy group (278 people), respectively.

 

As a clinical result, intracranial ORR in the co-therapy group was 73%, similar to 69% for monotherapy.

 

However, the complete response (cEAS) in the two was 59% in the co-use group and 43% in the monotherapy group.

 

The median intra-two non-progress survival (PFS) assessed by the Independent Review Committee (BICR) was 30.2 months for the combination therapy group and 27.6 months for the monotherapy group.

 

The risk of disease progression or death in combination therapy was found to be 42% lower.

 

The key evaluation element of combination therapy, 'OS·brain transfer effect' Leclaza+Rybrevant, Tagrisso +, and chemotherapy all differed in PFS.

 

The OS data was still immature, but favorable tendencies were observed for both combination therapies.

 

As the PFS difference is not significant, the OS data that will be released in the future will be the key to becoming the primary treatment for EGFR mutations for non-small cell lung cancer.

 

It is also noteworthy that the two combination therapies have an effect on patients.

 

PATIENTS WITH CEREBRAL EMBRACTION INCLUDED 43% IN THE MARIPOSA CLINICAL AND 40% IN THE FLAURA2 CLINICAL.

 

It is known that anticancer drugs fail to pass through the Blood Brain Barrier (BBB) if the cancer has spread to the brain.

 

Especially since encephaly occurs frequently in patients with lung cancer, the proportion of patients with epilepsy including epilepsy is emphasized in the two clinical trials that evaluate the effectiveness of combination therapy.

 

The utilization of Leclaza+Rybrevant, Tagrisso + chemotherapy is analyzed and effective data will play a decisive role in patients with OS and Brain metastasis, which will be released at a later date.