'Effective in Asian patients' Leclaza vs Tagrisso comb

data have been unveiled

Leclaza+Rybrevant subcutaneous (SC) inj demonstrates non-inferiority compared to the IV inj

Tagrisso+chemotherapy improves overall survival compared to Tagrisso monotherapy

Leclaza plus Rybrevant and Tagrisso plus platinum-based chemotherapy have shown consistent effects in Asian patients.

 

The effects of the combination therapy of Leclaza and Tagrisso, which are non-small cell lung cancer (NSCLC) treatments, have been unveiled at the European Society for Medical Oncology (ESMO) Asia Congress 2024.

 

ESMO Asia Congress 2024 took place over three days, starting on December 6, in Singapore.

 

The concurrent use of Leclaza with Rybrevant subcutaneous (SC) formulation showed non-inferior results compared to the conventional Rybrevant intravenous (IV) injection.

 

Tagrisso plus platinum-based chemotherapy has consistently improved overall survival compared to Tagrisso monotherapy in Asian patients.

 

Leclaza plus Rybrevant SC formulation, injection-related adverse reactions sixfold↓in the PALOMA-3 study

Combination therapy of Yuhan

According to industry sources on December 10, Janssen unveiled the result of the PALOMA-3 clinical trial, which was to investigate the potential of Leclaza plus Rybrevant SC formulation, treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

 

Previously, in this clinical study, Leclaza plus Rybrevant SC showed non-inferiority compared to Leclaza plus Rybrevant IV.

 

Leclaza plus SC Rybrevant combination therapy had an objective response rate (ORR) of 30.1%, whereas Leclaza plus IV Rybrevant combination therapy had an ORR of 32.5%, meeting the non-inferiority requirement.

 

Leclaza plus SC Rybrevant combination therapy showed a positive trend regarding progression-free survival (PFS).

 

PFS refers to a duration during which a patient's disease does not worsen.

 

Unlike the oral formulation of Leclaza, Rybrevant was developed as an IV injection.

 

For Rybrevant IV inj, patients have the inconvenience of visiting the hospital once every 2-3 weeks, and the administration takes more than an hour.

 

Janssen plans to develop an SC formulation to offer ease of administration and reduce concern regarding adverse reactions related to injection.

 

SC formulation is expected to improve patient convenience since it can significantly reduce the administration duration to within 10 minutes.

 

The latest presentation is a follow-up clinical result where the efficacy and safety of the drug were evaluated in 255 Asian patients out of the total 418 study participants.

 

Patients had previous treatment history of receiving AstraZeneca's targeted therapy Tagrisso and platinum-based chemotherapy.

 

During the first 4 months of the treatment, 74% of the Leclaza+Rybrevant SC group and 75% of the Leclaza+Rybrevant IV group received anticoagulant agents to prevent venous thromboembolism (VTE).

 

The key endpoints included disease control rate (DCR), duration of response (DOR), PFS, overall survival (OS), and safety.

 

Clinical results showed that the Leclaza+Rybrevant SC group had a DCR of 80.2%, and the Leclaza+Rybrevant IV group had a DCR of 72.9%.

 

DCR refers to a percentage of delaying the disease progression to extend patient survival.

 

For PFS, Leclaza+Rybrevant SC group showed a favorable trend.

 

At 12 months, 77% of the patients treated with Leclaza+Rybrevant SC survived.

 

It was 61% for those treated with Leclaza+Rybrevant IV.

 

DOR and PFS could not be estimated.

 

For injection-related response (IRR), the Leclaza+Rybrevant SC group had an IRR sixfold less than the Leclaza+Rybrevant IV group.

 

Most responses were mild, Grade 1-2.

 

For the VTE occurrence rate, 11% of the Leclaza+Rybrevant SC group treated with anticoagulant had VTE, and it was 12% for the Leclaza+Rybrevant IV group.

 

It was 18% and 22% for those who did not receive anticoagulants, respectively.

 

The safety profile of Asian patients corresponded to those in other countries.

 

The effectiveness of Tagrisso+platinum-based chemotherapy as a first-line treatment has been reconfirmed

AstraZeneca

AstraZeneca unveiled the study results of the FLAURA2 cohort study, which involved Tagrisso+platinum-based chemotherapy in Asian patients.

 

Previous results of this clinical study showed that Tagrisso+platinum-based chemotherapy demonstrates a statistically significant improvement in PFS compared to Tagrisso monotherapy.

 

Patients had not previously received treatment, and they were randomly assigned 1:1 to Tagrisso plus pemetrexed (product name: Alimta) plus cisplatin/carboplatin group and Tagrisso monotherapy group.

 

Participants were categorized into Chinese Asian/non-Chinese Asian/non-Asian.

 

The primary endpoint included PFS, and the secondary endpoints included OS, ORR, DOR, and safety.

 

The clinical results showed that the PFS of the Tagrisso combination therapy group was 25.5 months, which was over six months older than the 19.4 months in the Tagrisso monotherapy group.

 

The median OS was 40.5 months for the Tagrisso combination therapy group and 38.3 months for the Tagrisso monotherapy group.

 

The safety profile showed that the adverse event rates over Grade 3 in the Tagrisso combination therapy group were 67%, higher than in the Tagrisso monotherapy group.

 

The adverse event rates due to discontinued use of Tagrisso were 10% for the Tagrisso combination group and 7% for the monotherapy group.

 

"Tagrisso+platinum-based chemotherapy showed consistent benefits in Asian patients similar to the previous clinical results.

 

Such clinical results demonstrate the potential of the therapy as a first-line treatment of Asian patients with EGFR-positive advanced NSCLC," a researcher remarked.