More data on Leclaza·Lorviqua showcased

amid booming lung cancer drugs

Leclaza has been confirmed to have synergy with subcutaneous Rybrevant injection…primary endpoints were met

Lorviqua’s five-year, long-term follow-up clinical data were disclosed…60% of patients had progression-free survival

Positive clinical results for targeted therapies, such as EGFR and ALK, were featured at the international conference.

 

Clinical achievements of major targeted therapies for non-small cell lung cancer (NSCLC), including Leclaza, Rybrevant, and Lorviqua, were presented at the American Society of Clinical Oncology (ASCO 2024) annual meeting in Chicago, U.S., on May 31.

 

For Leclaza, subcutaneous (SC) Rybrevant combined with Leclaza was found to be effective as well as intravenous (IV) Rybrevant combined Leclaza.

 

Leclaza plus Rybrevant combination therapy has been submitted for U.S.

 

Food and Drug Administration (FDA) approval as a first-line treatment of EGFR-positive NSCLC.

 

Pfizer’s Lorviqua, a targeted drug used to treat ALK-positive NSCLC, demonstrated clinical benefit in patients who had no treatment experience.

 

Based on these clinical results, Lorviqua garners attention for use as a first-line treatment compared to its competitors, such as Alecensa and Alunbrig.

 

Leclaza combined with SC Rybrevant injection offers benefit The clinical results of Leclaza plus SC Rybrevant combination therapy were presented during ASCO 2024 on May 31st.

 

This combination therapy is undergoing trials for potential use as a first-line treatment for EGFR-positive NSCLC, and the developer plans to secure ease of administration as well.

 

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.

 

PALOMA-3 Phase 3 study design to evalute the efficacy of Leclaza plus SC Rybrevant inj (source: snapshot of ASCO 2024 lecture presentation).

The Phase 3 PALOMA-3 study has evaluated the efficacy and safety of Leclaza plus SC Rybrevant combination therapy compared to Leclaza plus IV Rybrevant combination therapy in patients with EGFR-positive NSCLC who have failed previous treatments.

 

The study enrolled 418 patients with advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 mutations.

 

The primary endpoint of the study was the non-inferiority assessment of Leclaza and SC Rybrevant combination therapy in pharmacokinetics aspect.

 

The secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR), patient satisfaction, and safety.

 

At a median follow-up of 7 months, Leclaza plus SC Rybrevant combination therapy showed non-inferiority compared to Leclaza plus IV Rybrevant combination therapy.

 

Leclaza plus SC Rybrevant combination therapy had an 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 in terms of PFS.

 

For infusion-related reactions (IRR), Leclaza plus SC Rybrevant combination therapy had 13% of IRR, which was significantly lower than the 66% of IRR for Leclaza plus IV Rybrevant combination therapy.

 

Whether the SC formulation therapy would overcome the IRR adverse reactions observed in the MARIPOSA study, which evaluated the efficacy of Leclaza plus IV Rybrevant combination therapy is to be watched.

 

Five-year follow-up data of Lorviqua have been disclosed…60% of patients had PFS

Dr.

 

Benjamin J.

 

Solomon presented the CROWN clinical study results, which confirmed Lorviqua’s five-year survival benefit as the third-generation targeted therapy for ALK-positive cancer (source: snapshot of ASCO 2024 lecture presentation).

On May 31st, the five-year follow-up clinical data of Lorviqua, a targeted drug for the treatment of ALK-positive NSCLC, were disclosed at ASCO 2024.

 

The CROWN Phase 3 study compared the efficacy of Lorviqua to Xalkori for the first-line treatment of ALK-positive NSCLC.

 

Lorviqua is Pfizer’s third-generation targeted drug for the treatment of ALK-positive NSCLC.

 

Along with Lorviqua, Takeda’s second-generation Alunbrig and Roche’s Alecensa compete in the market for targeted drugs for treating ALK-positive NSCLC.

 

As Lorviqua’s effectiveness has been confirmed in five-year long-term data, all eyes in the industry are on whether it will take the lead in the competition among first-line treatments.

 

The clinical trial involved 296 patients with ALk-positive NSCLC who had no prior treatment experience.

 

The patients were randomly assigned to the Lorviqua treatment group and the Xalkori treatment group by a 1:1 ratio.

 

According to the clinical result, during the follow-up period of 60.2 months, the Lorviqua treatment group did not reach the median PFS value.

 

The Xalkori treatment group recorded 9.1 months of PFS during the follow-up for 55.1 months.

 

For the five-year PFS rate, 60% of the Lorviqua treatment group reached the PFS, whereas 8% of the Xalkori treatment group reached the PFS.

 

Furthermore, 77% of the Lorviqua treatment group had Grade 3-4 adverse reactions (AE), whereas 57% of the Xalkori treatment group had Grade 3-4 AE.

 

The safety profile was aligned with that observed in the previous analysis.

 

Dr.

 

Benjamin J.

 

Solomon, Professor of Peter MacCallum Cancer Centre in Australia, said, “Based on the results of the five-year follow-up data of Lorviqua and Xalkori treatment groups, the Lorviqua treatment group’s media PFS value has not been reached.

 

This is the longest reported PFS among advanced NSCLC.” He added, “Without any additional safety issues, this will be the unprecedented outcome among ALK-positive NSCLC clinical results.”