AZ 'September'·Yuhan 'October'... Who Will Gain the Upper Hand in the Lung Cancer Drug Battle?

AZ 'Tagrisso'·Yuhan 'Reclaza'
Competition for the Throne of Non-Small Cell Lung Cancer Treatments

AZ to Present 'FLAURA2' at WCLC in September
Yuhan Expected to Reveal 'Mariposa' at ESMO in October

Competition is intensifying in the lung cancer treatment market between AstraZeneca (AZ)'s Tagrisso (active ingredient Osimertinib) and Yuhan Corporation's Leclaza (Lazertinib).

Cancer treatments approved only as second- or third-line therapies cannot be used if the patient is cured or dies during initial treatment, meaning the drug has no opportunity to be used. This is why companies continuously attempt to enter the first-line treatment market to gain more opportunities. Tagrisso was approved by the U.S. Food and Drug Administration (FDA) as a second-line treatment in 2015 and expanded its indication to first-line treatment in 2018. Leclaza also received approval as a second-line treatment from the Korean Ministry of Food and Drug Safety in 2019 and successfully obtained approval for first-line treatment just last month.

With both drugs successfully entering the first-line treatment market, competition is fierce. In addition to monotherapy using only one drug, there is intense exploration of combination therapies that can create synergy by using drugs or treatment methods together. Attention is focused on the upcoming clinical trial results from each company in September and October, which will determine the superiority of first-line combination therapies.

AZ will present the clinical trial results of 'FLAURA2,' which uses a combination of Tagrisso and platinum-based chemotherapy drugs such as cisplatin as a first-line treatment for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations, at the 2023 World Conference on Lung Cancer (2023 WCLC) held in Singapore from September 9 to 12 (local time). The results will be announced during the plenary session on the 11th, and the full abstract will be released on October 16.

AZ explained that significant improvements were confirmed compared to the existing Tagrisso monotherapy. One of the key efficacy endpoints for anticancer drugs, progression-free survival (PFS), was reported to be higher than the median PFS of 18.9 months observed with Tagrisso as a first-line monotherapy. Specific figures are expected to be revealed at this WCLC, raising great anticipation. PFS refers to the period during which the cancer does not progress after treatment. In other words, when chemotherapy is used in combination, it successfully delays the cancer recurrence point beyond the average 1 year and 7 months seen with Tagrisso alone.

This FLAURA2 trial is also seen as an attempt to outpace Leclaza. If significant effects are confirmed through chemotherapy, it could change the dominant first-line treatment method. It appears AZ aims to surpass the combination therapy of Leclaza and Janssen's (a Johnson & Johnson subsidiary) bispecific antibody immunotherapy 'Rybrevant (Amivantamab),' to which Yuhan Corporation has licensed Leclaza.

Yuhan Corporation conducts 'MARIPOSA' trial with Janssen... 'Unlimited Free Supply' in Korea

The 'MARIPOSA' clinical trial, a combination therapy of Leclaza and Rybrevant, is expected to reveal results at the European Society for Medical Oncology (ESMO) conference in Madrid, Spain, in October, one of the world's top three oncology conferences. With Tagrisso set as the control group for a direct competition, attention is focused on whether the results will surpass the 20.6 months median PFS confirmed with Leclaza monotherapy. In fact, the small-scale 'CHRYSALIS' trial of this combination therapy, presented at the American Society of Clinical Oncology (ASCO) last month, showed a median treatment duration of 33.5 months.

On the 21st, during a Johnson & Johnson conference call, statements expressing high expectations for this combination therapy becoming the new standard first-line treatment were made. Joaqu?n Duato, CEO of Janssen, also identified this combination therapy as one of the major pipelines expected to generate annual sales exceeding $5 billion (approximately 6.36 trillion KRW), reflecting the company's strong expectations.

Another strength of this combination therapy is that Rybrevant is a bispecific antibody treatment. Rybrevant targets not only EGFR mutations but also MET gene mutations. Although MET mutations account for only about 2-3% of all NSCLC patients, it is known that 20-30% of patients treated with third-generation EGFR therapies develop MET mutations, suggesting significant efficacy at this point as well.

AZ is also preparing countermeasures by developing combination therapies of Tagrisso and Rybrevant. A global phase 2 clinical trial is underway, and if the Leclaza-Rybrevant combination therapy succeeds, AZ plans to demonstrate the feasibility of Tagrisso-Rybrevant combination therapy in advance to compete.

Jo Wook-je, CEO of Yuhan Corporation, is speaking at the 'Yuhan Corporation R&D and Social Contribution Press Conference' held on the afternoon of the 10th at the Plaza Hotel in Jung-gu, Seoul. At the conference, Yuhan Corporation announced a compassionate use program (EAP) to provide Lekraza free of charge without limitation to domestic patients.
[Photo by Lee Chun-hee]

Meanwhile, fierce competition is ongoing domestically to gain the upper hand in first-line monotherapy. Although Tagrisso was approved as a first-line treatment in Korea in 2018, it has yet to enter the reimbursed market due to a five-year delay in passing the Cancer Disease Review Committee, the first hurdle for health insurance coverage. Meanwhile, Leclaza succeeded in expanding its indication to first-line treatment last month, intensifying the competition.

While Tagrisso's health insurance reimbursement is expected to be possible at the earliest by the end of this year, Yuhan Corporation is taking the lead by offering Leclaza to domestic patients through an Expanded Access Program (EAP) providing 'unlimited free supply.' This is seen as an effort to actively contribute to society and to reach patients first in a situation where Tagrisso has not yet fully entered the market. Recently, the first and second EAP patients were registered at Busan Kosin University Gospel Hospital, and the number of eligible patients is expected to continue expanding.

This content was produced with the assistance of AI translation services.