Sales of Tagrisso stay strong, Leclaza rises in lung cancer

Among targeted anticancer therapies for lung cancer in the Korean market

Leclaza posted sales of KRW 22.6 billion last year… up 40.3% YoY

Sales of Tagrisso and Giotrif increase slightly …. Sales of first-generation drugs Iressa and Tarceva sluggish

In the EGFR-positive non-small cell lung cancer (NSCLC) treatment market, Leclaza’s sales growth stood out amid strong sales of Tagrisso.

 

Tagrisso and Leclaza are both third-generation targeted therapies, and the two were approved as a first-line treatment for lung cancer this year and were given the green light to expand sales.

 

Among first- and second-generation targeted therapies, all drugs other than Giotrif posted sluggish sales last year.

 

According to the market research institution IQVIA on the 20th, Tagrisso generated sales of KRW 111 billion last year, up 4.2% YoY.

 

Tagrisso is a third-generation tyrosine kinase inhibitor (TKI) that was developed by AstraZeneca.

 

EGFR-positive lung cancer treatments are categorized into four types: first-generation EGFR TKIs like AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib); second-generation EGFR TKIs like Boheringer Ingelheim's Giotrif and Pfizer's Vizimpro (dacomitinib); and third-generation EGFR TKIs like Leclaza (lasertinib) and AstraZeneca's Tagrisso (osimertinib).

 

Sales of Tagrisso, which exceeded the KRW 100 billion mark in sales in 2020, have remained stagnant for 2 years.

 

After reaching KRW 106.5 billion in 2020, the drug posted similar sales in 2021 and 2022.

 

After working to receive reimbursement for the drug as a first-line treatment for years, AstraZeneca received the reimbursement approval this year as a first-line treatment for EGFR-positive lung cancer, and this is also expected to expand sales.

 

Moreover, Tagrisso is also the only third-generation TKI to be approved for use in early-stage lung cancer.

 

In December last year, Tagrisso was approved as an adjuvant therapy for patients with EGFR exon 19 and exon 21 mutated NSCLC after complete resection.

 

In the phase III ADAURA study, Tagrisso was shown to reduce the risk of death by 51% compared to conventional therapy.

 

Powered by the advantages, Tagrisso’s sales are expected to increase further in the coming years.

 

Leclaza posted sales of KRW 22.6 billion last year, up 40.3% YoY.

 

Leclaza, which was approved in Korea in January 2021, was also granted reimbursement the same year.

 

After posting KRW 4.1 billion in sales in Q2, it posted sales of KRW 16 billion the following year, then surpassed KRW 20 billion last year.

 

Leclaza’s approval as a first-line treatment for EGFR-positive NSCLC in July last year is analyzed to have contributed to the rise in sales.

 

Before the approval, patients had to be confirmed to be T790M-positive through an additional tissue test after using a first- or second-generation EGFR TKI to be eligible to use Leclaza with reimbursement.

 

With all 3 TKIs, including Leclaza and Tagrisso, now covered as first-line treatments, physicians and patients will have a full range of first- and third-generation targeted therapies to choose from.

 

Another benefit of Leclaza is its potential for use in combination with Rybrevant.

 

Combination therapies, including Tagrisso plus platinum-based chemotherapy and Rybrevant plus platinum-based chemotherapy, are currently approved by regulatory authorities abroad for the first-line treatment of lung cancer.

 

Combining the use of Leclaza, which targets EGFR-mutated exon 19 and exon 21 deletion, with Rybrevant, which targets exon 20 deletion, has been attracting attention as a viable targeted therapy combination.

 

Currently, the Leclaza + Rybrevant combination is being reviewed for approval in the US as a first-line treatment for lung cancer.

 

Sales of all first-generation EGFR TKIS other than Giotrif decline During the same period, first- and second-generation TKIs saw sluggish growth.

 

Only Giotrif’s sales showed growth, while all others declined.

 

Giotrif generated KRW 27.2 billion in sales last year, up 5.8% from 2022.

 

Since its launch in Korea in 2014, Giotrif has seen a gradual but steady increase in sales.

 

After surpassing the KRW 10 billion mark in sales for the first time in 2017, Giotrif posted sales of KRW 16.6 billion in 2019, KRW 22 billion in 2021, and KRW 25.7 billion in 2022.

 

Giotrif benefited how third-generation TKIs not being used as first-line treatments.

 

On the other hand, Vizimpro’s sales had been sluggish.

 

Vizimpro, which had been released later in 2020, had increased slightly to KRW 1.4 billion in 2021 and KRW 2.8 billion in 2022, but stagnated at KRW 2.7 billion last year.

 

The weakness of Vizympro is in its side effects.

 

In the ARCHER 1050 study, the Phase III trial that became the grounds for its approval, Vizympro showed better efficacy compared to first-generation TKIs, but also a higher rate of adverse events.

 

60% of patients in the Vizympro arm required dose adjustments due to adverse events.

 

In general, first-generation TKIs are continuing to show declining sales.

 

First, Iressa posted sales of KRW 12.7 billion last year, down 9.2% YoY.

 

Sales have been on a steady decline since 2020 when sales fell below KRW 20 billion (USD 19.6 billion).

 

Iressa posted KRW 16.7 billion in sales in 2021 and KRW 14 billion in 2022.

 

Iressa is known to be a milder cancer drug with fewer side effects among targeted therapy options.

 

As such, it has been used as a priority in patients with relatively poor health.

 

However, sales have been declining with more treatment options becoming available, with latecomers confirming their efficacy over Iressa.

 

Tarceva’s sales fell 13.8% YoY to KRW 3.1 billion last year.

 

This is the fifth consecutive year the drug saw declining sales after posting KRW 8.2 billion in 2019.

 

Compared to the KRW 17.3 billion it had earned in 2016, Tarceva’s sales have more than halved.

 

Tarceva’s sales are also on a decline due to the emergence of more effective second and third-generation targeted therapies.

 

Tarceva also suffered a setback in 2016 when its maintenance therapy indication was removed for patients with stage IIIA or higher NSCLC.

 

Also, Tarceva was not proven effective in retrospective clinical studies.

 

Therefore, its sales are expected to continue to decline when combined targeted therapies are approved for use in the first line.