Pfizer seeks generation change in the ALK market

Xalkori's sales have fallen to around ₩10 billion due to second-generation drugs

The third generation Lorviqua

ALK target treatment Xalkori and Pfizer’s Lorviqua

Pfizer, which developed the first ALK-targeted treatment, has released a third-generation new product.

 

A new option has emerged in the ALK targeted treatment market, where subsequent drugs were not appropriate.

 

Third-generation drugs are also expected to compete with second-generation products as a primary treatment.

 

Pfizer was approved by the MFDS on the 29th of last month to treat ALK-positive non-small cell lung cancer.

 

Lorviqua can be used at least once to treat patients who have been treated with conventional first-generation or second-generation treatments.

 

The third-generation drug, Lorviqua, can be an alternative to the treatment of patients with resistance after the first-generation drugs Xalkori and the second-generation drugs Zykadia, Alecensa and Alunbrig.

 

If Xalkori is used in the first generation, it can be used in the second generation and then in the second generation, it can be used in the second generation, and chemotherapy had to be used if secondary drugs developed resistance.

 

G1202R is the most common type of resistant mutation that occurs after the second generation medication, and depending on the drug, F1174L (Zykadia), I1171T/N/S (Alecensa), and E1210K (Alunbrig).

 

Lorlatinib is known to have an effect on all known resistant mutations.

 

In the second phase of 275 previously treated patients, including the second generation ALK TKI, Lorviqua showed 47% ORR and 63% ORR in patients with brain metastasis.

 

Lorviqua quickly became effective after taking.

 

The time median to the first response and the time median to the first two in-reactions were 1.4 months, respectively.

 

In the sub-analysis classified by second-generation drugs, Lorviqua maintained a consistently significant effect.The objective response rates in Alecensa, Alunbrig and Zykadia groups were 40.3%, 37.5%, and 40.4%, respectively.

 

Attention is focusing on whether Pfizer, which has weakened its position in the ALK TKI market due to the advent of second-generation drugs, will succeed as third-generation Lorviqua.

 

Pfizer has developed the first ALK targeted treatment called Xalkori, but sales continue to decline as second-generation drugs enter the primary treatment option.

 

Xalkori, which had more than ₩10 billion in sales in the quarter of 2018 based on IQVIA, started to see a sharp drop in sales in 2019 due to the expansion of benefit for the second generation Alecensa and the termination of the risk-sharing contract.

 

Annual sales fell 59% from ₩49.6 billion in 2018 to ₩20.3 billion in 2019.

 

Last year, it also dropped 28% year-on-year to ₩14.6 billion.

 

A three-phase CROWN study identified the primary treatment effect of Lorviqua.

 

In this clinical trial, Lorviqua showed an improved OR (73% vs.

 

58%).

 

It also reduced the risk of disease progression and death compared to Xalkori by 72%.

 

The U.S.

 

Food and Drug Administration (FDA) added an indication in March to use Lorviqua as a primary drug.

 

It is expected that it will soon obtain additional indications in Europe.

 

It is also expected that Lorviqua will expand its adaptation in Korea.

 

However, competition between second-generation drugs is expected to continue for the time being because many steps have to be passed before applying domestic benefits.