Second-line treatment options are increasing for patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose first-line treatment with Xalkori (crizotinib) failed.
|Kim Dong-wan, a professor at Hemato-Oncology Department of Seoul National University Hospital, speaks during a news conference in Seoul, Thursday.|
However, most secondary drugs have still failed to extend progression-free survival (PFS) or improve intracranial responses. Despite challenges, Takeda’s Alunbrig (ingredient: briganitib) seems to have resolved such problems, a hematologist said.
In Korea, physicians use three medications as the first-line treatment for ALK-positive NSCLC – Pfizer’s Xalkori, Novartis’ Zykadia (ingredient: ceritinib), and Roche’s Alecensa. For the second-line therapy, they use Zykadia, Alecensa, or more recently, Alunbrig.
Kim Dong-wan, a professor at Hemato-Oncology Department of Seoul National University Hospital, explained about Alunbrig’s superior efficacy in extending PFS, raising central nervous system’s response, and lowering tolerance and side effects, in a news conference on Thursday.
Citing each clinical trial on Zykadia, Alecensa, and Alunbrig and their respective PFS results, Kim emphasized how Alunbrig was better than the other two to extend PFS. However, he made it clear that each trial was not conducted under the same condition and so it was not possible to directly compare them.
According to Kim, in the second-line treatment for patients who failed Xalkori therapy, the median PFS of Zykadia was 7.2 months, that of Alecensa, 8.9 months and that of Alunbrig, 16.7 months.
Concerning objective response rate (ORR), Zykadia had 56 percent, Alecensa, 50 percent, and Alunbrig, 56 percent.
However, Alunbrig had high nervous central system response of 67 percent, whereas that of Zykadia was 36 percent, and that of Alecensa, 57 percent. Among the three, Alunbrig showed the most excellent intracranial response, Kim said.
He went on to say that Alunbrig also improved tolerance with fewer ALK mutations, compared to other treatments. Its side effects such as functional gastrointestinal disorder and headache were relatively mild, Kim noted.
Despite the impressive clinical results of Alunbrig among available ALK inhibitors on the market, the treatment has many limitations in Korea, observers said.
The food and drug safety ministry granted the nod for Alunbrig on Nov. 30. However, it is still not covered by insurance. Takeda said it was doing its best to get reimbursement for Alunbrig as soon as possible, but the company has a long way to go before doing so.
Xalkori, the first-line treatment for ALK-positive NSCLC, is rapidly being replaced by Alecensa. Alunbrig is allowed only for patients who failed the first-line treatment with Xalkori. Patients who failed the Alecensa treatment cannot receive Alunbrig therapy.
Although Takeda is conducting a trial of Alunbrig to obtain U.S. approval for the first-line treatment and hoping to apply to the U.S. regulator within this year, it may take several years to expand indication in Korea and get reimbursed, industry watchers said.
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