What if ALUNBRIG® (brigatinib) is Your
Second Line of Treatment?

Why Did My Doctor Recommend That I Start a New Treatment?

Even with targeted treatments, ALK+ NSCLC that has spread to other parts of your body can progress (worsen). This progression may happen when the disease develops resistance, which can be caused by a number of different factors. One such factor is defects in the ALK gene, which prevent the treatment from blocking the growth of cancer cells. This can cause the drug to stop working.

Alternatively, some patients may not be able to tolerate treatments and your healthcare provider may recommend a new medication.

ALUNBRIG Was Shown to Shrink Tumors After Crizotinib Treatment in Patients with ALK+ NSCLC Whose Cancer Had Spread to Other Parts of the Body

In a previous ALUNBRIG study, researchers followed 222 patients with ALK+ NSCLC whose cancer had spread to other parts of the body and who had taken the medicine crizotinib and whose disease had worsened.

112 patients received 90 mg orally once daily (90-mg group).

The other group of 110 patients received the recommended dosing regimen of 90 mg orally once daily for 7 days, followed by an increase to 180 mg orally once daily thereafter (90→180-mg group).

Study Results for the Recommended Dosing Regimen (90→180-mg Group)

More than half (53%) of patients achieved a response, meaning their tumors either shrank or disappeared while taking ALUNBRIG.

Pie chart showing that 53% of patients achieved an overall response rate in the 90 mg→180 mg Group)

Overall, 58 out of 110 achieved a response

Additional Study Results
In the same study, 112 patients received 90 mg of ALUNBRIG orally once daily (90-mg group) without having their dose increased.

  • 54 out of 112 (48%) patients achieved a response
    • 4 out of 112 (3.6%) patients achieved a complete response
    • 50 out of 112 (45%) patients achieved a partial response

Responses lasted a median of 13.8 months for both dosing groups.

Additional Second-Line Study Results

ALUNBRIG also showed results in the brain

Study Results for the Recommended Dosing Regimen (90→180-mg Group)
In the same study, 18 patients receiving the recommended dosing regimen had measurable tumors that had spread to the brain.

67% of patients' brain tumors shrank
Nearly 2 out of every 3 patients saw their brain tumors shrink.

  • None of the patients had a complete response in the brain
  • 67% (12 out of 18) had a partial response in the brain

Of the 12 patients who responded to treatment with ALUNBRIG:

  • 6 patients responded for 6 months or longer, and
  • 3 patients responded for 12 months or longer

 

Additional Study Results for 90-mg Group

26 patients with ALK+ NSCLC in the 90-mg group had measurable tumors that had spread to the brain.

Overall, brain tumors shrank in 11 out of 26 (42%) patients

  • 2 out of 26 (7.7%) patients had a complete response in the brain
  • 9 out of 26 (35%) patients had a partial response in the brain

Of the 11 patients who responded to treatment with ALUNBRIG:

  • 7 patients responded for 6 months or longer, and
  • 4 patients responded for 12 months or longer
How to Take ALUNBRIG

Glossary

ALK gene-A gene that makes a protein called anaplastic lymphoma kinase or ALK, which is involved in cell growth. Mutated or genetically changed forms of the ALK gene and protein have been found in some types of cancer, such as NSCLC.

Complete response-The disappearance of tumors in response to a given treatment. This is not the same as a cure.

Median-The middle number in a set of measurements arranged from lowest to highest.

Partial response-The decrease in size and spread of tumors in response to a given treatment.

Resistance-When cancer cells do not respond to a drug used to destroy or weaken them. Drug resistance may happen at the beginning of a treatment or may happen over time.

A gene that makes a protein called anaplastic lymphoma kinase or ALK, which is involved in cell growth. Mutated or genetically changed forms of the ALK gene and protein have been found in some types of cancer, such as NSCLC.

The disappearance of tumors in response to a given treatment. This is not the same as a cure.

The middle number in a set of measurements arranged from lowest to highest.

The decrease in size and spread of tumors in response to a given treatment.

When cancer cells do not respond to a drug used to destroy or weaken them. Drug resistance may happen at the beginning of a treatment or may happen over time.


 

 

 

ALUNBRIG(TM) BRIGATINIB 39 mg TABLETS

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In Vitro: ALUNBRIG Inhibited 17
ALK-Inhibitor-Resistant Mutations1,2

ALUNBRIG exhibited in vivo antitumor activity against 4 mutant forms of EML4-ALK, including the G1202R and L1196M mutants identified in NSCLC tumors in patients who had progressed on crizotinib.


 

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