Ibrance can be used regardless of underlying condition in BC

Professor Kyong-Hwa Park (Department of Oncology and Hematology, Korea University Medical Center

PFS of breast cancer patients improved greatly with the introduction of the trusted Ibrance

Shows stable effect in patients regardless of underlying preexisting condition… may be maintained over 40 months

“A real-world study on Koreans in plan… the role of CDK4/6 inhibitors will continue to expand"

It has been 5 years since Pfizer’s breast cancer treatment ‘Ibrance (Palbociclib)’ was introduced to the Korean market.

 

As the first cyclin-dependent kinase 4/6 (CDF 4/6) inhibitor, the drug had innovated the treatment paradigm for patients with metastatic and recurrent hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer.

 

With 5 years' worth of accumulated data, Ibrance has settled in as a trusted and reliable drug for doctors.

 

In particular, Ibrance is considered the ‘go-to drug’ for those who have underlying conditions or have side effect concerns.

 

At a meeting with Dailypharm, Kyong-Hwa Park, Professor of Oncology and Hematology at Korea University Medical Center, said that “Ibrance is suitable for use in patients who have poor liver conditions, the elderly, and those with poor kidney functions as it demonstrated long-lasting effect with little side effects in the field.

 

Detailed QA of Dailypharm’s interview with Professor Park is listed below.

 

Professor Kyong-Hwa Park

-What has the diagnostic status been like for breast cancer in Korea recently?

 

=The number of breast cancer patients has increased greatly recently.

 

Korea’s prevalence rate of breast cancer had surpassed Japan and is now ranked highest in Asia.

 

One silver lining is that the long-term survival rate of Korean patients is very good.

 

Although there are some drugs that are not reimbursed, Korea’s breast cancer treatment environment in terms of treatment, medical service, and accessibility is quite good.

 

- After Ibrance, other CDK4/6 inhibitors have also been started to enter the market.

 

Nevertheless, Ibrance seems to be considered as the drug that can be stably used due to the immense amount of accumulated data and prescription experience. = That is true.

 

Ibrance is the first CDK4/6 inhibitor that was approved in Korea and owns the most amount of long-term data as well as clinical experience.

 

This is why it is a good choice for patients with various concerns.

 

For example, patients who are at risk of side effects due to underlying diseases, old age, etc, may require a period of adaptation when using a drug or take various medications.

 

It would be difficult for the doctor to opt for other CDK4/6 inhibitors in these cases.

 

- Ibrance demonstrated consistent efficacy in patients with underlying diseases in clinical trials.

 

Were you also able to observe this in the field?

 

= A more diverse range of patients always exist in the real world.

 

Some patients are very old, there are those who have poor kidney function, those with bad heart function, and even liver cirrhosis.

 

The number of patients with such underlying conditions increase immensely if we add those who have diabetes or high blood pressure.

 

All of these patients may use Ibrance.

 

For example, I have a patient who has rheumatoid arthritis.

 

She had a fatty liver due to long-term use of rheumatoid arthritis drugs.

 

By using Ibrance with liver condition management, the patient is currently on Ibrance for 4 years with stable liver function.

 

The drug can also be stably used in patients with bad kidney function as well.

 

Also, in Korea, there are patients who have bad liver due to hepatitis B or C.

 

In these patients, we first use the drug and then adjust the dose if they develop leukopenia/neutropenia or thrombocytopenia.

 

- A total of 3 CDK4/6 inhibitors including Verzenio, Kisqali, and Ibrance are available in the market.

 

What other considerations do you make other than the patient’s underlying condition when selecting the kind of CDK 4/6 inhibitor for use? = ECG monitoring is required for the use of Kisqali, at least up to its second cycle, due to its influence on heart activity.

 

Also, the drug may not be used in patients with observed QT prolongation.

 

However, Kisqali is the only drug reimbursed for premenopausal patients who have never received endocrine therapy in Korea, and we induce menopause in such patients to allow the use of various drugs with the same indication.

 

In the case of Verzenio, patients adapt quickly to the drug if educated well on the treatment process, but it is difficult to use in patients who may not be able to tolerate diarrhea.

 

On the other hand, the advantage of Verzenio is that it is good for patients who have metastases to the liver or those who we would have considered using chemotherapy first in the past.

 

-A large-scale real-world data on Ibrance was presented this year in the U.S.

 

The study demonstrated PFS and OS improvement in combination with letrozole in the first-line.

 

This may be similar or different in Korea’s case.

 

How did you interpret the data?

 

=The average age of breast cancer patients in the US is around 15 years older than those in Korea.

 

Also, medical accessibly is not as good in the US as in Korea.

 

However still, the real-world results were comparable to that of clinical trials.

 

The median OS had not been reached yet, but I believe the results would show an improvement.

 

With the younger patient population, better accessibility to treatment, and higher self-management ability, results in the Korean patient population in clinical trials has always exceeded the performance observed in the overall patient population.

 

Therefore, I believe the real-world data in Korea would also come out similarly.

 

-The role of CDK4/6 inhibitors is expected to continue to grow in the field of breast cancer treatment.

 

What direction should Ibrance pursue in the aspect?

 

=Ibrance is being frequently selected as a combination therapy option in novel endocrine therapy combination studies.

 

Although it is currently used in combination with an aromatase inhibitor or faslodex in the first-line, many other 3rd generation oral endocrine therapies are also currently in development.

 

And all of these oral therapies are being developed in combination with Ibrance, so I believe Ibrance will be able to solidify its position as a first-line treatment while switching its partner drugs.

 

Also, PIK3CA mutation is a very important mechanism in endocrine resistance, and studies to tackle this with a three-drug combination are also being conducted using Ibrance.

 

The toxicity of the three drugs does not overlap, so I believe it can be well used in this aspect as well.