Venclexta combo in the spotlight as a new lymphoma Tx option

5-year survival rate less than 30%... rate gets much lower with age

Anticancer treatment environment for AML at a standstill for 40 years… welcomes much needed new option recently

“Venclexta+hypomethylating agent combination is the optimal treatment option for elderly patients"

The treatment landscape for elderly patients with acute myeloid leukemia (AML), which has a 5-year relative survival rate of less than 10%, is changing with the introduction of a new drug that addresses the unmet needs and improves survival rate.

 

AML is one of the most common types of leukemia in adults with a high unmet need in patients and HCPs alike.

 

As one of the more aggressive types of leukemia in adults, around 140,000 new cases occur globally every year, of which around 100,000 cases end in deaths.

 

With the same treatment being used in AML for over 40 years, not much improvement has been made in the overall survival (OS) until recently.

 

The 5-year survival rate was at a mere 29% and was even lower for older patients.

 

According to a study by the National Cancer Center, the relative survival rate of AML patients was very low in elderly patients - less than 10% for patients over the age of 65 and 0% for those 80 years and older.

 

Considering that the average age of AML patients is 67 and that one-third of the patients are 75 years old, the urgency and need for an appropriate treatment was high in this respect.

 

Also, there had been a high demand for treatment with improved efficacy and lower toxicity that can be used in older patients.

 

Experts advised that intensive chemotherapy, the main treatment used for AML, is unsuitable in elderly patients who are likely to have comorbidities and are not generally in good condition.

 

Venclexta combination therapy provides new opportunities for elderly AML patients The most important goal in treating AML patients is improving the overall survival period.

 

With active R&D being conducted in the field recently, the treatment environment has improved to allow more options from combination therapy to targeted therapies to be provided according to each patient’s condition.

 

A new treatment option is also available for the elderly patients who were not considered candidates for intensive chemotherapy.

 

Among the new drugs that were recently introduced to the field, Abbvie’s ‘Venclexta (venetoclax)’ in combination with azacytidine, or decitabine, or low-dose cytarabine is being considered the most appropriate therapy for patients who have difficulty receiving intensive chemotherapy.

 

Venclexta, which was approved by the Ministry of Food and Drug Safety in January, may be used in combination with azacytidine or decitabine in ‘newly-diagnosed AML adult patients aged 75 or more, or who have comorbidities that preclude the use of intensive induction chemotherapy.’ Results of the Phase III VIALE-A trial that evaluated the safety and efficacy of the Venclexta and azacitidine combination showed that the combination’s median OS was 14.7 months, 5 months longer than the 9.6 months found in the control group (placebo+ azacitidine combination).

 

The Phase I M14-35 trial that evaluated the safety and efficacy of the Venclexta in combination with decitabine also showed that the median OS was 16.2 months.

 

Also, the median time to first complete remission(CR) or CR with incomplete count recovery (Cri) was shorter for the Venclexta and azacitidine combination (1.3 months) than the control group (2.3 months), showing that the responses to the combination therapy occurred quickly in elderly patients as well.

 

Also, over 60% of the patients achieved transfusion independence, raising expectations that the treatment could reduce the burden of treatment in elderly patients.

 

Joon Ho Jang, Professor of Hematology and Oncology at the Samsung Medical Center said, “It is encouraging that a treatment that dramatically improved overall survival was introduced in the ALK treatment environment, a field where no new treatment option had been available for a long period of time.

 

The new treatment option could provide opportunities for the difficult-to-treat patient population, such as those who are older or have comorbidities.

 

We expect an improvement in the overall patients’ quality of life as the Venclexta+hypomethylating agent combination is effective not only in improving OS but has a short period to CR and can lower transfusion dependence.

 

Professor Jang continued, “I hope that accessibility to these new treatment options is improved as soon as possible in consideration of the poor physical and economic conditions of patients suffering from AML in Korea."