AbbVie's Venclexta (Ingredient: venetoclax) has acquired approval from the Ministry of Food and Drug Safety as a secondary treatment in combined therapy with Roche's MabThera (Ingredient: rituximab) for patients with chronic lymphocytic leukemia (CLL).

Although the treatment term for the combined modality therapy of Venclexta with MabThera has been fixed at two years, Venclexta has become the first treatment for CLL that can maintain therapeutic effects even after the period, AbbVie said.

As Venclexta, which received approval from the ministry as the monotherapy for stage 3 or higher CLL in May 2019, has now won the nod as a secondary combination therapy, an increasing number of patients will be able to receive treatment with the drug, it added.

The permit was based on the results of phase 3 clinical trials (MURANO) comparing the efficacy and safety of Venclexta and MabThera combination therapy and the standard treatment of Bendamustine and MabThera combination therapy.

AbbVie's Venclexta wins regulator’s OK for leukemia treatment

The subjects of the trial were relapsed or refractory CLL patients who have received chemotherapy at least once in the past. The Venclexta and MabThera combination therapy group showed a significantly longer duration of progression-free survival as the researchers analyzed the first evaluation index of the study.

The risk of mortality or disease progression of the Venclexta-MabThera group fell by 83 percent with a hazard ratio (HR) of 0.17, 95-percent confidence interval (CI) of 0.11 to 0.25, and p-value less than 0.001.

The Venclexta-MabThera group also showed higher overall survival than that of the standard treatment of Bendamustine and MabThera combination therapy group with HR of 0.48, 95-percent CI of 0.25 to 0.90, which failed to reach the median survival.

Also, in the post-treatment follow-up study of phase 3 MURANO trial, the non-progression survival rate of the Venclexta-MabThera combination group that has 130 patients who completed two years of dosage without disease progression was estimated at 75.5 percent at 18 months and 68 percent at 24 months. The CI was 67.4 and 83.7 at 18 months and 57.6 and 78.4 at 24 months.

"We need various effective treatments for CLL because it is a disease that is highly likely to refract or recur after the first treatment," said Professor Eom Ki-seong of the CLL Center at the Seoul St. Mary's Blood Hospital.

The study showed a high rate of minimal residual disease-negative (MRD) complete response, which indicates the Venclexta-MabThera combination therapy can induce a profound response. Therefore, the research team expected a higher possibility of full recovery in earlier stages as well as a lower death rate.

The second evaluation index was measured based on MRD at the end of the combination therapy. MRD is the number of leukemia cells remaining in peripheral blood or bone marrow. MRD-negative means that less than one chronic lymphocytic leukemia cell is present among 10,000 leukocytes.

The result showed that 62.4 percent of the Venclexta-MabThera combination therapy group reached MRD-negative. In comparison, 13.3 percent of patients treated with Bendamustine and Mabthera combination therapy reached MRD-negative in peripheral blood.

Chronic lymphocytic leukemia is a common disease in the West, but only 0.4 to 0.5 percent of Korean leukemia patients are identified with CLL, which makes it a rare disease. The disease mainly occurs among people over 65.

"The quality of a patient's life is expected to improve in various aspects as the treatment minimizes the manifestation of toxicity with an off-treatment period and reduces the economic burden of the patient with a two-year fixed treatment," said Jung Soo-jin, AbbVie’s country medical director.

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