Roche’s lung cancer drug Alecensa proves safety, effects on Korean patients

Roche’s ALK (anaplastic lymphoma kinase)-positive target anticancer therapy, Alecensa (alectinib), has shown consistent results with the existing studies in its long-term clinical trial of Asian, including Korean, patients, reaffirming its safety and effectiveness.

In the ESMO (European Society for Medical Oncology) 2022 held recently, the company released the updated results of ALESIA. This phase 3 clinical trial evaluated Alecensa’s effectiveness and safety on Asian patients with ALK-positive progressive non-small cell lung cancer (NSCLC) who have had no treatment experiences.

The prevalence of lung cancer is especially high in Asia, accounting for more than half of lung cancer patients worldwide.

ALESIA was a “bridging study” conducted to confirm the consistency of Alecensa’s global phase 3 clinical trial called ALEX on Asian patients. Researchers carried out the trial on 187 Asian, including Korean, patients with ALK-positive, locally progressive, or metastatic NSCLC with no previous treatment experiences, compared to the existing standard therapy of Xalcory (crizotinib).

In ESMO Asia 2022, researchers announced the updated results of comparing the Alecensa and Xalcory groups through follow-up monitoring of the median value of 61 months and 51 months through the ALESIA study.

The results showed that updated median values of progression-free survival (PFS) were 41.6 months for the Alecensa group against 11.1 months for the Xalcory group, improving it by 67 percent and proving consistent treatment effects.

More specifically, when looking at the PFS value, the presence or absence of metastasis to the central nerve system (CNS) confirmed consistent data regardless of the metastasis to CNS compared to a basis time. When the CNS metastasis occurred, the PFS was 42.3 months for the Alecensa group compared to Xalcory’s group’s 9.2 months. Even when CNS metastasis did not occur, the PFS was 41.6 months for the Alecensa group vs. 12.7 months for the Xalcory group.

However, neither group reached the median overall survival (OS) value during the updated period, with the Alecensa group improving the value by 40 percent against the Xalcory group. Five-year survival rate was 66.4 percent for the Alecensa group, significantly higher than the Xalcory group’s 56 percent.

Updated safety results were consistent with existing data and previous clinical trial results of Alecensa. Besides, no new safety problems showed a risk of new adverse reactions during the long-term use of Alecensa.

“It was a significant result for Korean ALK-positive NSCLC patients that Alecensa recorded the five-year survival rate of 66 percent or higher in Korean and other Asian patients,” said Professor Lee Se-hun of the Hemato-oncology Department at Samsung Medical Center who participated in the ALESIA study. “Through the results of this study that confirmed the long-term effectiveness and safety in Asian patients, Alecensa will solidify its clinical status as the standard primary treatment, playing an important role in medical fields.”