• Alecensa shows a clinically meaningful benefit in overall survival compared with crizotinib (The 5-year survival rate was 62.5% in Alecensa arm and 45.5% in crizotinib arm)
• No new safety concerns were identified, safety for Alecensa was consistent with the known safety profile

TOKYO, May 29, 2020-- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that updated data from the global phase III study (the ALEX study) for Alecensa^® was presented on May 29 (local time) at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. The ALEX study compared Alecensa and crizotinib as the first-line therapy for patients with ALK fusion gene positive non-small cell lung cancer (NSCLC).

Abstract #9518;
Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC
https://meetinglibrary.asco.org/record/190248/abstract

Dr. Osamu Okuda, Chugai's President and COO, said "This five-year follow-up data from the ALEX study shows the long-term benefits of Alecensa as the first-line treatment of ALK-positive NSCLC. This reaffirms the position of Alecensa as one of the standard treatments."

Latest data from the ALEX study shows:

• At the updated data cut-off point, median duration of follow-up was 48.2 months (range: 0.5 - 62.7) and 23.3 months (range: 0.3 - 60.6) in the Alecensa and crizotinib arms, respectively. The number of overall survival (OS) events was 37% of the ITT population, median OS in the crizotinib arm was 57.4 months (95%CI: 34.6 – not estimable) and not estimable in the Alecensa arm (HR=0.67, 95％CI: 0.46 - 0.98). The 5-year survival rate was 62.5% (95%CI: 54.3 - 70.8) and 45.5% (95%CI: 33.6 - 57.4) in the Alecensa and crizotinib arms, respectively (secondary endpoint).
• In patients with CNS metastases at baseline, the OS hazard ratio was 0.58 (95%CI: 0.34 - 1.00) and 0.76 (95%CI: 0.45 - 1.26) in patients without CNS metastases at baseline (secondary endpoint).
• No new safety signals were observed, and the safety profile of Alecensa was consistent with previous reports.

Note: The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.

[Reference information]

• Media release issued by Roche on September 28, 2019:
  Roche to present new and updated data at ESMO 2019 reinforcing the use of Alecensa in the first-line setting for advanced ALK-positive non-small cell lung cancer
  https://www.roche.com/media/releases/med-cor-2019-09-28.htm

• Media release issued by Roche on May 17, 2018:
  Follow-up phase III data showed Roche's Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death
  https://www.roche.com/media/releases/med-cor-2018-05-17b.htm

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