Final Progression-Free Survival Data and the Second Interim Analysis of Overall Survival from the J-ALEX Study for Alecensa Presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

• Alecensa reduced the risk of disease progression or death by 63%
  compared to crizotinib
• Long-term follow-up reconfirmed that Alecensa prolonged
  progression-free survival compared to crizotinib

TOKYO–(BUSINESS WIRE)–#oncology—Chugai
Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the final
progression-free survival (PFS) data and the second interim analysis of
overall survival (OS) from the Japanese phase III J-ALEX study for
Alecensa^® were presented on June 2 (local time) at the 2019
American Society of Clinical Oncology (ASCO) Annual Meeting, taking
place from May 31 to June 4 in Chicago, IL, United States. J-ALEX study
compared Alecensa and crizotinib as the first-line treatment for
patients with ALK fusion gene positive non-small cell lung cancer
(NSCLC).

Abstract #9092;
Final PFS analysis and safety data from the phase
III J-ALEX study of Alectinib (ALC) vs. Crizotinib (CRZ) in
ALK-inhibitor naïve ALK-positive Non-Small Cell Lung Cancer (ALK+NSCLC)

“The long-term data from the J-ALEX study confirms the benefits of
Alecensa as the first-line treatment for patients with ALK-positive
NSCLC,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head
of Project & Lifecycle Management Unit.

The J-ALEX study is an open-label, randomized phase III study that
compares the efficacy and safety between Alecensa and crizotinib. The
J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK
fusion gene positive advanced or recurrent NSCLC, who either had not
undergone chemotherapy or had undergone one chemotherapy regimen. The
primary endpoint of the J-ALEX study was PFS as assessed by an
independent review facility (IRF). The secondary endpoints included OS,
time to disease progression of brain metastases in patients with brain
metastases at baseline, and safety.

In February, 2016, Chugai carried out a prospectively defined interim
analysis, and had an independent data monitoring committee examine the
results. Since the results showed that Alecensa significantly prolonged
PFS to a higher extent than anticipated, the committee decided to
recommend an early discontinuation of the study [Alecensa arm: not
estimable (95% CI: 20.3-not estimable), crizotinib arm: 10.2 months (95%
CI: 8.2-12.0), HR=0.34 (99.7% CI: 0.17-0.70), stratified log-rank test,
p<0.0001)].

Latest data from the J-ALEX study shows:

• Risk of progression or death was reduced by 63% (HR=0.37, 95% CI:
  0.26-0.52) in the Alecensa arm compared to the crizotinib arm. Median
  PFS (primary endpoint) was 34.1 months in the Alecensa arm (95% CI:
  22.1-not estimable) versus 10.2 months (95% CI: 8.3-12.0) in the
  crizotinib arm.
• In the second interim analysis, the superiority of OS in the Alecensa
  arm over the crizotinib arm was not conclusive (stratified HR=0.80,
  95% CI: 0.35-1.82). The investigation on OS will be continued.

• The safety profile of Alecensa was consistent with previous reports.

[Reference information]
Media release issued by Chugai on May 11,
2017:
Results of the J-ALEX Study for Chugai’s Alecensa^®
are Published in “The Lancet” Online;
https://www.chugai-pharm.co.jp/english/news/detail/20170511113001_82.html

About Chugai

Chugai Pharmaceutical is one of Japan’s leading research-based
pharmaceutical companies with strengths in biotechnology products.
Chugai, based in Tokyo, specializes in prescription pharmaceuticals and
is listed on the 1st section of the Tokyo Stock Exchange. As an
important member of the Roche Group, Chugai is actively involved in R&D
activities in Japan and abroad. Specifically, Chugai is working to
develop innovative products which may satisfy the unmet medical needs,
mainly focusing on the oncology area. Additional information is
available on the internet at https://www.chugai-pharm.co.jp/english.

Trademarks used or mentioned in this release are protected by law.

Contacts

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Chugai Pharmaceutical Co., Ltd.
Media Relations
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Tomoko Shimizu
Tel:
+81-3-3273-0881
E-mail: [email protected]

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Chugai Pharma USA Inc.
Casey Astringer
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+1-908-516-1350
E-mail: [email protected]

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Chugai Pharma U.K. Ltd.
Carter Westwood
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+44-20-8987-5680
E-mail: [email protected]

For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou
Tel:
+886-2-2715-2000
E-mail: [email protected]

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Chugai Pharmaceutical Co., Ltd.
Investor
Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel:
+81-3-3273-0554
E-mail: [email protected]