BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage
biotechnology company focused on developing and commercializing
innovative medicines worldwide, today announced that a supplemental
Biologics License Application (sBLA) for anti-PD1 antibody
tislelizumab was accepted by the Center for Drug Evaluation (CDE)
of the China National Medical Products Administration (NMPA) for
treatment in the second- or third-line setting of patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC)
who have progressed on prior platinum-based chemotherapy.
“We are excited to submit the third marketing application for
tislelizumab from its broad program in lung cancer which consists
of five completed or ongoing Phase 3 trials. Results from our Phase
3 RATIONALE 303 trial demonstrated improved overall survival over
chemotherapy in advanced NSCLC patients who have progressed after
treatment with chemotherapy at its interim analysis, which we have
been able to file quickly with the CDE for its review,” commented
Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at
BeiGene. “With three approvals for tislelizumab in China, as well
as three sBLAs under review, we are excited to continue to build
upon our broad development program for tislelizumab, a potentially
differentiated checkpoint inhibitor and explore additional
opportunities with our new partner Novartis.”
RATIONALE 303 Trial of Tislelizumab Compared to Docetaxel in
Patients with Locally Advanced or Metastatic NSCLC Who Progressed
on Prior Platinum-Based Chemotherapy
The sBLA is supported by clinical results from the Phase 3
RATIONALE 303 trial, a randomized, open-label, multicenter global
Phase 3 clinical trial (NCT03358875) designed to evaluate the
efficacy and safety of tislelizumab compared to docetaxel in the
second- or third-line setting in patients with locally advanced or
metastatic NSCLC who have progressed on a prior platinum-based
chemotherapy. The primary endpoint of the trial is OS in all
patients (the ITT population) and in patients with high PD-L1
expression; key secondary endpoints include objective response rate
(ORR), duration of response (DoR), progression-free survival (PFS),
and safety. A total of 805 patients in 10 countries across Asia,
Europe, the Americas, and Oceania were randomized 2:1 to either the
tislelizumab arm or the docetaxel arm.
As announced in November 2020, RATIONALE 303 met the primary
endpoint of OS at the planned interim analysis, as recommended by
the independent Data Monitoring Committee (DMC). The safety profile
of tislelizumab was consistent with the known risks with no new
safety signals identified. BeiGene expects to present results from
the RATIONALE 303 trial at an upcoming medical conference in the
first half of 2021.
About Non-Small Cell Lung Cancer
In China, the lung cancer incidence rate is increasing.i There
were approximately 815,563 new cases of lung cancer in China in
2020, and it is the leading cause of cancer-related death in both
men and women, with approximately 714,699 deaths in China in
2020.ii Non-small cell lung cancer (NSCLC) is the most common form
of lung cancer, accounting for approximately 80 to 85 percent of
all cases.iii
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal
antibody specifically designed to minimize binding to FcγR on
macrophages. In pre-clinical studies, binding to FcγR on
macrophages has been shown to compromise the anti-tumor activity of
PD-1 antibodies through activation of antibody-dependent
macrophage-mediated killing of T effector cells. Tislelizumab is
the first drug from BeiGene’s immuno-oncology biologics program and
is being developed internationally as a monotherapy and in
combination with other therapies for the treatment of a broad array
of both solid tumor and hematologic cancers.
The China National Medical Products Administration (NMPA) has
granted tislelizumab full approval for first-line treatment of
patients with advanced squamous non-small cell lung cancer (NSCLC)
in combination with chemotherapy. Tislelizumab has also received
conditional approval from the NMPA for the treatment of patients
with classical Hodgkin’s lymphoma (cHL) who received at least two
prior therapies, and for the treatment of patients with locally
advanced or metastatic urothelial carcinoma (UC) with PD-L1 high
expression whose disease progressed during or following
platinum-containing chemotherapy or within 12 months of neoadjuvant
or adjuvant treatment with platinum-containing chemotherapy. Full
approval for these indications is contingent upon results from
ongoing randomized, controlled confirmatory clinical trials.
In addition, three supplemental Biologics License Applications
for tislelizumab have been accepted by the Center for Drug
Evaluation (CDE) of the NMPA and are under review for first-line
treatment of patients with advanced non-squamous NSCLC in
combination with chemotherapy, for the second- or third-line
treatment of patients with locally advanced or metastatic NSCLC who
progressed on prior platinum-based chemotherapy, and for previously
treated unresectable hepatocellular carcinoma.
Currently, 15 potentially registration-enabling clinical trials
are being conducted in China and globally, including 12 Phase 3
trials and two pivotal Phase 2 trials.
In January 2021, BeiGene and Novartis entered into a
collaboration and license agreement to develop, manufacture, and
commercialize tislelizumab in North America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.
About the Tislelizumab Clinical Program
Clinical trials of tislelizumab include:
- Phase 3 trial comparing tislelizumab with docetaxel in the
second- or third-line setting in patients with NSCLC
(NCT03358875);
- Phase 3 trial comparing tislelizumab to salvage chemotherapy in
patients with relapsed/refractory classical Hodgkin Lymphoma
(NCT04486391);
- Phase 3 trial in patients with locally advanced or metastatic
urothelial carcinoma (NCT03967977);
- Phase 3 trial of tislelizumab in combination with chemotherapy
versus chemotherapy as first-line treatment for patients with
advanced squamous NSCLC (NCT03594747);
- Phase 3 trial of tislelizumab in combination with chemotherapy
versus chemotherapy as first-line treatment for patients with
advanced non-squamous NSCLC (NCT03663205);
- Phase 3 trial of tislelizumab in combination with
platinum-based doublet chemotherapy as neoadjuvant treatment for
patients with NSCLC (NCT04379635);
- Phase 3 trial of tislelizumab combined with platinum and
etoposide versus placebo combined with platinum and etoposide in
patients with extensive-stage small cell lung cancer
(NCT04005716);
- Phase 3 trial comparing tislelizumab with sorafenib as
first-line treatment for patients with hepatocellular carcinoma
(HCC; NCT03412773);
- Phase 2 trial in patients with previously treated unresectable
HCC (NCT03419897);
- Phase 3 trial comparing tislelizumab with chemotherapy as
second-line treatment for patients with advanced esophageal
squamous cell carcinoma (ESCC; NCT03430843);
- Phase 3 trial of tislelizumab in combination with chemotherapy
as first-line treatment for patients with ESCC (NCT03783442);
- Phase 3 trial of tislelizumab versus placebo in combination
with chemoradiotherapy in patients with localized ESCC
(NCT03957590);
- Phase 3 trial of tislelizumab combined with chemotherapy versus
placebo combined with chemotherapy as first-line treatment for
patients with gastric cancer (NCT03777657);
- Phase 2 trial in patients with MSI-H/dMMR solid tumors
(NCT03736889); and
- Phase 3 trial of tislelizumab combined with chemotherapy versus
placebo combined with chemotherapy as first-line treatment in
patients with nasopharyngeal cancer (NCT03924986).
About BeiGene
BeiGene is a global, commercial-stage biotechnology company
focused on discovering, developing, manufacturing, and
commercializing innovative medicines to improve treatment outcomes
and access for patients worldwide. Our 5,400+ employees around the
world are committed to expediting the development of a diverse
pipeline of novel therapeutics. We currently market two internally
discovered oncology medicines: BTK inhibitor BRUKINSA®
(zanubrutinib) in the United States and China, and anti-PD-1
antibody tislelizumab in China. We also market or plan to market
additional oncology products in China licensed from Amgen Inc.;
Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company; and
EUSA Pharma; and have entered a collaboration with Novartis Pharma
AG for Novartis to develop and commercialize tislelizumab in North
America, Europe and Japan. To learn more about BeiGene, please
visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
data from the RATIONALE-303 global Phase 3 trial of tislelizumab
compared to docetaxel in the second- or third-line setting in
patients with locally advanced or metastatic non-small cell lung
cancer who have progressed on prior platinum-based chemotherapy,
the filing and potential approval of a sBLA in China based on this
data, BeiGene’s plans to present the data at an upcoming medical
conference, and BeiGene's advancement, anticipated clinical
development, regulatory milestones and commercialization of
tislelizumab. Actual results may differ materially from those
indicated in the forward-looking statements as a result of various
important factors, including BeiGene's ability to demonstrate the
efficacy and safety of its drug candidates; the clinical results
for its drug candidates, which may not support further development
or marketing approval; actions of regulatory agencies, which may
affect the initiation, timing and progress of clinical trials and
marketing approval; BeiGene's ability to achieve commercial success
for its marketed products and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual
property for its medicines and technology; BeiGene's reliance on
third parties to conduct drug development, manufacturing and other
services; BeiGene’s limited operating history and BeiGene's ability
to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates; the
impact of the COVID-19 pandemic on the Company’s clinical
development, commercial, regulatory, and other operations, as well
as those risks more fully discussed in the section entitled “Risk
Factors” in BeiGene’s most recent annual report on Form 10-K as
well as discussions of potential risks, uncertainties, and other
important factors in BeiGene's subsequent filings with the U.S.
Securities and Exchange Commission. All information in this press
release is as of the date of this press release, and BeiGene
undertakes no duty to update such information unless required by
law.
i She J, Yang P, Hong Q, et al. Lung cancer in China: challenges
and interventions. Chest 2013;143:1117-26.
ii The Global Cancer Observatory. Available at
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed March 2021.
iii American Cancer Society. Available at
https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar.
Accessed December 2020.
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Investor Craig West +1 857-302-5189 ir@beigene.com
Media Liza Heapes or Vivian Ni +1 857-302-5663 or +1
857-302-7596 media@beigene.com
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