Clovis Oncology Completes U.S. and E.U. Regulatory Submissions for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that it has
submitted its New Drug Application (NDA) regulatory filing to the U.S.
Food and Drug Administration (FDA) for rociletinib for the treatment of
patients with mutant epidermal growth factor receptor (EGFR) non-small
cell lung cancer (NSCLC) who have been previously treated with an
EGFR-targeted therapy and have the EGFR T790M mutation as detected by an
FDA approved test. Rociletinib is the Company’s novel, oral targeted
covalent (irreversible) mutant-selective inhibitor of EGFR in
development for the treatment of NSCLC in patients with initial
activating EGFR mutations, as well as the dominant resistance mutation
T790M. Rociletinib was granted Breakthrough Therapy designation by the
U.S. FDA in May 2014.

In addition, Clovis has also submitted its Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) through the
centralized procedure for rociletinib for the treatment of adult
patients with mutant EGFR NSCLC who have been previously treated with an
EGFR-targeted therapy and have the EGFR T790M mutation.

There is a validation period before both applications are formally
accepted, after which the review commences.

“The submissions of our first NDA and MAA for rociletinib represent a
major step forward for our company,” said Patrick J. Mahaffy, President
and CEO of Clovis Oncology. “These two submissions – completed on the
same day, no less — were made possible through the tremendous
commitment and hard work of Clovis employees and our clinical
collaborators at leading U.S. and international academic institutions
over the last many months, and I am grateful for their tireless efforts.
We are actively preparing for what we hope to be our first U.S.
commercial launch, and the opportunity to address the needs of patients
with T790M-positive EGFR-mutant non-small cell lung cancer. We are also
actively building our commercial organization in Europe to prepare for a
potential launch next year.”

QIAGEN, Clovis’ companion diagnostic partner, intends to file a
supplemental PMA application of its approved therascreen EGFR
test with the FDA to allow for regulatory approval of the companion
diagnostic concurrent with rociletinib approval. Analytical performance
of the therascreen EGFR test has been established for
21 EGFR mutations, including the most prevalent resistance mutation,
T790M. The test supports efficient laboratory workflow with real-time
PCR technology on the FDA approved Rotor-Gene Q MDx, which is part
of QIAGEN’s QIAsymphony family of laboratory solutions.

About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal
growth factor receptor (EGFR) under investigation for the treatment of
EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the
activating mutations of EGFR (L858R and Del19), while also inhibiting
the dominant acquired resistance mutation, T790M, which develops in
approximately 60 percent of patients treated with first- and
second-generation EGFR inhibitors, while sparing wild-type, or “normal”
EGFR at anticipated therapeutic doses. Accordingly, it has the potential
to treat NSCLC patients with EGFR mutations both as a first-line or
second-line treatment. Rociletinib was granted Breakthrough Therapy
designation by the U.S. FDA in May 2014.

About Rociletinib Clinical Development

Clovis has several studies underway in EGFR-mutant NSCLC:

  • TIGER-X is a Phase 1/2 study designed to evaluate the safety and
    efficacy of three different doses of rociletinib in a very advanced
    patient population.
  • TIGER-1 is a randomized Phase 2/3 registration study versus erlotinib
    in newly-diagnosed patients.
  • TIGER-2 is a global registration study in both T790M-positive and
    T790M-negative patients directly after progression on their first and
    only TKI therapy.
  • TIGER-3 is a randomized, comparative study versus chemotherapy in both
    T790M-positive and T790M-negative patients with acquired TKI
    resistance.
  • A Phase 1 study of rociletinib in Japan has completed enrollment and a
    Phase 2 study in Japanese patients, agreed upon with Japanese
    regulatory authorities, is expected to initiate in the second half of
    2015.
  • Multiple combination studies are planned to initiate in the second
    half of 2015, including inhibitors of PD-L1, PD-1 and MEK.
  • For more information, please visit www.tigertrials.com.

About Lung Cancer and EGFR Mutations

Lung cancer is the most common cancer worldwide with 1.35 million new
cases annually, with NSCLC accounting for almost 85 percent of all lung
cancers. NSCLC progresses rapidly with a five-year survival rate in
advanced NSCLC patients of less than five percent. EGFR activating
mutations occur in approximately 10 to 15 percent of NSCLC cases in
Caucasian patients and approximately 30 to 35 percent in East Asian
patients. These patients often experience significant tumor response to
erlotinib, afatinib and gefitinib, which are first- and
second-generation EGFR inhibitors. However, most patients ultimately
progress on these therapies, with approximately 60 percent of patients
developing acquired resistance from a second, “gatekeeper” mutation,
T790M. Currently, no targeted therapies are approved for treatment of
this mutation.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops diagnostic tools that direct a
compound in development to the population that is most likely to benefit
from its use. Clovis Oncology is headquartered in Boulder, Colorado.

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995.
Such
forward-looking statements involve substantial risks and uncertainties
that could cause our clinical development programs, future results,
performance or achievements to differ significantly from those expressed
or implied by the forward-looking statements.
Such risks and
uncertainties include, among others, the uncertainties inherent in our
clinical development programs for our drug candidates, the corresponding
development pathways of our companion diagnostics, actions by the FDA,
the EMA or other regulatory authorities regarding whether to approve
drug applications that may be filed, as well as their decisions
regarding drug labeling, and other matters that could affect the
availability or commercial potential of our drug candidates or companion
diagnostics, including competitive developments.
Clovis Oncology
does not undertake to update or revise any forward-looking statements. A
further description of risks and uncertainties can be found in Clovis
Oncology’s filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K and its reports on Form 10-Q
and Form 8-K.

Contacts

Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com

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