Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company
dedicated to the discovery, development and commercialization of
novel therapies for the treatment of cancer, today announced
topline data showing that oral paclitaxel and encequidar (Oral
Paclitaxel) met the primary efficacy endpoint with statistically
significant improvement over IV paclitaxel in a Phase III pivotal
study in metastatic breast cancer.
A total of 402 typical metastatic breast cancer patients were
enrolled in a 2 to 1 ratio of Oral Paclitaxel to IV paclitaxel in
the ITT population (265 in the Oral Paclitaxel group versus 137 in
the IV paclitaxel group). Patient demographics were balanced in the
two treatment groups. The primary efficacy endpoint was overall
tumor response rate (ORR) confirmed at two consecutive timepoints
using RECIST v1.1 criteria. Blinded assessments of tumor response
were made by two independent radiologists and an independent
adjudicator, using a computer algorithm to assign responses.
Oral Paclitaxel showed a statistically significant improvement
compared to IV paclitaxel on the primary efficacy endpoint, with an
ORR of 36% for the Oral Paclitaxel group compared to 24% for IV
paclitaxel patients based on ITT analysis (p = 0.01). Oral
Paclitaxel also showed statistically significant improvement
compared to IV paclitaxel based on other analyses on populations
excluding non-evaluable patients (which would give higher response
rates), with p-values ≤ 0.01 in all analyses. In addition, the
results showed that the proportion of confirmed responders with a
duration of response of more than 150 days was 2.5 times higher in
the Oral Paclitaxel group than in the IV paclitaxel group.
Based on the data cut-off on July 25, 2019, there was a strong
trend in progression-free survival (p = 0.077) favoring Oral
Paclitaxel over IV paclitaxel, and a strong trend in overall
survival (p = 0.11) favoring Oral Paclitaxel over IV paclitaxel. At
the cut-off date, a higher proportion of patients on Oral
Paclitaxel compared with IV paclitaxel remained progression-free
and Athenex expects the PFS and OS trend will continue to improve
upon follow-up.
In the study, the Oral Paclitaxel group had lower incidence and
severity of neuropathy compared to IV paclitaxel: 57% of IV
paclitaxel patients experienced neuropathy (all grades) versus 17%
of Oral Paclitaxel patients, with grade 3 neuropathy observed in 8%
of IV paclitaxel patients versus 1% of Oral Paclitaxel patients.
The results also showed lower incidence of alopecia, arthralgia and
myalgia in the Oral Paclitaxel group. The incidence of neutropenia
was similar in both groups, but there were more incidents of grade
4 neutropenia and infection in the Oral Paclitaxel group. There
were also more gastro-intestinal side effects in the Oral
Paclitaxel group.
Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, “This
is the second successful Phase III clinical program accomplished by
the clinical team this year. We are excited by the positive results
in the Phase III pivotal study, demonstrating improved ORR for Oral
Paclitaxel compared to IV paclitaxel across a full spectrum of
analyses and lower incidence of neuropathy in the Oral Paclitaxel
group. We will be preparing our NDA submission as soon as possible.
We are also investigating additional indications for Oral
Paclitaxel as well as combinations with other anti-cancer drugs,
including biologics and immuno-oncology drugs. With a longer
duration of response observed in this trial, we will look into the
potential of this drug candidate in metronomic dosing and
maintenance therapy. Based on these results, we will aggressively
advance the other oral chemotherapy programs.”
Dr. Johnson Lau, Chief Executive Officer and Chairman of
Athenex, commented, “Based on the results of the Phase III study,
together with the preliminary results generated in the angiosarcoma
study, Athenex believes that Oral Paclitaxel has the potential to
represent a new class of oral anti-cancer drugs, if approved, based
on the findings from this Phase III study showing statistically
significant improvement in ORR as monotherapy and longer duration
of response over IV paclitaxel, as well as strong trends in
improved PFS and OS in patients with metastatic breast cancer.
There is also evidence of early onset of activity in angiosarcoma.
Adding to this potential are the favorable safety data from this
study showing lower incidence of neuropathy, which is currently a
major reason for discontinuing IV paclitaxel treatment. There is a
potential for Oral Paclitaxel, which is not designed to require
steroid pre-medication for immunosuppression, to serve as a
cornerstone in chemotherapy in combination with other small
molecule anti-cancer drugs, biologics, and immuno-oncology
treatment approaches, including other drug candidates in our
oncology pipeline.”
“We believe the success of the Oral Paclitaxel program serves as
a validation for our Orascovery technology platform, which also
includes the oral delivery of docetaxel, cabazitaxel, irinotecan,
topotecan and eribulin,” continued Dr. Lau. “Athenex is
transforming from a clinical stage company into a fully integrated
company with late-stage oncology product candidates and
capabilities across the pharmaceutical value chain, including
manufacturing and marketing.”
Athenex is also evaluating Oral Paclitaxel in combination with
ramucirumab in patients with gastric cancer in an expansion phase
of a Phase 1b study, which has shown encouraging preliminary data.
Oral Paclitaxel also showed encouraging clinical activity in a
pilot study of patients with angiosarcoma. The company is also
testing the combination of Oral Paclitaxel with an anti-PD1,
pembrolizumab, in patients with advanced solid malignancies.
The Orascovery platform was initially developed by Hanmi
Pharmaceuticals and licensed exclusively to Athenex for all major
worldwide territories except Korea, which is retained by Hanmi.
PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam
rights of Oral Paclitaxel and ZenRx licensed the Australia and New
Zealand rights of Oral Paclitaxel from Athenex.
About the Phase III Study of Oral Paclitaxel and
EncequidarThe Phase III pivotal study is a randomized,
controlled clinical trial designed to compare the the safety and
efficacy of Oral Paclitaxel monotherapy against intravenous
paclitaxel monotherapy in patients with metastatic breast cancer.
The primary endpoint was tumor response rate (confirmed by scans at
two consecutive timepoints) as assessed by RECIST v1.1 criteria, a
generally accepted method for assessing tumor response. Blinded
assessments of tumor response are made by two independent
radiologists and an independent adjudicator, using a computer
algorithm to assign responses.
Conference Call and Webcast InformationCompany
management will discuss the Phase III results during its quarterly
earnings conference call, today, Wednesday, August 7, 2019, at
8:00am Eastern Time. To participate in the call, dial 877-407-0784
(domestic) or 201-689-8560 (international) fifteen minutes before
the conference call begins and reference the conference passcode
13691069. The live conference call and replay can be accessed
via audio webcast at http://public.viavid.com/index.php?id=134662
and also on the Investor Relations section of the Company’s
website, located at http://ir.athenex.com/.
About Athenex, Inc.Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery, development and commercialization of next generation
drugs for the treatment of cancer. Athenex is organized
around three platforms, including an Oncology Innovation Platform,
a Commercial Platform and a Global Supply Chain Platform. The
Company’s current clinical pipeline is derived from four different
platform technologies: (1) Orascovery, based on non-absorbed
P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell
receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation
therapy. Athenex’s employees worldwide are dedicated to improving
the lives of cancer patients by creating more active and tolerable
treatments. Athenex has offices
in Buffalo and Clarence, New York; Cranford,
New Jersey; Houston, Texas; Chicago, Illinois; Hong
Kong; Taipei, Taiwan; multiple locations
in Chongqing, China; and Manchester, UK. For more
information, please visit www.athenex.com.
Forward-Looking Statements Except for
historical information, all of the statements, expectations, and
assumptions contained in this press release are forward-looking
statements. These forward-looking statements are typically
identified by terms such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “evaluate,” “expect,” “foresee,” “guidance,”
“intend,” “investigate,” “likely,” “may,” “plan,” “potential,”
“predict,” “preliminary,” “prepare,” “potential,” “probable,”
“project,” “promising,” “seek,” “should,” “will,” “would,” and
similar expressions. Actual results might differ materially
from those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ
materially include: the development stage of our primary clinical
candidates and related risks involved in drug development, clinical
trials, regulation, manufacturing and commercialization; our
reliance on third parties for success in certain areas of
Athenex’s business; our history of operating losses and need to
raise additional capital to continue as a going concern;
competition; intellectual property risks; risks relating to doing
business in China; the uncertainty of when, if at all, we will
be able to resume producing API in our Chongqing plant; and the
other risk factors set forth from time to time in
our SEC filings, copies of which are available for free
in the Investor Relations section of our website
at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or
upon request from our Investor Relations Department. All
information provided in this release is as of the date hereof and
we assume no obligation and do not intend to update these
forward-looking statements, except as required by law.
CONTACTS Investor Relations: Tim McCarthy
Managing Director, LifeSci Advisors, LLC Tel: +1
716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.: Randoll Sze Chief Financial Officer
Email: randollsze@athenex.com
Jacqueline Li Corporate Development and Investor Relations
Email: jacquelineli@athenex.com
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