Positive Phase III Clinical Results for EirGenix's Proposed Trastuzumab Biosimilar
PR88594
TAIPEI, March 23, 2021 /PRNewswire=KYODO JBN/ --
In a press conference today, EirGenix, Inc. (6589.TT) announced that the Phase
III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer
biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has
met its primary endpoint. EG12014 has shown equivalent efficacy to Herceptin(R)
in regards to its clinical response (pathologic complete response, pCR), in
addition to demonstrating a comparable safety profile. EirGenix will proceed
with the preparations for submissions of Biologics License Application (BLA) to
the U.S. FDA, Market Approval Application (MAA) to European Medicines Agency
(EMA) and New Drug Application to TFDA, exact timings remain confidential.
This phase III clinical trial is a multi-national, multi-center, randomized,
double-blinded study involving female with early, HER2-positive breast cancer.
The purpose of the trial was to demonstrate the therapeutic equivalence in
terms of efficacy between EG12014 to Herceptin(R), and to compare the safety,
immunogenicity and PK between the two trastuzumab products. A total of 807
enrolled patients were randomly assigned in a 1:1 ratio to one of the two
parallel treatment groups and received anthracycline-based chemotherapy every 3
weeks for 12 weeks (cycle 1 to 4). After chemotherapy, patients received
EG12014 or Herceptin(R) in combination with paclitaxel, every 3 weeks for 12
weeks (cycle 5 to 8). All patients were scheduled for tumor removal surgery
(breast and axillary lymph nodes) 3 to 6 weeks after completion of neoadjuvant
therapy (pre-operative treatment). Two (2) to 6 weeks after surgery, eligible
patients continued with trastuzumab therapy in the adjuvant study to complete
12 months of overall trastuzumab treatment (adjuvant cycle 1 to 13), followed
by a 20-week long-term safety follow-up (after final dose of trastuzumab).
During tumor removal surgery, samples were collected for assessment of a
pathologic complete response (pCR) by an independent central laboratory. The
primary endpoint of pCR is defined as absence of invasive cancer in the breast
and axillary nodes, irrespective of ductal carcinoma in situ (ypT0/is ypN0).
Demonstration of therapeutic equivalence in regards to the pCR between the two
treatment groups (EG12014 vs Herceptin(R)) in the pre-operative treatment
setting was based on the pre-specified risk ratio (0.741 – 1.349) and
probability difference (-0.13 – 0.13). The topline results demonstrated that
EG12014 met equivalence to Herceptin® in terms of clinical response in both
analysis populations (per-protocol and full-analysis sets). Additionally, the
safety profiles of the two treatment arms were shown to be comparable in the
pre-operative treatment setting.
According to Roche's annual report, global sales of Herceptin(R) totaled 3.73
billion CHF in 2020. The US and EU market are 1.36 billion CHF and 0.67 billion
CHF respectively. Herceptin(R) sales were 34% lower than in 2019, driven by
biosimilar competition, which was introduced in the second half of 2019 in the
US and mid-2018 in Japan and Europe. Upon approval Sandoz AG, a global leader
in generics and biosimilars will sell EG12014 globally in all markets except
for Taiwan and Mainland China, as per the licensing agreement signed with
EirGenix in April 2019. The licensing agreement included a signing fee and
milestone payments , and a profit sharing of product sales in the authorized
markets after product launch. The revenue from the milestone payments will be
recognized in stages in accordance to standard accounting procedures and will
serve to benefit the company's current operations and further development. In
2019, Taiwan's National Health Insurance (NHI) paid approximately 1.657 billion
New Taiwan Dollars (NTD) for Herceptin(R).
Current demand for complex biological drugs has increased and will continue to
rise in the future. With the drug patents of major biological drugs set to
expire in the near future, the development of biosimilars has been greatly
encouraged within the industry. The demand has been driven by the need for more
cost-effective drugs in countries with limited medical resources. EirGenix is
currently the first and only biopharmaceutical company in Taiwan to have
successfully signed a licensing agreement with a global pharmaceutical company
for a biosimilar. EirGenix is also one of only a handful of Taiwanese
biopharmaceutical companies to have independently developed a biosimilar
product into Phase III clinical trials and successfully demonstrating its
equivalent efficacy. With such developmental achievements, EirGenix is
rightfully worthy of investors' attention and expectations.
SOURCE EirGenix, Inc.
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