TIDMGSK
RNS Number : 4559F
GlaxoSmithKline PLC
15 July 2019
Issued: 15 July 2019, London UK - LSE announcement
GSK announces positive headline results in Phase 3 PRIMA study
of ZEJULA (niraparib) for patients with ovarian cancer in the first
line maintenance setting
Niraparib demonstrates significant improvement in progression
free survival for women regardless of their biomarker status
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive
results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized,
double-blind, placebo-controlled, study of ZEJULA (niraparib) as a
maintenance therapy in patients with first-line ovarian cancer
following platinum-based chemotherapy. The study met its primary
endpoint of a statistically significant improvement in progression
free survival for women regardless of their biomarker status.
The safety and tolerability profile of niraparib was consistent
with previous clinical trials.
Dr Hal Barron, Chief Scientific Officer and President, R&D,
GSK, said: "Almost 300,000 women around the world are diagnosed
with ovarian cancer every year, yet only about 15% of patients are
currently eligible to receive PARP inhibitors as their initial
therapy. These exciting data demonstrate that ZEJULA has the
potential to significantly benefit even more women with this
devastating cancer."
The full results from PRIMA will be presented at an upcoming
scientific meeting.
Niraparib is marketed in the United States and Europe under the
trade name ZEJULA(R).
####
About PRIMA
PRIMA is a double-blind, randomized Phase 3 study designed to
evaluate niraparib versus placebo in first-line Stage III or IV
ovarian cancer patients. The study assesses the efficacy of
niraparib as maintenance treatment, as measured by progression free
survival. Platinum responsive patients were randomized 2:1 to
niraparib or placebo. The trial incorporated an individualized
niraparib starting dose of 200 mg once-daily in patients with
baseline weight <77kg or platelet count <150K/<MU>L and
300 mg in all other patients.
About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian
cancer in the United States, and more than 65,000 women are
diagnosed annually in Europe. Ovarian cancer is the fifth most
frequent cause of cancer death among women. Despite high response
rates to platinum-based chemotherapy in the second-line advanced
treatment setting, approximately 85% of patients will experience
recurrence within two years.
About niraparib
Niraparib is an oral, once-daily PARP inhibitor that is
currently being evaluated in three pivotal trials. The ongoing
development program for niraparib includes the Phase 3 PRIMA trial,
a Phase 3 trial for the treatment of patients with germline
BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a
registrational Phase 2 treatment trial in patients with ovarian
cancer (the QUADRA trial). Several combination studies are also
underway, including trials of niraparib plus pembrolizumab in
metastatic, triple-negative breast cancer and advanced,
platinum-resistant ovarian cancer (the TOPACIO trial) and niraparib
plus bevacizumab in recurrent, platinum-sensitive ovarian cancer
(the ENGOT-OV24/AVANOVA trial). Janssen Biotech has licensed rights
to develop and commercialize niraparib specifically for patients
with prostate cancer worldwide, except in Japan.
Important Safety Information for ZEJULA
Myelodysplastic Syndrome/Acute Myeloid Leukaemia (MDS/AML),
including some fatal cases, was reported in 1.4% of patients
receiving ZEJULA vs 1.1% of patients receiving placebo in Trial 1
(NOVA), and 0.9% of patients treated with ZEJULA in all clinical
studies. The duration of ZEJULA treatment in patients prior to
developing MDS/AML varied from <1 month to 2 years. All patients
had received prior chemotherapy with platinum and some had also
received other DNA damaging agents and radiotherapy. Discontinue
ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anaemia and
neutropenia) have been reported in patients receiving ZEJULA. Grade
>=3 thrombocytopenia, anaemia and neutropenia were reported in
29%, 25%, and 20% of patients receiving ZEJULA, respectively.
Discontinuation due to thrombocytopenia, anaemia, and neutropenia
occurred, in 3%, 1%, and 2% of patients, respectively. Do not start
ZEJULA until patients have recovered from haematological toxicity
caused by prior chemotherapy (<= Grade 1). Monitor complete
blood counts weekly for the first month, monthly for the next 11
months of treatment, and periodically thereafter. If haematological
toxicities do not resolve within 28 days following interruption,
discontinue ZEJULA, and refer the patient to a haematologist for
further investigations.
Hypertension and hypertensive crisis have been reported in
patients receiving ZEJULA. Grade 3-4 hypertension occurred in 9% of
patients receiving ZEJULA vs 2% of patients receiving placebo in
Trial 1, with discontinuation occurring in <1% of patients.
Monitor blood pressure and heart rate monthly for the first year
and periodically thereafter during treatment with ZEJULA. Closely
monitor patients with cardiovascular disorders, especially coronary
insufficiency, cardiac arrhythmias, and hypertension. Manage
hypertension with antihypertensive medications and adjustment of
the ZEJULA dose, if necessary.
Based on its mechanism of action, ZEJULA can cause foetal harm.
Advise females of reproductive potential of the potential risk to a
foetus and to use effective contraception during treatment and for
6 months after receiving their final dose. Because of the potential
for serious adverse reactions from ZEJULA in breastfed infants,
advise lactating women to not breastfeed during treatment with
ZEJULA and for 1 month after receiving the final dose.
In clinical studies, the most common adverse reactions (Grades
1-4) in >=10% of patients included: thrombocytopenia (61%),
anaemia (50%), neutropenia (30%), leukopenia (17%), palpitations
(10%), nausea (74%), constipation (40%), vomiting (34%), abdominal
pain/distention (33%), mucositis/stomatitis (20%), diarrhoea (20%),
dyspepsia (18%), dry mouth (10%), fatigue/asthenia (57%), decreased
appetite (25%), urinary tract infection (13%), aspartate
aminotransferase (AST)/alanine aminotransferase (ALT) elevation
(10%), myalgia (19%), back pain (18%), arthralgia (13%), headache
(26%), dizziness (18%), dysgeusia (10%), insomnia (27%), anxiety
(11%), nasopharyngitis (23%), dyspnoea (20%), cough (16%), rash
(21%) and hypertension (20%).
Common lab abnormalities (Grades 1-4) in >=25% of patients
included: decrease in haemoglobin (85%), decrease in platelet count
(72%), decrease in white blood cell count (66%), decrease in
absolute neutrophil count (53%), increase in AST (36%) and increase
in ALT (28%).
About TESARO
TESARO, an oncology-focused business within GSK, devoted to
providing transformative therapies to people facing cancer. For
more information, visit www.tesarobio.com, and follow us on Twitter
and LinkedIn.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
US Media enquiries: Kristen Neese +1 (804) 217-8147 (Philadelphia)
Analyst/Investor Sarah Elton-Farr +44 (0) 208 047 (London)
enquiries: 5194
Danielle Smith +44 (0) 20 8047 (London)
7562
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item
3.D 'Principal risks and uncertainties' in the company's Annual
Report on Form 20-F for 2018.
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