LYNPARZA’s New Tablet Formulation Approved
as Maintenance Treatment for Women With Platinum-Sensitive
Recurrent Ovarian Cancer Regardless of BRCA-Mutation Status
LYNPARZA Tablets Also Indicated in
BRCA-Mutated Ovarian Cancer Beyond the Third-Line Setting
Newly-Approved Tablet Formulation Means
Improved Patient Convenience
AstraZeneca and Merck & Co., Inc. (NYSE:MRK), known as MSD
outside the United States and Canada, today announced that the U.S.
Food and Drug Administration (FDA) has granted approval for the
PARP inhibitor, LYNPARZA (olaparib), as follows:
- New use of LYNPARZA as a maintenance
treatment for recurrent, epithelial ovarian, fallopian tube or
primary peritoneal adult cancer who are in response to
platinum-based chemotherapy, regardless of BRCA status;
- New use of LYNPARZA tablets (2 tablets
twice daily) as opposed to capsules (8 capsules twice daily);
- LYNPARZA tablets also now indicated
(conversion from the current accelerated approval) for the use in
patients with deleterious or suspected deleterious germline
BRCA-mutated advanced ovarian cancer, who have been treated with
three or more prior lines of chemotherapy.
Sean Bohen, executive vice president, global medicines
development and chief medical officer of AstraZeneca, said:
“Physicians have almost three years of clinical experience with
LYNPARZA on the market and we are now pleased to bring this
important medicine, in a new tablet formulation, to a broader group
of women. Today’s approvals validate more than 10 years of
dedicated research behind LYNPARZA, the world’s first PARP
inhibitor, which now provides oncologists with the greater
flexibility for use in terms of treatment settings. It builds on
our recently-announced collaboration with Merck, which aims to
further increase the number of treatment options available to
patients.”
Eric Pujade-Lauraine, head of the women cancers and clinical
research department at Hôpitaux Universitaires Paris Centre, site
Hôtel-Dieu, AP-HP and principal investigator of the SOLO-2 trial,
one of the trials supporting the approval, said: “Today’s approval
is welcome news for U.S. patients with ovarian cancer, who are now
able to benefit from treatment with olaparib irrespective of their
BRCA-mutation status. This latest regulatory milestone underscores
the breadth and depth of clinical data on olaparib, and not only
demonstrates its efficacy as maintenance therapy, but adds to the
data presented earlier this year showing sustained quality of life
for patients undergoing treatment for this serious disease.”
Roger M. Perlmutter, president of Merck Research Laboratories,
said: “We congratulate AstraZeneca on the approval of these new
indications and the new dosage form and schedule for LYNPARZA, an
important therapeutic advance for many patients with ovarian
cancer. This is a significant first regulatory event in our
collaboration with AstraZeneca. We look forward to working with
AstraZeneca in our global collaboration to bring this medicine with
its new indications to patients.”
Two randomized trials supported the new approvals and the
conversion of accelerated approval to full approval which was
originally based on a single-arm trial:
- SOLO-2 (n=295) confirmed the benefit of
LYNPARZA in germline BRCA-mutated (gBRCAm) patients, demonstrating
a 70% reduced risk of disease progression or death (HR 0.30 [95%
CI, 0.22-0.41], P<0.0001) and improved progression-free survival
(PFS) to 19.1 vs 5.5 months for placebo by investigator-assessed
analysis.
- Study 19 (n=265) showed that LYNPARZA
reduced the risk of disease progression or death by 65% and
improved PFS compared with placebo in patients of any BRCA status
(HR 0.35 [95% CI, 0.25-0.49], P<0.0001; median PFS of 8.4 months
vs 4.8 months for placebo). Additionally, patients in Study 19,
treated with LYNPARZA as a maintenance therapy, had a median
overall survival (OS) of 29.8 months vs 27.8 months for placebo (HR
0.73 [95% CI, 0.55-0.95]).
Table 1. Summary of key efficacy
results from randomized trials:
Analysis
Reduction in the risk ofdisease
progression or death(PFS)
Reduction in the risk ofdeath (OS)
SOLO-2[gBRCAm]
LYNPARZA
70% (HR 0.30 [95% CI, 0.22-0.41],
P<0.0001)
Data not yet mature Placebo
Study 19[PSR OC*]
LYNPARZA
65% (HR 0.35 [95% CI, 0.25-0.49],
P<0.0001)
27% (HR 0.73 [95% CI,0.55-0.95]
Placebo
*PSR = Platinum-sensitive recurrent
ovarian cancer
The most-common adverse events reported in 20% or more of
patients across the SOLO-2 trial in the LYNPARZA arm were anaemia
(44%), nausea (76%), vomiting (37%), diarrhoea (33%),
fatigue/asthenia (66%), decreased appetite (22%), headache (25%),
and dysgeusia (27%). The most-common Grade 3 or 4 adverse events
were anaemia (20%), nausea (2.6%), vomiting (2.6%), diarrhoea
(1.0%), fatigue/asthenia (4.1%), and headache (0.5%).
Discontinuation of LYNPARZA resulting from adverse events was seen
in 11% of patients. Dose interruptions of LYNPARZA due to an
adverse reaction of any grade was 45%. Dose reductions of LYNPARZA
due to an adverse reaction was 25%.
The most-common adverse events reported in 20% or more of
patients across the Study 19 trial in the LYNPARZA arm were anaemia
(23%), nausea (71%), vomiting (35%), diarrhoea (27%), fatigue
(including asthenia) (63%), decreased appetite (21%), and headache
(21%). The most-common Grade 3 or 4 adverse events were anaemia
(7.4%), nausea (2.2%), vomiting (2.2%), diarrhoea (2.2%), and
fatigue (including asthenia) (8.8%). Discontinuation of LYNPARZA
resulting from adverse events was seen in 4% of patients. Dose
interruptions of LYNPARZA due to an adverse reaction of any grade
was 25%. Dose reductions of LYNPARZA due to an adverse reaction was
15%.
The full data from the SOLO-2 trial can be found in the July 25,
2017 publication of The Lancet Oncology.
LYNPARZA was first approved under the FDA’s Accelerated Approval
program in December 2014, as a capsule formulation, making it the
first poly ADP-ribose polymerase (PARP) inhibitor approved. Since
then, more than 3,000 advanced ovarian cancer patients have been
treated with LYNPARZA capsules in its approved indication.
About SOLO-2
SOLO-2 was a Phase III, randomized, double-blinded, multicenter
trial designed to determine the efficacy of LYNPARZA tablets as a
maintenance monotherapy compared with placebo, in patients with
platinum-sensitive, relapsed or recurrent gBRCA-mutated ovarian,
fallopian tube and primary peritoneal cancer. The trial, conducted
in collaboration with the European Network for Gynaecological
Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs
National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO),
randomised 295 patients with documented germline BRCA1 or BRCA2
mutations who had received at least 2 prior lines of platinum-based
chemotherapy and were in complete or partial response. Eligible
patients were randomized to receive 300mg LYNPARZA tablets twice
daily or placebo tablets twice daily.
About Study 19
Study 19 was a Phase II, randomized, double-blinded,
placebo-controlled, multicenter trial, which evaluated the efficacy
and safety of LYNPARZA compared with placebo in relapsed,
high-grade serous ovarian cancer patients, involving 82 sites
across 16 countries. Patients received LYNPARZA maintenance
monotherapy, at a dose of 400mg per day or matching placebo.
Treatment continued until disease progression if toxicities were
manageable.
About LYNPARZA
LYNPARZA is an innovative, first-in-class oral poly ADP-ribose
polymerase (PARP) inhibitor that may exploit tumor DNA damage
response (DDR) pathway deficiencies to preferentially kill cancer
cells. It is approved by regulatory authorities in the EU and US
for the treatment of women with BRCAm ovarian cancer. LYNPARZA
tablets are currently being tested in combinations in a range of
tumor types including breast, prostate, and pancreatic cancers.
About the AstraZeneca and Merck Strategic Oncology
Collaboration
On July 27, 2017, AstraZeneca and Merck & Co., Inc.
announced a global strategic oncology collaboration to co-develop
and co-commercialize AstraZeneca’s LYNPARZA, the world’s first and
leading PARP inhibitor, and potential new medicine selumetinib, a
MEK inhibitor, for multiple cancer types. The collaboration is
based on increasing evidence that PARP and MEK inhibitors can be
combined with PDL-1/PD-1 inhibitors for a range of tumor types.
Working together, the companies will jointly develop LYNPARZA and
selumetinib in combination with other potential new medicines and
as a monotherapy. Independently, the companies will develop
LYNPARZA and selumetinib in combination with their respective PD-L1
and PD-1 medicines.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey – from lab to clinic – to potentially
bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 500 clinical
trials evaluating our anti-PD-1 therapy across more than 30 tumor
types. We also continue to strengthen our immuno-oncology portfolio
through strategic acquisitions and are prioritizing the development
of several promising immunotherapeutic candidates with the
potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials,
visit www.merck.com/clinicaltrials.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us
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