First PARP inhibitor and new hormonal agent
combination approved for these patients in Europe
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the
United States and Canada, today announced that LYNPARZA has been
approved in the European Union (EU) in combination with abiraterone
and prednisone or prednisolone for the treatment of adult patients
with metastatic castration-resistant prostate cancer (mCRPC) in
whom chemotherapy is not clinically indicated.
This approval by the European Commission follows the positive
recommendation from the Committee for Medicinal Products for Human
Use received in November this year and was based on the Phase 3
PROpel trial, results of which were published in NEJM Evidence in
June 2022.
In PROpel, LYNPARZA in combination with abiraterone and
prednisone or prednisolone reduced the risk of disease progression
or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p<0.0001) versus
placebo plus abiraterone and prednisone or prednisolone, based on
investigator assessment. Median radiographic progression-free
survival (rPFS) was 24.8 months for the LYNPARZA plus abiraterone
arm (95% CI, 20.5, 27.6) versus 16.6 months for the placebo plus
abiraterone arm (95% CI, 13.9, 19.2). A planned sensitivity
analysis by blinded independent central review was consistent with
the investigator-based analysis, with a median rPFS of 27.6 months
for the LYNPARZA plus abiraterone arm compared to 16.4 months for
the placebo plus abiraterone arm.
Interim results for the key secondary efficacy endpoint of
overall survival (OS) did not reach statistical significance, with
an event rate of 37.1% in the LYNPARZA plus abiraterone arm versus
43.1% in the placebo plus abiraterone arm at the time of the
analysis (HR=0.83 [95% CI, 0.66-1.03]).
The safety and tolerability of LYNPARZA in combination with
abiraterone and prednisone or prednisolone was generally consistent
with that of the individual medicines. Approximately 16% of
patients who received LYNPARZA in combination with abiraterone and
prednisone or prednisolone discontinued treatment due to an adverse
event (AE). As previously reported, based on an analysis from the
PROpel trial presented earlier this year at the American Society of
Clinical Oncology Genitourinary Cancers Symposium, the most common
AEs (≥20%) were anemia (46%), fatigue (37%) and nausea (28%). Grade
≥3 AEs were anemia (15%), hypertension (4%), urinary tract
infection (2%), fatigue (2%), decreased appetite (1%), vomiting
(1%), back pain (1%), diarrhea (1%) and nausea (0.3%).
Prostate cancer is the most commonly diagnosed cancer in men in
Europe, with an estimated 473,000 cases and 108,000 deaths in 2020.
Approximately 10-20% of patients with prostate cancer are estimated
to develop castration-resistant prostate cancer (CRPC) within five
years, with at least 84% of these patients presenting with
metastases at the time of CRPC diagnosis. Patients diagnosed with
advanced prostate cancer have a particularly poor prognosis, with a
five-year relative survival rate of about 30%, compared to patients
diagnosed with earlier stages of the disease, with a five-year
relative survival rate of more than 99%.
Noel Clarke, urological surgeon and professor of urological
oncology at Manchester’s Christie/Salford Royal Hospitals and
Manchester University, a senior investigator of the PROpel trial,
said, “The results of the PROpel Phase 3 trial of olaparib in
combination with abiraterone as a first-line treatment show that
this therapeutic combination can provide significant clinical
benefit to patients with mCRPC. Patients with this condition in the
EU will now, for the first time, have the opportunity to benefit
from this new treatment combination.”
Dave Fredrickson, executive vice president, oncology business
unit, AstraZeneca, said, “Many patients with mCRPC are only able to
receive one line of active therapy, as the disease can progress
quickly. LYNPARZA in combination with abiraterone has been shown to
reduce the risk of disease progression by 34% versus the standard
of care treatment in the PROpel trial. Moreover, the combination of
LYNPARZA with abiraterone as a first-line treatment expands the use
of LYNPARZA to a broader group of mCRPC patients than those treated
with LYNPARZA alone in the second-line setting in the PROfound
trial. Today’s approval marks a significant advance toward
addressing the unmet need of patients with mCRPC in the EU.”
Dr. Eliav Barr, senior vice president, head of global clinical
development and chief medical officer, Merck Research Laboratories,
said, “Merck is committed to developing new treatment options for
patients with mCRPC, a complex disease that urgently needs more
therapies. This approval by the European Commission marks another
step toward delivering on that commitment, and we look forward to
extending the benefits of LYNPARZA to more patients with mCRPC in
the EU.”
Use of LYNPARZA in combination with abiraterone and prednisone
or prednisolone is currently under review by the U.S. FDA for the
treatment of adult patients with mCRPC. LYNPARZA is approved in the
U.S. as monotherapy for patients with homologous recombination
repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene
mutations) who have progressed following prior treatment with
enzalutamide or abiraterone and in the EU, Japan and China for
patients with BRCA-mutated mCRPC who have progressed following
prior therapy that included a new hormonal agent (NHA). These
approvals were based on the data from the Phase 3 PROfound
trial.
About PROpel PROpel is a randomized, double-blind Phase 3
trial testing the efficacy, safety and tolerability of LYNPARZA
versus placebo when given in addition to abiraterone and prednisone
or prednisolone in patients with mCRPC who had not received prior
chemotherapy or NHAs in the mCRPC setting. The major efficacy
outcome was rPFS as assessed by investigator per RECIST v1.1 and
Prostate Cancer Working Group (bone) criteria. OS was an additional
efficacy outcome measure.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
There are no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS Myelodysplastic
Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in
approximately 1.5% of patients exposed to LYNPARZA monotherapy, and
the majority of events had a fatal outcome. The median duration of
therapy in patients who developed MDS/AML was 2 years (range: <6
months to >10 years). All of these patients had previous
chemotherapy with platinum agents and/or other DNA-damaging agents,
including radiotherapy.
Do not start LYNPARZA until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤Grade 1).
Monitor complete blood count for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities, interrupt LYNPARZA and monitor
blood count weekly until recovery.
If the levels have not recovered to Grade 1 or less after 4
weeks, refer the patient to a hematologist for further
investigations, including bone marrow analysis and blood sample for
cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.
Pneumonitis: Occurred in 0.8% of patients exposed to
LYNPARZA monotherapy, and some cases were fatal. If patients
present with new or worsening respiratory symptoms such as dyspnea,
cough, and fever, or a radiological abnormality occurs, interrupt
LYNPARZA treatment and initiate prompt investigation. Discontinue
LYNPARZA if pneumonitis is confirmed and treat patient
appropriately.
Venous Thromboembolic Events (VTE): Including severe or
fatal pulmonary embolism (PE) occurred in patients treated with
LYNPARZA. VTE occurred in 7% of patients with metastatic
castration-resistant prostate cancer who received LYNPARZA plus
androgen deprivation therapy (ADT) compared to 3.1% of patients
receiving enzalutamide or abiraterone plus ADT in the PROfound
study. Patients receiving LYNPARZA and ADT had a 6% incidence of
pulmonary embolism compared to 0.8% of patients treated with ADT
plus either enzalutamide or abiraterone. Monitor patients for signs
and symptoms of venous thrombosis and pulmonary embolism, and treat
as medically appropriate, which may include long-term
anticoagulation as clinically indicated.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings in animals, LYNPARZA can cause fetal harm. A pregnancy
test is recommended for females of reproductive potential prior to
initiating treatment.
Females Advise females of reproductive potential of the
potential risk to a fetus and to use effective contraception during
treatment and for 6 months following the last dose.
Males Advise male patients with female partners of reproductive
potential or who are pregnant to use effective contraception during
treatment and for 3 months following the last dose of LYNPARZA and
to not donate sperm during this time.
ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced
Ovarian Cancer Most common adverse reactions (Grades 1-4) in
≥10% of patients who received LYNPARZA in the first-line
maintenance setting for SOLO-1 were: nausea (77%),
fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%),
diarrhea (37%), constipation (28%), upper respiratory tract
infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia
(26%), decreased appetite (20%), dizziness (20%), neutropenia
(17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary
tract infection (13%), thrombocytopenia (11%), and stomatitis
(11%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the first-line maintenance
setting for SOLO-1 were: decrease in hemoglobin (87%),
increase in mean corpuscular volume (87%), decrease in leukocytes
(70%), decrease in lymphocytes (67%), decrease in absolute
neutrophil count (51%), decrease in platelets (35%), and increase
in serum creatinine (34%).
ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian
Cancer in Combination with Bevacizumab Most common adverse
reactions (Grades 1-4) in ≥10% of patients treated with
LYNPARZA/bevacizumab and at a ≥5% frequency compared to
placebo/bevacizumab in the first-line maintenance setting
for PAOLA-1 were: nausea (53%), fatigue (including asthenia)
(53%), anemia (41%), lymphopenia (24%), vomiting (22%), and
leukopenia (18%). In addition, the most common adverse reactions
(≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of
the frequency compared with the placebo/bevacizumab arm were:
diarrhea (18%), neutropenia (18%), urinary tract infection (15%),
and headache (14%).
In addition, venous thromboembolic events occurred more commonly
in patients receiving LYNPARZA/bevacizumab (5%) than in those
receiving placebo/bevacizumab (1.9%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients for LYNPARZA in combination with bevacizumab in the
first-line maintenance setting for PAOLA-1 were:
decrease in hemoglobin (79%), decrease in lymphocytes (63%),
increase in serum creatinine (61%), decrease in leukocytes (59%),
decrease in absolute neutrophil count (35%), and decrease in
platelets (35%).
ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients who
received LYNPARZA in the maintenance setting for
SOLO-2 were: nausea (76%), fatigue (including asthenia)
(66%), anemia (44%), vomiting (37%), nasopharyngitis/upper
respiratory tract infection (URI)/influenza (36%), diarrhea (33%),
arthralgia/myalgia (30%), dysgeusia (27%), headache (26%),
decreased appetite (22%), and stomatitis (20%).
Study 19: nausea (71%), fatigue (including asthenia)
(63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory
tract infection (22%), constipation (22%), headache (21%),
decreased appetite (21%), and dyspepsia (20%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the maintenance setting
(SOLO-2/Study 19) were: increase in mean corpuscular volume
(89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes
(69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute
neutrophil count (51%/47%), increase in serum creatinine (44%/45%),
and decrease in platelets (42%/36%).
ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm,
HER2-Negative, High-Risk Early Breast Cancer Most common
adverse reactions (Grades 1-4) in ≥10% of patients who received
LYNPARZA in the adjuvant setting for OlympiA were:
nausea (57%), fatigue (including asthenia) (42%), anemia (24%),
vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%),
neutropenia (16%), decreased appetite (13%), dysgeusia (12%),
dizziness (11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the adjuvant setting for
OlympiA were: decrease in lymphocytes (77%), increase in
mean corpuscular volume (67%), decrease in hemoglobin (65%),
decrease in leukocytes (64%), and decrease in absolute neutrophil
count (39%).
ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast
Cancer Most common adverse reactions (Grades 1-4) in ≥20% of
patients who received LYNPARZA in the metastatic setting for
OlympiAD were: nausea (58%), anemia (40%), fatigue
(including asthenia) (37%), vomiting (30%), neutropenia (27%),
respiratory tract infection (27%), leukopenia (25%), diarrhea
(21%), and headache (20%).
Most common laboratory abnormalities (Grades 1-4) in
>25% of patients who received
LYNPARZA in the metastatic setting for OlympiAD were:
decrease in hemoglobin (82%), decrease in lymphocytes (73%),
decrease in leukocytes (71%), increase in mean corpuscular volume
(71%), decrease in absolute neutrophil count (46%), and decrease in
platelets (33%).
ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic
Pancreatic Adenocarcinoma Most common adverse reactions (Grades
1-4) in ≥10% of patients who received LYNPARZA in the first-line
maintenance setting for POLO were: fatigue (60%), nausea
(45%), abdominal pain (34%), diarrhea (29%), anemia (27%),
decreased appetite (25%), constipation (23%), vomiting (20%), back
pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%),
dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia
(11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the first-line maintenance
setting for POLO were: increase in serum creatinine
(99%), decrease in hemoglobin (86%), increase in mean corpuscular
volume (71%), decrease in lymphocytes (61%), decrease in platelets
(56%), decrease in leukocytes (50%), and decrease in absolute
neutrophil count (25%).
ADVERSE REACTIONS—HRR Gene-mutated Metastatic
Castration-Resistant Prostate Cancer Most common adverse
reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA
for PROfound were: anemia (46%), fatigue (including
asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea
(21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and
dyspnea (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA for PROfound were: decrease
in hemoglobin (98%), decrease in lymphocytes (62%), decrease in
leukocytes (53%), and decrease in absolute neutrophil count
(34%).
DRUG INTERACTIONS Anticancer Agents: Clinical
studies of LYNPARZA with other myelosuppressive anticancer agents,
including DNA-damaging agents, indicate a potentiation and
prolongation of myelosuppressive toxicity.
CYP3A Inhibitors: Avoid coadministration of strong or
moderate CYP3A inhibitors when using LYNPARZA. If a strong or
moderate CYP3A inhibitor must be coadministered, reduce the dose of
LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice,
Seville oranges, and Seville orange juice during LYNPARZA
treatment.
CYP3A Inducers: Avoid coadministration of strong or
moderate CYP3A inducers when using LYNPARZA.
USE IN SPECIFIC POPULATIONS Lactation: No data are
available regarding the presence of olaparib in human milk, its
effects on the breastfed infant or on milk production. Because of
the potential for serious adverse reactions in the breastfed
infant, advise a lactating woman not to breastfeed during treatment
with LYNPARZA and for 1 month after receiving the final dose.
Pediatric Use: The safety and efficacy of LYNPARZA have
not been established in pediatric patients.
Hepatic Impairment: No adjustment to the starting dose is
required in patients with mild or moderate hepatic impairment
(Child-Pugh classification A and B). There are no data in patients
with severe hepatic impairment (Child-Pugh classification C).
Renal Impairment: No dosage modification is recommended
in patients with mild renal impairment (CLcr 51-80 mL/min estimated
by Cockcroft-Gault). In patients with moderate renal impairment
(CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice
daily. There are no data in patients with severe renal impairment
or end-stage renal disease (CLcr ≤30 mL/min).
INDICATIONS LYNPARZA is a poly (ADP-ribose) polymerase
(PARP) inhibitor indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer For
the maintenance treatment of adult patients with deleterious or
suspected deleterious germline or somatic BRCA-mutated (gBRCAm or
sBRCAm) advanced epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in complete or partial response to
first-line platinum-based chemotherapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD-Positive Advanced Ovarian Cancer
in Combination with Bevacizumab In combination with bevacizumab
for the maintenance treatment of adult patients with advanced
epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in complete or partial response to first-line platinum-based
chemotherapy and whose cancer is associated with homologous
recombination deficiency (HRD)-positive status defined by
either:
- a deleterious or suspected deleterious BRCA mutation,
and/or
- genomic instability
Select patients for therapy based on an FDA-approved companion
diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer For the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who are in complete
or partial response to platinum-based chemotherapy.
Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early
Breast Cancer For the adjuvant treatment of adult patients with
deleterious or suspected deleterious gBRCAm, human epidermal growth
factor receptor 2 (HER2)-negative high-risk early breast cancer who
have been treated with neoadjuvant or adjuvant chemotherapy. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
gBRCAm, HER2-Negative Metastatic Breast Cancer For the
treatment of adult patients with deleterious or suspected
deleterious gBRCAm, human epidermal growth factor receptor 2
(HER2)-negative metastatic breast cancer who have been treated with
chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
Patients with hormone receptor (HR)-positive breast cancer should
have been treated with a prior endocrine therapy or be considered
inappropriate for endocrine therapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic
Cancer For the maintenance treatment of adult patients with
deleterious or suspected deleterious gBRCAm metastatic pancreatic
adenocarcinoma whose disease has not progressed on at least 16
weeks of a first-line platinum-based chemotherapy regimen. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
HRR Gene-mutated Metastatic Castration-Resistant Prostate
Cancer For the treatment of adult patients with deleterious or
suspected deleterious germline or somatic homologous recombination
repair (HRR) gene-mutated metastatic castration-resistant prostate
cancer (mCRPC) who have progressed following prior treatment with
enzalutamide or abiraterone. Select patients for therapy based on
an FDA-approved companion diagnostic for LYNPARZA.
Please see complete Prescribing Information,
including Medication Guide.
Financial considerations Under the oncology collaboration
with AstraZeneca and following this new approval for LYNPARZA,
AstraZeneca will receive a $105 million payment from Merck.
About LYNPARZA® (olaparib) LYNPARZA is a first-in-class
PARP inhibitor and the first targeted treatment to potentially
exploit DNA damage response (DDR) pathway deficiencies, such as
BRCA mutations, to preferentially kill cancer cells. Inhibition of
PARP with LYNPARZA leads to the trapping of PARP bound to DNA
single-strand breaks, stalling of replication forks, their collapse
and the generation of DNA double-strand breaks and cancer cell
death. LYNPARZA is being tested in a range of tumor types with
defects and dependencies in the DDR.
LYNPARZA, which is being jointly developed and commercialized by
AstraZeneca and Merck, has a broad clinical trial development
program, and AstraZeneca and Merck are working together to
understand how it may affect multiple PARP-dependent tumors as a
monotherapy and in combination across multiple cancer types.
About metastatic castration-resistant prostate cancer
Prostate cancer is the second most common cancer in male patients
globally and is associated with a significant mortality rate.
Development of prostate cancer is often driven by male sex hormones
called androgens, including testosterone. In patients with mCRPC,
their prostate cancer grows and spreads to other parts of the body,
despite the use of androgen-deprivation therapy to block the action
of male sex hormones. Approximately 10-20% of patients with
prostate cancer will develop CRPC within five years, with at least
84% of these patients presenting with metastases at the time of
CRPC diagnosis. Of patients with no metastases at CRPC diagnosis,
33% are likely to develop metastases within two years.
About the AstraZeneca and Merck strategic oncology
collaboration In July 2017, AstraZeneca and Merck, known as MSD
outside of the United States and Canada, announced a global
strategic oncology collaboration to co-develop and co-commercialize
certain oncology products including LYNPARZA, the world’s first
PARP inhibitor, for multiple cancer types. Working together, the
companies will develop these products in combination with other
potential new medicines and as monotherapies. Independently, the
companies will develop these oncology products 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, the potential to bring new
hope to people with cancer drives our purpose and supporting
accessibility to our cancer medicines is our commitment. As part of
our focus on cancer, Merck is committed to exploring the potential
of immuno-oncology with one of the largest development programs in
the industry across more than 30 tumor types. We also continue to
strengthen our portfolio through strategic acquisitions and are
prioritizing the development of several promising oncology
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 At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world – and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, Instagram,
YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
N.J., USA (the “company”) includes “forward-looking statements”
within the meaning of the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of the
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candidates that the candidates will receive the necessary
regulatory approvals or that they will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
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including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
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