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Bayer
to Present New Clinical Data in Indolent non-Hodgkin's Lymphoma and Additional Research on its Oncology Portfolio at AACR Annual Meeting 2021
2021-04-06
·
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WHIPPANY, N.J.--(BUSINESS WIRE)--
Bayer
will present new research across its oncology portfolio at the virtual American Association for
Cancer
Research (AACR) Annual Meeting 2021, taking place over two weeks on April 10-15 and May 17-21, 2021. The data include an oral presentation in a Clinical Trials Plenary Session on the Phase III randomized, double-blind, placebo-controlled clinical study of the investigational use of
Aliqopa
® (
copanlisib
) in combination with
rituximab
given intravenously in patients with
relapsed indolent non-Hodgkin’s Lymphoma (iNHL)
who have relapsed after ≥1 line of treatment, including
rituximab
(CHRONOS-3). In 2017,
Aliqopa
was approved for the treatment of adult patients with
relapsed follicular lymphoma (FL)
who have received at least two prior systemic therapies based on the results of a single arm, multi-center, Phase II clinical trial (CHRONOS-1).1 Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Data related to
Bayer
's biomarker-driven treatment
Vitrakvi
® (
larotrectinib
), a first-in-class
TRK
inhibitor for
TRK fusion cancer
across
solid tumors
, will also be presented, including long-term outcomes in patients with
TRK fusion cancer
TRK
fusion cancer receiving
Vitrakvi
and data from the 100,000 Genomes Project analyzing the prognostic factor for survival for patients with
tumors
that harbor a
neurotrophic receptor tyrosine kinase (NTRK)
gene fusion. The new data reaffirm
Bayer
's continued efforts to investigate the clinical impact a biomarker-driven approach can have on patients.
Vitrakvi
is approved for the treatment of adult and pediatric patients with
solid tumors
that have a
NTRK
gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Patients should be selected for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Prostate cancer
research featuring
NUBEQA
® (
darolutamide
) in non-
metastatic castration-resistant prostate cancer (nmCRPC)
,
Xofigo
® (
radium Ra 223 dichloride
) in
metastatic castration-resistant prostate cancer (mCRPC)
with symptomatic
bone metastases
with no known visceral metastases, and the investigational targeted thorium conjugate (TTC)
BAY 2315497 (PSMA-TTC)
, will also be presented. This includes preclinical data on
NUBEQA
analyzing the impact of androgen stimulation and
NUBEQA
treatment. In addition, preclinical data on the synergistic antitumor effect of the investigational combination of
Xofigo
and
enzalutamide
in the intratibial
LNCaP prostate cancer
xenograft model will be presented. TTCs are an emerging class of targeted alpha radiotherapy that may be a potential treatment modality for
cancer
patients. A featured investigational TTC presentation will highlight the
PSMA-TTC
BAY 2315497
, which is thought to target
prostate specific membrane antigen (PSMA)
in
prostate cancer
cells, and its anti-
tumor
activity in combination with
PARP inhibitor olaparib
PARP
inhibitor olaparib in preclinical
prostate cancer
models.
PSMA-TTC
is currently being investigated in Phase I studies. These data further add to
Bayer
’s comprehensive body of research and support the company’s commitment to help men access appropriate treatment options across multiple stages of
prostate cancer
.
NUBEQA
is an
androgen receptor inhibitor (ARi)
with a distinct chemical structure that competitively inhibits androgen binding,
AR
nuclear translocation and
AR
-mediated transcription.
NUBEQA
is indicated in the U.S. for the treatment of men with nmCRPC.
Xofigo
is indicated for the treatment of patients with CRPC,
symptomatic bone metastases
and no known
visceral metastatic disease
.
Bayer
will also reveal the latest data from its differentiated early pipeline across other focus areas, including precision molecular oncology and immuno-oncology. For the first time,
Bayer
will be presenting preclinical data on investigational small molecule epidermal growth factor receptor (EGFR) exon 20 inhibitor
BAY 2476568
, which was discovered through the company’s strategic research alliance with the
Broad Institute of MIT
and Harvard in Cambridge, Massachusetts, U.S.A. In the area of immuno-oncology,
Bayer
will showcase preclinical findings on investigational oral small molecule inhibitor
BAY-405
, which is thought to target the intracellular immune checkpoint
MAP4K1 (HPK1)
, jointly developed in the strategic research alliance with the
German Cancer Research Center
Cancer
Research Center (DKFZ) in Heidelberg, Germany. Overall, these data stress
Bayer
’s commitment to continued research in some of the company’s key areas of focus in
oncology
. Ongoing investigation into these fields underscores
Bayer
’s emphasis on developing patient-centric treatments that may help address areas of greatest unmet need across multiple disease states, potentially providing patients with more treatment options. Key presentations on
Bayer
research, to be presented in week 1 of AACR 2021 from April 10-15, are listed below:
Copanlisib
Abstract title: CHRONOS-3: Randomized Phase III study of
copanlisib
plus
rituximab
vs
rituximab
/placebo in
relapsed indolent non-Hodgkin lymphoma (iNHL)
Abstract CT001; April 10, 11:30am EDT
Larotrectinib
Abstract title: Long-term outcomes of patients with
TRK fusion cancer
TRK
fusion cancer treated with
larotrectinib
Abstract CT020; April 10, 2:50pm EDT Abstract title: Prognosis and molecular characteristics of patients with
TRK fusion cancer
TRK
fusion cancer in the 100,000 Genomes Project Abstract 394; April 10, 8:30am EDT
Darolutamide
Abstract title: Comparative proteomics and transcriptomics analysis of the impact of androgen stimulation and
darolutamide
inhibition in a
prostate cancer
model Abstract 1008; April 10, 8:30am EDT
Radium Ra 223 dichloride
Abstract title: Synergistic antitumor effect of
radium-223
in combination with
enzalutamide
in the intratibial
LNCaP prostate cancer
xenograft model Abstract 1392; April 10, 8:30am EDT Targeted Thorium Conjugates Abstract title:
PSMA
-Targeted Thorium Conjugate (
BAY 2315497
) and
olaparib
combination show synergistic anti-
tumor
activity in
prostate cancer
models Abstract 1393; April 10, 8:30am EDT Projects in Preclinical Development Abstract title: Preclinical activity of the first reversible inhibitor of
EGFR
exon 20 insertions Abstract 1470; April 10, 8:30am EDT Abstract title: Enhancement of anti-
tumor
T-cell immunity by means of an oral small molecule targeting the intracellular immune checkpoint
MAP4K1
Abstract 1722; April 10, 8:30am EDT About
Aliqopa
® (
copanlisib
) Injection1
Aliqopa
(
copanlisib
) is indicated for the treatment of adult patients with
relapsed follicular lymphoma (FL)
who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Aliqopa
is an inhibitor of
phosphatidylinositol-3-kinase (PI3K)
with inhibitory activity predominantly against
PI3K-α
and
PI3K-δ
isoforms expressed in malignant B cells.
Aliqopa
has been shown to induce
tumor
cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines.
Aliqopa
inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in
lymphoma
cell lines. IMPORTANT SAFETY INFORMATION FOR
ALIQOPA
® (
copanlisib
)
Infections
: Serious, including fatal,
infections
occurred in 19% of 317 patients treated with
ALIQOPA
monotherapy. The most common serious
infection
was
pneumonia
. Monitor patients for signs and symptoms of
infection
and withhold
ALIQOPA
for Grade 3 and higher
infection
. Serious
pneumocystis jiroveci pneumonia
(PJP)
infection
occurred in 0.6% of 317 patients treated with
ALIQOPA
monotherapy. Before initiating treatment with
ALIQOPA
, consider PJP prophylaxis for populations at risk. Withhold
ALIQOPA
in patients with suspected
PJP infection
of any grade. If confirmed, treat
infection
until resolution, then resume
ALIQOPA
at previous dose with concomitant PJP prophylaxis.
Hyperglycemia
: Grade 3 or 4
hyperglycemia
(blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with
ALIQOPA
monotherapy. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with
ALIQOPA
may result in
infusion-related hyperglycemia
. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after
ALIQOPA
infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment. Of the twenty patients with
diabetes mellitus
treated in CHRONOS-1, seven developed
Grade 4 hyperglycemia
and two discontinued treatment. Patients with
diabetes mellitus
should only be treated with
ALIQOPA
following adequate glucose control and should be monitored closely. Achieve optimal blood glucose control before starting each
ALIQOPA
infusion. Withhold, reduce dose, or discontinue
ALIQOPA
depending on the severity and persistence of
hyperglycemia
.
Hypertension
: Grade 3
hypertension
(systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients treated with
ALIQOPA
monotherapy. Serious hypertensive events occurred in 0.9% of 317 patients. Treatment with
ALIQOPA
may result in
infusion-related hypertension
. The mean change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion;
BP
remained elevated for 6 to 8 hours after the start of the
ALIQOPA
infusion. Optimal BP control should be achieved before starting each
ALIQOPA
infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue
ALIQOPA
depending on the severity and persistence of
hypertension
.
Non-infectious Pneumonitis
:
Non-infectious pneumonitis
occurred in 5% of 317 patients treated with
ALIQOPA
monotherapy. Withhold
ALIQOPA
and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as
cough
,
dyspnea
,
hypoxia
, or
interstitial infiltrates
on radiologic exam. Patients with
pneumonitis
thought to be caused by
ALIQOPA
have been managed by withholding
ALIQOPA
and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue
ALIQOPA
depending on the severity and persistence of
non-infectious pneumonitis
.
Neutropenia
:
Grade 3 or 4 neutropenia
occurred in 24% of 317 patients treated with
ALIQOPA
monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly during treatment with
ALIQOPA
. Withhold, reduce dose, or discontinue
ALIQOPA
depending on the severity and persistence of
neutropenia
. Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with
ALIQOPA
monotherapy respectively. Serious cutaneous reaction events were reported in 0.9%. The reported events included
dermatitis
exfoliative,
exfoliative rash
,
pruritus
, and
rash
(including
maculo-papular rash
). Withhold, reduce dose, or discontinue
ALIQOPA
depending on the severity and persistence of severe
cutaneous reactions
. Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action,
ALIQOPA
can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of
copanlisib
to pregnant rats during organogenesis caused embryo-fetal death and
fetal abnormalities
in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose. Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were
pneumonia
(8%),
pneumonitis
(5%) and
hyperglycemia
(5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (≥20%) in
ALIQOPA
-treated patients were:
hyperglycemia
(54%),
leukopenia
(36%),
diarrhea
(36%), decreased general strength and energy (36%),
hypertension
(35%),
neutropenia
(32%),
nausea
(26%),
thrombocytopenia
(22%), and
lower respiratory tract infections
(21%). Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the
ALIQOPA
dose to 45 mg when concomitantly administered with strong
CYP3A
inhibitors. Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment with
ALIQOPA
and for at least 1 month after the last dose. For important risk and use information about
Aliqopa
, please see the full Prescribing Information. About
Vitrakvi
®
(larotrectinib)2
Vitrakvi
® (
larotrectinib
) is indicated for the treatment of adult and pediatric patients with
solid tumors
that have a
neurotrophic receptor tyrosine kinase (NTRK)
gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Important Safety Information for
VITRAKVI
® (
larotrectinib
) Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving
VITRAKVI
, including
dizziness
,
cognitive impairment
,
mood disorders
, and
sleep disturbances
. In patients who received
VITRAKVI
, all grades CNS effects including
cognitive impairment
,
mood disorders
,
dizziness
and
sleep disorders
were observed in 42% with Grades 3-4 in 3.9% of patients.
Cognitive impairment
occurred in 11% of patients. The median time to onset of
cognitive impairment
was 5.6 months (range: 2 days to 41 months).
Cognitive impairment
occurring in ≥ 1% of patients included
memory impairment
(3.6%),
confusional state
(2.9%),
disturbance in attention
(2.9%),
delirium
(2.2%), cognitive disorders (1.4%), and Grade 3 cognitive adverse reactions occurred in 2.5% of patients. Among the 30 patients with
cognitive impairment
, 7% required a dose modification and 20% required dose interruption.
Mood disorders
occurred in 14% of patients. The median time to onset of
mood disorders
was 3.9 months (range: 1 day to 40.5 months).
Mood disorders
occurring in ≥1% of patients included
anxiety
(5%),
depression
(3.9%),
agitation
(2.9%), and
irritability
(2.9%). Grade 3
mood disorders
occurred in 0.4% of patients.
Dizziness
occurred in 27% of patients, and
Grade 3 dizziness
occurred in 1.1% of patients. Among the 74 patients who experienced
dizziness
, 5% of patients required a dose modification and 5% required dose interruption.
Sleep disturbances
occurred in 10% of patients.
Sleep disturbances
included
insomnia
(7%),
somnolence
(2.5%), and
sleep disorder
(0.4%). There were no Grade 3-4
sleep disturbances
. Among the 28 patients who experienced
sleep disturbances
, 1 patient each (3.6%) required a dose modification or dose interruption. Advise patients and caretakers of these risks with
VITRAKVI
. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue
VITRAKVI
based on the severity. If withheld, modify the
VITRAKVI
dosage when resumed.
Skeletal Fractures
: Among 187 adult patients who received
VITRAKVI
across clinical trials,
fractures
were reported in 7% and among 92 pediatric patients,
fractures
were reported in 9% (N=279; 8%). Median time to
fracture
was 11.6 months (range 0.9 to 45.8 months) in patients followed per
fracture
.
Fractures
of the femur, hip or acetabulum were reported in 4 patients (3 adult, 1 pediatric). Most
fractures
were associated with minimal or moderate trauma. Some
fractures
were associated with radiologic abnormalities suggestive of local
tumor
involvement.
VITRAKVI
treatment was interrupted due to
fracture
in 1.4% patients. Promptly evaluate patients with signs or symptoms of potential
fracture
(e.g.,
pain
, changes in mobility,
deformity
). There are no data on the effects of
VITRAKVI
on healing of known
fractures
or risk of future
fractures
. Hepatotoxicity: In patients who received
VITRAKVI
, increased
AST
of any grade occurred in 52% of patients and increased ALT of any grade occurred in 45%. Grade 3-4 increased
AST
or ALT occurred in 3.1% and 2.5% of patients, respectively. The median time to onset of increased
AST
was 2.1 months (range: 1 day to 4.3 years). The median time to onset of increased ALT was 2.3 months (range: 1 day to 4.2 years). Increased
AST
and ALT leading to dose modifications occurred in 1.4% and 2.2% of patients, respectively. Increased
AST
or ALT led to permanent discontinuation in 3 (1.1%) of patients. Monitor liver tests, including ALT and
AST
, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue
VITRAKVI
based on the severity. If withheld, modify the
VITRAKVI
dosage when resumed. Embryo-Fetal Toxicity:
VITRAKVI
can cause fetal harm when administered to a pregnant woman.
Larotrectinib
resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of
VITRAKVI
. Most Common Adverse Reactions (≥20%): The most common adverse reactions (≥20%), including laboratory abnormalities, were: increased
AST
(52%), increased ALT (45%),
anemia
(42%),
musculoskeletal pain
(42%),
fatigue
(36%),
hypoalbuminemia
(36%),
neutropenia
(36%), increased
alkaline phosphatase
(34%),
cough
(32%),
leukopenia
(28%),
constipation
(27%),
diarrhea
(27%),
dizziness
(27%),
hypocalcemia
(25%),
nausea
(25%),
vomiting
(25%), pyrexia (24%), lymphopenia (22%) and abdominal pain (21%). Drug Interactions: Avoid coadministration of
VITRAKVI
with strong
CYP3A4
inhibitors (including grapefruit or grapefruit juice), strong
CYP3A4
inducers (including St. John’s wort), or sensitive
CYP3A4
substrates. If coadministration of strong
CYP3A4
inhibitors or inducers cannot be avoided, modify the
VITRAKVI
dose as recommended. If coadministration of sensitive
CYP3A4
substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs. Lactation: Advise women not to breastfeed during treatment with
VITRAKVI
and for 1 week after the final dose. Please see the full Prescribing Information for
VITRAKVI
® (
larotrectinib
). About
NUBEQA
®
(darolutamide)3
NUBEQA
is an
androgen receptor inhibitor (ARi)
with a distinct chemical structure that competitively inhibits androgen binding,
AR
nuclear translocation, and
AR
-mediated transcription.3 A Phase III study in
metastatic hormone-sensitive prostate cancer
(ARASENS) is ongoing. Information about this trial can be found at . INDICATION FOR
NUBEQA
® (
darolutamide
)
NUBEQA
® (
darolutamide
) is an
androgen receptor
inhibitor indicated for the treatment of patients with
non-metastatic castration-resistant prostate cancer
. IMPORTANT SAFETY INFORMATION FOR
NUBEQA
® (
darolutamide
) Embryo-Fetal Toxicity: Safety and efficacy of
NUBEQA
have not been established in females.
NUBEQA
can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with
NUBEQA
and for 1 week after the last dose. Adverse Reactions Serious adverse reactions occurred in 25% of patients receiving
NUBEQA
and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received
NUBEQA
were
urinary retention
,
pneumonia
, and
hematuria
. Overall, 3.9% of patients receiving
NUBEQA
and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%),
cardiac failure
(0.3%),
cardiac arrest
(0.2%), general physical health deterioration (0.2%), and
pulmonary embolism
(0.2%) for
NUBEQA
. Adverse reactions occurring more frequently in the
NUBEQA
arm (≥2% over placebo) were
fatigue
(16% vs 11%),
pain
in extremity (6% vs 3%) and
rash
(3% vs 1%). Clinically significant adverse reactions occurring in ≥2% of patients treated with
NUBEQA
included
ischemic heart disease
(4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo). Drug Interactions Effect of Other Drugs on
NUBEQA
– Combined
P-gp
and strong or moderate
CYP3A4
inducers decrease
NUBEQA
exposure, which may decrease
NUBEQA
activity. Avoid concomitant use. Combined
P-gp
and strong
CYP3A4
inhibitors increase
NUBEQA
exposure, which may increase the risk of
NUBEQA
adverse reactions. Monitor more frequently and modify
NUBEQA
dose as needed. Effects of
NUBEQA
on Other Drugs –
NUBEQA
inhibits
breast cancer resistance protein (BCRP)
transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of
BCRP
substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.
NUBEQA
inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of
OATP1B1
or
OATP1B3
substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates. Review the prescribing information of drugs that are
BCRP
,
OATP1B1
, and
OATP1B3
substrates when used concomitantly with
NUBEQA
. For important risk and use information about
NUBEQA
, please see the accompanying full Prescribing Information. About
Xofigo
® (
radium Ra 223 dichloride
) Injection4
Xofigo
is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic
bone metastases
and no known
visceral metastatic disease
. Important Safety Information for
Xofigo
® (radium Ra 223 dichloride) Injection Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the
Xofigo
arm experienced
bone marrow failure
or ongoing
pancytopenia
, compared to no patients treated with placebo. There were two deaths due to
bone marrow failure
. For 7 of 13 patients treated with
Xofigo
bone marrow failure
was ongoing at the time of death. Among the 13 patients who experienced
bone marrow failure
, 54% required blood transfusions. Four percent (4%) of patients in the
Xofigo
arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to
vascular hemorrhage
in association with
myelosuppression
were observed in 1% of
Xofigo
-treated patients compared to 0.3% of patients treated with placebo. The incidence of
infection
-related deaths (2%), serious
infections
(10%), and
febrile neutropenia
(<1%) was similar for patients treated with
Xofigo
and placebo. Myelosuppression–notably
thrombocytopenia
,
neutropenia
,
pancytopenia
, and
leukopenia
–has been reported in patients treated with
Xofigo
. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue
Xofigo
in patients who experience life-threatening complications despite supportive care for
bone marrow failure
Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of
Xofigo
. Prior to first administering
Xofigo
, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue
Xofigo
if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with
Xofigo
have not been established. Outside of a clinical trial, concomitant use of
Xofigo
in patients on chemotherapy is not recommended due to the potential for additive
myelosuppression
. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period,
Xofigo
should be discontinued Increased
Fractures
and Mortality in Combination With
Abiraterone
Plus
Prednisone
/
Prednisolone
:
Xofigo
is not recommended for use in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of
Xofigo
in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of
fractures
(28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received
Xofigo
in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
compared to patients who received placebo in combination with
abiraterone acetate
plus
prednisone
/
prednisolone
. Safety and efficacy with the combination of
Xofigo
and agents other than
gonadotropin-releasing hormone analogues
have not been established Embryo-Fetal Toxicity: The safety and efficacy of
Xofigo
have not been established in females.
Xofigo
can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with
Xofigo
Administration and Radiation Protection:
Xofigo
should be received, used, and administered only by authorized persons in designated clinical settings. The administration of
Xofigo
is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status:
Dehydration
occurred in 3% of patients on
Xofigo
and 1% of patients on placebo.
Xofigo
increases adverse reactions such as
diarrhea
,
nausea
, and
vomiting
, which may result in
dehydration
. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of
dehydration
or
hypovolemia
Injection Site Reactions:
Erythema
,
pain
, and
edema
at the injection site were reported in 1% of patients on Xofigo
Secondary Malignant Neoplasms
:
Xofigo
contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of
cancer
and hereditary defects. Due to its mechanism of action and neoplastic changes, including
osteosarcomas
, in rats following administration of
radium-223 dichloride
,
Xofigo
may increase the risk of
osteosarcoma
or other
secondary malignant neoplasms
. However, the overall incidence of new
malignancies
in the randomized trial was lower on the
Xofigo
arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of
secondary malignancies
exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the
Xofigo
group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with
Xofigo
will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the
Xofigo
arm vs the placebo arm, respectively, were
nausea
(36% vs 35%),
diarrhea
(25% vs 15%),
vomiting
(19% vs 14%), and
peripheral edema
(13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of
Xofigo
-treated patients and 63% of placebo-treated patients. The most common
hematologic laboratory abnormalities
in the
Xofigo
arm (≥10%) vs the placebo arm, respectively, were
anemia
(93% vs 88%),
lymphocytopenia
(72% vs 53%),
leukopenia
(35% vs 10%),
thrombocytopenia
(31% vs 22%), and
neutropenia
(18% vs 5%) Please see the full Prescribing Information for
Xofigo
(
radium Ra 223 dichloride
). About Oncology at
Bayer
Bayer
is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at
Bayer
now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that
cancer
is treated. About
Bayer
Bayer
is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.
Bayer
is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The
Bayer
brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to . © 2021
Bayer
BAYER
, the Bayer Cross,
Aliqopa
,
Vitrakvi
,
NUBEQA
and
Xofigo
are registered trademarks of
Bayer
. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by
Bayer
management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in
Bayer
’s public reports which are available on the
Bayer
website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References
Aliqopa
(
copanlisib
) for injection [prescribing information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals Inc.
; November 2020.
Vitrakvi
® [package insert]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals, Inc.
; March 2021.
NUBEQA
® (
darolutamide
) tablets [Prescribing Information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals
, January 2021.
XOFIGO
® (
radium-223
dichloride) Injection [Prescribing Information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals
, December 2019. PP-PF-ONC-US-1780-1
机构
BP International Ltd.
The Broad Institute, Inc.
Bayer AG
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