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Bayer
presents latest data from oncology portfolio at 2024 ASCO Annual Meeting
2024-05-16
·
BioSpace
临床3期
临床结果
ASCO会议
上市批准
Bayer will showcase latest data for growth driver
NUBEQA
® (
darolutamide
) and targeted radionuclide therapy
XOFIGO
® (radium Ra 223 dichloride) Bayer will also present a late-breaking abstract on the Phase I/II study of
BAY 2927088
in patients with
HER2-mutant non-small cell lung cancer (NSCLC)
, and data from
VITRAKVI
® in patients with tropomyosin receptor kinase (TRK) fusion
lung cancer
Abstracts: 5022, 5083, TPS5122, TPS5127, e17040, LBA8598, 8570, 6095, 3105 WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer will present new data across its oncology portfolio at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, from May 31 – June 4, 2024. The breadth of new data in different
tumor
types underscores Bayer’s ambition to deliver innovative and effective oncological therapies in areas with the highest unmet medical needs.
Prostate cancer
is a key focus for Bayer Oncology, with data to be presented on
NUBEQA
® (
darolutamide
) and
XOFIGO
® (
radium Ra 223 dichloride
) across multiple stages of the disease.
NUBEQA
data will include a post hoc analysis from the Phase III ARASENS trial, evaluating post-progression survival with
NUBEQA
and androgen-deprivation therapy (ADT) plus
docetaxel
in patients with
metastatic hormone-sensitive prostate cancer (mHSPC)
, which will further support the established efficacy pro
NUBEQA
. Additionally a follow-up analysis from the Phase III ARAMIS trial, evaluating the association between
prostate-specific antigen (PSA)
level and risk of radiological progression with
NUBEQA
and ADT in patients with
non-metastatic castration-resistant prostate cancer (nmCRPC)
will also be presented. An overview of the ongoing investigational Phase III ARASTEP trial in
hormone sensitive prostate cancer
patients with high-risk biochemical recurrence will also be presented. Additionally, new data from the ongoing Bayer sponsored ALADDIN study, conducted by the Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, investigating the impact of
NUBEQA
plus ADT and radiation therapy on failure-free survival in patients with newly diagnosed
prostate cancer
and
pelvic lymph nodes metastases
will be presented.
NUBEQA
is currently indicated in the U.S. in combination with
docetaxel
for the treatment of adult patients with mHSPC and for the treatment of adult patients with
non-metastatic castration-resistant prostate cancer (nmCRPC)
. In the field of targeted radionuclide therapies, Bayer will present data from the Phase III REASSURE study, evaluating patient profiles and treatment outcomes in patients with
metastatic castration resistant prostate cancer (mCRPC)
with
XOFIGO
in the real-world setting, will be shared.
XOFIGO
is indicated for the treatment of patients with mCRPC,
symptomatic bone metastases
, and no known
visceral metastatic disease
. Bayer will present a late-breaking abstract on
BAY 2927088
in patients with
HER2-mutant non-small cell lung cancer (NSCLC)
from the Phase I/II SOHO-01 trial.
BAY 2927088
is an oral, small molecule
tyrosine kinase
inhibitor being investigated for patients with
NSCLC
harboring
HER2
activating mutations. Bayer will highlight long-term efficacy and safety data from the VICTORIA study for
VITRAKVI
®, including outcomes in patients with
tropomyosin receptor kinase (TRK) fusion cancer
treated with
VITRAKVI
in clinical trials (NCT02122913, NCT02576431, NCT02637687).
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 a FDA-approved test. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Details on selected abstracts from Bayer at the 2024 ASCO Annual Meeting are listed below:
Darolutamide
Abstract title: Association between
prostate-specific antigen (PSA)
level <0.2 ng/mL and risk of radiological progression in patients (pts) with
nonmetastatic castration-resistant prostate cancer (nmCRPC)
: Follow-up analysis of ARAMIS Poster: 5022; June 2, 2024. 09:00 AM – 12:00 PM CDT Abstract title: Post-progression survival of patients with
metastatic hormone-sensitive prostate cancer (mHSPC)
who received
darolutamide
or placebo: Post hoc analysis of ARASENS Poster: 5083; June 2, 2024. 09:00 AM – 12:00 PM CDT Abstract title:
Darolutamide
plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of
prostate cancer
: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP) Trial in Progress TiP Poster: TPS5122; June 2, 2024. 09:00 AM – 12:00 PM CDT Abstract title: ALADDIN: Evaluation of
darolutamide
in addition to androgen deprivation therapy and radiation therapy in newly diagnosed
prostate cancer
with
pelvic lymph nodes metastases
TiP Poster: TPS5127; June 2, 2024. 9:00AM CDT Radium-223 dichloride Abstract title: Comparing patient profiles and treatment outcomes with
radium-223 (223Ra)
in real-world settings: Academic vs. community practice in the US—Insights from the REASSURE study ePoster: e17040; Published J Clin Oncol 42, 2024, suppl 16 BAY 2927088 Abstract title: Safety and clinical activity of
BAY 2927088
from a Phase I/II trial expansion cohort in patients with
HER2-mutant non-small cell lung cancer (NSCLC)
Late Breaking Abstract: LBA8598; June 3, 2024. 1:30PM CDT
Larotrectinib
Abstract title: Long-term efficacy and safety of
larotrectinib
in patients (pts) with
TRK fusion lung cancer
Poster: 8570; June 3, 2024. 1:30PM CDT Abstract title: Long-term efficacy and safety of
larotrectinib (laro)
in patients (pts) with
TRK fusion thyroid carcinoma (TC)
Poster: 6095; June 2, 2024. 9:00AM CDT Abstract title: Outcomes of
larotrectinib
compared with real-world data from non-
TRK inhibitor
therapies in patients with TRK fusion
cancer
: VICTORIA study Poster: 3105; June 1, 2024. 9:00AM CDT About
NUBEQA
®
(darolutamide)1
NUBEQA
® (
darolutamide
) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding,
AR
nuclear translocation, and
AR
-mediated transcription. On July 30, 2019, the FDA approved
NUBEQA
based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral
NUBEQA
in patients with
non-metastatic castration-resistant prostate cancer (nmCRPC)
. Based on results from the ARASENS trial, a randomized, Phase III, multi-center, double-blind, placebo-controlled trial,
NUBEQA
plus androgen deprivation therapy (ADT) and
docetaxel
was approved on August 5, 2022 for the treatment of adult patients with
metastatic hormone-sensitive prostate cancer (mHSPC)
.
NUBEQA
is also being investigated in additional studies across various stages of
prostate cancer
, including in the Phase III ARANOTE trial evaluating
NUBEQA
plus ADT versus ADT alone for mHSPC, the ARASTEP Phase III trial evaluating
NUBEQA
plus ADT versus ADT alone in HSPC patients with high-risk BCR and no evidence of metastatic disease, as well as in the Australian and New Zealand Urogenital and
Prostate Cancer
Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating
NUBEQA
as an adjuvant treatment for
localized prostate cancer
with very high risk of recurrence. Information about these trials can be found at Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company,
NUBEQA
is indicated for the treatment of adults with nmCRPC or with mHSPC in combination with docetaxel.1 Filings in other regions are underway or planned. INDICATIONS
NUBEQA
® (
darolutamide
) is an
androgen receptor
inhibitor indicated for the treatment of adult patients with: Non-
metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic hormone-sensitive prostate cancer (mHSPC)
in combination with
docetaxel
IMPORTANT SAFETY INFORMATION
NUBEQA
® (
darolutamide
) is an
androgen receptor
inhibitor indicated for the treatment of adult patients with: Non-
metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic hormone-sensitive prostate cancer (mHSPC)
in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS),
ischemic heart disease
occurred in 3.2% of patients receiving
NUBEQA
versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving
NUBEQA
vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS),
ischemic heart disease
occurred in 3.2% of patients receiving
NUBEQA
with
docetaxel
vs. 2% receiving placebo with
docetaxel
, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving
NUBEQA
with
docetaxel
vs. 0% receiving placebo with
docetaxel
. Monitor for signs and symptoms of
ischemic heart disease
. Optimize management of cardiovascular risk factors, such as
hypertension
,
diabetes
, or
dyslipidemia
. Discontinue
NUBEQA
for Grade 3-4
ischemic heart disease
. Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving
NUBEQA
vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of
NUBEQA
. In ARASENS,
seizure
occurred in 0.6% of patients receiving
NUBEQA
with
docetaxel
, including one Grade 3 event, vs. 0.2% receiving placebo with
docetaxel
. Seizure occurred 38 to 340 days after initiation of
NUBEQA
. It is unknown whether antiepileptic medications will prevent
seizures
with
NUBEQA
. Advise patients of the risk of developing a
seizure
while receiving
NUBEQA
and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of
NUBEQA
in patients who develop a
seizure
during treatment. 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 In ARAMIS, serious adverse reactions occurred in 25% of patients receiving
NUBEQA
vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received
NUBEQA
included
urinary retention
,
pneumonia
, and
hematuria
. Fatal adverse reactions occurred in 3.9% of patients receiving
NUBEQA
vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received
NUBEQA
included death (0.4%),
cardiac failure
(0.3%),
cardiac arrest
(0.2%), general physical health deterioration (0.2%), and
pulmonary embolism
(0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased
AST
, decreased neutrophil count,
fatigue
, increased bilirubin,
pain
in extremity and
rash
. Clinically relevant adverse reactions occurring in ≥2% of patients treated with
NUBEQA
included
ischemic heart disease
and
heart failure
. In ARASENS, serious adverse reactions occurred in 45% of patients receiving
NUBEQA
with
docetaxel
vs. 42% of patients receiving placebo with
docetaxel
. Serious adverse reactions in ≥2% of patients who received
NUBEQA
with
docetaxel
included
febrile neutropenia
(6%), decreased neutrophil count (2.8%),
musculoskeletal pain
(2.6%), and
pneumonia
(2.6%). Fatal adverse reactions occurred in 4% of patients receiving
NUBEQA
with
docetaxel
vs. 4% of patients receiving placebo with
docetaxel
. Fatal adverse reactions in patients who received
NUBEQA
included
COVID-19/COVID-19 pneumonia
(0.8%),
myocardial infarction
(0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with
docetaxel
) were
constipation
,
rash
,
decreased appetite
,
hemorrhage
, increased weight, and
hypertension
. The most common laboratory test abnormalities (≥30%) were
anemia
,
hyperglycemia
, decreased lymphocyte count, decreased neutrophil count, increased
AST
, increased ALT, and
hypocalcemia
. Clinically relevant adverse reactions in <10% of patients who received
NUBEQA
with
docetaxel
included
fractures
,
ischemic heart disease
,
seizures
, and
drug-induced liver injury
. 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
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
) Injection2
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
VITRAKVI
®
(larotrectinib)3
VITRAKVI
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 is likely to 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 Warnings and Precautions 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: Hepatotoxicity including
drug induced liver injury (DILI)
has been reported in patients taking
VITRAKVI
. 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. There have been reports in adult patients from clinical studies and post-marketing cases of Grade ≥ 2 increases in ALT and/or
AST
with increases in bilirubin ≥ 2 x ULN. Obtain liver function tests (ALT,
AST
,
ALP
and bilirubin) before initiation of
VITRAKVI
and monitor every 2 weeks during the first two months of treatment, then monthly thereafter, or more frequently following the occurrence of Grade 2 or greater
AST
or ALT elevation. Temporarily withhold, reduce the dose, or permanently discontinue
VITRAKVI
based on severity. 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 last dose of
VITRAKVI
. Adverse Reactions 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
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
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. For coadministration with moderate
CYP3A4 inhibitors
CYP3A4
inhibitors, monitor for adverse reactions more frequently and reduce the dosage based on severity. For coadministration with moderate
CYP3A4
inducers, modify dose as recommended. Use in Specific Populations Lactation: Advise women not to breastfeed during treatment with
VITRAKVI
and for 1 week after the last dose. Please see the full Prescribing Information for
VITRAKVI
® (
larotrectinib
). 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 includes 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. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to . © 2024 Bayer BAYER, the Bayer Cross,
NUBEQA
,
XOFIGO
and
VITRAKVI
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
NUBEQA
® (
darolutamide
) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2024.
XOFIGO
® (
radium-223
dichloride Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2024.
VITRAKVI
® (
larotrectinib
) [Package Insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2024. PP-PF-ONC-US-3156-1 5/24
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机构
Bayer AG
适应症
HER2突变型非小细胞肺癌
肺癌
肿瘤
[+71]
靶点
KLK3
Tyrosine kinase
HER2
[+10]
药物
达罗他胺
二氯化镭[223Ra]
BAY-2927088
[+9]
标准版
¥
16800
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