Approval follows Priority Review and is
supported by the robust TRUST clinical program, in which IBTROZI
treatment demonstrated high, durable response rates and
brain-penetrant efficacy across different lines of therapy
The safety and tolerability of IBTROZI have
been well established in the pivotal program, with one of the
largest safety datasets in ROS1+ NSCLC showing a favorable and
consistent profile
Company to host conference call tomorrow,
June 12 at 7:30 a.m. EDT
Nuvation Bio Inc. (NYSE: NUVB), a global oncology company
focused on tackling some of the toughest challenges in cancer
treatment, today announced that the U.S. Food and Drug
Administration (FDA) has approved IBTROZI™ (taletrectinib) for the
treatment of adult patients with locally advanced or metastatic
ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). IBTROZI
is a highly selective, next-generation oral ROS1 tyrosine kinase
inhibitor (TKI) designed to address some of the outstanding
challenges of treating ROS1+ NSCLC. It has demonstrated high
response rates with durable benefit and intracranial activity and
is generally well tolerated, providing a new treatment option for
patients with advanced ROS1+ NSCLC.
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“The FDA approval of IBTROZI marks a major milestone in the
evolution of targeted therapy for advanced ROS1-positive NSCLC,”
said David Hung, M.D., Founder, President and Chief Executive
Officer of Nuvation Bio. “We believe one of the greatest threats to
ROS1-positive lung cancer patients is disease progression,
especially in the first-line setting. In pivotal trials, IBTROZI
delivered high response rates with sustained durability—truly
meaningful benefits for patients. With its clinically proven
efficacy and safety profile, we believe IBTROZI has the potential
to become a new standard for what targeted therapies can achieve in
this type of lung cancer. With approvals for IBTROZI now in the
U.S. and China, and additional global filings underway, we remain
committed to delivering innovative therapies that help patients
stay ahead of their disease.”
ROS1+ NSCLC is a rare and aggressive form of lung cancer,
accounting for approximately 2% of new NSCLC cases, or about 3,000
new diagnoses of advanced disease annually in the U.S. The median
age at diagnosis for patients with this type of lung cancer is
approximately 50 years old, and the disease is more likely to occur
in people who have never smoked. Brain metastases are common and a
leading cause of disease progression and mortality in this
population.
“For people living with advanced ROS1-positive lung cancer, who
tend to be diagnosed at a younger age, having another treatment
option can make a real difference for them and their loved ones,”
said Janet Freeman-Daily, Co-Founder and President of The ROS1ders.
“The approval of this new targeted therapy is a meaningful step
forward for the advanced ROS1+ lung cancer community and offers
hope for patients facing the added challenge of cancer spreading to
the brain.”
The FDA approval of IBTROZI is supported by one of the largest
global clinical trial programs in ROS1+ NSCLC to date, with over
300 patients enrolled in the pivotal TRUST-I and TRUST-II
studies.
In TRUST-I, IBTROZI achieved a confirmed overall response rate
(cORR) of 90% in TKI-naïve patients. These findings were reinforced
by the TRUST-II results, with a cORR of 85% in TKI-naïve patients.
The median duration of response (DOR) was not yet reached for
either trial, based on a cutoff date that is nearly five months
later than that of the pooled TRUST-I and TRUST-II analysis
published in April in the Journal of Clinical Oncology. For
TRUST-I, with a median follow-up for responses of 40 months, the
longest DOR was observed at 46.9 months and ongoing. For TRUST-II,
with a median follow-up for responses of 19 months, the longest DOR
was observed at 30.4 months and ongoing as of October 2024. Given
the single-arm nature of the TRUST clinical studies, median
progression-free survival (PFS) is not provided in the label.
Across the pivotal studies, consistent results were also
observed among patients who were previously treated with a ROS1 TKI
(TKI-pretreated). In TRUST-I, treatment with IBTROZI achieved a
cORR of 52% and median DOR of 13.2 months for TKI-pretreated
patients, with median follow-up for responses of 33 months. In
TRUST-II, treatment with IBTROZI achieved a cORR of 62%, and as of
October 2024 the median DOR was 19.4 months in these patients, with
a median follow-up for responses of 19 months.
Brain metastases are among the most common and devastating
complications in advanced ROS1+ NSCLC. IBTROZI was designed to
penetrate the central nervous system (CNS) and has demonstrated
consistent intracranial responses in patients with measurable brain
metastases at baseline. An intracranial response was achieved in
73% of TKI-naive patients (11/15) and 63% of TKI-pretreated
patients (15/24).
“Patients living with advanced ROS1+ non-small cell lung cancer
and their healthcare providers are in need of new treatment
options,” added Nathan Pennell, M.D., Ph.D., TRUST study
investigator and Professor of Medicine at the Cleveland Clinic.
“IBTROZI’s durability of response and ability to effectively
penetrate the brain, coupled with a well-characterized and
manageable safety profile, further addresses these critical needs
for patients. I believe this now-approved therapy offers providers
and patients a promising new option for the treatment of advanced
ROS1+ non-small cell lung cancer.” Dr. Pennell is a compensated
member of Nuvation Bio’s advisory committee.
IBTROZI was generally well-tolerated, with most adverse events
being low grade, transient and manageable. Patients infrequently
(7%) discontinued treatment due to treatment-emergent adverse
events (TEAEs). The most common adverse reactions (≥20%) included
diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash
(22%), constipation (21%), and fatigue (20%). Overall, the majority
of CNS events were mild to moderate (~90%) and resolved within
days, and dose modifications due to these events were low (~5%).
Approximately 90% of reported cases of dizziness were Grade 1
(mild) and transient. Liver enzyme elevations (AST 87%/ALT 85%) and
QT prolongation (19%) were manageable with standard monitoring and
dose modifications. IBTROZI is approved as a 600 mg once-daily oral
dose, supported by a half-life of approximately 66 hours and broad
tissue distribution, including the brain, enabling sustained
systemic and CNS exposure.
Nuvation Bio also announced the launch of NuvationConnect, a
program designed to support patients prescribed IBTROZI. The
program will offer financial assistance, access to resources and
personalized support for eligible patients. Prescribers can learn
more at NuvationConnect.com or by calling 1-877-NUV-CON1
(1-877-688-2661).
Conference Call & Business Update
Nuvation Bio will host a conference call on June 12, 2025 at
7:30 a.m. EDT / 4:30 a.m. PDT, where company executives will
provide an overview of the FDA approval of IBTROZI and our plans to
now bring this medicine to patients.
As a reminder to investors, the approval, together with the
first commercial sale, makes the funding secured from Sagard
Healthcare Partners in March fully available to the company.
Nuvation Bio expects that this finances the launch of IBTROZI in
full and provides further resources to continue advancing our
pipeline in areas of unmet need.
Investors and the general public are invited to register and
listen to a live webcast of the event through the company website
at https://investors.nuvationbio.com. Those unable to register can
access the live conference call by dialing +1 833-470-1428 (U.S.
toll-free) and entering access code 783971. A replay of the event
will be available shortly after the conclusion.
About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed
with non-small cell lung cancer (NSCLC), the most common form of
lung cancer. It is estimated that approximately 2% of patients with
NSCLC have ROS1+ disease. About 35% of patients newly diagnosed
with metastatic ROS1+ NSCLC have tumors that have spread to their
brain. The brain is also the most common site of disease
progression, with about 50% of previously treated patients
developing CNS metastases. Despite recent progress for patients
with ROS1+ NSCLC, there remains a need for more effective and
tolerable treatment options.
About IBTROZI
IBTROZI is an oral, potent, central nervous system-active,
selective, next-generation ROS1 inhibitor therapy approved for the
treatment of adult patients with advanced ROS1-positive non-small
cell lung cancer. Learn more at IBTROZI.com.
About the TRUST Clinical Program
The TRUST clinical program evaluating IBTROZI for the treatment
of adult patients with advanced ROS1+ NSCLC included two Phase 2
single-arm pivotal studies: TRUST-I (NCT04395677) in China, which
enrolled 173 patients, and TRUST-II (NCT04919811), a global study,
which enrolled 164 patients. The primary endpoint of these
registrational studies is confirmed objective response rate (cORR)
as assessed by an independent review committee (IRC). Key secondary
endpoints include intracranial cORR, duration of response,
progression-free survival, and safety.
Indication
IBTROZI is indicated for the treatment of adult patients with
locally advanced or metastatic ROS1+ non-small cell lung cancer
(NSCLC).
IMPORTANT SAFETY INFORMATION FOR IBTROZITM
(taletrectinib)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Hepatotoxicity, including drug-induced
liver injury and fatal adverse reactions, can occur. 88% of
patients experienced increased AST, including 10% Grade 3/4. 85% of
patients experienced increased ALT, including 13% Grade 3/4. Fatal
liver events occurred in 0.6% of patients. Median time to first
onset of AST or ALT elevation was 15 days (range: 3 days to 20.8
months).
Increased AST or ALT each led to dose interruption in 7% of
patients and dose reduction in 5% and 9% of patients, respectively.
Permanent discontinuation was caused by increased AST, ALT, or
bilirubin each in 0.3% and by hepatotoxicity in 0.6% of
patients.
Concurrent elevations in AST or ALT ≥3 times the ULN and total
bilirubin ≥2 times the ULN, with normal alkaline phosphatase,
occurred in 0.6% of patients.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe,
life-threatening, or fatal ILD or pneumonitis can occur.
ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade
3/4. One fatal ILD case occurred at the 400 mg daily dose. Median
time to first onset of ILD/pneumonitis was 3.8 months (range: 12
days to 11.8 months).
ILD/pneumonitis led to dose interruption in 1.1% of patients,
dose reduction in 0.6% of patients, and permanent discontinuation
in 0.6% of patients.
QTc Interval Prolongation: QTc interval prolongation can
occur, which can increase the risk for ventricular tachyarrhythmias
(e.g., torsades de pointes) or sudden death. IBTROZI prolongs the
QTc interval in a concentration-dependent manner.
In patients who received IBTROZI and underwent at least one post
baseline ECG, QTcF increase of >60 msec compared to baseline and
QTcF >500 msec occurred in 13% and 2.6% of patients,
respectively. 3.4% of patients experienced Grade ≥3. Median time
from first dose of IBTROZI to onset of ECG QT prolongation was 22
days (range: 1 day to 38.7 months). Dose interruption and dose
reduction each occurred in 2.8% of patients.
Significant QTc interval prolongation may occur when IBTROZI is
taken with food, strong and moderate CYP3A inhibitors, and/or drugs
with a known potential to prolong QTc. Administer IBTROZI on an
empty stomach. Avoid concomitant use with strong and moderate CYP3A
inhibitors and/or drugs with a known potential to prolong QTc.
Hyperuricemia: Hyperuricemia can occur and was reported
in 14% of patients, with 16% of these requiring urate-lowering
medication without pre-existing gout or hyperuricemia. 0.3% of
patients experienced Grade ≥3. Median time to first onset was 2.1
months (range: 7 days to 35.8 months). Dose interruption occurred
in 0.3% of patients.
Myalgia with Creatine Phosphokinase (CPK) Elevation:
Myalgia with or without CPK elevation can occur. Myalgia occurred
in 10% of patients. Median time to first onset was 11 days (range:
2 days to 10 months).
Concurrent myalgia with increased CPK within a 7-day time period
occurred in 0.9% of patients. Dose interruption occurred in 0.3% of
patients with myalgia and concurrent CPK elevation.
Skeletal Fractures: IBTROZI can increase the risk of
fractures. ROS1 inhibitors as a class have been associated with
skeletal fractures. 3.4% of patients experienced fractures,
including 1.4% Grade 3. Some fractures occurred in the setting of a
fall or other predisposing factors. Median time to first onset of
fracture was 10.7 months (range: 26 days to 29.1 months). Dose
interruption occurred in 0.3% of patients.
Embryo-Fetal Toxicity: Based on literature, animal
studies, and its mechanism of action, IBTROZI can cause fetal harm
when administered to a pregnant woman.
ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently
reported adverse reactions (≥20%) were diarrhea (64%), nausea
(47%), vomiting (43%), dizziness (22%), rash (22%), constipation
(21%), and fatigue (20%).
The most frequently reported Grade 3/4 laboratory abnormalities
(≥5%) were increased ALT (13%), increased AST (10%), decreased
neutrophils (5%), and increased creatine phosphokinase (5%).
DRUG INTERACTIONS
- Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and
Drugs that Prolong the QTc Interval: Avoid concomitant
use.
- Gastric Acid Reducing Agents: Avoid concomitant use with
PPIs and H2 receptor antagonists. If an acid-reducing agent cannot
be avoided, administer locally acting antacids at least 2 hours
before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS
- Pregnancy: Please see important information in Warnings
and Precautions under Embryo-Fetal Toxicity.
- Lactation: Advise women not to breastfeed during
treatment and for 3 weeks after the last dose.
- Effect on Fertility: Based on findings in animals,
IBTROZI may impair fertility in males and females. The effects on
animal fertility were reversible.
- Pediatric Use: The safety and effectiveness of IBTROZI
in pediatric patients has not been established.
- Photosensitivity: IBTROZI can cause photosensitivity.
Advise patients to minimize sun exposure and to use sun protection,
including broad-spectrum sunscreen, during treatment and for at
least 5 days after discontinuation.
Please see accompanying full Prescribing
Information.
About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling
some of the toughest challenges in cancer treatment by developing
therapies that create a profound, positive impact on patients’
lives. Our diverse pipeline includes IBTROZI (taletrectinib), a
next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1
inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate
(DDC) designed for targeted cancer treatment; and NUV-868, a
BD2-selective BET inhibitor.
Nuvation Bio was founded in 2018 by biopharma industry veteran
David Hung, M.D., who previously founded Medivation, Inc., which
brought to patients one of the world’s leading prostate cancer
medicines. Nuvation Bio has offices in New York, San Francisco,
Boston, and Shanghai. For more information, visit
www.nuvationbio.com or follow the company on LinkedIn and X
(@nuvationbioinc).
Forward-Looking Statements
Certain statements included in this press release that are not
historical facts are forward-looking statements for purposes of the
safe harbor provisions under the United States Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
sometimes accompanied by words such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,”
“would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,”
“outlook” and similar expressions that predict or indicate future
events or trends or that are not statements of historical matters.
These forward-looking statements include, but are not limited to,
our expectations regarding IBTROZI’s therapeutic potential in
advanced ROS1+ NSCLC and its potential to become a new standard of
care. These statements are based on various assumptions, whether or
not identified in this press release, and on the current
expectations of the management team of Nuvation Bio and are not
predictions of actual performance. These forward-looking statements
are subject to a number of risks and uncertainties that may cause
actual results to differ from those anticipated by the
forward-looking statements, including but not limited to the
challenges associated with conducting drug discovery and initiating
or conducting clinical studies due to, among other things,
difficulties or delays in the regulatory process, enrolling
subjects or manufacturing or acquiring necessary products; the
emergence or worsening of adverse events or other undesirable side
effects; risks associated with preliminary and interim data, which
may not be representative of more mature data; and competitive
developments. Risks and uncertainties facing Nuvation Bio are
described more fully in its Form 10-Q filed with the SEC on May 7,
2025 under the heading “Risk Factors,” and other documents that
Nuvation Bio has filed or will file with the SEC. You are cautioned
not to place undue reliance on the forward-looking statements,
which speak only as of the date of this press release. Nuvation Bio
disclaims any obligation or undertaking to update, supplement or
revise any forward-looking statements contained in this press
release.
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