In Subset of Patients with Relapsed or
Refractory CLL/SLL Treated for Over 2 Years, Duvelisib Achieves 89%
ORR and Median PFS of 40 Months
DUO™ Crossover Extension Study Demonstrates 77%
ORR and Median PFS of 15 Months in Patients with Relapsed or
Refractory CLL/SLL Who Had Experienced Disease Progression
Following Ofatumumab Monotherapy; Achieves 80% ORR in Patients with
17p Deletion
Researchers Identify Certain Prognostic and
Immune-Related Factors Associated with Response to Duvelisib in
Patients with Follicular Lymphoma
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company),
a biopharmaceutical company focused on developing and
commercializing medicines seeking to improve the survival and
quality of life of cancer patients, today announced that three
COPIKTRA (duvelisib) abstracts were presented at the 23rd Annual
International Congress on Hematologic Malignancies (ICHM), which
took place February 28 – March 3, 2019, in Miami, FL. The abstracts
describe duvelisib data, including long-term (>2 years) efficacy
and safety, the Phase 3 DUO crossover extension study in patients
with relapsed or refractory chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL), and prognostic and immune-related
factors associated with response to duvelisib from the Phase 2
DYNAMO™ study in indolent non-Hodgkin’s lymphoma (iNHL). COPIKTRA,
an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the
first approved dual inhibitor of PI3K-delta and PI3K-gamma,
received approval from the U.S. Food and Drug Administration (FDA)
in September 2018 for the treatment of patients with relapsed or
refractory CLL/SLL after at least two prior therapies.
COPIKTRA also received accelerated approval for the treatment of
adult patients with relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. Accelerated approval
was based on overall response rate and continued approval for this
indication may be contingent upon confirmatory trials.
“The subset of 46 patients who received duvelisib monotherapy
for greater than 2 years achieved an overall response rate (ORR) of
89% and a median progression-free survival (PFS) of 40 months,”
commented Ian Flinn, MD, PhD, Director, Lymphoma/CLL Program at
Sarah Cannon Research Institute and lead author of the abstract.
“In this study, we were able to manage most adverse events through
dose reductions and dosing holds, which allowed these patients to
remain on treatment. These data support duvelisib’s potential as a
long-term treatment in patients with relapsed or refractory CLL/SLL
and we are excited to share them with the medical community at ICHM
2019.”
Long-Term Efficacy and Safety of Duvelisib Monotherapy in
Patients with CLL/SLL on Treatment for More Than 2 Years Across 4
Clinical Studies
This presentation, authored by Dr. Flinn, describes a pooled
efficacy and safety analysis from four clinical studies in patients
with relapsed or refractory CLL/SLL in the subset of patients who
received duvelisib monotherapy (25mg twice daily) for greater than
2 years. Responses were determined by investigators using modified
IWCLL/IWG criteria. Among the 46 evaluable patients (median two
prior therapies), duvelisib monotherapy achieved a 89% ORR,
including 20% complete response or complete response with
incomplete blood count recovery (CR/CRi) and 70% partial response
(PR). Median PFS was 40 months. Among the 10 patients with 17p
deletion/TP53 mutation, duvelisib monotherapy achieved a 100% ORR
(30% CR/CRi and 70% PR) with a median PFS of 38 months. The most
common adverse events (AEs) of any grade in patients treated with
duvelisib for greater than 2 years were infections, diarrhea,
pneumonia and colitis and the most common Grade ≥3 AEs were
infections, rash, colitis and pneumonia. In general, the AE profile
for patients treated with duvelisib for greater than 2 years was
similar to the profile in patients on treatment for less than two
years. Dose reductions and dose holds were utilized to manage AEs
and allow patients to continue deriving benefit from treatment.
These data support duvelisib monotherapy as a long-term treatment
option for patients with relapsed or refractory CLL/SLL with the
potential for a durable response and tolerability to treatment.
Efficacy and Safety of Duvelisib Following Disease
Progression on Ofatumumab in Patients with Relapsed/Refractory CLL
or SLL: Updated Results from the DUO Crossover Extension
Study
This presentation, authored by Matthew Davids, M.D., of the
Dana-Farber Cancer Institute, describes data from the open-label,
DUO crossover extension study where patients with confirmed
progressive disease (PD) following treatment with ofatumumab in DUO
were given the option to receive treatment with duvelisib. Response
was determined by investigator assessment using modified IWCLL/IWG
criteria. Among the 90 evaluable patients (median three prior
therapies (range 2-8)) in the extension study, duvelisib
monotherapy achieved a 77% ORR (95% CI: 68, 85), including 4% CRi
and 62% PR. While on ofatumumab in the DUO study, these 90 patients
had a 29% ORR (95% CI: 20, 38), including 1% CR and 28% PR. The
median PFS for duvelisib-treated patients in the extension study
was 15.2 months (95% CI: 12, 20). While on ofatumumab in the DUO
study, these 90 patients had a median PFS of 9.4 months (95% CI: 9,
11), per investigator’s assessment. Duvelisib achieved a 63% ORR in
patients (n=56) who had a best overall response (BOR) of stable
disease (SD) on ofatumumab pre-crossover. The subset of patients
with 17p deletion (n=20) achieved an 80% ORR. In patients who did
not respond to ofatumumab pre-crossover (n=8), duvelisib achieved a
75% ORR. The median time to response was 2.6 months. Median
exposure to duvelisib in the extension study was 9.8 months (max:
39 months), with a median total follow-up of 12.5 months. The most
common treatment-emergent AEs of any grade occurring in ≥10% of
patients were diarrhea, rash, neutropenia, pyrexia, pneumonia,
colitis, cough, asthenia, vomiting, decreased appetite and nausea.
The most common treatment-emergent Grade ≥3 AEs occurring in ≥10%
of patients were neutropenia, diarrhea, pneumonia and colitis.
“In the DUO crossover extension study, duvelisib monotherapy
achieved a 77% ORR, with a median PFS of 15 months in patients with
relapsed or refractory CLL/SLL who had experienced disease
progression following ofatumumab monotherapy pre-crossover,” said
Dr. Davids. “In the subset of patients with 17p deletion the ORR
was 80%. These response rates are encouraging because they are
comparable to those seen in earlier lines of treatment, despite
being administered in this heavily pretreated patient population
who have progressed following this additional line of treatment.
The safety profile of duvelisib in this study was manageable and
consistent with the known safety profile in CLL/SLL. Collectively,
these data continue to support the clinical benefit of duvelisib
monotherapy in patients with relapsed or refractory CLL/SLL.”
Prognostic and Immune-Related Factors Associated with
Response to Duvelisib in the Phase 2 DYNAMO Clinical Trial in
Patients with Indolent Non-Hodgkin Lymphoma
The Phase 2 DYNAMO study (NCT01882803) evaluated duvelisib
monotherapy in patients indolent non-Hodgkin’s lymphoma (iNHL) who
were refractory to rituximab and to either chemotherapy or
radioimmunotherapy. Refractory disease was defined as less than a
partial remission or relapse within 6 months after the last dose.
Among this patient population, the FL subgroup (n=83) had a median
PFS of 8.3 months and an ORR of 42%. This presentation, authored by
Pier Luigi Zinzani, M.D., PH.D., University of Bologna Institute of
Hematology, describes an analysis of prognostic factors and indices
(FLIPI and M7-FLIPI) that was undertaken to identify FL patient
subgroups responsive to duvelisib. The analysis showed that median
PFS and ORR were similar for duvelisib-treated FL patients
regardless of poor prognostic indicators, including FLIPI,
M7-FLIPI, and chromosome 6q deletions. Multivariate LASSO
regressions with 84 variables revealed baseline characteristics
including the number of prior therapies (1 versus 2 or more), as
well as a biomarker profile of NK cellsL, IL17+ CD8 TL, and CCL19L
that correlated with improved ORR. A biomarker profile of NK
cellsL, IL17+ CD8 TL, CD3 TH, and CCL19L correlated with improved
PFS. In the DYNAMO study, the most frequent treatment-emergent AEs
of any grade were diarrhea, nausea, neutropenia, fatigue, and
cough. Among the 88.4% of patients with at least one Grade ≥3
treatment-emergent AE, the most common treatment-emergent AEs were
neutropenia, diarrhea, anemia, and thrombocytopenia. Patients
experiencing AEs, including potentially immune-related events,
demonstrated generally similar PFS to those patients who did not
experience AEs, after adjusting for time.
“In the Phase 2 DYNAMO study, ORR and median PFS were similar
for duvelisib-treated FL patients regardless of poor prognostic
indicators, including FLIPI, M7-FLIPI and chromosome 6q deletions.
Notably, certain baseline characteristics, including number of
prior therapies and the presence of certain biomarkers correlated
to ORR and median PFS. These data may be useful in identifying FL
patients who would be responsive to treatment with duvelisib.” said
Dr. Zinzani.
PDF copies of all of these abstract presentations are available
here.
COPIKTRA has a BOXED WARNING for four fatal and/or serious
toxicities: infections, diarrhea or colitis, cutaneous reactions,
and pneumonitis. Verastem Oncology has implemented a Risk
Evaluation and Mitigation Strategy to provide appropriate dosing
and safety information to better support physicians in managing
their patients on COPIKTRA.
Additionally, COPIKTRA is also associated with adverse reactions
which may require dose reduction, treatment delay or
discontinuation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided
for infections, diarrhea or colitis, cutaneous reactions,
pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal
toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of
patients) were diarrhea or colitis, neutropenia, rash, fatigue,
pyrexia, cough, nausea, upper respiratory infection, pneumonia,
musculoskeletal pain, and anemia.
Please see the Important Safety Information below and the full
Prescribing Information, including BOXED WARNING, and patient
Medication Guide found on www.COPIKTRA.com
COPIKTRA has been added to the National Comprehensive Cancer
Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN
Guidelines) for CLL/SLL, FL and Marginal Zone Lymphoma (MZL). The
NCCN Guidelines are the standard physician resource for determining
the appropriate course of treatment for patients. COPIKTRA is not
approved for use in MZL.
Verastem Oncology is committed to helping patients with CLL/SLL
and FL access COPIKTRA through our Verastem Cares™ program.
Verastem Cares is a comprehensive, personalized program designed to
provide information and assistance to patients who have been
prescribed COPIKTRA.
Patients, physicians, pharmacists, or other healthcare
professionals with questions about COPIKTRA should contact
1-833-570-2273 (CARE) or visit www.COPIKTRA.com.
Important Safety Information
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR
COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full prescribing information for complete boxed warning
- Fatal and/or serious infections
occurred in 31% of COPIKTRA-treated patients. Monitor for signs and
symptoms of infection. Withhold COPIKTRA if infection is
suspected.
- Fatal and/or serious diarrhea or
colitis occurred in 18% of COPIKTRA-treated patients. Monitor for
the development of severe diarrhea or colitis. Withhold
COPIKTRA.
- Fatal and/or serious cutaneous
reactions occurred in 5% of COPIKTRA-treated patients. Withhold
COPIKTRA.
- Fatal and/or serious pneumonitis
occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary
symptoms and interstitial infiltrates. Withhold COPIKTRA.
WARNINGS AND PRECAUTIONS
Infections: Serious, including fatal (18/442; 4%),
infections occurred in 31% of patients receiving COPIKTRA 25 mg BID
(N=442). The most common serious infections were pneumonia, sepsis,
and lower respiratory infections. Median time to onset of any grade
infection was 3 months (range: 1 day to 32 months), with 75% of
cases occurring within 6 months. Treat infections prior to
initiation of COPIKTRA. Advise patients to report new or worsening
signs and symptoms of infection. For grade 3 or higher infection,
withhold COPIKTRA until infection has resolved. Resume COPIKTRA at
the same or reduced dose.
Serious, including fatal, Pneumocystis jirovecii pneumonia (PJP)
occurred in 1% of patients taking COPIKTRA. Provide prophylaxis for
PJP during treatment with COPIKTRA and following completion of
treatment with COPIKTRA until the absolute CD4+ T cell count is
greater than 200 cells/μL. Withhold COPIKTRA in patients with
suspected PJP of any grade, and permanently discontinue if PJP is
confirmed.
Cytomegalovirus (CMV) reactivation/infection occurred in 1% of
patients taking COPIKTRA. Consider prophylactic antivirals during
COPIKTRA treatment to prevent CMV infection including CMV
reactivation. For clinical CMV infection or viremia, withhold
COPIKTRA until infection or viremia resolves. If COPIKTRA is
resumed, administer the same or reduced dose and monitor patients
for CMV reactivation by PCR or antigen test at least monthly.
Diarrhea or Colitis: Serious, including fatal (1/442;
<1%), diarrhea or colitis occurred in 18% of patients receiving
COPIKTRA 25 mg BID (N=442). Median time to onset of any grade
diarrhea or colitis was 4 months (range: 1 day to 33 months), with
75% of cases occurring by 8 months. The median event duration was
0.5 months (range: 1 day to 29 months; 75th percentile: 1
month).
Advise patients to report any new or worsening diarrhea. For
patients presenting with mild or moderate diarrhea (Grade 1-2)
(i.e., up to 6 stools per day over baseline) or asymptomatic (Grade
1) colitis, initiate supportive care with antidiarrheal agents,
continue COPIKTRA at the current dose, and monitor the patient at
least weekly until the event resolves. If the diarrhea is
unresponsive to antidiarrheal therapy, withhold COPIKTRA and
initiate supportive therapy with enteric acting steroids (e.g.,
budesonide). Monitor the patient at least weekly. Upon resolution
of the diarrhea, consider restarting COPIKTRA at a reduced
dose.
For patients presenting with abdominal pain, stool with mucus or
blood, change in bowel habits, peritoneal signs, or with severe
diarrhea (Grade 3) (i.e., > 6 stools per day over baseline),
withhold COPIKTRA and initiate supportive therapy with enteric
acting steroids (e.g., budesonide) or systemic steroids. A
diagnostic work-up to determine etiology, including colonoscopy,
should be performed. Monitor at least weekly. Upon resolution of
the diarrhea or colitis, restart COPIKTRA at a reduced dose. For
recurrent Grade 3 diarrhea or recurrent colitis of any grade,
discontinue COPIKTRA. Discontinue COPIKTRA for life-threatening
diarrhea or colitis.
Cutaneous Reactions: Serious, including fatal (2/442;
<1%), cutaneous reactions occurred in 5% of patients receiving
COPIKTRA 25 mg BID (N=442). Fatal cases included drug reaction with
eosinophilia and systemic symptoms (DRESS) and toxic epidermal
necrolysis (TEN). Median time to onset of any grade cutaneous
reaction was 3 months (range: 1 day to 29 months, 75th percentile:
6 months) with a median event duration of 1 month (range: 1 day to
37 months, 75th percentile: 2 months).
Presenting features for the serious events were primarily
described as pruritic, erythematous, or maculo-papular. Less common
presenting features include exanthem, desquamation, erythroderma,
skin exfoliation, keratinocyte necrosis, and papular rash. Advise
patients to report new or worsening cutaneous reactions. Review all
concomitant medications and discontinue any medications potentially
contributing to the event. For patients presenting with mild or
moderate (Grade 1-2) cutaneous reactions, continue COPIKTRA at the
current dose, initiate supportive care with emollients,
antihistamines (for pruritus), or topical steroids, and monitor the
patient closely. Withhold COPIKTRA for severe (Grade 3) cutaneous
reaction until resolution. Initiate supportive care with steroids
(topical or systemic) or antihistamines (for pruritus). Monitor at
least weekly until resolved. Upon resolution of the event, restart
COPIKTRA at a reduced dose. Discontinue COPIKTRA if severe
cutaneous reaction does not improve, worsens, or recurs. For
life-threatening cutaneous reactions, discontinue COPIKTRA. In
patients with SJS, TEN, or DRESS of any grade, discontinue
COPIKTRA.
Pneumonitis: Serious, including fatal (1/442; <1%),
pneumonitis without an apparent infectious cause occurred in 5% of
patients receiving COPIKTRA 25 mg BID (N=442). Median time to onset
of any grade pneumonitis was 4 months (range: 9 days to 27 months),
with 75% of cases occurring within 9 months. The median event
duration was 1 month, with 75% of cases resolving by 2 months.
Withhold COPIKTRA in patients with new or progressive pulmonary
signs and symptoms such as cough, dyspnea, hypoxia, interstitial
infiltrates on a radiologic exam, or a decline by more than 5% in
oxygen saturation, and evaluate for etiology. If the pneumonitis is
infectious, patients may be restarted on COPIKTRA at the previous
dose once the infection, pulmonary signs and symptoms resolve. For
moderate non-infectious pneumonitis (Grade 2), treat with systemic
corticosteroids and resume COPIKTRA at a reduced dose upon
resolution. If non-infectious pneumonitis recurs or does not
respond to steroid therapy, discontinue COPIKTRA. For severe or
life-threatening non-infectious pneumonitis, discontinue COPIKTRA
and treat with systemic steroids.
Hepatotoxicity: Grade 3 and 4 ALT and/or AST elevation
developed in 8% and 2%, respectively, of patients receiving
COPIKTRA 25 mg BID (N=442). Two percent of patients had both an ALT
or AST > 3 X ULN and total bilirubin > 2 X ULN. Median time
to onset of any grade transaminase elevation was 2 months (range: 3
days to 26 months), with a median event duration of 1 month (range:
1 day to 16 months).
Monitor hepatic function during treatment with COPIKTRA. For
Grade 2 ALT/AST elevation (> 3 to 5 X ULN), maintain COPIKTRA
dose and monitor at least weekly until return to < 3 X ULN. For
Grade 3 ALT/AST elevation (> 5 to 20 X ULN), withhold COPIKTRA
and monitor at least weekly until return to < 3 X ULN. Resume
COPIKTRA at the same dose (first occurrence) or at a reduced dose
for subsequent occurrences. For grade 4 ALT/AST elevation (> 20
X ULN), discontinue COPIKTRA.
Neutropenia: Grade 3 or 4 neutropenia occurred in 42% of
patients receiving COPIKTRA 25 mg BID (N=442), with Grade 4
neutropenia occurring in 24% of all patients. Median time to onset
of grade ≥3 neutropenia was 2 months (range: 3 days to 31 months),
with 75% of cases occurring within 4 months.
Monitor neutrophil counts at least every 2 weeks for the first 2
months of COPIKTRA therapy, and at least weekly in patients with
neutrophil counts < 1.0 Gi/L (Grade 3-4). Withhold COPIKTRA in
patients presenting with neutrophil counts < 0.5 Gi/L (Grade 4).
Monitor until ANC is > 0.5 Gi/L, then resume COPIKTRA at same
dose for the first occurrence or at a reduced dose for subsequent
occurrences.
Embryo-Fetal Toxicity: Based on findings in animals and
its mechanism of action, COPIKTRA can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Conduct pregnancy testing before
initiating COPIKTRA treatment. Advise females of reproductive
potential and males with female partners of reproductive potential
to use effective contraception during treatment and for at least 1
month after the last dose.
ADVERSE REACTIONS
B-cell Malignancies Summary
Fatal adverse reactions within 30 days of the last dose occurred
in 8% (36/442) of patients treated with COPIKTRA 25 mg BID. Serious
adverse reactions were reported in 289 patients (65%). The most
frequent serious adverse reactions that occurred were infection
(31%), diarrhea or colitis (18%), pneumonia (17%), rash (5%), and
pneumonitis (5%).
Adverse reactions resulted in treatment discontinuation in 156
patients (35%) most often due to diarrhea or colitis, infection,
and rash. COPIKTRA was dose reduced in 104 patients (24%) due to
adverse reactions, most often due to diarrhea or colitis and
transaminase elevation. The most common adverse reactions (reported
in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash,
fatigue, pyrexia, cough, nausea, upper respiratory infection,
pneumonia, musculoskeletal pain and anemia.
CLL/SLL: Fatal adverse reactions within 30 days of the
last dose occurred in 12% (19/158) of patients treated with
COPIKTRA and in 4% (7/155) of patients treated with ofatumumab.
Serious adverse reactions were reported in 73% (115/158) of
patients treated with COPIKTRA and most often involved infection
(38%; 60/158) and diarrhea or colitis (23%; 36/158). COPIKTRA was
discontinued in 57 patients (36%), most often due to diarrhea or
colitis, infection, and rash. COPIKTRA was dose reduced in 46
patients (29%) due to adverse reactions, most often due to diarrhea
or colitis and rash. The most common adverse reactions with
COPIKTRA (reported in ≥20% of patients) were diarrhea or colitis,
neutropenia, pyrexia, upper respiratory tract infection, pneumonia,
rash, fatigue, nausea, anemia and cough.
FL: Serious adverse reactions were reported in 58% of
patients and most often involved diarrhea or colitis, pneumonia,
renal insufficiency, rash, and sepsis. The most common adverse
reactions (≥20% of patients) were diarrhea or colitis, nausea,
fatigue, musculoskeletal pain, rash, neutropenia, cough, anemia,
pyrexia, headache, mucositis, abdominal pain, vomiting,
transaminase elevation, and thrombocytopenia. Adverse reactions
resulted in COPIKTRA discontinuation in 29% of patients, most often
due to diarrhea or colitis and rash. COPIKTRA was dose reduced in
23% due to adverse reactions, most often due to transaminase
elevation, diarrhea or colitis, lipase increased and infection.
DRUG INTERACTIONS
- CYP3A Inducers: Coadministration with a
strong CYP3A inducer may reduce COPIKTRA efficacy. Avoid
coadministration with strong CYP3A4 inducers.
- CYP3A Inhibitors: Coadministration with
a strong CYP3A inhibitor may increase the risk of COPIKTRA
toxicities. Reduce COPIKTRA dose to 15 mg BID when coadministered
with a strong CYP3A4 inhibitor.
- CYP3A Substrates: Coadministration of
COPIKTRA with sensitive CYP3A4 substrates may increase the risk of
toxicities of these drugs. Consider reducing the dose of the
sensitive CYP3A4 substrate and monitor for signs of toxicities of
the coadministered sensitive CYP3A substrate.
- Please see the full Prescribing
Information, including BOXED WARNING, and patient Medication Guide
found on www.COPIKTRA.com.
About Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic
lymphoma (SLL) are cancers that affect lymphocytes and are
essentially the same disease, with the only difference being the
location where the cancer primarily occurs. When most of the cancer
cells are located in the bloodstream and the bone marrow, the
disease is referred to as CLL, although the lymph nodes and spleen
are often involved. When the cancer cells are located mostly in the
lymph nodes, the disease is called SLL. The symptoms of CLL/SLL
include a tender, swollen abdomen and feeling full even after
eating only a small amount. Other symptoms can include fatigue,
shortness of breath, anemia, bruising easily, night sweats, weight
loss, and frequent infections. However, many patients with CLL/SLL
will live for years without symptoms. There are approximately
200,000 patients in the US affected by CLL/SLL with nearly 20,000
new diagnoses this year alone. While there are therapies currently
available, real-world data reveals that a significant number of
patients either relapse following treatment, become refractory to
current agents, or are unable to tolerate treatment, representing a
significant medical need. The potential of additional oral agents,
particularly as a monotherapy that can be used in the general
community physician’s armamentarium, may hold significant value in
the treatment of patients with CLL/SLL.
About Follicular Lymphoma
Follicular lymphoma (FL) is typically a slow-growing or indolent
form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes,
making it a B-cell lymphoma. This lymphoma subtype accounts for 20
to 30 percent of all NHL cases, with more than 140,000 people in
the US with FL and more than 13,000 newly diagnosed patients this
year. Common symptoms of FL include enlargement of the lymph nodes
in the neck, underarms, abdomen, or groin, as well as fatigue,
shortness of breath, night sweats, and weight loss. Often, patients
with FL have no obvious symptoms of the disease at diagnosis.
Follicular lymphoma is usually not considered to be curable, but
more of a chronic disease, with patients living for many years with
this form of lymphoma. The potential of additional oral agents,
particularly as a monotherapy that can be used in the general
community physician’s armamentarium, may hold significant value in
the treatment of patients with FL.
About COPIKTRA™ (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first approved dual inhibitor of PI3K-delta and
PI3K-gamma, two enzymes known to help support the growth and
survival of malignant B-cells. PI3K signaling may lead to the
proliferation of malignant B-cells and is thought to play a role in
the formation and maintenance of the supportive tumor
microenvironment.1,2,3 COPIKTRA is indicated for the treatment of
adult patients with relapsed or refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two
prior therapies and relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. COPIKTRA is also being
developed by Verastem Oncology for the treatment of peripheral
T-cell lymphoma (PTCL), for which it has received Fast Track
status, and is being investigated in combination with other agents
through investigator-sponsored studies.4 For more information on
COPIKTRA, please visit www.COPIKTRA.com. Information about
duvelisib clinical trials can be found on
www.clinicaltrials.gov.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial
biopharmaceutical company committed to the development and
commercialization of medicines to improve the lives of patients
diagnosed with cancer. We are driven by the strength, tenacity and
courage of those battling cancer – single-minded in our resolve to
deliver new therapies that not only keep cancer at bay, but improve
the lives of patients diagnosed with cancer. Because for us, it’s
personal.
Our first FDA approved product is now available for the
treatment of patients with certain types of indolent non-Hodgkin’s
lymphoma (iNHL). Our pipeline comprises product candidates that
seek to treat cancer by modulating the local tumor
microenvironment. For more information, please visit
www.verastem.com.
Forward looking statements notice
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements regarding the development and activity of Verastem
Oncology’s lead product COPIKTRA, and Verastem Oncology’s PI3K and
FAK programs generally, its commercialization of COPIKTRA, the
potential commercial success of COPIKTRA, the anticipated adoption
of COPIKTRA by patients and physicians, the structure of its
planned and pending clinical trials and the timeline and
indications for clinical development, regulatory submissions and
commercialization activities. The words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict,"
"project," "target," "potential," "will," "would," "could,"
"should," "continue," and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statement.
Applicable risks and uncertainties include the risks and
uncertainties, among other things, regarding: the commercial
success of COPIKTRA in the United States; physician and patient
adoption of COPIKTRA, including those related to the safety and
efficacy of COPIKTRA; the uncertainties inherent in research and
development of COPIKTRA, such as negative or unexpected results of
clinical trials; whether and when any applications for COPIKTRA may
be filed with regulatory authorities in any other jurisdictions;
whether and when regulatory authorities in any other jurisdictions
may approve any such other applications that may be filed for
COPIKTRA, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality
of the efficacy and safety information submitted and, if approved,
whether COPIKTRA will be commercially successful in such
jurisdictions; our ability to obtain, maintain and enforce patent
and other intellectual property protection for COPIKTRA and our
other product candidates; the scope, timing, and outcome of any
legal proceedings; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of COPIKTRA; the fact that regulatory
authorities in the U.S. or other jurisdictions, if approved, could
withdraw approval; whether preclinical testing of our product
candidates and preliminary or interim data from clinical trials
will be predictive of the results or success of ongoing or later
clinical trials; that the timing, scope and rate of reimbursement
for our product candidates is uncertain; that third-party payors
(including government agencies) may not reimburse for COPIKTRA;
that there may be competitive developments affecting our product
candidates; that data may not be available when expected; that
enrollment of clinical trials may take longer than expected; that
COPIKTRA or our other product candidates will cause unexpected
safety events, experience manufacturing or supply interruptions or
failures, or result in unmanageable safety profiles as compared to
their levels of efficacy; that COPIKTRA will be ineffective at
treating patients with lymphoid malignancies; that we will be
unable to successfully initiate or complete the clinical
development and eventual commercialization of our product
candidates; that the development and commercialization of our
product candidates will take longer or cost more than planned; that
we may not have sufficient cash to fund our contemplated
operations; that we, CSPC Pharmaceutical Group, Yakult Honsha Co.,
Ltd. or Infinity Pharmaceuticals, Inc. will fail to fully perform
under the duvelisib license agreements; that we may be unable to
make additional draws under our debt facility or obtain adequate
financing in the future through product licensing, co-promotional
arrangements, public or private equity, debt financing or
otherwise; that we will not pursue or submit regulatory filings for
our product candidates, including for duvelisib in patients with
chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
or indolent non-Hodgkin lymphoma (iNHL) in other jurisdictions; and
that our product candidates will not receive regulatory approval,
become commercially successful products, or result in new treatment
options being offered to patients.
Other risks and uncertainties include those identified under the
heading "Risk Factors" in the Company’s Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2018 as filed
with the Securities and Exchange Commission (SEC) on November 7,
2018, its Annual Report on Form 10-K for the year ended December
31, 2017 as filed with the SEC on March 13, 2018 and in any
subsequent filings with the SEC. The forward-looking statements
contained in this press release reflect Verastem Oncology’s views
as of the date hereof, and the Company does not assume and
specifically disclaims any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by law.
References
1 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and
PI3K-gamma inhibition by IPI-145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models.
Chem Biol 2013; 20:1-11.
2 Reif K et al. Cutting Edge: Differential Roles for
Phosphoinositide 3 kinases, p110-gamma and p110-delta, in
lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
3 Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs
Unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell
2011;19:715-727.
4 www.clinicaltrials.gov, NCT03372057.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190307005861/en/
Verastem Oncology:Erin CoxSenior Director, Investor Relations
and Corporate Communications+1
781-469-1553ecox@verastem.comInvestors:Joseph RayneArgot Partners+1
617-340-6075joseph@argotpartners.com
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Apr 2024 to May 2024
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From May 2023 to May 2024