Verastem, Inc. VSTM, 2.48% (Verastem Oncology or the Company), focused on developing and commercializing medicines to advance the adaptation and affection of action of blight patients, today appear that the after-effects of the Appearance 3 DUO™ study, which evaluated COPIKTRA™ (duvelisib) capsules against ofatumumab in patients with relapsed or adverse abiding lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), was appear online in the peer-reviewed account Blood.
COPIKTRA is an articulate inhibitor of phosphoinositide 3-kinase (PI3K), and the aboriginal accustomed bifold inhibitor of PI3K-delta and PI3K-gamma. COPIKTRA was accustomed by the U.S. Food and Biologic Administration (FDA) on September 24 [th] , 2018 for the assay of relapsed or adverse CLL/SLL afterwards at atomic two above-mentioned therapies. The COPIKTRA NDA was accurate by analytic abstracts from the randomized, multicenter, open-label Appearance 3 DUO abstraction (NCT02004522), which compared COPIKTRA against ofatumumab in 319 developed patients with CLL (N = 312) or SLL (N = 7) afterwards at atomic one above-mentioned therapy. The abstraction randomized patients with a 1:1 arrangement to accept either COPIKTRA 25mg BID until ache progression or unacceptable toxicity, or ofatumumab for 7 cycles.
“Continued assay for new assay options is important to abode the needs of patients with relapsed or adverse CLL/SLL already they accept progressed,” said Ian Flinn, M.D., Ph.D., Director of the Lymphoma Assay Program at Sarah Cannon Assay Institute, advance investigator of the Appearance 3 DUO abstraction and advance columnist of the manuscript. “Duvelisib is an important accession to the evolving assay archetype for patients with CLL/SLL and we are captivated to accept the abstraction after-effects appear in Claret to allotment with the medical and accurate communities.”
The abounding arrangement blue-blooded “The appearance 3 DUO trial: duvelisib against ofatumumab in relapsed and adverse CLL/SLL,” is accessible here.
The approval and agnate characterization of COPIKTRA in CLL/SLL was based on adeptness and assurance assay of the majority of patients (n=196) in DUO that had been advised with at atomic 2 above-mentioned curve of therapy, area the benefit:risk appeared greater in this added heavily pretreated citizenry compared to the all-embracing balloon population. Per this analysis, COPIKTRA accomplished a best progression-free adaptation (PFS) compared to ofatumumab in patients with relapsed or adverse CLL/ SLL afterwards at atomic two above-mentioned therapies (median PFS of 16.4 months against 9.1 months, with a accepted absurdity (SE) of 2.1 and 0.5, respectively; HR=0.40, SE=0.2). Added adeptness measures included all-embracing acknowledgment amount (ORR) area COPIKTRA accustomed a 78% ORR compared to 39% accustomed by ofatumumab. Adeptness was based on PFS as adjourned by an Independent Review Committee (IRC).
Use of COPIKTRA is associated with a BOXED WARNING for four baleful and/or austere toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an advisory Accident Evaluation and Mitigation Action to accommodate adapted dosing and assurance advice to bigger abutment physicians in managing their patients on COPIKTRA.
Additionally, use of COPIKTRA is additionally associated with adverse reactions which may crave dosage reduction, assay adjournment or cessation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The best accepted ADVERSE REACTIONS (reported in greater-than or according to 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, high respiratory infection, pneumonia, musculoskeletal pain, and anemia.
Please see important Assurance Advice provided beneath and Prescribing Advice including BOXED WARNING and Medication Guide at www.COPIKTRAHCP.com/prescribinginformation
COPIKTRA Indication and Usage in CLL/SLL
Abiding Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
COPIKTRA is adumbrated for the assay of developed patients with relapsed or adverse CLL or SLL afterwards at atomic two above-mentioned therapies.
Adeptness in Relapsed or Adverse CLL/SLL
A randomized, multicenter, open-label balloon (DUO™; NCT02004522) compared COPIKTRA against ofatumumab in 319 developed patients with CLL (N = 312) or SLL (N = 7) afterwards at atomic one above-mentioned therapy. The abstraction randomized patients with a 1:1 arrangement to accept either COPIKTRA 25mg BID until ache progression or unacceptable toxicity, or ofatumumab for 7 cycles.
The approval of COPIKTRA was based on adeptness and assurance assay of patients with at atomic 2 above-mentioned curve of therapy, area the benefit:risk appeared greater in this added heavily pretreated citizenry compared to the all-embracing balloon population.
In this subset (95 randomized to COPIKTRA, 101 to ofatumumab), the average accommodating age was 69 years (range:40 to 90 years), 59% were male, and 88% had an ECOG achievement cachet of 0 or 1. Forty-six percent accustomed 2 above-mentioned curve of therapy, and 54% accustomed 3 or added above-mentioned lines. At baseline, 52% of patients had at atomic one bump greater-than or according to 5 cm, and 22% of patients had a accurate 17p deletion.
During randomized treatment, the average continuance of acknowledgment to COPIKTRA was 13 months (range:0.2 to 37), with 80% of patients accepting at atomic 6 months and 52% accepting at atomic 12 months of COPIKTRA. The average continuance of acknowledgment to ofatumumab was 5 months (range:< 0.1 to 6).
Efficacy was based on progression-free adaptation (PFS) as adjourned by an Independent Review Committee (IRC). Added adeptness measures included all-embracing acknowledgment amount (ORR). Adeptness of COPIKTRA compared to ofatumumab accurately in patients advised with at atomic two above-mentioned therapies is below.
COPIKTRA N = 95
Ofatumumab N = 101
Abbreviations: CR = complete response; IRC = Independent Review Committee; PFS = progression-free survival; PR = fractional response; SE = accepted absurdity [a] Kaplan-Meier appraisal [b ] Standard Absurdity of ln(hazard ratio) = 0.2 [c] IWCLL or revised IWG acknowledgment criteria, with modification for treatment-related lymphocytosis
Important Assurance Advice
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See abounding prescribing advice for complete boxed admonishing
WARNINGS AND PRECAUTIONS
Infections: Serious, including baleful (18/442; 4%), infections occurred in 31% of patients accepting COPIKTRA 25 mg BID (N=442). The best accepted austere infections were pneumonia, sepsis, and lower respiratory infections. Average time to access of any brand infection was 3 months (range:1 day to 32 months), with 75% of cases occurring aural 6 months. Amusement infections above-mentioned to admission of COPIKTRA. Advise patients to address new or deepening signs and affection of infection. For brand 3 or college infection, abstain COPIKTRA until infection is resolved. Resume COPIKTRA at the aforementioned or bargain dose.
Serious, including fatal, Pneumocystis jirovecii pneumonia (PJP) occurred in 1% of patients demography COPIKTRA. Accommodate prophylaxis for PJP during assay with COPIKTRA and afterward achievement of assay with COPIKTRA until the complete CD4 T corpuscle calculation is greater than 200 cells/µL. Abstain COPIKTRA in patients with doubtable PJP of any grade, and assuredly abandon if PJP is confirmed.
Cytomegalovirus (CMV) reactivation/infection occurred in 1% of patients demography COPIKTRA. Accede antibacterial antivirals during COPIKTRA assay to anticipate CMV infection including CMV reactivation. For analytic CMV infection or viremia, abstain COPIKTRA until infection or viremia resolves. If COPIKTRA is resumed, administrate the aforementioned or bargain dosage and adviser patients for CMV reactivation by PCR or antigen analysis at atomic monthly.
Diarrhea or Colitis: Serious, including baleful (1/442; <1%), diarrhea or colitis occurred in 18% of patients accepting COPIKTRA 25 mg BID (N=442). Average time to access of any brand diarrhea or colitis was 4 months (range:1 day to 33 months), with 75% of cases occurring by 8 months. The average accident continuance was 0.5 months (range:1 day to 29 months)(75th percentile:1 month).
Advise patients to address any new or deepening diarrhea. For patients presenting with balmy or abstinent diarrhea (Grade 1-2) (i.e., up to 6 stools per day over baseline) or asymptomatic (Grade 1) colitis, admit admiring affliction with antidiarrheal agents, abide COPIKTRA at the accepted dose, and adviser the accommodating at atomic account until the accident resolves. If the diarrhea is above to antidiarrheal therapy, abstain COPIKTRA and admit admiring assay with enteric acting steroids (e.g., budesonide). Adviser the accommodating at atomic weekly. Aloft resolution of the diarrhea, accede restarting COPIKTRA at a bargain dose.
For patients presenting with belly pain, stool with fungus or blood, change in bowel habits, peritoneal signs, or with astringent diarrhea (Grade 3) (i.e., > 6 stools per day over baseline), abstain COPIKTRA and admit admiring assay with enteric acting steroids (e.g., budesonide) or systemic steroids. A analytic work-up to actuate etiology, including colonoscopy, should be performed. Adviser at atomic weekly. Aloft resolution of the diarrhea or colitis, restart COPIKTRA at a bargain dose. For alternate Brand 3 diarrhea or alternate colitis of any grade, abandon COPIKTRA. Abandon COPIKTRA for life-threatening diarrhea or colitis.
Cutaneous Reactions: Serious, including baleful (2/442; <1%), cutaneous reactions occurred in 5% of patients accepting COPIKTRA 25 mg BID (N=442). Baleful cases included biologic acknowledgment with eosinophilia and systemic affection (DRESS) and baneful epidermal necrolysis (TEN). Average time to access of any brand cutaneous acknowledgment was 3 months (range:1 day to 29 months)(75th percentile:6 months) with a average accident continuance of 1 ages (range:1 day to 37 months)(75th percentile:2 months).
Presenting appearance for the austere contest were primarily declared as pruritic, erythematous, or maculo-papular. Less accepted presenting appearance accommodate exanthem, desquamation, erythroderma, bark exfoliation, keratinocyte necrosis, and papular rash. Advise patients to address new or deepening cutaneous reactions. Review all accessory medications and abandon any medications potentially accidental to the event. For patients presenting with balmy or abstinent (Grade 1-2) cutaneous reactions, abide COPIKTRA at the accepted dose, admit admiring affliction with emollients, antihistamines (for pruritus), or contemporary steroids, and adviser the accommodating closely. Abstain COPIKTRA for astringent (Grade 3) cutaneous acknowledgment until resolution. Admit admiring affliction with steroids (topical or systemic) or antihistamines (for pruritus). Adviser at atomic account until resolved. Aloft resolution of the event, restart COPIKTRA at a bargain dose. Abandon COPIKTRA if astringent cutaneous acknowledgment does not improve, worsens, or recurs. For life-threatening cutaneous reactions, abandon COPIKTRA. In patients with SJS, TEN, or DRESS of any grade, abandon COPIKTRA.
Pneumonitis: Serious, including baleful (1/442; <1%), pneumonitis afterwards an credible communicable account occurred in 5% of patients accepting COPIKTRA 25 mg BID (N=442). Average time to access of any brand pneumonitis was 4 months (range:9 canicule to 27 months), with 75% of cases occurring aural 9 months. The average accident continuance was 1 month, with 75% of cases absolute by 2 months.
Withhold COPIKTRA in patients with new or accelerating pulmonary signs and affection such as cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic exam, or a abatement by added than 5% in oxygen saturation, and appraise for etiology. If the pneumonitis is infectious, patients may be restarted on COPIKTRA at the antecedent dosage already the infection, pulmonary signs and affection resolve. For abstinent non-infectious pneumonitis (Grade 2), amusement with systemic corticosteroids and resume COPIKTRA at a bargain dosage aloft resolution. If non-infectious pneumonitis recurs or does not acknowledge to steroid therapy, abandon COPIKTRA. For astringent or life-threatening non-infectious pneumonitis, abandon COPIKTRA and amusement with systemic steroids.
Hepatotoxicity: Brand 3 and 4 ALT and/or AST acclivity developed in 8% and 2%, respectively, of patients accepting COPIKTRA 25 mg BID (N=442). Two percent of patients had both an ALT or AST > 3 X ULN and absolute bilirubin > 2 X ULN. Average time to access of any brand transaminase acclivity was 2 months (range:3 canicule to 26 months), with a average accident continuance of 1 ages (range:1 day to 16 months).
Monitor hepatic action during assay with COPIKTRA. For Brand 2 ALT/AST acclivity (> 3 to 5 X ULN), advance COPIKTRA dosage and adviser at atomic account until acknowledgment to < 3 X ULN. For Brand 3 ALT/AST acclivity (> 5 to 20 X ULN), abstain COPIKTRA and adviser at atomic account until acknowledgment to < 3 X ULN. Resume COPIKTRA at the aforementioned dosage (first occurrence) or at a bargain dosage for consecutive occurrences. For brand 4 ALT/AST acclivity (> 20 X ULN), abandon COPIKTRA.
Neutropenia: Brand 3 or 4 neutropenia occurred in 42% of patients accepting COPIKTRA 25 mg BID (N=442), with Brand 4 neutropenia occurring in 24% of all patients. Average time to access of brand greater-than or according to 3 neutropenia was 2 months.
Monitor neutrophil counts at atomic every 2 weeks for the aboriginal 2 months of COPIKTRA therapy, and at atomic account in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4). Abstain COPIKTRA in patients presenting with neutrophil counts < 0.5 Gi/L (Grade 4). Adviser until ANC is > 0.5 Gi/L, again resume COPIKTRA at aforementioned dosage for the aboriginal accident or at a bargain dosage for consecutive occurrences.
Embryo-Fetal Toxicity: Based on allegation in animals and its apparatus of action, COPIKTRA can account fetal abuse back administered to a abundant woman. Advise abundant women of the abeyant accident to a fetus. Conduct abundance testing afore initiating COPIKTRA treatment. Advise females of changeable abeyant and males with changeable ally of changeable abeyant to use able contraception during assay and for at atomic 1 ages afterwards the aftermost dose.
B-cell Malignancies Summary
Fatal adverse reactions aural 30 canicule of the aftermost dosage occurred in 8% (36/442) of patients advised with COPIKTRA 25 mg BID. Austere adverse reactions were appear in 289 patients (65%). The best accepted austere adverse reactions that occurred were infection (31%), diarrhea or colitis (18%), pneumonia (17%), adventurous (5%), and pneumonitis (5%).
Adverse reactions resulted in assay cessation in 156 patients (35%) best about due to diarrhea or colitis, infection, and rash. COPIKTRA was dosage bargain in 104 patients (24%) due to adverse reactions, best about due to diarrhea or colitis and transaminase elevation. The best accepted adverse reactions (reported in greater-than or according to 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, high respiratory infection, pneumonia, musculoskeletal affliction and anemia.
Fatal adverse reactions aural 30 canicule of the aftermost dosage occurred in 12% (19/158) of patients advised with COPIKTRA and in 4% (7/155) of patients advised with ofatumumab. Austere adverse reactions were appear in 73% (115/158) of patients advised with COPIKTRA and best about complex infection (38%; 60/158) and diarrhea or colitis (23%; 36/158). COPIKTRA was discontinued in 57 patients (36%), best about due to diarrhea or colitis, infection, and rash. COPIKTRA was dosage bargain in 46 patients (29%), best about due to diarrhea or colitis and rash. The best accepted adverse reactions with COPIKTRA (greater-than or according to 20% of patients) were diarrhea or colitis, neutropenia, pyrexia, high respiratory amplitude infection, pneumonia, rash, fatigue, nausea, anemia and cough.
About Abiding Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and baby lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are about the aforementioned disease, with the abandoned aberration actuality the area area the blight primarily occurs. Back best of the blight beef are amid in the bloodstream and the cartilage marrow, the ache is referred to as CLL, although the lymph nodes and annoyance are about involved. Back the blight beef are amid mostly in the lymph nodes, the ache is alleged SLL. Affection can accommodate fatigue, conciseness of breath, anemia, able-bodied easily, night sweats, weight loss, and accepted infections. However, abounding patients with CLL/SLL will alive for years afterwards symptoms. There are about 200,000 patients in the US afflicted by CLL/SLL with about 20,000 new diagnoses this year alone. While there are therapies currently available, real-world abstracts reveals that a cogent cardinal of patients either backsliding afterward treatment, become adverse to accepted agents, or are clumsy to abide treatment, apery a cogent medical need. The abeyant of added articulate agents, decidedly as a monotherapy that can be acclimated in the accepted association physician’s armamentarium, may authority cogent amount in the assay of patients with CLL/SLL.
About COPIKTRA™ (duvelisib)
COPIKTRA is an articulate inhibitor of phosphoinositide 3-kinase (PI3K), and the aboriginal accustomed bifold inhibitor of PI3K-delta and PI3K-gamma, two enzymes accepted to advice abutment the advance and adaptation of cancerous B-cells. PI3K signaling may advance to the admeasurement of cancerous B-cells and is anticipation to comedy a role in the accumulation and aliment of the admiring bump microenvironment. [2,3,4 ] COPIKTRA is adumbrated for the assay of developed patients with relapsed or adverse abiding lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) afterwards at atomic two above-mentioned therapies. COPIKTRA is additionally actuality developed by Verastem Oncology for the assay of borderline T-cell lymphoma (PTCL), for which it has accustomed Fast Track status, and is actuality advised in aggregate with added agents through investigator-sponsored studies.  For added advice on COPIKTRA, amuse appointment www.COPIKTRA.com. Advice about duvelisib analytic trials can be begin on www.clinicaltrials.gov.
About Verastem Oncology
Verastem Oncology VSTM, 2.48% is a bartering biopharmaceutical aggregation committed to the development and commercialization of medicines to advance the lives of patients diagnosed with cancer. We are apprenticed by the strength, application and adventuresomeness of those aggressive blight – committed in our dness to bear new therapies that not abandoned accumulate blight at bay, but advance the lives of patients diagnosed with cancer. Because for us, it’s personal.
Our aboriginal FDA accustomed artefact is now accessible for the assay of patients with assertive types of blah non-Hodgkin’s lymphoma (iNHL). Our action comprises artefact candidates that seek to amusement blight by modulating the bounded bump microenvironment. For added information, amuse appointment www.verastem.com.
Forward attractive statements apprehension
This columnist absolution includes advanced statements about Verastem Oncology’s strategy, approaching affairs and prospects, including statements apropos the development and action of Verastem Oncology’s advance artefact COPIKTRA, and Verastem Oncology’s PI3K and FAK programs generally, its absorbed to commercialize COPIKTRA, the abeyant bartering success of COPIKTRA, the advancing acceptance of COPIKTRA by patients and physicians, the anatomy of its planned and awaiting analytic trials and the timeline and break for analytic development, authoritative submissions and commercialization activities. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and agnate expressions are advised to analyze advanced statements, although not all advanced statements accommodate these anecdotic words. Each advanced account is accountable to risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated in such statement. Applicable risks and uncertainties include, amid added things, uncertainties apropos the barrage timing and bartering success of COPIKTRA in the United States; uncertainties apropos physician and accommodating acceptance of COPIKTRA, including those accompanying to the assurance and adeptness of COPIKTRA; the uncertainties inherent in assay and development of COPIKTRA, such as abrogating or abrupt after-effects of analytic trials; whether and back any applications for COPIKTRA may be filed with authoritative authorities in any added jurisdictions; whether and back authoritative authorities in any added jurisdictions may accept any such added applications that may be filed for COPIKTRA, which will depend on the appraisal by such authoritative authorities of the benefit-risk contour appropriate by the accumulation of the adeptness and assurance advice submitted and, if approved, whether COPIKTRA will be commercially acknowledged in such jurisdictions; Verastem Oncology’s adeptness to obtain, advance and accomplish apparent and added bookish acreage aegis for COPIKTRA and its added artefact candidates; the scope, timing, and aftereffect of any acknowledged proceedings; decisions by authoritative authorities apropos labeling and added affairs that could affect the availability or bartering abeyant of COPIKTRA; that authoritative authorities in the U.S. or added jurisdictions, if approved, could abjure approval; whether preclinical testing of Verastem Oncology’s artefact candidates and basic or acting abstracts from analytic trials will be predictive of the after-effects or success of advancing or after analytic trials; that the timing, ambit and amount of agreement for Verastem Oncology’s artefact candidates is uncertain; the accident that third affair payors (including government agencies) will not balance for COPIKTRA; that there may be aggressive developments affecting its artefact candidates; that abstracts may not be accessible back expected; that acceptance of analytic trials may booty best than expected; that COPIKTRA or Verastem Oncology’s added artefact candidates will account abrupt assurance events, acquaintance accomplishment or accumulation interruptions or failures, or aftereffect in annoying assurance profiles as compared to their levels of efficacy; that COPIKTRA will be abortive at alleviative patients with lymphoid malignancies; that Verastem Oncology will be clumsy to auspiciously admit or complete the analytic development and closing commercialization of its artefact candidates; that the development and commercialization of Verastem Oncology’s artefact candidates will booty best or amount added than planned; that Verastem Oncology may not accept acceptable banknote to armamentarium its advised operations; that Verastem Oncology or Infinity Pharmaceuticals, Inc. will abort to absolutely accomplish beneath the duvelisib authorization agreement; that Verastem Oncology may be clumsy to accomplish added draws beneath its debt ability or access able costs in the approaching through artefact licensing, co-promotional arrangements, accessible or clandestine equity, debt costs or otherwise; that Verastem Oncology will not accompany or abide authoritative filings for its artefact candidates, including for duvelisib in patients with CLL/SLL or FL in added jurisdictions; and that Verastem Oncology’s artefact candidates will not accept authoritative approval, become commercially acknowledged products, or aftereffect in new assay options actuality offered to patients.
Other risks and uncertainties accommodate those articular beneath the branch “Risk Factors” in the Company’s Annual Address on Form 10-Q for the annual aeon concluded June 30, 2018 as filed with the Securities and Exchange Commission (SEC) on August 8, 2018, its Annual Address on Form 10-K for the year concluded December 31, 2017 as filed with the SEC on March 13, 2018 and in any consecutive filings with the SEC. The advanced statements independent in this columnist absolution reflect Verastem Oncology’s angle as of the date hereof, and the Aggregation does not accept and accurately disclaims any obligation to amend any advanced statements whether as a aftereffect of new information, approaching contest or otherwise, except as appropriate by law.
 Decision Resources Group 2018 Estimates.  Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates allowed responses and suppresses action in autoimmune and anarchic ache models. Chem Biol 2013; 20:1-11.  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.  Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly actuate myeloid corpuscle PI3K, a distinct allied point announcement bump deepening and progression. Blight Corpuscle 2011;19:715-727.  www.clinicaltrials.gov, NCT03372057.
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SOURCE: Verastem, Inc.
Verastem Oncology: Brian Sullivan, 1 781-469-1636 Senior Director, Corporate Development firstname.lastname@example.org or Media: FleishmanHillard Adam Silverstein, 1 917-697-9313 email@example.com or Investors: Argot Ally Joseph Rayne, 1 617-340-6075 firstname.lastname@example.org
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