On December 6, 2015 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, and Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, reported the results from their Phase 1 combination trial of belinostat (Beleodaq) with the CHOP (Cyclophosphamide, Hydroxyl-doxorubicin; Vincristine, and Prednisone) chemotherapy regimen as first-line treatment for newly diagnosed peripheral T-cell lymphoma (PTCL) (Press release, Spectrum Pharmaceuticals, DEC 6, 2015, View Source [SID:1234508432]). Schedule your 30 min Free 1stOncology Demo! Beleodaq is a histone deacetylase (HDAC) inhibitor that received accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory PTCL in July 2014.
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The results were presented today in an oral presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition by Dr. Patrick Johnston, MD, PhD, Assistant Professor of Medicine at the Mayo Clinic, Rochester, MN, USA.
Abstract #253: Safe and Effective Treatment of Patients with Peripheral T-cell Lymphoma (PTCL) with the Novel HDAC Inhibitor, Belinostat, in Combination with CHOP: Results of the Bel-CHOP Phase 1 Trial
This open-label, two-part trial enrolled a total of 23 patients. Eleven were enrolled in Part A, the dose-escalation phase, to determine the study’s primary endpoint, the maximum tolerated dose (MTD). Part B of the study, the Expansion Phase, enrolled 12 additional patients at this dose level. The MTD of belinostat was established at 1,000 mg/m2 IV infusion on Days 1-5 (the recommended single agent dose) when combined with the CHOP regimen, with each component given at its full recommended dose. Secondary endpoints included safety, tolerability, Objective Response Rate (ORR: Complete Response + Partial Response), and pharmacokinetics.
Results outlined in the oral presentation showed an ORR of 86% with the belinostat and CHOP combination, based on 21 evaluable patients (18/21), with the vast majority, 67%, achieving a Complete Response (14/21), and 19% achieving a Partial Response (4/21). In addition, the belinostat and CHOP combination was shown to have an acceptable safety profile with no new or unexpected toxicities. The most common ( > 10%) Grade 3-4 hematologic adverse events (AEs) reported with Bel-CHOP were as expected: neutrophil count decreased (30%), anemia (22%), neutropenia (22%), white blood cell (WBC) count decreased (22%), febrile neutropenia (17%) and lymphocyte count decreased (17%). No Grade 3-4 non-hematologic AEs > 10% were reported. No patient discontinued therapy due to AEs. One patient died as a result of disease progression during the study.
Dr. Patrick Johnston, MD, PhD, Assistant Professor of Medicine at the Mayo Clinic and investigator on the trial, commented, "PTCL is a very difficult lymphoma to treat due to its heterogeneous nature, and its association with multiple recurrence and poor prognosis; only approximately 37% of patients achieve 5-year overall survival. New combination treatment strategies are undeniably needed to improve efficacy without compromising tolerability, and we are encouraged by these Phase 1 study results indicating that the combination of belinostat and CHOP is a potentially viable treatment option. A good safety profile combined with an Objective Response Rate of 86%, and 67% of patients achieving complete response, are unusual in an early trial of this cancer type. We look forward to further evaluating the combination in a planned Phase 3 trial."
"We are proud to have had several presentations on our products at the ASH (Free ASH Whitepaper) meeting, and are optimistic about the new combination data with belinostat," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "Beleodaq was approved for the treatment of patients with relapsed or refractory PTCL based on an Objective Response Rate in the pivotal Phase 2 BELIEF study of 25.8%. The results of this Phase 1 study indicate encouraging safety and efficacy for the combination of belinostat and CHOP in newly diagnosed patients. The clinical activity suggests that earlier treatment with belinostat could be beneficial for the treatment of this devastating disease. Spectrum has a unique PTCL franchise with two FDA approved drugs; we are very proud to be able to offer patients and clinicians additional treatment options for a disease which had no FDA-approved treatments until a few years ago."
Graham Dixon, PhD, Chief Scientific Officer of Onxeo, added, "We are very excited to have these results discussed in an oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting. Collectively, the efficacy and safety findings demonstrate the potential value of belinostat plus CHOP, and Onxeo is thrilled to continue the development of belinostat to more broadly assess this promising therapy in PTCL and beyond."
References
1. Johnston, P. "Safe and Effective Treatment of Patients with Peripheral T-cell Lymphoma (PTCL) with the Novel HDAC Inhibitor, Belinostat, in Combination with CHOP: Results of the BelCHOP Phase 1 Trial." Abstract #253 accepted for Oral Presentation at the 2015 ASH (Free ASH Whitepaper) Annual Meeting, Dec. 5-8, 2015. Abstract available online at: View Source
About BELEODAQ
Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations ( < 250 nM).
Indications and Usage
Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Important Beleodaq Safety Information
Warnings and Precautions
Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary.
Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections.
Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities. Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity.
Tumor lysis syndrome has occurred in Beleodaq-treated patients in the clinical trial of patients with relapsed or refractory PTCL.
Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions.
Nausea, vomiting and diarrhea occur with Beleodaq and may require the use of antiemetic and antidiarrheal medications.
Beleodaq can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid pregnancy while receiving Beleodaq. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of potential hazard to the fetus.
Adverse Reactions
The most common adverse reactions observed in the trial in patients with relapsed or refractory PTCL treated with Beleodaq were nausea (42%), fatigue (37%), pyrexia (35%), anemia (32%), and vomiting (29%).
Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq or within 30 days after their last dose of Beleodaq.
Drug Interactions
Beleodaq is primarily metabolized by UGT1A1. Avoid concomitant administration of Beleodaq with strong inhibitors of UGT1A1.
Use in Specific Populations
It is not known whether belinostat is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Beleodaq, a decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother.
Author: [email protected]
Novartis drug PKC412 (midostaurin) improves overall survival by 23% in global Phase III study of AML patients with FLT3 mutations
On December 6, 2015 Novartis reported positive results from the global Phase III RATIFY (CALGB 10603) clinical trial (Press release, Novartis, DEC 6, 2015, View Source [SID:1234508430]). Schedule your 30 min Free 1stOncology Demo! In the study, adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) who received the investigational compound PKC412 (midostaurin) plus standard induction and consolidation chemotherapy experienced a 23% improvement in overall survival (OS) (hazard ratio [HR] = 0.77, P = 0.0074) compared to those treated with standard induction and consolidation chemotherapy alone[4]. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval [CI]: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group[4].
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The trial evaluated the addition of either PKC412 (midostaurin) or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase; patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 (midostaurin) or placebo as a single agent for up to one year[4].
The data, collected and analyzed in partnership with the Alliance for Clinical Trials in Oncology, are from the largest clinical trial in FLT3-mutated AML to date, with 3,279 patients screened and 717 study participants from around the world[4]. Results will be presented today at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, first during the official ASH (Free ASH Whitepaper) media briefing at 11:00 am EST and then during the plenary session at 2:00 pm EST.
"The overall survival results for midostaurin, plus standard chemotherapy, in treating FLT3-mutated AML is a long-awaited advancement for hematologists and the AML community," said Richard M. Stone, MD, Professor of Medicine at the Dana-Farber Cancer Institute and Alliance for Clinical Trials in Oncology study chair for the RATIFY trial. "FLT3 is a common genetic mutation in AML and is currently associated with poorer prognoses, underscoring the critical need for new treatment options."
The treatment strategy in AML has remained unchanged for more than 25 years[2],[3]. Of the approximately 350,000 people with leukemias worldwide[5], about 25% have AML[1]. One-third of AML patients also harbor a FLT3 gene mutation[6], which is associated with worse outcomes and shorter survival than in those without the mutation[7]. PKC412 (midostaurin) is the first drug to illustrate an overall survival benefit targeting FLT3 in AML – a hematological malignancy with no approved targeted treatments.
In addition to meeting the primary endpoint of OS, event free survival (EFS, defined as the earliest death, relapse or no complete response within 60 days of the start of induction therapy) was significantly higher in the PKC412 (midostaurin) treatment group versus the placebo group [HR = 0.79, P = 0.0025 and median of 8.0 months (95% CI: 5.14, 10.6) vs. 3.0 months (95% CI: 1.9, 5.9)] [4].
No statistically significant differences were observed in the overall rate of grade 3 or higher hematologic and non-hematologic adverse events (AEs) [4]. A total of 37 deaths were reported, with no difference in treatment-related deaths observed between groups[4].
"The RATIFY study, in partnership with the Alliance for Clinical Trials in Oncology, reflects our relentless pursuit to develop targeted therapies that can improve and extend people’s lives," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Based on the results of this trial, we plan to move forward with global regulatory submissions for PKC412 (midostaurin) in the first half of 2016."
In order to help identify patients who may have a FLT3 mutation and potentially benefit from treatment with PKC412 (midostaurin), Novartis is collaborating with Invivoscribe Technologies, Inc. who will lead regulatory submissions for a companion diagnostic.
About the RATIFY trial
RATIFY (Randomized AML Trial In FLT3 in patients <60 Years old; also known as CALGB 10603) was a Phase III, international, randomized, placebo-controlled, double-blind group trial of newly-diagnosed AML patients aged 18 to less than 60 with a FLT3 mutation[4]. The study compared PKC412 (midostaurin) to placebo administered orally with up to two cycles of standard induction (daunorubicin/cytarabine) chemotherapy, and up to four cycles of consolidation (high-dose cytarabine) chemotherapy, followed by PKC412 (midostaurin) or placebo treatment as a single agent for up to one year in patients who continue in complete remission after consolidation chemotherapy[4]. The primary endpoint was OS and the key secondary endpoint was EFS[4].
The data were collected by the Alliance for Clinical Trials in Oncology ("Alliance") on behalf of 13 contributing international cooperative groups. The Alliance was the sponsor of the study in North America and Novartis was the sponsor in Europe and Australia. A total of 225 sites from 17 countries participated in this study, spanning North America, Europe and Australia. A total of 3,279 patients with AML were screened, and 717 patients with an activating FLT3 mutation aged 18 to less than 60 were enrolled[4].
Patients were stratified according to the following mutation subtypes: tyrosine kinase domain (TKD), internal tandem duplications (ITD) high allelic mutation fraction (>0.7) and ITD low allelic mutation fraction (0.05-0.7)[4]. All three subtypes treated with PKC412 (midostaurin) demonstrated improved OS versus placebo[4]. Allogeneic hematopoietic stem cell transplantation (SCT) was allowed[4]. PKC412 (midostaurin) benefited patients regardless of whether they went on to receive a SCT[4].
About acute myeloid leukemia (AML) and the FLT3 mutation
AML is an aggressive cancer of the blood and bone marrow[8]. It prevents white blood cells from maturing, causing an accumulation of "blasts" which do not allow room for the normal blood cells[8]. AML is the most common acute leukemia in adults, but also has the lowest survival rate[1]. AML accounts for approximately 25% of all adult leukemias worldwide, with the highest incidence rates occurring in the United States, Europe and Australia[1].
Mutations in specific genes are found in many cases of AML, and biomarker testing is considered standard of care for newly-diagnosed patients to help determine the best possible treatment option[6]. FLT3 is a receptor tyrosine kinase, a type of cell-surface receptor, which plays a role in the proliferation, or increase, in the number of certain blood cells[9].
About PKC412 (midostaurin)
PKC412 (midostaurin) is an investigational, oral, multi-targeted kinase inhibitor in development for the treatment of patients with AML with a FLT3 mutation. PKC412 (midostaurin) inhibits multiple kinases, or enzymes, including FLT3, that help regulate many essential cell processes, thereby interrupting cancer cells’ ability to grow and multiply[10].
PKC412 (midostaurin) is also being investigated for the treatment of aggressive systemic mastocytosis/mast cell leukemia[11].
PKC412 (midostaurin) is an investigational compound; the safety and efficacy profile have not been fully established.
New Results from CLL11 Study Show Gazyva® Provided People with Previously Untreated Chronic Lymphocytic Leukemia a Treatment-free Period of Nearly Four Years
On December 5, 2015 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported updated data from the pivotal CLL11 study confirming that Gazyva (obinutuzumab) plus chlorambucil reduced the risk of disease worsening or death by more than half compared to Rituxan (rituximab) plus chlorambucil (progression-free survival, PFS; HR=0.46, median PFS 28.7 months versus 15.7 months; p<0.0001) (Press release, Genentech, DEC 5, 2015, View Source [SID:1234508546]). New results to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from a secondary endpoint that measured time to next treatment (TTNT) showed that, after completing the set six-month Gazyva regimen, people remained treatment-free for nearly four years on average before needing the next treatment for their cancer (TTNT; 51.1 months, including the six-month initial treatment period). No unexpected safety signals were observed with Gazyva.
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"These updated CLL11 data confirmed that Gazyva helped people with previously untreated chronic lymphocytic leukemia live significantly longer without disease worsening or death compared to Rituxan," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "After a fixed course of therapy with Gazyva, people remained treatment-free for nearly four years on average. Time free from treatment is an important consideration for a disease like CLL, which occurs in older adults who frequently have other health issues. "
In the GREEN safety study, data from a subgroup analysis showed there were no unexpected safety signals when Gazyva was combined with bendamustine. In addition, nearly 80 percent of people responded to treatment with Gazyva plus bendamustine (overall response rate, ORR), and a third of people (32.3 percent) achieved a complete response (CR). A substantial number of people were also minimal residual disease (MRD)-negative when measured in the bone marrow or blood (28 percent and 59 percent, respectively), which means no cancer can be detected using a specific test. ORR and MRD-negativity were secondary endpoints of the study.
Gazyva in combination with chlorambucil is approved in the United States for use in people with previously untreated CLL and in the EU for use in people with previously untreated CLL who have co-existing medical conditions (comorbidities) making them unsuitable for an intensive therapy (full-dose fludarabine based therapy).
About the CLL11 Study
CLL11 is a Phase III, multicenter, open-label, randomized three-arm study investigating the efficacy and safety profile of Gazyva plus chlorambucil, Rituxan plus chlorambucil and chlorambucil alone in 781 people with previously untreated CLL. Stage 1 (n=589) compared Gazyva plus chlorambucil to chlorambucil alone and Rituxan plus chlorambucil to chlorambucil alone. Stage 2 (n=663) compared Gazyva plus chlorambucil with Rituxan plus chlorambucil.
The primary endpoint of the study was PFS and secondary endpoints included ORR, overall survival (OS), CR, response duration, disease free survival (DFS), TTNT, MRD-negativity and safety profile.
The updated analysis from CLL11 will be presented at a poster session on Saturday, December 5 at 5:30 P.M. EST (Abstract #1733).
About the GREEN Study
GREEN is an ongoing Phase IIIb safety study. This multicenter, open-label, single-arm study is evaluating the safety and efficacy of Gazyva alone or in combination with chemotherapy, including bendamustine, in people with previously untreated or relapsed/refractory CLL. The primary endpoint of the study was safety with secondary endpoints including ORR and MRD-negativity.
The study included a subgroup of people who were previously untreated and who received treatment with Gazyva in combination with bendamustine. Data from this subgroup analysis will be presented at an oral presentation on Monday, December 7 at 7:00 A.M. EST (Abstract #493).
About Chronic Lymphocytic Leukemia (CLL)
CLL is one of the most common forms of blood cancer and in 2015, it is expected that there will be about 4,650 deaths from CLL in the United States. Most cases of CLL (95 percent) start in white blood cells called B-cells that have a protein called CD20 on their surface.
About Gazyva
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body’s immune system. Gazyva is thought to have an increased ability to induce direct cell death and induces greater activity in how it recruits the body’s immune system to attack B-cells (antibody dependent cellular cytotoxicity; ADCC) when compared to Rituxan. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen Idec.
Gazyva is being studied in a large clinical program, including the Phase III GOYA and GALLIUM studies. GOYA is comparing Gazyva head-to-head with Rituxan plus chemotherapy in first line diffuse large B-cell lymphoma (DLBCL) and GALLIUM is comparing Gazyva plus chemotherapy head-to-head with Rituxan plus chemotherapy in first line indolent non-Hodgkin’s lymphoma (NHL). Additional combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.
Gazyva Indication
Gazyva is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
Important Safety Information
Patients must tell their doctor right away about any side effects they experience.
Gazyva can cause side effects that can become serious or life threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If a patient has had history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen for hepatitis B before, and monitor the patient for hepatitis during and after, treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. A patient’s weakened immune system could put the patient at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that may become severe or life threatening, including:
Infusion Reactions: These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If a patient has a reaction, the infusion is either slowed or stopped until the patient’s symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is serious, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Signs of infusion reactions may include: dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, and chest pain.
Tumor Lysis Syndrome (TLS): Gazyva works to break down cancer cells quickly.
As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. TLS, including death, has been reported in patients receiving Gazyva. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness.
Infections: While a patient is taking Gazyva, the patient may develop infections. Some of these infections may be severe. Fatal infections have been reported, so the patient should be sure to talk to the doctor if the patient thinks the patient has one. Patients with active infection should not be treated with Gazyva. Infections may continue even after the patient stops taking Gazyva. The patient’s doctor may prescribe medications to help prevent infections. Symptoms of infection include fever and cough.
Low White Blood Cell Count : When a patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s white blood cell counts. Neutropenia can develop during or after treatment with Gazyva. It may also last for more than one month. If a patient’s white blood cell count is low, the patient’s doctor may prescribe medication to help prevent infections.
Low Platelet Count: Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in the blood. This may affect the clotting process. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s platelet count.
Most common side effects of Gazyva
The most common side effects of Gazyva are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.
Before receiving Gazyva, patients should talk to their doctor about:
Immunizations: Before receiving Gazyva therapy, the patient should tell the patient’s healthcare provider if the patient has recently received or is scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines.
Pregnancy: A patient should tell the doctor if the patient is pregnant, plans to become pregnant, or is breastfeeding. Gazyva may harm the unborn baby. Mothers who have been exposed to Gazyva during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. It is not known if Gazyva may pass into the patient’s breast milk. The patient should speak to the doctor about using Gazyva if the patient is breastfeeding.
Patients must tell their doctor about any side effects.
These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.
Gazyva is available by prescription only.
Report side effects to the FDA at (800) FDA-1088, or View Source Report side effects to Genentech at (888) 835-2555.
Please visit View Source for the full Prescribing Information, including
Boxed WARNINGS, for additional Important Safety Information.
Rituxan Indications
Rituxan (rituximab) is indicated for the treatment of patients with:
· Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
· Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy
· Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
· Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
· Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
Rituxan is not recommended for use in patients with severe, active infections.
Important Safety Information:
Rituxan can cause serious side effects that can lead to death, including:
Infusion Reactions: may occur during or within 24 hours of the infusion. The
patient’s doctor should give the patient medicines before their treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart or chest pain.
Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on the skin, lips or mouth; peeling skin; rash; or pustules.
Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving Rituxan could cause the virus to become an active infection again. Patient should not receive Rituxan if they have active HBV liver disease. The patient’s doctor will do blood tests to check for HBV infection prior to treatment and will monitor the patient during and for several months following their treatment.
Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of the body or blurred or lost vision.
What are the additional possible serious side effects of Rituxan?
Patients must tell their doctor right away about any side effects they experience. Rituxan can cause serious side effects that can lead to death, including:
Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm and can lead to death. The patient’s doctor may give the patient medicines before their treatment to help prevent TLS.
Serious Infections: can happen during and after treatment and can lead to
death. These infections may be bacterial, fungal or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen or painful.
Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. The patient’s doctor may need to stop their treatment.
Kidney Problems: the patient’s doctor should do blood tests to check how well the patient’s kidneys are working.
Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom.
Low Blood Cell Counts: the patient’s blood cell counts may be monitored during treatment.
The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness and low white blood cells.
Patients must tell their doctor if they are pregnant, plan to become pregnant or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.
Patients must tell their doctor about any side effect that bothers them or that does not go away.
These are not all of the possible side effects of Rituxan. For more information, patients should ask their doctor or pharmacist.
Novartis announces Phase III studies of Jakavi show disease improvement in patients with myelofibrosis and polycythemia vera
On December 5, 2015 Novartis reported that five-year treatment with Jakavi (ruxolitinib) suggested an overall survival advantage for patients with myelofibrosis (MF), despite crossover to Jakavi from the best available therapy arm after the primary analysis at 48 weeks (intent-to-treat analysis: 33% reduction in risk of death, hazard ratio=0.67 [95% confidence interval (CI), 0.44-1.02], crossover-corrected hazard ratio=0.44 [95% CI, 0.18-1.04]) (Press release, Novartis, DEC 5, 2015, View Source [SID:1234508421]). In the COMFORT-II (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) Phase III study, more than half of the patients with MF (53.4%) also experienced significant reductions (>=35%) in spleen size with Jakavi therapy, and sustained this benefit over prolonged periods of time (median duration of 3.2 years)[1]. Findings from this study were presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting (ASH) (Free ASH Whitepaper) in Orlando, Florida.
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"Given that patients with myelofibrosis have shortened survival expectations and are at an increased risk of complications, the five-year findings from COMFORT-II demonstrate a long-term benefit with Jakavi therapy that is meaningful to the community," said Claire Harrison, MD, study investigator and Consultant Hematologist, Guy’s and St. Thomas’ NHS Foundation Trust, London. "These data help to confirm the important role Jakavi plays in these difficult-to-treat patients."
In addition to the Jakavi data presented at ASH (Free ASH Whitepaper), Novartis announced that a separate Phase III study met its primary endpoint-patients with polycythemia vera (PV) resistant to or intolerant of hydroxyurea who did not have an enlarged spleen who were treated with Jakavi maintained hematocrit control without the need for phlebotomy. In the Phase III RESPONSE 2 (Randomized Study of Efficacy and Safety in POlycythemia Vera with JAK INhibitor Ruxolitinib VerSus BEst Available Care) study, the safety profile of Jakavi was consistent with previous studies. Full results from the trial continue to be evaluated and will be presented at a future medical congress.
"The growing body of research confirms the benefit of Jakavi for patients with rare blood cancers, such as myelofibrosis and polycythemia vera, who have limited treatment options," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "In addition to exhibiting long-term benefits in myelofibrosis, Jakavi also showed potential to benefit a broader population of patients with polycythemia vera, bringing hope to another underserved patient community."
About the COMFORT-II Study
COMFORT-II (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) is a randomized, open-label, Phase III study of 219 patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) in 56 study locations in Europe. Two-thirds of patients (146) received Jakavi twice daily and one-third of patients (73) received best available therapy, which was administered at doses and schedules determined by the investigator. Best available therapy was selected by the investigator for each patient and could have included a combination of available agents to treat the disease and/or its symptoms. Of the patients on the best available therapy arm, 61.6% crossed over to receive Jakavi upon protocol-defined progression following the primary analysis after week 48. All patients randomized to best available therapy have crossed over or discontinued. An analysis of the study at five years was performed to evaluate the safety and efficacy of Jakavi in patients with MF[1].
In the Phase III trial, fibrosis grades, a key indicator of disease control in MF, improved (15.8%) or were maintained (32.2%) in nearly half of patients with long-term Jakavi treatment. Nearly one-quarter of patients (26.7% from Jakavi treatment arm; 24.4% who crossed over from best available treatment arm) remained on treatment with Jakavi for five years. All adverse events (AEs) were consistent with previous analyses of treatment with Jakavi in patients with MF. The most common AEs in Jakavi-treated patients either after randomization or after crossing over from best available therapy were thrombocytopenia (52.4%), anemia (49.2%), diarrhea (35.6%) and peripheral edema (33.0%). The most common grade 3/4 AEs included anemia (22.5%), thrombocytopenia (15.2%), pneumonia (5.8%), general physical health deterioration (4.2%) and shortness of breath (4.2%)[1].
About the RESPONSE 2 Study
RESPONSE 2 (Randomized Study of Efficacy and Safety in POlycythemia Vera with JAK INhibitor Ruxolitinib VerSus BEst Available Care) is a multi-center, open label, randomized, Phase IIIb study evaluating the efficacy and safety of Jakavi versus best available therapy. The trial randomized 149 patients with PV who were resistant to or intolerant of hydroxyurea, dependent on phlebotomy for hematocrit control and did not have an enlarged spleen. Patients were randomized 1:1, by stratification (based on hydroxyurea resistance or intolerance) to receive either Jakavi (10 mg twice daily) or best available therapy, which was defined as investigator selected monotherapy or observation only. The dose was adjusted as needed throughout the study.
About Myelofibrosis
MF is part of a group of related rare blood cancers known as myeloproliferative neoplasms (MPNs) where a patient’s bone marrow can no longer produce enough normal blood cells, causing the spleen to enlarge[2]. As a result, patients with MF may suffer from debilitating symptoms and have a poor quality of life[4]. After diagnosis, patients with MF have a decreased life expectancy, with an average survival of approximately five to six years[5]. Although allogeneic stem cell transplantation may cure MF, the procedure is associated with significant morbidity and transplant-related mortality, and is available to less than 5% of patients who are young and fit enough to undergo the procedure[6].
About Polycythemia Vera
Also an MPN, PV is associated with an overproduction of blood cells in the bone marrow and affects roughly one to three people per 100,000 globally[3],[7]. The disease is driven by the dysregulation of the JAK-STAT pathway[8]. It is typically characterized by elevated hematocrit, the volume percentage of red blood cells in whole blood, which can lead to a thickening of the blood and an increased risk of blood clots, as well as an elevated white blood cell and platelet count[3]. This can cause serious cardiovascular complications, such as stroke and heart attack, resulting in increased morbidity and mortality[9]. Approximately 60 to 70% of patients with PV do not have enlarged spleen[10].
A common PV treatment includes phlebotomy, a procedure to remove blood from the body to reduce the concentration of red blood cells, which is used to help maintain a hematocrit level below 45%[3],[9]. However, for a subset of patients, including those with high-risk PV, phlebotomy is usually unsuitable as a permanent treatment option due to its inability to control symptoms or effectively manage the overproduction of red blood cells, therefore cytoreductive agents, such as hydroxyurea, may be added[9]. For patients requiring phlebotomy in combination with hydroxyurea, hematocrit may fluctuate and remain at unsafe levels for significant periods of time[11]. Unfortunately, approximately 25% of patients with PV become resistant to or intolerant of hydroxyurea treatment according to European LeukemiaNet (ELN) criteria, resulting in inadequate disease control and an increased risk of progression[12].
About Jakavi
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF. Jakavi is approved in more than 95 countries for patients with MF, including countries in the European Union, Canada, Japan and countries in Asia, Latin and South America, and in 49 countries for patients with PV, including countries in the European Union, Japan and Canada. The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.
Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States. Jakavi is marketed in the United States by Incyte Corporation as Jakafi for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea and for the treatment of patients with intermediate or high-risk MF.
The recommended starting dose of Jakavi in PV is 10 mg given orally twice daily. The recommended starting dose of Jakavi in MF is 15 mg twice daily for patients with a platelet count between 100,000 cubic millimeters (mm3) and 200,000 mm3, and 20 mg twice daily for patients with a platelet count of >200,000 mm3. Doses may be titrated based on safety and efficacy. There is limited information to recommend a starting dose for MF and PV patients with platelet counts between 50,000/mm3 and <100,000/mm3. The maximum recommended starting dose in these patients is 5 mg twice daily, and patients should be titrated cautiously[13].
Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte Corporation. The safety and efficacy profile of Jakavi has not yet been established outside the approved indications.
Jakavi Important Safety Information for Treatment of Myelofibrosis (MF) and Polycythemia Vera (PV)
Jakavi can cause serious side effects, including a decrease in blood cell count and infections. Complete blood count monitoring is recommended. Dose reduction or interruption may be required in patients with any hepatic impairment or severe renal impairment or in patients developing hematologic adverse reactions such as thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use of Jakavi during pregnancy is not recommended, and women should avoid becoming pregnant during Jakavi therapy. Women taking Jakavi should not breast feed. Progressive multifocal leukoencephalopathy (PML) has been reported. Physicians should be alert for neuropsychiatric symptoms suggestive of PML. Hepatitis B viral load (HBV-DNA titer) increases have been reported in patients with chronic HBV infections. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. Non-melanoma skin cancer (NMSC) has been reported in Jakavi treated patients. Periodic skin examination is recommended. Very common adverse reactions in MF (>10%) include urinary tract infections, anemia, thrombocytopenia, neutropenia, hypercholesterolemia, dizziness, headache, alanine aminotransferase increased, aspartate aminotransferase increased, bruising and weight gain. Common adverse reactions in MF (1 to 10%) include herpes zoster and flatulence. Uncommon adverse reactions in MF include tuberculosis. Very common adverse reactions in PV (>10%) include anemia, thrombocytopenia, hypercholesterolemia, hypertriglyceridemia, dizziness, alanine aminotransferase increased and aspartate aminotransferase increased. Common adverse reactions in PV (1 to 10%) include urinary tract infections, herpes zoster, weight gain, constipation and hypertension.
Two Phase 3 Studies Reinforce Sustained Benefits of Treatment with Jakafi® (ruxolitinib) in Patients with Myeloproliferative Neoplasms (MPNs)
On December 5, 2015 Incyte Corporation (Nasdaq:INCY) reported data from two Phase 3 studies evaluating the long-term safety and efficacy of Jakafi (ruxolitinib) in patients with Myeloproliferative Neoplasms (MPNs) (Press release, Incyte, DEC 5, 2015, View Source;p=RssLanding&cat=news&id=2120390 [SID:1234508420]). In myelofibrosis (MF), results of a five-year follow-up from the COMFORT-II study demonstrate a continued survival benefit in patients originally randomized to ruxolitinib compared with patients randomized to best available therapy (BAT), with a 33 percent reduction in the risk of death (HR, 0.67; 95%CI, 0.44-1.02; P=.06). Because patients in the BAT arm had crossed over to receive ruxolitinib therapy (median 17 months after randomization), these data may suggest that earlier treatment with ruxolitinib may be associated with improved long-term survival in patients with intermediate-2 or high-risk MF. Additionally, 53 percent of patients treated with ruxolitinib (n=78/146) achieved at least a 35 percent reduction in spleen volume from baseline that was sustained over time (median duration 3.2 years).
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"These data from the COMFORT-II study reinforce the positive and long-term clinical benefits seen in patients with myelofibrosis who are treated with Jakafi," said Rich Levy, MD, Chief Drug Development Officer, Incyte. "The reduction in the risk of death and the sustained improvements in spleen volume are meaningful and important results for the community of patients with this rare blood cancer."
An analysis of the RESPONSE study is also planned for presentation at ASH (Free ASH Whitepaper). Previously published results in the New England Journal of Medicine showed that treatment with ruxolitinib, compared to standard therapy improved hematocrit control and reduced spleen volume in patients with polycythemia vera (PV) who had an inadequate response to or had unacceptable side effects from hydroxyurea (HU). The data at ASH (Free ASH Whitepaper) demonstrate that in patients with elevated white blood cell (WBC) counts at baseline, a greater proportion of patients in the ruxolitinib treatment arm (45%) achieved normalization of their WBC counts (achieving a WBC ≤10×109/L or a ≥50% reduction from baseline) compared to BAT (22%) or HU (9%) at week 32.
These data are scheduled for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 5-8, 2015 in Orlando, FL.
Results from the COMFORT-II Study
Data from a five-year follow-up of the COMFORT-II trial, a randomized, open-label Phase 3 study evaluating long-term safety and efficacy of ruxolitinib in patients with intermediate-2 or high-risk primary myelofibrosis, post-PV myelofibrosis, or post-ET myelofibrosis, allowing crossover from the BAT arm to ruxolitinib after 48 weeks upon protocol-defined progression, revealed that 53 percent of patients treated with ruxolitinib (n=78/146) achieved at least a 35 percent reduction in spleen volume from baseline while on treatment during the study. Additionally, approximately one-third of evaluable JAK2 V617F-positive patients had more than a 20 percent reduction in allele burden at 3.2 years (38%) and 3.7 years (31%). Patients treated with ruxolitinib also experienced improvements in bone marrow fibrosis (15.8%) with 32.2 percent reporting stable fibrosis scores.
Overall, 59 (40%) and 35 (48%) deaths were reported in the ruxolitinib and BAT arms, respectively. Median overall survival (OS) was not reached in the ruxolitinib arm and was 4.1 years in the group of patients originally receiving BAT. There was a 33 percent reduction in risk of death with ruxolitinib (HR, 0.67; 95 percent CI, 0.44-1.02; P=.06). The estimated probability of survival at 5 years was 56 percent with ruxolitinib and 44 percent with patients originally receiving BAT. At week 48, BAT patients were allowed to cross over to receive ruxolitinib upon protocol-defined progression and after week 48 all BAT patients, irrespective of their progression status, were allowed to crossover to receive ruxolitinib; therefore, a confounding effect on OS was observed. An analysis correcting for crossover will be presented.
Adverse events (AEs) were consistent with those reported in previous studies of ruxolitinib and there was no increase in the incidence of AEs with longer exposure to treatment.
COMFORT-II is scheduled for presentation as an oral session by Dr. Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, Saturday, December 5, 2015, 9:30-11:30 AM EST, Room W224.
Results from the RESPONSE Study
The RESPONSE trial is a Phase 3 open-label study evaluating long-term safety and efficacy of ruxolitinib in patients with PV compared to BAT who had an inadequate response to or had unacceptable side effects from HU. The analysis from RESPONSE to be presented at ASH (Free ASH Whitepaper) shows that patients who received ruxolitinib had greater mean reductions in WBC counts compared with BAT or the HU subgroup of the BAT arm, and these reductions were maintained over time. In patients with baseline WBC counts ≥11×109/L, worsening WBC counts were observed in 10.8 percent of patients in the ruxolitinib arm versus 35.4 percent in the BAT arm (P=0.0002) and 47.8 percent in the HU subgroup (P<0.0001). In this same subgroup of patients with elevated WBC counts at baseline, a greater proportion of patients in the ruxolitinib arm (45%) normalized their WBC counts (achieving a WBC ≤10×109/L or a ≥50% reduction from baseline) compared with BAT (22%) or HU (9%) at week 32. The median time to achieve this response with ruxolitinib therapy was 8 weeks.
These data are scheduled for presentation as a poster session by Dr. Carole Miller, Saint Agnes Cancer Institute, Monday, December 7, 2015, 6:00-8:00 PM EST, Hall A.
About Myelofibrosis
MF is part of a group of related rare blood cancers known as myeloproliferative neoplasms (MPNs) where a patient’s bone marrow can no longer produce enough normal blood cells, causing the spleen to enlarge1. As a result, patients with MF may suffer from debilitating symptoms and have a poor quality of life2. After diagnosis, patients with MF have a decreased life expectancy, with an average survival of approximately five to six years3. Although allogeneic stem cell transplantation may cure MF, the procedure is associated with significant morbidity and transplant-related mortality, and is available to less than 5% of patients who are young and fit enough to undergo the procedure4.
About Polycythemia Vera
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) and is typically characterized by elevated hematocrit, the volume percentage of red blood cells in whole blood, which can lead to a thickening of the blood and an increased risk of blood clots, as well as an elevated white blood cell and platelet count5. Patients with PV who fail to consistently maintain appropriate blood count levels, including appropriate hematocrit levels, have an approximately four times higher risk of major thrombosis (blood clots) or cardiovascular death6. Patients with PV can also suffer from an enlarged spleen and a significant symptom burden which may be attributed to thickening of the blood and lack of oxygen to parts of the body7. These symptoms commonly include fatigue, itching, night sweats, bone pain, fever, and weight loss8.
Approximately 100,000 patients in the U.S. are living with PV9. Current standard treatment for PV is phlebotomy (the removal of blood from the body) plus aspirin. When phlebotomy can no longer control PV, chemotherapy such as hydroxyurea, or interferon, is utilized10,11. Approximately one in four patients with PV are considered uncontrolled12,13 because they have an inadequate response to or are intolerant of hydroxyurea, the most commonly used chemotherapeutic agent for the treatment of PV.
About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
The most common side effects of Jakafi include: anemia, low platelet count, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.