On December 6, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX), reported the presentation yesterday of data from three combination studies involving the Company’s lead compounds, TGR-1202, the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in San Diego, California (Press release, TG Therapeutics, DEC 6, 2016, View Source [SID1234516973]).

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Michael S. Weiss, the Company’s Executive Chairman and Interim CEO stated, "We are very pleased to continue to see a highly differentiated safety profile for TGR-1202 across multiple double and triple combination studies with a high level of activity. Each of the four clinical studies presented at the ASH (Free ASH Whitepaper) meeting, enhanced our overall understanding of the breadth of activity of TGR-1202. In addition to DLBCL, FL and CLL, where we have already shown data previously, it was nice to see the flexibility of TGR-1202 and its ability to be combined with brentuximab vedotin in relapsed or refractory Hodgkin’s and with ruxolitinib in Myelofibrosis." Mr. Weiss continued, "We are also encouraged by the triple combination data of TG-1101, TGR-1202, and bendamustine in relapsed or refractory, difficult to treat, DLBCL and FL patients which showed no discontinuations for a treatment related adverse event, as well as an 80% overall response rate across both DLBCL and FL patients and a high level of CR’s. We, and our investigators, believe this triplet combination is a promising regimen and plan to study it in this patient population in a registration-directed trial."

Highlights from yesterday’s presentations include the following:

Poster Presentation: Combination of Ublituximab, TGR-1202, and Bendamustine Demonstrates Significant Activity in Patients with Advanced DLBCL and Follicular Lymphoma (Abstract Number 4197)

This poster presentation includes data from patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) treated with the triple combination of TG-1101 (ublituximab), TGR-1202 and bendamustine. Nineteen patients were evaluable for safety of which 15 were evaluable for efficacy (3 patients were too early to evaluate and 1 patient had a non-related adverse event (AE) prior to efficacy assessment). The triple combination appears well tolerated with no discontinuations for a treatment related AE. Neutropenia and anemia were the only Grade 3/4 AE’s occurring in more than 1 patient. Importantly, no Grade 3/4 transaminitis was reported, no events of pneumonia or pneumonitis, and only 1 transient event of Grade 3 diarrhea, with a duration of 1 day, was observed. Eleven patients (58%) were refractory to prior treatment. Median time on study at the data cut off was approximately 6 months with the majority of patients continuing on study and follow-up ongoing.

Efficacy highlights from this poster include:

71% (5 of 7) Overall Response Rate (ORR), including a 43% Complete Response (CR) rate observed in patients with relapsed or refractory DLBCL
88% (7 of 8) ORR, including a 37% CR rate observed in patients with relapsed or refractory FL 4/6 CR’s that were achieved between the DLBCL and FL groups occurred at the first 8 week efficacy assessment
First response assessment occurred at Month 3 following initiation of therapy, with durable responses observed notably amongst DLBCL patients.
Poster Presentation: A Phase I Trial of TGR-1202, a Next Generation Once-Daily PI3Kδ Inhibitor, in Combination with Brentuximab Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma (Abstract Number 4146)

This poster presentation includes data from patients with relapsed and refractory Hodgkin’s Lymphoma (HL) treated with TGR-1202 at either 400mg or 600mg dosed orally once daily in combination with brentuximab vedotin in continuous 21 day cycles. 14 patients were evaluable for safety, of which 11 were evaluable for efficacy (3 discontinued prior to disease evaluation (2 AE’s and 1 withdrew consent)). 43% (6 of 14) of patients had prior exposure to brentuximab vedotin and all were refractory to prior brentuximab vedotin therapy. The combination demonstrated tolerability with nausea, diarrhea, and neutropenia being the most prevalent adverse events. Notably all but one case of diarrhea was Grade 1 or 2 in severity.

Efficacy highlights from this poster include:

60% (3 of 5) ORR, including a 40% CR rate observed across brentuximab vedotin refractory patients
64% (7 of 11) ORR, including a 45% CR rate observed across all patients treated

Oral Presentation: Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kδ Inhibitor TGR-1202 in Myelofibrosis (Abstract Number 1125)
This oral presentation includes data from patients with myelofibrosis treated with the combination of ruxolitinib, the JAK1/2 inhibitor and TGR-1202. The combination was well tolerated and efficacious in the twelve patients treated. The most prevalent adverse events deemed at least possibly related to TGR-1202 included anemia, thrombocytopenia, neutropenia, AST/ALT elevation and amylase/lipase elevation and diarrhea, all of which were notably Grade 1/2 with the exception of Grade 3 amylase/lipase elevation seen in 2 patients (16.7%), and Grade 3 diarrhea seen in 1 patient (8.3%). Presentation highlights included:

The patient population enrolled was advanced, with the majority having 2 or more prior mutations at baseline;
Per protocol, all enrolled patients were on a stable dose of ruxolitinib monotherapy with best response to ruxolitinib monotherapy achieved prior to enrollment;
Following the addition of TGR-1202, 11/12 patients experienced improvement in hemoglobin, many with a concomitant reduction in platelet counts indicating clinical benefit beyond ruxolitinib monotherapy; and
83% of study participants experienced clinical benefit (hematologic improvement, reduced spleen size and/or improvement in symptoms) including one patient who achieved a CR and continues on study, now out 72 weeks

PRESENTATION DETAILS:
Copies of the above referenced presentations are available on the Company’s website at www.tgtherapeutics.com, located on the Publications page.

TG THERAPEUTICS INVESTOR & ANALYST EVENT:
TG Therapeutics held an investor and analyst reception yesterday, at the Marriott Gaslamp, in San Diego, California. The audio file and slide presentation are available for review on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com.

On December 6, 2016 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX:ONC) (OTCQX:ONCYF) reported that Dr. Kevin Kelly and colleagues made a poster presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting (Filing, 6-K, Oncolytics Biotech, DEC 6, 2016, View Source [SID1234516972]). The poster presentation, titled "Oncolytic Reovirus Immune Priming: A Phase Ib Study of REOLYSIN with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma," provides initial findings from the Company’s REO 019 Phase Ib trial. The ASH (Free ASH Whitepaper) Annual Meeting runs from December 3rd to 6th in San Diego, CA.

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The study is a two-stage open-label Phase Ib trial of adult patients with relapsed or refractory multiple myeloma following at least one line of therapy. This study was designed to evaluate tolerability, to confirm that the addition of REOLYSIN to bortezomib increases endoplasmic reticulum stress and death of myeloma cells (as shown in preclinical models) and to document pharmacodynamic effects as part of the characterization of the mechanism(s) of action of REOLYSIN in multiple myeloma. Kevin Kelly, M.D., Ph.D. of the Keck School of Medicine of the University of Southern California (USC), is the principal investigator.

"The combination of REOLYSIN, bortezomib and dexamethasone was well-tolerated in these heavily pre-treated patients, even in those who had been previously exposed to bortezomib," said Dr. Kevin Kelly. "Preliminary evidence of activity of this combination was documented. It was also shown that the combination therapy induced the apoptosis of myeloma cells and stimulated the immune system, highlighted by improved cytotoxic T cell infiltration and activation of checkpoint inhibitors (IDO, PD-L1) in the tumor."

The dose escalation study tested three doses ranging from 3 to 9×1010 TCID50 on days 1, 2, 8, 9, 15 and 16, with 40 mg dexamethasone and 1.5 mg/m2 bortezomib on days 1, 8, and 15. Cycles were repeated every 28 days. A maximum tolerated dose was not defined because there were no dose-limiting toxicities in the first two cohorts. Cohort 3 is still enrolling patients. The combination was well tolerated and most treatment emergent toxicities were transient and easily managed with supportive care. The most common treatment related toxicities were grade 1 diarrhea, grade 1 fatigue, grade 1 flu-like symptoms and grade 1 headache.

Three patients completed 1 cycle of treatment only, 2 completed 3 cycles, 1 completed 4 cycles and 1 completed 7 cycles. Two patients remain on protocol (1 has completed 3 cycles (Cohort 3) and the other 7 cycles (Cohort 2)). Six patients were evaluable for response, 4 patients had stable disease lasting at least 1 cycle, whereas 3 patients had progressive disease at the end of cycle 1.

"It is intriguing that this combination therapy with REOLYSIN induced an immune response with mainly grade 1 level toxicity, which is consistent with what we have observed in studies with other REOLYSIN combinations in solid tumors," said Dr. Matt Coffey, Interim President and CEO of Oncolytics Biotech. "These data build on what we have observed in previous studies in both multiple myeloma and solid tumours, and further investigation is needed to evaluate if the immune modulatory and anti-tumor activity of REOLYSIN can provide a therapeutic opportunity to patients with hematological malignancies when combined with other targeted treatments including immunotherapies."

A copy of the poster will be available on the Oncolytics website at: View Source

About Multiple Myeloma
Multiple Myeloma is a cancer of the plasma cells and the second most common hematological malignancy. The American Cancer Society estimates there will be 30,330 new cases diagnosed in the United States and 12,650 deaths from the disease in 2016.

On December 6, 2016 Novartis reported results from its Phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study, which found that patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) treated with first-line Zykadia (ceritinib) had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) in patients treated with standard first-line chemotherapy with maintenance (Press release, Novartis, DEC 6, 2016, View Source [SID1234516971]). This equated to a 45% reduction in the risk of disease progression (hazard ratio [HR] = 0.55, P<0.001)[1]. Results were presented during the Presidential Symposium at the 17th World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC), in Vienna. These late-breaking results were also featured in an official conference press briefing.

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"These data demonstrate the potential to more than double a patient’s progression-free survival when they take Zykadia as their first ALK inhibitor rather than undergoing treatment with chemotherapy," said lead investigator Dr. Gilberto de Castro Jr., head of Thoracic Oncology and Head and Neck Cancer clinic in the Clinical Oncology Service of the Institute of Cancer of São Paulo (ICESP), in São Paulo, Brazil. "For clinicians, who are constantly working to extend a patient’s response to treatment in the first-line setting, the ASCEND-4 results are very compelling."

Overall survival data, a key secondary endpoint of the study, are immature; however, a positive trend in favor of Zykadia was observed, despite 72.4% of patients in the chemotherapy arm receiving an ALK inhibitor as their first treatment after discontinuing chemotherapy. Pre-specified secondary endpoints demonstrating the efficacy of Zykadia in ALK+ advanced NSCLC patients included overall response rate (ORR), overall intracranial response rate (OIRR), disease control rate (DCR) and duration of response (DoR).

Patients taking Zykadia had an ORR of 72.5% (95% CI: 65.5, 78.7) compared to 26.7% (95% CI: 20.5, 33.7) in patients treated with standard chemotherapy. Further, patients with measurable brain metastases experienced an OIRR of 72.7% (95% CI: 49.8, 89.3, n=22) with Zykadia compared to 27.3% (95% CI: 10.7, 50.2, n=22) with standard chemotherapy. Patients without brain metastases at screening experienced a median PFS of 26.3 months (95% CI: 15.4, 27.7, n=130) with Zykadia compared to 8.3 months (95% CI: 6.0, 13.7, n=125) with standard chemotherapy. Additionally, patients taking Zykadia demonstrated a DCR of 84.7% (95% CI: 78.7, 89.5) and DoR of 23.9 months (95% CI: 16.6, not estimable)[1]. Study results were measured by a blinded independent review committee (BIRC). Patients treated with Zykadia also reported better overall general health status and improvement in lung cancer-specific symptoms compared to patients treated with standard chemotherapy[2].

"The patient response to treatment is high and durable in the first-line setting," said Bruno Strigini, CEO, Novartis Oncology. "Based on these results, Novartis is initiating discussions with regulatory authorities worldwide regarding this potential use of Zykadia to further improve outcomes for patients with ALK+ advanced NSCLC."

The safety profile of Zykadia in the ASCEND-4 study was consistent with the previously known safety profile in patients with ALK+ advanced NSCLC. The most common adverse events (AEs) occurring in more than 50% of Zykadia patients were diarrhea (84.7%), nausea (68.8%), vomiting (66.1%), ALT increase (60.3%) and AST increase (52.9%), which were mostly grade 1 and 2 and managed with dose interruption, dose reduction and concomitant medication. No new or unexpected safety concerns were observed[1].

Novartis also presented an initial investigation of the pharmacokinetic (PK) profile of Zykadia 450 mg or 600 mg taken with a low-fat meal versus Zykadia 750 mg taken after fasting, as currently indicated. This Phase I prospective, open-label, multicenter, randomized study found (in Part 1) that relative to the 750 mg fasted arm, the 450 mg fed arm demonstrated comparable steady-state PK, while the 600 mg fed arm showed approximately 25% higher steady-state PK. Further, preliminary safety data found the overall frequency of AEs were comparable between groups; however, incidences of gastrointestinal-related AEs (diarrhea, nausea or vomiting) were lowest in the Zykadia 450 mg group that ate a low-fat meal, with no grade 3/4 AEs reported[3]. This study is ongoing and continues to enroll treatment-naïve patients into Part 2, assessing efficacy across the three treatment arms and evaluating safety follow-up.

One of 12 known genetic drivers of NSCLC, the ALK gene arrangement affects approximately 2-7% of people with NSCLC[4],[5]. These patients are candidates for treatment with a targeted ALK inhibitor[5]. To determine a personalized treatment plan, medical organizations recommend genetic testing for patients with lung cancer[6].

About ASCEND-4
ASCEND-4 was a Phase III randomized, open-label, multicenter, global clinical trial to evaluate the safety and efficacy of Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK+ advanced NSCLC who received no prior therapy for their advanced disease. Patients received Zykadia orally at 750 mg/daily or standard pemetrexed-based platinum doublet chemotherapy per label (pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin AUC 5-6) for 4 cycles followed by pemetrexed maintenance.
Of 376 patients, 189 (59 with brain metastases) were randomized to Zykadia and 187 (62 with brain metastases) to chemotherapy. Among patients randomized to the chemotherapy arm, 105 (60%) received an ALK inhibitor as their first treatment after chemotherapy.

About Zykadia
Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal "fusion protein" that promotes the development and growth of certain tumors in cancers including non-small cell lung cancer (NSCLC). Zykadia was granted conditional approval in the EU for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. In the US, Zykadia was granted accelerated approval for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.

Zykadia is currently approved in over 55 countries worldwide. Please visit www.NovartisOncology.com/news/product-portfolio/zykadia for additional information.

Zykadia Important Safety Information
Zykadia may cause serious side effects.

Zykadia may cause stomach upset and intestinal problems in most patients, including diarrhea, nausea, vomiting and stomach-area pain. These problems can be severe. Patients should follow their doctor’s instructions about taking medicines to help these symptoms, and should call their doctor for advice if symptoms are severe or do not go away.

Zykadia may cause severe liver injury. Patients should have blood tests prior to the start of treatment with Zykadia, every two weeks for the first month of treatment and monthly thereafter, and should talk to their doctor right away if they experience any of the following symptoms: tiredness (fatigue), itchy skin, yellowing of the skin or the whites of the eyes, nausea or vomiting, decreased appetite, pain on the right side of the abdomen, urine turns dark or brown, or bleeding or bruising more easily than normal.

Zykadia may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those symptoms from lung cancer. Patients should tell their doctor right away about any new or worsening symptoms, including trouble breathing or shortness of breath, fever, cough, with or without mucous, or chest pain.

Zykadia may cause very slow, very fast, or abnormal heartbeats. Doctors should check their patient’s heart during treatment with Zykadia. Patients should tell their doctor right away if they feel new chest pain or discomfort, dizziness or lightheadedness, faint, or have abnormal heartbeats, blue discoloration of lips, shortness of breath, swelling of lower limbs or skin, or if they start to take or have any changes in heart or blood pressure medicines.

Zykadia may cause high levels of glucose in the blood. People who have diabetes or glucose intolerance, or who take a corticosteroid medicine have an increased risk of high blood sugar with Zykadia. Patients should have glucose blood tests prior to the start of treatment with Zykadia and during treatment. Patients should follow their doctor’s instructions about blood sugar monitoring and call their doctor right away with any symptoms of high blood sugar, including increased thirst and/or urinating often.

Zykadia may cause high levels of pancreatic enzymes in the blood and may cause pancreatitis. Patients should have blood tests prior to the start of treatment with Zykadia and as needed during their treatment with Zykadia. Patients should talk to their doctor if they experience signs and symptoms of pancreatitis which including upper abdominal pain that may spread to the back and get worse with eating.

Before patients take Zykadia, they should tell their doctor about all medical conditions, including liver problems; diabetes or high blood sugar; heart problems, including a condition called long QT syndrome; if they are pregnant, if they think they may be pregnant, or if they plan to become pregnant; are breastfeeding or plan to breastfeed.

Zykadia may harm unborn babies. Women who are able to become pregnant must use a highly effective method of birth control (contraception) during treatment with Zykadia and up to 3 months after stopping Zykadia. It is not known if Zykadia passes into breast milk. Patients and their doctor should decide whether to take Zykadia or breastfeed, but should not do both.

Patients should tell their doctor about medicines they take, including prescription medicines, over-the-counter medicines, vitamins and herbal supplements. If they take Zykadia while using oral contraceptives, the oral contraceptives may become ineffective.

The most common adverse reactions with an incidence of >=10% were diarrhea, nausea, vomiting, tiredness (fatigue), liver laboratory test abnormalities (requires blood test monitoring), abdominal pain, decreased appetite, constipation, rash, kidney laboratory test abnormalities (requires blood test monitoring), heartburn and anemia. Grade 3-4 adverse reactions with an incidence of >=5% were liver laboratory test abnormalities, tiredness (fatigue), diarrhea, nausea and hyperglycemia (requires blood test monitoring).

Patients should stop taking Zykadia and seek medical help immediately if they experience any of the following, which may be signs of an allergic reaction:

Difficulty in breathing or swallowing
Swelling of the face, lips, tongue or throat
Severe itching of the skin, with a red rash or raised bumps
Patients should tell their doctor of any side effect that bothers them or does not go away. These are not all of the possible side effects of Zykadia. For more information, patients should ask their doctor or pharmacist.

Patients should take Zykadia exactly as their health care provider tells them. Patients should not change their dose or stop taking Zykadia unless their health care provider advises them to. Zykadia should be taken once a day on an empty stomach. Patients should not eat for at least 2 hours before and 2 hours after taking Zykadia. If a dose of Zykadia is missed, they should take it as soon as they remember. If their next dose is due within the next 12 hours, they should skip the missed dose and take the next dose at their regular time. They should not take a double dose to make up for a forgotten dose. Patients should not drink grapefruit juice or eat grapefruit during treatment with Zykadia, as it may make the amount of Zykadia in their blood increase to a harmful level. If patients have to vomit after swallowing Zykadia capsules, they should not take more capsules until their next scheduled dose.

Please see full Prescribing Information for Zykadia.

On December 6, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported the presentation of SL-401 lead-in data from its ongoing Phase 2 trial in acute myeloid leukemia (AML) in remission with minimal residual disease (MRD) and ongoing Phase 2 trial in high-risk myeloproliferative neoplasms (MPN) at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Stemline Therapeutics, DEC 6, 2016, View Source [SID1234516963]). The AML/MRD results were delivered via oral presentation by Andrew A. Lane, M.D., Ph.D., from the Dana-Farber Cancer Institute (Boston, MA) and the MPN results were presented by Mrinal S. Patnaik, M.D. from the Mayo Clinic (Rochester, MN).

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The full presentations are available on the Stemline website, under the "Scientific Presentations" tab (see: View Source).

Safety Overview

SL-401 was found to be safe and well tolerated, and side effects were predictable and manageable. The lead-in dose escalation stages of both Phase 2 studies (3 x 3 design) were completed without dose limiting toxicity (DLT) and a maximum tolerated dose (MTD) was not reached in either study (n=9 patients in AML/MRD lead-in; n=9 patients in MPN lead-in). 12 ug/kg/day was the highest tested dose in both studies and is currently the dose level being used in the expansion stage of both studies.
Efficacy Overview

AML/MRD – Early signs of efficacy in the AML study included an MRD+ AML patient who sustained a decrease in MRD, determined locally, treated at 12 ug/kg/day who then went on to stem cell transplant. The expansion stage is currently enrolling and, for uniformity, will utilize a central facility for MRD analysis.

MPN – Early signs of efficacy in the MPN study including a patient with chronic myelomonocytic leukemia (CMML) who sustained a bone marrow complete response (BMCR) and reduction in spleen size. The expansion stage is currently enrolling CMML as well as additional MPN types including myelofibrosis, mastocytosis, and primary eosinophilic disorder.
Andrew A. Lane, M.D., Ph.D., lead author on the AML study, commented, "Given the unacceptably high relapse rates seen in AML, MRD has emerged as an important predictor of relapse with CD123 as a key target for therapy. The preliminary results seen with SL-401 in this setting are promising. We look forward to enrolling patients in the expansion stage of the trial as we continue to optimize and refine methods to assess and follow MRD."

Mrinal S. Patnaik, M.D., lead author on the MPN study, noted, "The early data from the dose escalation portion of the trial suggests SL-401 can be dosed safely in this patient population. Additionally, we are observing encouraging signs of clinical activity in several patients. We look forward to enrolling patients in the expansion stage of the trial."

On December 6, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology reported the presentation of data from a case match control analysis of the PROPEL Study in a poster presentation session at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Spectrum Pharmaceuticals, DEC 6, 2016, View Source [SID1234516962]).

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Abstract #4149: Case Match Control Analysis of Propel Reveals Survival Advantage for Patients with Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) Treated with Pralatrexate

In this retrospective, observational study, 80 patients out of 109 treated on the PROPEL study were successfully matched 1:1 with the control population. A highly significant difference in the Overall Survival between the control population and the pralatrexate group was observed. The overall survival observed in the control population was 4.04 months (95% CI 2.60, 6.01) which was consistent with historical controls, while the median OS in for pralatrexate treated cohort was 14.78 months (95% CI 10.61-22.31). The most common adverse reactions from the PROPEL study were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. See below for Important Safety Information.

"In this case match controlled study, the overall survival observed in the pralatrexate group was over three-fold higher than a case matched control group," said Owen A. O’Connor, MD, PhD, Director of the Center for Lymphoid Malignancies, Professor of Medicine and Experimental Therapeutics at Columbia Medical Center, New York Presbyterian Medical Center. "The PROPEL study, which was a Phase 2, open-label, single-arm, multi-center, international trial, included patients that were heavily pretreated, with a median of three prior systemic therapies (ranging between 1 and 12). This is one of the first times a case match control analysis has been used to understand the impact of a drug on the outcome of a rare disease, like PTCL. Importantly, we believe this may be a valuable paradigm that can be used in other orphan diseases in cancer medicine."

"We are honored to present this important data at the 58th ASH (Free ASH Whitepaper) Meeting," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We are encouraged to see positive data continuing to emerge from the PROPEL study that was the basis for FOLOTYN’s approval. FOLOTYN was the first drug approved for the treatment of relapsed or refractory PTCL and continues to have the leading market share in 2nd line therapy. PTCL is an aggressive disease with a poor prognosis and we are excited that FOLOTYN has the potential to improve outcome for PTCL patients. We are also looking forward to emerging new data in combination treatments that might prove to benefit PTCL patients in earlier lines of treatment and with the possibility to include FOLOTYN in future PTCL first line regimens."

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum’s strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

About FOLOTYN

FOLOTYN, (pralatrexate injection), a folate analogue metabolic inhibitor, was discovered by Memorial Sloan-Kettering Cancer Center, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. FOLOTYN has been available to patients in the U.S. since October 2009. An updated analysis of data from PROPEL, the pivotal study of FOLOTYN in patients with relapsed or refractory PTCL, was published in the March 20, 2011 issue of the Journal of Clinical Oncology. FOLOTYN has patent protection through July 2022, based on a five-year patent term extension through the Hatch-Waxman Act.

Important FOLOTYN Safety Information

Warnings and Precautions

FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.

Mucositis may occur. If greater-than or equal to Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.

Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor patients and treat if needed.

FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.

Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.

Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are greater-than or equal to Grade 3, omit or modify dose.

Adverse Reactions

The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Use in Specific Patient Population

Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Drug Interactions

Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance.

Please see FOLOTYN Full Prescribing Information at www.FOLOTYN.com.