On June 6, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported results from its Phase 3 trial of VYXEOS (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Press release, Celator Pharmaceuticals, JUN 6, 2016, View Source [SID:1234513035]). As previously reported, the trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. The Phase 3 trial compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3.

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The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005) which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Event-free survival was also statistically significant in favor of VYXEOS. The HR was 0.74 (p-value=0.021). The median event-free survival was 2.53 months in the VYXEOS arm compared to 1.31 months in the 7+3 arm.

"We believe the promising primary efficacy results of CPX-351 in high risk AML, across multiple parameters, support its use as the new standard of care in a difficult-to-treat population," said Jeffrey E. Lancet, M.D., senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study. "This is an important step forward in the treatment of a terrible disease, and hopefully this platform for synergistic drug delivery will continue to advance the field."

VYXEOS also demonstrated a statistically significant improvement in induction response rate (CR+CRi of 47.7% versus 33.3%; p=0.016) and this significance was maintained for the analysis of CR alone (CR of 37.3% versus 25.6%, p=0.040).

Thirty-four percent of VYXEOS treated patients received a stem cell transplant (SCT) compared to 25% of 7+3 treated patients. In a landmark survival analysis of patients receiving a SCT, VYXEOS patients had significantly improved survival post-transplant (HR was 0.46 (p-value=0.0046)). The median overall survival had not been reached in the VYXEOS treated patients compared to 10.25 months in the 7+3 treated patients.

Thirty-day and sixty-day all-cause mortality favored VYXEOS. Thirty-day mortality was 5.9% compared to 10.6% and sixty-day mortality was 13.7% versus 21.2%.

Grade 3-5 non-hematologic and hematologic adverse events were similar between the VYXEOS and 7+3 arms.

The company expects to submit a New Drug Application (NDA) for VYXEOS with the U.S. Food and Drug Administration (FDA) by the end of the third quarter of 2016 and submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first quarter of 2017.

"We are very pleased to have this opportunity to share the data from our Phase 3 trial with the oncology community. This successful outcome represents an important advance for AML patients, their families and clinicians," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "We thank the patients and investigators who participated in this study and we will work closely with regulatory authorities to make this new treatment available to the AML community as soon as possible."

The clinical trial was conducted in partnership with The Leukemia & Lymphoma Society (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.

Phase 3 Trial Design

The randomized, controlled, Phase 3 trial (Protocol NCT01696084), enrolled 309 patients at 39 sites in the United States and Canada, and compared VYXEOS to the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older (60-75 years of age) patients with high-risk (secondary) AML. Patients were stratified for age (60 to 69 and 70 to 75 years of age) and AML type; treatment-related AML, AML with documented history of myelodysplastic syndrome (MDS) with prior treatment with hypomethylating agent therapy, AML with documented history of MDS without prior hypomethlyating agent therapy, AML with a documented history of chronic myelomonocytic leukemia (CMMoL), and de novo AML with a karyotype characteristic of MDS.

Patients were randomized 1:1 to receive either VYXEOS or 7+3. Patients could receive one or two inductions, and responding patients could receive one or two consolidations. First induction for VYXEOS was 100u/m2; days 1, 3, and 5 by 90-minute infusion and for the control arm was cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3 (7+3). Second induction for VYXEOS-treated patients was 100u/m2 on days 1 and 3, and the control arm was cytarabine 100mg/m2/day by continuous infusion for 5 days and daunorubicin 60mg/m2 on days 1 and 2 (5+2).

Only patients with documented CR or CRi were eligible to receive chemotherapy consolidation. Consolidation for VYXEOS-treated patients was 65u/m2 on days 1 and 3 and the control arm was cytarabine 100mg/m2/day by continuous infusion for 5 days and daunorubicin 60mg/m2 on days 1 and 2 (5+2).

About VYXEOS

VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission. VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.

About AML

Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. The American Cancer Society estimates that there will be 19,950 new cases of AML and 10,430 deaths from AML in the U.S. in 2016. In Europe the number of new cases is estimated to be 18,000 and in Japan the number is 5,500. The Company estimates that nearly 70 percent of AML patients are over the age of 60, and approximately 75% are intermediate or high risk. Furthermore, approximately half of those patients are considered suitable for intensive treatment.

Even with current treatment, overall survival for AML is poor. In patients over 60 years of age, the 5 year survival rate is less than 10%. In high-risk (secondary) AML, overall survival is lower, resulting in an acute need for new treatment options for these patients.

On June 06, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported that it will be presenting data today from a bladder cancer study featured as a poster and also highlighted during a live panel discussion during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, BioTime, JUN 6, 2016, View Source;p=RssLanding&cat=news&id=2175182 [SID:1234513033]).

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The poster abstract, entitled Derivation of Gene Expression Classifiers for the Non-invasive Detection of Bladder Cancer in the Hematuria and Recurrence Surveillance Populations, describes OncoCyte’s recent results in the development of a urine-based test for bladder cancer. Dr. Matthew T. Olson, Department of Pathology at Johns Hopkins University School of Medicine, Baltimore, MD, will serve as the presenting author in the live panel discussion. He will be joined by Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research.

"We are very encouraged by the accuracy of our non-invasive test for the detection of high-grade and low-grade lesions in both the screening (hematuria) and recurrence cohorts. Of particular note, the test was 100 percent accurate in detecting high-grade lesions within the 241 patient group studied." said OncoCyte President & Chief Executive Officer William Annett. "There was also high accuracy in the detection of low-grade lesions, with 77 percent for screening and 75 percent for recurrence. The results warrant a larger study to validate these findings."

The detection of bladder cancer is typically accomplished with a combination of cystoscopy and urine cytology, each with inherent limitations. Urine cytology lacks the desired level of sensitivity, whereas cystoscopy is relatively invasive for routine screening and recurrence surveillance.

OncoCyte’s study developed four gene expression classifiers (GECs) optimized for the non-invasive detection of both high-grade and low-grade urothelial carcinoma in patients presenting with hematuria or for bladder cancer recurrence surveillance. This study included 241 patient urine samples taken at multiple centers. Individual patient results for high-grade and low-grade screening or high-grade and low-grade recurrence can be obtained from a patient’s single urine sample which utilizes two sequential algorithms.

OncoCyte’s approach of sequential GECs optimized for the detection of high-grade and low-grade malignancies provides information to distinguish between these different types of lesions and benign conditions in a non-invasive manner. Low-grade urothelial carcinoma is usually a non-aggressive cancer, whereas high-grade urothelial carcinoma is more aggressive, invasive and causes significantly more cancer-related mortality. The GEC optimized for the detection of high-grade urothelial carcinoma in patients presenting with hematuria performed with a cross-validated Receiver Operating Characteristic Area Under the Curve (ROC AUC) of 0.93, while the low-grade performed with an ROC AUC of 0.81. In the recurrence surveillance cohort, the detection of high-grade performed with an ROC AUC of 0.81 and low-grade with an ROC AUC of 0.64.

ROC AUCs

Low Grade High Grade
Screening (Hematuria) 0.81 0.93

Recurrence 0.64 0.81

"Currently, there is an unmet need for a non-invasive test for bladder cancer for patients requiring recurrence surveillance and for patients presenting with hematuria," added Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research, who led the study. "These results establish the feasibility of using a non-invasive, urine-based test to detect bladder cancer and also to distinguish between high-grade and low-grade cancers. A multicenter clinical trial will allow us to validate test performance on a larger independent test set of prospectively collected urine samples."

About Bladder Cancer

Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease. The detection of bladder cancer in hematuria and recurrence patients is routinely accomplished with a combination of urine cytology and cystoscopy which is invasive, and lacks the desired level of sensitivity. Approximately 3 million patients present with hematuria every year in the U.S., of whom about 77,000 are diagnosed with bladder cancer. In addition there are about 587,000 patients in the U.S. living with bladder cancer, and they are candidates for recurrence testing.

On June 06, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that the Gynecologic Oncology Group (GOG), now part of NRG Oncology (NRG) will present additional preliminary data from a two-stage Phase 2 study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy (Press release, Advaxis, JUN 6, 2016, View Source [SID:1234513031]).

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These data will be featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Ill., in the Gynecologic Cancer General Poster Session on June 6 at 1:00 PM CT and also in an Oral Poster Discussion Session at 4:45 PM. The poster (abstract #5516), "ADXS11-001 immunotherapy in squamous or non-squamous persistent/recurrent metastatic cervical cancer: Results from stage 1 [and stage 2] of the phase II GOG/NRG-0265 study" and presentation are available at www.advaxis.com. Warner K. Huh, M.D., Professor and Division Director of Gynecologic Oncology and Senior Scientist at the University of Alabama at Birmingham, is the lead author and principal investigator.

GOG/NRG-0265 is a single-arm two-stage, Phase 2 multicenter study (NCT01266460). Stage 1 of the trial enrolled 26 AXAL-treated patients who received up to three doses at 1×109 colony forming units administered in 28 day intervals. Results from Stage 1 demonstrated a twelve-month survival rate of 38.5 percent, which exceeds prior historical GOG trials in this patient population. The twelve-month survival rate among the 69 percent of patients who received the maximum three per protocol doses was 56 percent, with a 12.1-month median overall survival. Safety and efficacy results of Stage 1 met the criteria for the initiation of Stage 2, which was amended for continuous cycles of AXAL (greater than three doses).

Twenty-four patients were treated with AXAL in Stage 2. However, a temporary clinical hold limited overall exposure to the immunotherapy, which necessitated 10 patients who had not progressed to discontinue AXAL treatment. Further, only 12 of the 24 patients received three or more doses. Demographics in the truncated Stage 2 cohort were similar to Stage 1, but a substantially higher proportion of patients were pre-treated with bevacizumab (83 percent (Stage 2) vs. 31 percent (Stage 1)).

At a median follow-up of 8.7 months, these Stage 2 results demonstrate a 42 percent six-month overall survival rate, which increases to 67 percent in those 12 patients who received three or more doses of AXAL. Preliminary results from Stage 2 appear consistent with the promising survival results from Stage 1 in a more heavily bevacizumab pre-treated population.

Investigator assessment of tumor best response showed disease control rates (CR+PR+SD) of 27 percent and 37 percent in Stage 1 and 2, respectively. Of particular note, a patient in Stage 2 experienced a complete response following three doses of AXAL. This patient continues to be followed with no evidence of disease at 11 months. Treatment with AXAL will resume under a compassionate use single-patient IND.

The safety profile across both stages was similar, with primarily grade one and two treatment-related events such as fatigue, chills, fever, nausea. Grade three events (n = 4 in Stage 1) included hypotension and cytokine release syndrome. No grade four or five treatment-related adverse events were observed.

Given the substantial proportion of Stage 2 patients that discontinued treatment with AXAL as a result of the clinical hold, Advaxis and the GOG/NRG agreed to re-enroll a new cohort of Stage 2 patients. The re-enrollment of Stage 2 is expected to commence shortly.

"We are excited about the potential of AXAL to help women with recurrent cervical cancer as there are so few options available," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

The Company and the GOG Foundation plan to commence enrollment to an international Phase 3 adjuvant study, AIM2CERV, for patients with high risk, locally advanced cervical cancer.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. In the U.S., nearly 13,000 new cases are diagnosed, and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About the Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG), now part of NRG Oncology, is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of its processes is utilized in order to constantly improve the quality of patient care. The GOG conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina and vulva. General information on many of these trials for medical professionals and the lay public can be obtained from ClinicalTrials.gov.

NRG Oncology is one of four adult cooperative groups funded under the newly structured NCI National Clinical Trials Network. NRG Oncology is comprised of three legacy cooperative groups, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG).

About Axalimogene Filolisbac

Axalimogene filolisbac (AXAL) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, AXAL showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the Company’s Lm Technology. AXAL has Orphan Drug Designations in the U.S. for the treatment of invasive cervical cancer, head and neck cancer and anal cancer.

On June 6, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") reported results to be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from a study of low-dose chemotherapy conditioning followed by anti-CD19 chimeric antigen receptor (CAR) T-cell therapy (Press release, Kite Pharma, JUN 6, 2016, View Source [SID:1234513027]). The results showed that CAR T-cell therapy was effective in inducing a high response rate in patients with advanced non-Hodgkin lymphoma (NHL). The results will be presented today as a Late Breaking Abstract by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the National Cancer Institute (NCI) Center for Cancer Research (Hall D2, Time: 4:42PM CDT, Abstract #3010).

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In this study of 22 patients (19 diffuse large B-cell lymphoma, 2 follicular lymphoma, and 1 mantle cell lymphoma), objective responses were seen in 16 patients (73%). Twelve of 22 patients (55%) achieved complete responses following low-dose chemotherapy conditioning regimen. Kite is using a similar conditioning regimen in its ZUMA-1 Study of KTE-C19, an anti-CD19 CAR T cell therapy. Nine of 19 patients (47%) with diffuse large B-cell lymphoma (DLBCL) achieved complete responses, which are all ongoing with a duration of 7+ to 20+ months. Additionally, the three patients with mantle cell lymphoma and follicular lymphoma achieved complete responses. Reversible grade 3 or 4 neurotoxicity including confusion, dysphasia, encephalopathy, and gait disturbances was observed in 55% of treated patients.

"Patients with chemorefractory DLBCL have few effective treatment options," said Jeff Wiezorek, M.D., M.S., Kite’s Senior Vice President, Clinical Development. "These early results are encouraging and served as the foundation for Kite’s ongoing KTE-C19 ZUMA-1 Study."

According to the American Cancer Society, NHL is one of the most common cancers in the United States and DLBCL is the most common form of the disease accounting for one out of every three cases of NHL.1 It is estimated that approximately 26,000 people will be diagnosed with DLBCL in the United States in 2016. DLBCL is an aggressive and fast growing lymphoma, but considered curable in patients who respond to initial treatment with a chemotherapy-based regimen. Patients with chemorefractory DLBCL face limited treatment options and historically poor outcomes.

This study was performed pursuant to a Cooperative Research and Development Agreement (CRADA) between the NCI and Kite.

On June 6, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") reported updated durability of complete responses in the Phase 1 portion of the ZUMA-1 trial (Press release, Kite Pharma, JUN 6, 2016, View Source [SID:1234513026]). The study is evaluating KTE-C19 in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL). KTE-C19 is an investigational therapy in which a patient’s T-cells are genetically modified to express a chimeric antigen receptor (CAR) that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. The results will be presented today at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (abstract #7559).

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"Three reported complete remissions in patients with chemorefractory DLBCL after a single treatment with CAR T-cell therapy are still ongoing at nine months. This is remarkable given that single-digit complete response rates are historically observed in patients who do not respond to chemotherapy," said Sattva S. Neelapu, Associate Professor and Director of Translational Research, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center. "These results are extremely important as CAR engineered T-cells have the potential to transform the treatment landscape for chemorefractory DLBCL."

The Phase 1 portion of ZUMA-1 treated a total of 7 patients with chemorefractory DLBCL. The results showed that treatment with KTE-C19 achieved rapid and durable responses in patients with chemorefractory disease (objective response rate 71%, complete response rate 57%). Ongoing complete responses were observed in 3 patients after nine months of follow-up. KTE-C19 related adverse events consisted predominantly of cytokine release syndrome (CRS) and neurotoxicity, which were generally reversible. Grade 3 or higher CRS was observed in 14% and neurotoxicity in 57%; all were reversible except in one patient with dose-limiting toxicity.

KTE-C19, currently in Phase 2 clinical studies, has received Breakthrough Therapy Designation and Orphan Drug status from the U.S. Food and Drug Administration for the treatment of patients with chemorefractory DLBCL, primary mediastinal B-cell lymphoma, and transformed follicular lymphoma. The European Medicines Agency has also granted KTE-C19 access to regulatory support under its Priority Medicines (PRIME) initiative for the treatment of DLBCL and Orphan Drug Designation for various hematological indications.

About Diffuse Large B-Cell Lymphoma

According to the American Cancer Society, NHL accounts for about four percent of all cancers in the United States, making it one of the most common cancers diagnosed. DLBCL is the most common form of the disease, accounting for one out of every three cases of NHL.1 It is estimated that 26,000 people will be diagnosed with DLBCL in the United States in 2016. DLBCL is an aggressive and fast growing lymphoma, but considered curable in patients who respond to initial treatment with a chemotherapy-based regimen. Patients with chemorefractory DLBCL face limited treatment options and historically poor outcomes.

About Kite’s ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T-cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies.

Study Phase Indication Status
ZUMA-1
NCT02348216 Phase 2 Pivotal
(N=112)
Chemorefractory DLBCL, PMBCL, TFL
Phase 2 enrolling
ZUMA-2
NCT02601313 Phase 2 Pivotal
(N=70) Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4
NCT02625480 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Pediatric ALL Phase 1/2 enrolling

DLBCL = diffuse large B-cell lymphoma
PMBCL = primary mediastinal B-cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia