September 2014PDF

Breast Cancer 
Results from CLEOPATRA Phase III Trial Show Perjeta Increased OS 15.7 Months

Final phase III trial results showed that adding Perjeta to Herceptin and docetaxel chemotherapy increased overall survival to over four-and-a-half years in patients with previously untreated HER2-positive metastatic breast cancer.

Data from the CLEOPATRA study showed that the addition of Perjeta (pertuzumab) increased median overall survival 15.7 months compared to Herceptin (trastuzumab) and docetaxel alone—to 56.5 and 40.8 months, respectively. 

The data were presented at the Presidential Symposium at the European Society for Medical Oncology Congress in Madrid. 

Pancreatic Neuroendocrine Tumors

Afinitor Increases Overall Survival To 3.5 Years in Phase III Trial

An analysis of mature overall survival data from a phase III trial showed that Afinitor increased median overall survival by 6.34 months compared to placebo, for a total of over 3.5 years in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.

Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology Congress in Madrid. Results from the primary analysis, which focused on progression-free survival, in which Afinitor (everolimus) more than doubled median PFS compared to placebo, were previously published in the New England Journal of Medicine.

Non-Small Cell Lung Cancer

Merck Serono Cancels Tecemotide Program In NSCLC, Including Two Phase III Trials

Merck Serono will discontinue its worldwide clinical development program of MUC1 antigen-specific immunotherapy tecemotide as a monotherapy in stage III non-small cell lung cancer. This includes the phase III START2 and INSPIRE studies.

The decision comes after a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled phase I/II study in Japanese patients with stage III unresectable, locally advanced NSCLC. Patients had received concurrent or sequential chemoradiotherapy with a minimum of two cycles of platinum-based chemotherapy and radiation dose greater than or equal to 50 Gy.

Multiple Myeloma
Phase III Trial: Panobinostat Increases PFS by Four Months
Gastric Cancer
Phase III Cyramza Trial Meets OS Primary Endpoint
Colorectal Cancer
Phase III Xilonix Study Halted Following Unscheduled Analysis
Ovarian Cancer
Cediranib/Olaparib Combination Nearly Doubles PFS in Phase II
Chemotherapy
Fidaxomicin for CDI Therapy More Cost-Effective Than Vancomycin 
NCI CTEP-Approved Trials for the Month of September
FDA News

  • Keytruda granted accelerated approval in metastatic melanoma

  • FDA approves new indication for Xtandi in prostate cancer

  • FDA removes clinical holds for two agents: ipafricept and PEGPH20

  • Soligenix Inc. reaches agreement with FDA on phase III trial design

October 2014
August 2014PDF

Leukemia 
Arzerra Maintenance Therapy Extends PFS In Phase III Trial, Compared to Observation

A phase III trial of Arzerra as a maintenance therapy for chronic lymphocytic leukemia met its primary endpoint of extending progression-free survival at an interim analysis.

The study evaluated Arzerra (ofatumumab) maintenance therapy versus no further treatment and observation in patients with relapsed CLL who responded to treatment at relapse.

The independent data monitoring committee did not identify any new safety signals and will continue to monitor patients for safety until all study patients complete therapy.  

Stomach Cancer

TCGA Researchers Discover Stomach Cancer Falls Into Four Distinct Molecular Subtypes

Researchers with The Cancer Genome Atlas Network found that stomach cancers fall into four distinct molecular subtypes.

Previous attempts to examine the clinical characteristics of gastric cancer were hindered by how differently cancer cells can look under a microscope, even when from the same tumor. Researchers say the new classification system can serve as a valuable adjunct to the current pathology classification system, which has two categories: diffuse and intestinal.

The researchers identified the new subgroups through complex statistical analyses of molecular data from 295 tumors. They used six molecular analysis platforms including DNA sequencing, RNA sequencing, and protein arrays. The study was published in Nature.

Breast Cancer

Lymphoma
Researchers Find Two Types Of MCL Drug Resistance
Human Papillomavirus
International Working Group Suggests Earlier Endpoints For HPV Vaccine Trials
Multiple Myeloma
Phase III Kyprolis Trial Fails OS Primary Endpoint
Kidney Cancer
Researchers Plan to Extend Phase IIa Asonep Trial
Smoking & Survivorship
Study: Nine Years After Diagnosis 9.3% of Survivors Still Smoke
NCI CTEP-Approved Trials for the Month of August
FDA Approvals

  • Avastin combination approved for late-stage cervical cancer

  • FDA approves Cologuard screening test; CMS proposes national coverage determination

  • Health Canada approves Abraxane for first-line treatment of metastatic pancreatic cancer

  • European Medicines Agency approves request for accelerated assessment of lenvatini

  • Sanofi US launches generic Eloxatin

August 2014
July 2014PDF

Colorectal Cancer 
Trifluridine and Tipiracil Hydrochloride Increase OS, PFS in Phase III Trial

A phase III trial of trifluridine and tipiracil hydrochloride significantly improved both overall and progression-free survival in refractory metastatic colorectal cancer that had progressed after standard therapies. 

Data from the trial of the oral anticancer combination, also known as TAS-102, were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer in Barcelona, Spain.

The global, randomized, double-blind trial, named RECOURSE, met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR=0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32 percent when compared to placebo. 

Melanoma

IDMC Halts Mekinist-Tafinlar Trial Early Due to OS Benefit; Recommends Crossover

An independent data monitoring committee recommended an early stop a phase III trial of Mekinist and Tafinlar in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, following a demonstrated overall survival benefit.

The randomized, open-label study, named COMBI-v, compared the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. 

Also:
Gastroenteropancreatic Neuroendocrine Tumors
Somatuline Demonstrates 65.1 Percent Of Patients Progression-Free at 96 Weeks

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Acute Myeloid Leukemia
Volasertib and LDAC Doubled Response in Older Patients
Cervical Cancer
Study: Negative HPV Test More Accurate than Negative Pap Test In Predicting Cancer Risk
Proton Therapy
Phase II Study: Proton Therapy Can Have Similar Success Rate, Smaller Level of Risk in Treatment of Hodgkin Lymphoma
NCI CTEP-Approved Trials for the Month of July
FDA Approvals

  • Zydelig tablets approved for three blood cancers

  • Imbruvica approved in chronic lymphocytic leukemia

  • Avastin granted priority review in metastatic cervical cancer

  • Blinatumomab granted breakthrough therapy designation in acute lymphoblastic leukemia

  • CTL019 granted breakthrough therapy designation in adult and pedtiatric ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Mylan Inc. launches generic carboplatin injection in multi-dose vials

  • FDA approves IBA Cone Beam Computed Tomography proton therapy solution

  • FDA issues drug safety communication regarding docetaxel

July 2014
June 2014PDF

Non-Small Cell Lung Cancer

Pooled Analysis of Two LUX-Lung Trials Shows Prolonged Survival with Afatinib

New overall survival data of two phase III clinical trials, LUX-Lung 3 and LUX-Lung 6, demonstrated that patients with advanced non-small cell lung cancer whose tumors have the most common epidermal growth factor receptor mutation lived longer if treated with first-line afatinib compared to chemotherapy. 

In the pooled analysis, afatinib (Gilotrif) prolonged survival of lung cancer patients whose tumors have common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 to 24.3 months) and significantly reduced the risk of death by 19 percent (HR=0.81, p=0.037). 

Also:
Prostate Cancer 
Enzalutamide Reduced Risk of Progression By 81 Percent in Metastatic Prostate Cancer

A drug used to treat men with late-stage prostate cancer proved effective in stemming progression of the disease in research participants who had not yet received chemotherapy and extended their survival, according to results from a multi-national phase III clinical trial 

An analysis of the study’s results, published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology annual meeting in Chicago, found that participants treated with enzalutamide saw an 81 percent reduction in the risk the cancer would progress and a 29 percent reduction in the risk of death. 

Pancreatic Cancer
Vaccine and LDCT Pretreatment Can Help PDACs Become Vulnerable to Immunotherapy

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Leukemia
Ibrutinib Increases OS, PFS Versus Ofatumumab in Phase III
Multiple Myeloma
Phase III PANORAMA-1 Trial Meets PFS Primary Endpoint
Thyroid Cancer
Phase III Trial Data: Lenvatinib Extends PFS by Over 14 Months
Glioblastoma
Vaccine Increases PFS by 4 Months In Phase II Per-Protocol Analysis
NCI Approved Trials for the Month of June
FDA Approvals

  • Lymphoseek label updated to include head and neck squamous cell carcinoma

  • Aloxi injection approved for preventing chemotherapy-related nausea in children as young as one month old

  • Orphan drug designation granted to mocetinostat for myelodysplastic syndrome

  • Invenia ABUS breast imaging technology approved 

June 2014
May 2014PDF

Lung Cancer Screening

Model Projects 54,900 New Lung Cancer Cases In Five Years with Nationwide LDCT Screening

A model projecting outcomes for nationwide low-dose CT screening for lung cancer estimated that gradual implementation of the program would detect roughly 54,900 more cases over five years in a high-risk Medicare population. The large majority of new cases would be early-stage disease. 

The model assumes that over a five-year period, an additional 20 percent of high risk patients are offered screening each year. Investigators considered three different screening use scenarios for the implementation: an expected-use scenario based on historic experience with mammography (50 percent of patients offered screening undergo screening every year), a low-use scenario (25 percent), and a high-use scenario (75 percent).

Breast Cancer 
ASCO Publishes Two Clinical Guidelines For Treating HER2-Positive Breast Cancer

The American Society of Clinical Oncology published two clinical practice guidelines on treating women with advanced, HER2-positive breast cancer. 

The first guideline lists appropriate systemic therapies for women newly-diagnosed with advanced disease and those whose early-stage disease progressed to advanced cancer. The second provides recommendations for treating brain metastases. Both guidelines were published in the Journal of Clinical Oncology.

Also:

Prostate Cancer
Study: Delaying ADT Until Symptoms Appear Can Be Safe in Men with a PSA-based Relapse

A study found that it may be safe to postpone androgen deprivation therapy in men with a PSA-only based relapse after prostate surgery or radiation therapy.

Delaying ADT until the onset of symptoms or appearance of cancer on a scan does not substantially compromise long-term survival, according to the population-based observational study. 

“Rising PSA levels trigger a lot of anxiety, and many men want to start treatment as soon as possible,” said lead study author Xabier Garcia-Albeniz, a research associate at Harvard University School of Public Health. 

“These findings suggest that there may be no need to rush to ADT.”

Also:

Non-Small Cell Lung Cancer

Colorectal Cancer
New Biomarker Findings Show Improvement in KRAS Subtype In Phase III Erbitux Trial
Childhood Neuroblastoma
Immunotherapy Shrinks Tumors In Phase I Study at St. Jude
Chemotherapy
Anti-Nausea Drug Successful In Phase III Trial in Highly Emetogenic Chemotherapy
NCI Approved Trials for the Month of May
Drug Development

  • FDA grants orphan drug designation to Advaxis HPV immunotherapy

  • EMA Committee for Medicinal Products for Human Use issues positive opinion for Gardasil

May 2014
April 2014PDF

 

Drug Approvals

FDA Approves Cyramza for Stomach Cancer;
Zykadia in NSCLC; Lipiodol for HCC Imaging;
And Cobas HPV Test for Primary Screening

FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. 

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for unresectable or metastatic cancers that have been treated with a fluoropyrimidine- or platinum-containing therapy. 

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. 

Prostate Cancer 
Phase III Custirsen/Docetaxel/Prednisone Trial Fails Primary Endpoint of Overall Survival

Top-line results from a phase III trial evaluating the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet its primary endpoint of a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer when compared to docetaxel/prednisone alone.

Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance.

Thyroid Cancer
Oral Sorafenib Trial Published in The Lancet; Tablets Extend PFS in Metastatic Disease

Last year, a phase III trial demonstrated Nexavar (sorafenib) tablets significantly extended progression-free survival in locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Results from the trial, named DECISION, were recently published in The Lancet. Based on these data, Nexavar was approved by FDA in November 2013.

Melanoma
Phase III Trial Fails to Extend OS After Meeting Primary Endpoint Of Durable Response Rate
Breast Cancer

 

Non-Small Cell Lung Cancer
LDK378 Demonstrates 58 Percent Overall Response Rate in Phase I
Survivorship
ASCO Releases Three Guidelines For Cancer Survivorship Care
NCI Approved Trials for the Month of April
More Drug Approvals

  • FDA approves sBLA for Arzerra in CLL
  • FDA and European Commission grant orphan status to volasertib in AML
  • CHMP issues positive opinion for Mekinist in metastatic melanoma
  • sNDA submitted for Imbruvica in CLL and SML based on phase III data
May 2014
March 2014PDF

Metastatic Melanoma

Phase III Trial Retrospective Analysis Finds Talimogene Laherparepvec Reduced Tumors

A retrospective analysis of a phase III study found that talimogene laherparepvec reduced the size of injected tumors and non-injected metastatic melanoma tumors that had metastasized to other parts of the body.

The study evaluated talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor. Full results were presented during an oral session at the Society of Surgical Oncology Annual Cancer Symposium in Phoenix.

Ovarian Cancer 
Avastin-Zybrestat Combination Increases Progression-Free Survival in Phase II Trial

A phase II study evaluating Avastin in combination with Zybrestat demonstrated increased progression-free survival in recurrent ovarian cancer. 

The study, known as Gynecologic Oncology Group protocol 186I, met its primary endpoint of a statistically significant increase in progression-free survival (p < 0.05; HR=0.685) for the combination compared to Avastin alone.

The study is the first and currently only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent, without including any cytotoxic chemotherapy.

Non-Small Cell Lung Cancer
IDMC Recommends Halting Phase III Trial Of Onartuzumab in MET-Positive NSCLC

An independent data monitoring committee recommended that the phase III METLung study be stopped due to a lack of clinically meaningful efficacy, following an interim analysis.

Also:

Palliative Care
Study: End-of-Life Chemotherapy Leads to More Deaths in Hospital
Metastases
Y-90 Radioembolization Stabilizes Liver Metastases in 98.5 Percent Of Breast Cancer Patients in Study
Prostate Cancer
Robotic-Assisted Surgery Offers Better Cancer Control, Study Says
NCI Approved Trials for the Month of March
Drug Approvals

  • European Commission approves subcutaneous MabThera

  • Japan approves Lonsurf combination tablet

  • UK’s National Institute for Health and Care Excellence recommends Pixuvri

  • FDA Microbiology Devices Panel recommends cobas HPV test for approval

  • FDA revises prescribing information for Thyrogen

  • And more…

March 2014
JANUARY 2014PDF

Pancreatic Cancer

Abraxane-Gemcitabine Combination Extends Overall Survival in Phase III Trial

A phase III trial of Abraxane extended overall survival in metastatic pancreatic cancer, with some patients surviving longer than three years, when used in combination with gemcitabine. 

The updated OS data from the Metastatic Pancreatic Adenocarcinoma Clinical Trial was presented at the American Society of Clinical Oncology Gastrointestinal Conference in San Francisco. 

Leukemia
Phase III Trial of Imbruvica Halted, Following
Increases in Progression-Free Survival

A phase III study of Imbruvica in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma was stopped early following an interim analysis and at the recommendation of an independent data monitoring committee, which concluded the study demonstrated a significant difference in progression-free survival compared to ofatumumab.

Breast Cancer
Long-term Follow-up Shows ADH and ALH Tissue
Abnormalities Can Carry Similar Risk

Contrary to existing understanding, long-term follow-up of patients with two types of breast tissue abnormalities suggests that both types of abnormalities have the same potential to progress to breast cancer.

Kidney Cancer
Patients on Hypertension Meds Lived Longer, Analysis Shows
Liver Cancer
Post-Hoc Analysis of ThermoDox Suggests OS Improvement
Prostate Cancer
Study: Gene Assay Can Provide Valid Prognostic Information
Colon Cancer
Studies of Oncotype DX Test Presented at ASCO Symposium
Lung Cancer
MicroRNA Assay Detects Cancer Two Years Before LDCT in Study
NCI Approved Trials for the Month of January
FDA News

  • Accelerated Approval granted to Mekinist-Tafinlar combination in unresectable or metastatic melanoma

  • 510(k) Clearance granted to spectral breast density measurement application

  • Reagent system approved for prevention of graft-versus-host disease

  • FDA launches advisory committee membership nomination web portal
  • Orphan drug designation granted to BL-8040 as a treatment for stem cell mobilization
  • FDA lifts clinical hold on tosedostat
  • And more…
February 2014
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