April 2017PDF

 

Breast cancer

Phase III abemaciclib study shows PFS improvement at interim analysis

Eli Lilly and Co. said that following a pre-planned interim analysis for MONARCH 3, the trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival. In addition, improvement was shown in a key secondary endpoint of objective response rate.

 

Hematologic malignancies

Blinatumomab produced remission in high-risk patients with Ph+ B-Cell precursor acute lymphoblastic leukemia

Amgen announced that the Journal of Clinical Oncology published results from the Phase 2, open-label ALCANTARA study evaluating the efficacy and safety of Blincyto (blinatumomab) in patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia who had failed at least one second-generation or later tyrosine kinase inhibitor.

 

Pancreatic cancer

SWOG DMC says PEGPH20 unlikely to demonstrate OS improvement

Halozyme Therapeutics Inc. announced it has been informed by SWOG, an independent network of researchers that design and conduct cancer clinical trials, that the SWOG phase Ib/II trial evaluating PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed to enrollment.

 

Childhood cancer

St. Jude study finds childhood cancer survivors would likely benefit from genetic screening

 

Prostate cancer

Active surveillance preserves quality of life for prostate cancer patients, Vanderbilt study concludes

 

Skin cancer

Gene-based blood tests identify more skin cancers

 

Guidelines

ASTRO guideline establishes standard of care for curative treatment of oropharyngeal cancer with RT

 

NCI CTEP-Approved Trials for April

 

Regulatory actions

Tecentriq receives accelerated approval as initial treatment for advanced bladder cancer

May 2017
March 2017PDF

 

Multiple Myeloma

Carfilzomib produces OS benefit vs. bortezomib in relapsed, refractory disease

Amgen announced positive results from a planned overall survival interim analysis of the Phase III head-to-head ENDEAVOR trial.

 

Chronic Myeloid Leukemia

NEJM publishes long-term results of Gleevec for 1,106 patients worldwide

The New England Journal of Medicine published results from a nearly 11-year follow-up study, that showed an estimated overall survival rate of 83.3 percent.

 

Breast Cancer

Phase III MONARCH 2 study of abemaciclib meets primary endpoint of PFS

Eli Lilly and Co. said its MONARCH 2 trial of abemaciclib met the primary endpoint of progression-free survival. The phase III study evaluated abemaciclib, a cyclin-dependent kinase  4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer who have relapsed or progressed after endocrine therapy.

 

Ovarian Cancer

Olaparib phase III SOLO-2 trial demonstrates significant PFS benefit in BRCA-mutated disease

AstraZeneca presented data from the confirmatory Phase III SOLO-2 trial demonstrating a statistically significant and clinically meaningful improvement of progression-free survival among patients treated with Lynparza (olaparib) compared to placebo.

 

Lung Cancer

Proton therapy offers treatment possibility for recurrent lung cancer

 

Bladder and Prostate Cancers

In phase II studies Apatorsen improved outcomes in bladder, prostate cancers

 

Medulloblastoma

St. Jude study reveals how an enzyme puts the brakes on aggressive disease

 

Health Disparities

Black and Hispanic women in Connecticut less likely to undergo gene expression profiling

 

NCI CTEP-Approved Trials for March

 

Regulatory Actions

Bavencio receives accelerated approval for Merkel cell carcinoma

March 2017
February 2017PDF

 

Prostate Cancer

Regimen Extends Life for Some Men With Recurrent Prostate Cancer

Adding hormonal therapy to radiation treatment can significantly improve the average long-term survival of men with prostate cancer who have had their prostate gland removed, according to a new Cedars-Sinai study published in the Feb. 2 issue of the New England Journal of Medicine.

 

Gastric Cancer

Opdivo Demonstrated Improved Survival in Advanced Gastric Cancer in Phase III Study

Bristol-Myers Squibb Company announced the results of ONO-4538-12 demonstrating Opdivo (nivolumab) significantly reduced the risk of death by 37% (HR 0.63; p<0.0001) in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy, a condition without current standard-of-care treatments.

 

Drugs & Targets

FDA Approves Opdivo for Urothelial Carcinoma Indication

FDA approved the nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

 

Urothelial Cancer

Durvalumab Shows Activity in Patients who Progressed on Platinum-Based Chemo

AstraZeneca and its global biologics research and development arm, MedImmune, announced updated efficacy and safety data for durvalumab in patients with locally-advanced or metastatic urothelial cancer.

 

Renal Cell Carcinoma

NKTR-214 Shows Activity in Phase I RCC Study

 

Hematologic Malignancies

Gene-Guided Targeted Therapy Used to Treat Hematologic Syndromes

 

Breast Cancer

Blood Test That Detects Changes in Tumor DNA Predicts Survival in Advanced Disease

 

Ovarian Cancer

TapImmune Announces Progress in Phase II Trial

 

Brain Tumors

Genome Analysis Helps Keep GBM at Bay for Five Years

 

Skin Cancer

Immune Responses in Virus-Related Skin Cancer Suggest Immunotherapy Strategy

 

Lung Cancer

Vanderbilt Team’s Discovery Offers New Insight on Lung Cancer Risk

 

Thyroid Cancer

Pitt Study Finds Potential Marker of Drug Response in Many Cancer Types

 

NCI CTEP-Approved Trials for February

 

Pharmacology

Newfound Effect of Cancer Drug May Expand its Use

 

Health Disparities

Study: Minority Women Receive Poorer Care for Cervical Cancer

February 2017
January 2017PDF

 

Prostate Cancer

Study Shows Only Nuclear-Localized AR-V7 Predictive of Benefit for Patients with Metastatic Disease

Investigators from Memorial Sloan Kettering Cancer Center and Epic Sciences published findings in European Urology that only nuclear localization of AR-V7 protein in circulating tumor cells from metastatic castration-resistant prostate cancer patient blood samples is predictive of therapeutic benefit.

 

Pediatric Cancers

Early-phase Study Shows Shrinkage in Pediatric Neural Tumors

In an early-phase clinical trial of a new oral drug, selumetinib, children with the common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas, tumors of the peripheral nerves, tolerated selumetinib and, in most cases, responded to it with tumor shrinkage. NF1 affects one in 3,000 people.

 

Breast Cancer

MammaPrint Substantially Impacts How Breast Cancer in Germany is Treated

Agendia Inc. has presented new prospective data demonstrating the strong impact of its 70-Gene Breast Cancer Recurrence Assay, MammaPrint, and the corresponding 80-Gene Molecular Subtyping Assay BluePrint, in clinical decision-making for patients with early-stage breast cancer in Germany.

 

Pancreatic Cancer

Halozyme’s Phase II Study In Advanced Pancreas Cancer Meets Endpoints

Halozyme Therapeutics Inc. reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a phase II randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE(nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.

 

Lung Cancer

Cota Study Suggests Some Patients Are Left Behind in Genomic Revolution

 

Ovarian Cancer

NewVac Meets Primary Endpoints in Phase II Trial of Quisinostat Combination in Platinum-Resistant Disease

 

Brain Tumors

ONC201 Glioblastoma Trial to Expand Based on Promising Initial Results

 

Head and Neck Cancer

Study Finds Biological Explanation for Racial Disparities in Survival for Certain Cancers

 

NCI CTEP-Approved Trials for January

 

Regulatory Actions

Tecentriq receives priority review for treatment of urothelial carcinoma

January 2017
December 2016PDF

 

Lung Cancer

Tagrisso Shows Superiority vs. Chemo in EGFR T790M Mutation-Positive Disease

Data from phase III trial showed that Tagrisso (osimertinib) second-line therapy improved progression-free survival by 5.7 months, compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3).

 

Breast Cancer

Lilly Presents Phase II Data on Abemaciclib in Early Breast Cancer

A phase II study of abemaciclib, a cyclin-dependent kinase 4 and CDK 6 inhibitor, met its primary endpoint of reducing expression of Ki67, a biomarker of cell proliferation, after two weeks of treatment.

 

Hematologic Malignancies

Imbruvica Shows Response in 2/3 of Steroid Dependent, Refractory cGVHD Patients in Phase II Study

In a phase II study, ibrutinib (Imbruvica) demonstrated clinically meaningful and durable responses and reduced symptom severity, with an overall response rate of 67% in patients with cGVHD.

 

Regulatory Actions

FDA Approves Indications for Rubraca and Avastin

 

KRAS

Cellular Immunotherapy Targets a Common Human Cancer Mutation

 

Head and Neck Cancer

Immune Response to HPV Has Impact on Prognosis

 

 Pain Management

Opioids Not Helpful in Treating Chronic Pain, Geisinger Study Finds

 

NCI CTEP-Approved Trials for December

December 2016
13651
November 2016PDF

 

Guidelines

New Evidence-Based Guideline on HER2 Testing for Patients with Gastric Cancer

The College of American Pathologists, the American Society for Clinical Pathology, and the American Society of Clinical Oncology released an evidence-based clinical practice guideline on human epidermal growth factor receptor 2 testing for patients with gastroesophageal cancers.

 

Urothelial Cancer

Phase III Keytruda Study Shows Better OS vs. Chemo for Advanced Urothelial Cancer

Merck announced that the phase III KEYNOTE-045 trial investigating the use of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival.

 

Regulatory Actions

FDA Approves New Indications for Darzalex, Keytruda, Opdivo

Janssen Biotech said FDA approved Nov. 21 daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

 

Multiple Myeloma

Study met Primary Endpoint of Non-Inferiority Versus Zoledronic Acid in Delaying Skeletal-Related Events

Amgen announced that a phase III study evaluating XGEVA (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.

 

Prostate Cancer

 

Testicular Cancer

High-Dose Chemo and Stem Cell Transplant Cures Most Relapsed Testis Cancer

 

Bladder Cancer

Positive Survival Results from Apatorsen Phase II Trial in Metastatic Bladder Cancer

 

Melanoma

 

Immunotherapy

Nektar Phase II Study: Anti-tumor activity in 7/18 evaluable patients with solid tumors

 

NCI CTEP-Approved Trials for November

November 2016
October 2016PDF

 

 

Non-Small Cell Lung Cancer

Phase III Tecentriq Study Shows Better Survival vs. Chemo Regardless of PD-L1 Status

Genentech said its pivotal phase III OAK study of Tecentriq (atezolizumab) showed a median survival of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 – 0.87).

The results were presented at the European Society of Medical Oncology 2016 Annual Meeting in Copenhagen.

The OAK study evaluated people with non-small cell lung cancer whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line).

 

Melanoma

Yervoy Improved OS in Fully Resected Stage III Patients from Phase III Study

Bristol-Myers Squibb Co. announced superior efficacy for Yervoy 10 mg/kg versus placebo on all survival endpoints in the phase III trial CA184-029 (EORTC 18071) evaluating stage III melanoma patients who are at high risk of recurrence following complete surgical resection.

In the study, Yervoy compared with placebo significantly improved overall survival (OS) (HR=0.72 [95.1% CI: 0.58-0.88; p=0.001]), a secondary endpoint, with five-year OS rates at 65.4% in the Yervoy group and 54.4% in the placebo group.

 

Head and Neck Carcinoma

Opdivo Stabilized Patient-Reported Outcomes in Phase III Study

Bristol-Myers Squibb Co. announced patient-reported quality-of-life data from an exploratory endpoint in the pivotal phase III CheckMate -141 trial evaluating Opdivo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel or cetuximab).

Outcome assessments showed Opdivo stabilized patients’ symptoms and functioning, including physical, role and social functioning across three separate instruments, the company said.

Both PD-L1 expressors and non-expressors treated with investigator’s choice of therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus Opdivo.

 

Bladder Cancer

Phase III Trial Confirms ORR in Previously Treated Patients who Received Opdivo

 

Renal Cell Carcinoma

Durable Responses Seen With Opdivo and Yervoy in Updated Analysis

 

Colorectal Cancer

 

Breast Cancer

Novartis’s LEE011 + Letrozole Shows Superior PFS as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

 

Pancreatic Cancer

ONIVYDE Regimen Produced OS, PFS Benefit In Metastatic Disease

 

Multiple Myeloma

Kyprolis Study in Newly Diagnosed Disease Doesn’t Meet Primary Endpoint—PFS

 

Retinoblastoma

Triple-drug Chemo with Topotecan Helps Preserve Vision in Patients

 

NCI CTEP-Approved Trials For the Month of October

 

Regulatory Actions

  • Genentech receives second Breakthrough Therapy Designation from FDA for Alecensa
  • Gamida Cell granted Breakthrough Therapy Designation for NiCord
  • Janssen Research & Development submits supplemental NDA for ibrutinib
  • European Medicines Agency recommends conditional marketing authorization for olaratumab in combination with doxorubicin
  • FDA accepts Array Biopharma’s NDA for binimetinib
October 2016
13380
August/September 2016PDF

 

 

Non-Small Cell Lung Cancer

Tecentriq Demonstrates Increase In Overall NSCLC Survival in Phase III Study

Genentech announced positive results for Tecentriq (atezolizumab) from the Phase III study OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer whose disease progressed on or after treatment with platinum-based chemotherapy.

Adverse events were consistent with what has been previously observed for Tecentriq. Genentech, a member of the Roche Group, will present full results at an upcoming medical meeting in 2016.

Also:

 

Lymphoma

Adcetris Improves ORR4 in Phase III Trial

Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. said that the phase III ALCANZA clinical trial evaluating Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4).

This randomized trial, which received a Special Protocol Assessment from FDA and scientific advice from the European Medicines Agency, compared the use of single-agent Adcetris to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.

 

Breast Cancer

Abemaciclib Phase III Trial Continues After Interim Efficacy Criteria Not Met

Eli Lilly and Co. said that following a pre-planned interim analysis of the MONARCH 2 trial, an independent data monitoring committee provided the recommendation to continue the study without modification as the interim efficacy criteria were not met.

The phase III trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

 

Prostate Cancer

Custirsen Trial Fails to Show Improvement in Survival

 

Melanoma

Two-drug Immunotherapy May Produce Better Survival in Advanced Melanoma

 

Hepatocellular Carcinoma

Study Confirms Association Between RFA Burn Time, OS In Patients Receiving ThermoDox

 

Kidney Cancer

Study Finds HIF-2 Inhibitors More Effective Than Sunitinib

 

Regulatory Actions

Novartis, MEI Pharma. Receive Breakthrough Therapy Designations

 

NCI CTEP-Approved Trials for the Months of August and September

 

Screening

FDA Warns Against Ovarian Cancer Screening

September 2016
July 2016PDF

 

 

Ovarian Cancer

Niraparib Demonstrates Prolonged PFS in Phase III Trial,
Achieving Primary Endpoint

Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.

The trial, NOVA, is a double-blind, international trial that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. There is currently no therapy approved by FDA for maintenance treatment of patients with recurrent ovarian cancer following response to platinum, according to Tesaro Inc., niraparib’s sponsor. Niraparib is an oral, once-daily PARP inhibitor.

 

Breast Cancer

Phase III Trial Rules Out Inferiority of
Trastuzumab Biosimilar ABP 980

Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody which targets HER2. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab in the U.S. and the European Union.

 

Drugs and Targets

 

Colorectal Cancer

 

Lymphoma

 

NCI CTEP-Approved Trials For the Month of July

August 2016
June 2016PDF

 

 

Leukemia and Lymphoma

Three Phase III Studies of Imbruvica Presented at ASCO Annual Meeting

AbbVie published longer-term follow-up results from three phase III studies of Imbruvica (ibrutinib) in chronic lymphocytic leukemia and small lymphocytic lymphoma: RESONATE, RESONATE-2 and HELIOS.

These data were presented at the annual meeting of the American Society of Clinical Oncology. Imbruvica is jointly developed and commercialized in the U.S. by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc.

“Our clinical data presented at this year’s ASCO from several randomized studies demonstrate solid durability of response with Imbruvica in patients with CLL/SLL with additional follow-up of up to three years,” said Danelle James, head of oncology at Pharmacyclics.

Also:

 

Breast Cancer

Combination of Surgery and Standard Therapy Increases Survival in Stage IV, Study Says

A combination of surgery to remove the primary tumor in women diagnosed with stage IV breast cancer, followed by standard therapies, can add months to patients’ lives when compared with standard therapy alone, according to an international phase III study.

“Our findings will change the standard of care for women newly diagnosed with stage IV breast cancer,” said lead investigator Atilla Soran, clinical professor of surgery at the University of Pittsburgh School of Medicine and breast surgical oncologist with UPMC CancerCenter. “We’ve shown that surgery to remove the primary tumor—either through lumpectomy or mastectomy—followed by standard therapy, is beneficial over no surgery.”

Also:

 

Drugs and Targets

FDA Approves EGFR Companion Diagnostic For Tarceva Therapy

 

Melanoma

 

Soft Tissue Sarcoma

Phase III Eribulin Trial Boosts OS in Liposarcoma Patients

 

Multiple Myeloma

Kyprolis, Lenalidomide and Dexamethasone Combination Improves PFS, OS in Phase III

 

NCI CTEP-Approved Trials for the Month of June

June 2016
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