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
May 2016PDF

 

 Multiple Myeloma

Study: Combination of ASCT and Bortezomib
Can Increase Survival

Early findings from a phase III clinical trial showed that patients with multiple myeloma who received an autologous stem cell transplant survived longer without disease progression than those who received only chemotherapy using novel agents.

The study was the largest reported aimed at comparing ASCT with a bortezomib-based regimen alone in patients younger than 65, and will be presented at this year’s annual meeting of the American Society of Clinical Oncology, June 3-7 in Chicago.

“Even in an age of novel therapies, proven approaches can retain their value. This study demonstrated that combining the best of both worlds—initial therapy with a novel agent followed by stem cell transplant—resulted in the best patient outcomes,” said ASCO President Julie Vose in a statement.

 Colorectal Cancer

Cancers Originating on Left Side of Colon
Associated with Longer Survival, Study Says

A retrospective analysis found that the location of the primary tumor within the colon predicts survival and may help inform optimal treatment selection for patients with metastatic colorectal cancer.

The data show that patients whose primary tumors originate on the left side of the colon—including the descending colon, sigmoid colon and rectum—survive significantly longer than those whose tumors originate on the right side, or the cecum and ascending colon.

Researchers retrospectively evaluated data from the phase III CALGB/SWOG 80405 clinical trial, a federally funded clinical trial designed to compare Avastin (bevacizumab) and Erbitux (cetuximab) in combination with chemotherapy as initial therapy for metastatic colorectal cancer.

 Drugs and Targets

FDA Approves Tecentriq, Opdivo, Imbruvica and Lenvima

FDA granted accelerated approval to Tecentriq (atezolizumab) for urothelial carcinoma, the most common type of bladder cancer. This is the first product in its class of PD-1/PD-L1 inhibitors approved to treat this type of cancer, according to the drug’s sponsor, Genentech.

Tecentriq is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgical treatment.

Also:

Non-Small Cell Lung Cancer

 Melanoma

Phase Ib Trial Shows 40 Percent of Patients
Receiving Keytruda Alive After 36-Month Follow Up

 

Mesothelioma

WT1 Vaccine Doubles PFS in Phase II Trial

 

Breast Cancer

LEE011 Meets Primary Endpoint, Improves PFS
in Phase III Trial

 

Precision Medicine

Study: Precision Medicine Yields Better
Outcomes in Phase I Clinical Trials

 

Palliative Care

Study: Early Palliative Care Provides Benefits
for Family Caregivers of Patients

 

NCI CTEP-Approved Trials for the Month of May
June 2016
April 2016PDF

 

Head and Neck Cancers

Opdivo Extends OS in Phase III Squamous Cell Carcinoma Trial

A phase III trial of PD-1 inhibitor Opdivo showed significant survival benefit at one year—compared to investigator’s choice of methotrexate, docetaxel or cetuximab—in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).

The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice. The safety profile of Opdivo in CheckMate-141 was consistent with prior studies, with no new safety signals identified.

     

    Melanoma

    Opdivo-Yervoy Combination Demonstrates Two-Year Survival Rate of 69 Percent

    Overall survival data from CheckMate-069, a phase II trial of a Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma, demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma.

    CheckMate-069 evaluated 142 patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo and Yervoy combination regimen (n=95) or Yervoy alone (n=47). The trial included patients with BRAF wild-type and BRAF V600 mutation-positive melanoma, and randomization was stratified by BRAF mutation status.

       

      Drugs and Targets

      FDA Grants Accelerated Approval To Venclexta Tablets in CLL

      FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

      The indication was approved based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

      Also:

         

        Ovarian Cancer

         

        Prostate Cancer

        Study: SBRT Delivers 98.6% Cure Rate at Five-Year Followup

         

        Soft Tissue Sarcoma

        Researchers: Radiation After Surgery Benefits Older Patients More than Younger Patients

         

        NCI CTEP-Approved Trials for the Month of April

         

        Letter to the Editor

        GOG Foundation Sends Rebuttal Letter to Oncolytics Biotech

        May 2016
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