December 2017PDF


Breast Cancer

Pfizer’s talazoparib extends PFS in phase III trial in metastatic breast cancer

The phase III EMBRACA trial in patients with germline BRCA1/2-positive locally advanced and/or metastatic breast cancer demonstrated superior progression-free survival in patients treated with talazoparib, compared to patients who received physician’s choice standard of care chemotherapy.



Juno Therapeutics and Celgene release additional data from TRANSCEND trial

Juno Therapeutics Inc., a biopharmaceutical company developing cellular immunotherapies for the treatment of cancer, released additional data from the TRANSCEND study of JCAR017 (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma in a presentation at the 59th American Society of Hematology Annual Meeting and Exposition.



Phase III study of venetoclax in combination with rituximab meets primary endpoint

MURANO, a randomized phase III study sponsored by Abbvie, showed that patients with relapsed or refractory chronic lymphocytic leukemia achieved significantly prolonged median progression-free survival with Venclexta/Venclyxto (venetoclax) in combination with Rituxan (rituximab) [median PFS, not reached], compared with bendamustine in combination with Rituxan [median PFS, 17.0 months; hazard ratio, 0.17; 95% CI, 0.11–0.25; P<0.0001].


Kidney Cancer

Genentech’s Tecentriq and Avastin reduce the risk of disease worsening or death from RCC


Skin Cancer

PD-1 antibody cemiplimab demonstrates 46.3% ORR in advanced cutaneous squamous cell carcinoma


Head and Neck Cancer

Galera Therapeutics reports statistically significant results in a 223-patient phase IIb trial of GC4419 for oral mucositis in head and neck cancer


Lung Cancer

Aggressive surgery is best treatment option for early stage lung cancer


Side Effects

Daily oral edoxaban met primary endpoint in Hokusai-VTE cancer study


Liquid Biopsy

Liquid biopsy results differed substantially between two providers in a study


NCI CTEP-Approved Trials for December

December 2017
November 2017PDF


Hematologic malignancies

CD22 CAR-T therapy shows results in leukemia study

A new type of CAR-T therapy that targets the protein CD22 helped achieve remission in nearly 60 percent of leukemia patients who had failed or relapsed on other treatments, according to a paper published in Nature Medicine.



Mount Sinai researchers develop first mathematical model for predicting patient response to immunotherapy

Researchers at the Icahn School of Medicine at Mount Sinai have created the first mathematical model that can predict how a cancer patient will benefit from certain immunotherapies, according to a study published in Nature.


Lung cancer

Phase III study shows Tecentriq and Avastin plus chemo reduced risk of disease progression or death in advanced lung cancer

Genentech said the phase III IMpower150 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer.


Breast Cancer

Novartis reports positive results from phase III trial of Kisqali for advanced or metastatic breast cancer


Genitourinary cancers

Clinical data for CXCR4 inhibitor, Inlyta showa 29% ORR in clear cell renal cell carcinoma


Brain tumors

Ziopharm announces positive updated results of Ad-RTS-hIL-12 study in brain cancer


NCI CTEP-Approved Trials for November


Regulatory actions

FDA approves adjuvant indication for Sutent in renal cell carcinoma

December 2017
October 2017PDF


Lung cancer

Researchers confirm IASLC proposed characterization of uncertain R Status R(un), prognosis between R0 and R1

A recent study confirmed the International Association for the Study of Lung Cancer’s proposed criteria for uncertain resection margin status, R(un), in residual tumor (R) classification.


Breast cancer

Trastuzumab for HER-2-expressing tumors needn’t delay breast reconstruction

Treatment with trastuzumab (Herceptin/Genentech) of breast cancers that express the HER-2 protein does not increase the risk for complications at the surgical site for women who undergo immediate breast reconstruction after mastectomy.


Brain Cancer

Local radiation provides comparable control of brain metastases compared to surgery

An analysis led by researchers at Fox Chase Cancer Center in collaboration with the European Organization for the Research and Treatment of Cancer found that treating cancer that has metastasized to the brain with focal, high-dose radiation yields improved early results compared with surgical removal.



Cleveland Clinic study: timing of melanoma diagnosis, treatment critical to survival


Prostate Cancer

Pfizer, Astellas report positive results from trial of Xtandi in non-metastatic castration-resistant disease


Kidney Cancer

Argos Therapeutics reports interim analysis of phase III ADAPT trial


NCI CTEP-Approved Trials for October


Regulatory actions

FDA approves Kite’s CAR-T cell therapy; another win for NCI’s intramural program

November 2017
August & September 2017PDF


Lung cancer

Two Opdivo trials show three-year survival in patients with previously treated advanced 

Bristol-Myers Squibb announced three-year overall survival data from CheckMate-017 and CheckMate-057, two pivotal phase III randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer.



Safety review update of Revlimid and risk of developing new types of malignancies

There is an increased risk of second primary malignancies in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide), according to FDA.


Urothelial carcinoma

Cyramza data results revealed for urothelial carcinoma

Eli Lilly announced phase III RANGE data that are the first detailed results from the global, randomized, double-blinded, placebo-controlled RANGE study of Cyramza (ramucirumab), in combination with docetaxel, in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.



Randomized data from CMB305 + checkpoint inhibitor study show clinical benefit and immune response


Head and neck cancer

Kura Oncology announces positive phase II study for Tipifarnib in HRAS mutant disease 



GIST tumors linked to NF1 mutations, genetic testing needed


Esophageal cancer

Large study finds that women have superior response to esophageal cancer treatment 


Anal cancer

Black men have lowest survival rates among patients with anal cancer



NCI study identifies essential genes for cancer immunotherapy



Study of 15,000 mammograms shows pressure guided mammography may improve test results 


NCI CTEP-Approved Trials for August 


NCI CTEP-Approved Trials for September


Regulatory actions

Novartis’s Kymriah becomes first gene therapy to get FDA approval 

October 2017
July 2017PDF


Hematologic Malignancies

Oral enasidenib demonstrates durable CRs in IDH2 mutant relapsed, refractory AML

Agios Pharmaceuticals Inc. published efficacy and safety data from the ongoing phase I/II dose-escalation and expansion study evaluating investigational oral Idhifa (enasidenib) in patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-2 mutation.


Lung cancer

First-line immunotherapy treatment can improve survival for subset of lung cancer patients

Findings from a phase III clinical trial for advanced lung cancer patients could help oncologists better predict which patients are likely to receive the most benefit from immunotherapy as a first-line treatment based on the unique molecular characteristics of their tumor, according to a new study reported by a global team led by David Carbone of Ohio State University Comprehensive Cancer–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.


Colon Cancer

UW study links insurance coverage to higher rates of colorectal cancer screenings

Researchers at the University of Wisconsin School of Medicine and Public Health determined that people with a certain type of insurance policy were more likely to be screened for colorectal cancer.  


Gastric Cancer

Differences in subtypes may determine prognosis and response to treatment


Pancreatic Cancer

Combined molecular biology test can identify patients with benign pancreatic abnormalities


Breast Cancer

Nipple-sparing mastectomy has low rate of breast cancer recurrence



Delaying lymph node biopsy after diagnosis doesn’t affect survival


Brain tumors

Experimental “enhancer” may boost conventional therapies for pediatric disease


NCI CTEP-Approved Trials for July


Regulatory actions

FDA approves treatment to reduce risk of breast cancer returning

August 2017
June 2017PDF



Takeda, Seattle Genetics announce data of ADCETRIS for CD30-positive cutaneous T-cell lymphoma

Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. announced that data from the randomized phase III Alcanza clinical trial evaluating Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma was published in Lancet.


Hepatocellular carcinoma

Lenvatinib shows positive results vs sorafenib in unresectable hepatocellular carcinoma

Eisai Inc. announced results from the REFLECT study, a phase III trial evaluating lenvatinib (Lenvima), the company’s multiple receptor tyrosine kinase inhibitor (including fibroblast growth factor receptors, for the first-line treatment of patients with unresectable hepatocellular carcinoma.


Breast cancer

Study: surgery prior to drug treatment not beneficial in metastasized breast cancer

A study from the Austrian Breast & Colorectal Cancer Study Group indicates that women with metastasized breast cancer do not benefit from surgery performed prior to drug treatment. This could cause a paradigm shift in treatment of the disease.


Ovarian cancer

Clovis Oncology’s rucaparib improved survival in ovarian cancer patients

Clovis Oncology Inc. announced topline data from the confirmatory phase III ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival by investigator review in each of the three populations studied.


Lung cancer

Breast cancer drug ineffective in treating squamous non-small cell lung cancer


Head and neck cancer

Study provides better understanding of how brain tumors “feed”


Bladder cancer

Combined modality treatment could be first course for muscle-invasive bladder cancer


Pancreatic cancer

Strategy for pancreatic cancer uses engineered exosomes targeting mutated KRAS gene



Efficacy results for ONC201 in recurrent glioblastoma published


Appendix cancer

Review of appendix cancer cases finds overdiagnosis


Colon cancer

Web calculator to more accurately predict bowel cancer survival


Beyond disease sites

Roswell Park-OmniSeq tool reflects response to checkpoint inhibition


Health services research

Fred Hutch study finds many cancer patients’ ER visits preventable



Balance, gait negatively impacted after chemotherapy


NCI CTEP-Approved Trials for June


Regulatory actions

FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer

July 2017
May 2017PDF


Breast cancer

Three-week radiation therapy treatment given post-mastectomy is safe and effective

A shorter course of radiation therapy given to breast cancer patients following mastectomy is safe and effective and cuts treatment time in half. That is according to data from a phase II clinical trial conducted by Rutgers Cancer Institute of New Jersey investigators and other colleagues who examined a hypofractionated regimen given over three weeks versus the traditional six week course of treatment.


Lung cancer

Imfinzi reduces the risk of disease worsening or death in the phase III PACIFIC trial in stage III disease

AstraZeneca and MedImmune, its global biologics research and development arm, announced positive results for the phase III PACIFIC trial, a randomized, double-blinded, placebo-controlled multi-center trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable non-small cell lung cancer who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.


Prostate cancer

AUA publishes list of tests and treatments to question as part of “Choosing Wisely”

AUA released a list of recommendations regarding tests and treatments that are commonly ordered but not always necessary in urology, or urologic management that could be improved, as part of the Choosing Wisely campaign, an initiative of the ABIM Foundation.


Pancreatic cancer

Mutations in pancreatic cancer provide clues on development of pancreatic cancer


Bladder cancer

Tecentriq in previously treated bladder cancer fails to meet OS endpoint


Head and neck cancer

HPV vaccine may prevent oropharyngeal cancers



Part 2 of phase III study of binimetinib and encorafenib produces positive top-line result


Thyroid cancer

NCCN publishes patient education resources for thyroid cancer


Brain tumors

Two studies shed light on aggressive brain cancer



First extensive immune profiling of sarcomas shows some likely susceptible to immunotherapy


Acute myeloid leukemia

Positive phase II data on AST-VAC1 for the treatment of AML published


Hepatocellular carcinoma

SIR-Spheres Y-90 resin microspheres improves quality of survival



About 150,000 women in the U.S. living with metastatic breast cancer as survival increases


Health services research

Pancreatic and thyroid cancer patients may live longer if they travel to an academic hospital for surgical care


NCI CTEP-Approved Trials for May


Regulatory actions

FDA grants regular, accelerated approvals to Keytruda for urothelial carcinoma

June 2017
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



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



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



Newfound Effect of Cancer Drug May Expand its Use


Health Disparities

Study: Minority Women Receive Poorer Care for Cervical Cancer

February 2017
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