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Issue 42 - Nov. 11, 2016
  • Conversation with The Cancer Letter

    FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings

    In an in-depth interview with The Cancer Letter, an FDA official clarified the agency’s criteria for approval of drugs that target PD-1 and PD-L1.

    Last month, The Cancer Letter reported that there are 803 registered clinical trials testing 20 PD-1 and PD-L1 drugs. These trials have slots for 166,736 patients. (The Cancer Letter, Oct. 7).

    The scope of this development effort appears to be unprecedented.

  • What the Trump Presidency Means for Cancer Care, the ACA, and the Moonshot

    President Barack Obama’s legacy health care programs—the Affordable Care Act, and the National Cancer Moonshot Initiative—have been thrown into uncertainty.

    Hours after Republican Donald Trump became president-elect of the United States, Washington is left in a muddle: hopeful Democratic appointees who expected to join Hillary Clinton’s ranks ended up empty-handed. At stake is leadership at federal agencies, including the HHS, NIH, NCI, and FDA.

  • Fred Hutchinson Opens Cellular Immunotherapy Clinic

    Fred Hutchinson Cancer Research Center has opened a first-of-its-kind clinic focused on cellular-based immunotherapies for cancer patients in clinical trials.

    The Bezos Family Immunotherapy Clinic will allow researchers to conduct twice as many immunotherapy trials in the next year in pursuit of speeding cures for cancer, officials said.

  • In Brief

    • Peter O’Dwyer elected group co-chair elect of the ECOG-ACRIN
    • Charles Drake joins NY-Presbyterian/Columbia as director of genitourinary oncology. associate director at the Columbia Cancer Center, co-director immunotherapy program.
    • William Cance joins University of Arizona Cancer Center as deputy director
    • Craig Reynolds to retire as as director of the NCI Office of Scientific Operations at Frederick
    • Elisabeth Heath, of Karmanos, receives the Michigan Cancer Consortium’s inaugural Champion Award
    • Felipe Suero joins Department of Anesthesiology at Fox Chase
    • Valierie Armstead joins Fox Chase Cancer Center as professor in anesthesiology
    • Susan Rawl, of Indiana University School of Nursing and IU Cancer Center, receives $2.6M from PCORI for colorectal cancer screening research
    • IU School of Nursing establishes Champion Center for Cancer Control Research, named after Distinguished Professor Victoria Champion.
    • NCCN launches Just Bag It campaign for safe handling of vincristine 
    • Weill Cornell Medicine and New York Genome Center receive a NCI grant worth $490,000-a-year five-year grant for joint cancer genomics data center
    • John Wayne Cancer Institute and Singapore’s Clearbridge BioMedics to establish a circulating tumor cell center
    • St. Baldrick’s Foundation provides infrastructure grants to nearly 40 childhood cancer institutions
  • Drugs and Targets

    • Opdivo receives FDA approval for recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
    • Amgen and Janssen Biotech to evaluate combination of Amgen’s Kyprolis and Janssen’s Darzalex in multiple clinical studies in multiple myeloma
    • Hopkins and BMS announce five-year collaboration to study resistance to checkpoint blockers and develop combination immunotherapies.
    • Mylan and Biocon submit BLA for biosimilar trastuzumab
    • FDA has accepts Genentech’s BLA for a subcutaneous formulation of rituximab in blood cancer indications
    • LEE011, Novartis’s selective cyclin dependent kinase inhibitor, granted FDA Priority Review
    • Verastem licenses exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib.
    • VENTANA ALK (D5F3) CDx gets FDA approval to use on the VENTANA BenchMark ULTRA automated slide stainer
  • Funding Opportunities

    • SU2C and Genentech form “Catalyst” to provide research funding and access to compounds in effort to find new indications
    • SU2C makes $7.5 million in grants available to early-career scientists focusing on immuno-oncology
Issue 41 - Nov. 4, 2016
  • MD Anderson Projects $450 Million Loss in Fiscal 2017

    MD Anderson Cancer Center lost $267.1 million on its operations in fiscal 2016. Now, a month into fiscal 2017, America’s largest cancer center is on track to lose $400 million to $450 million.

    In a confidential report intended for department chairs, MD Anderson’s administration attributes the operating loss to four factors:

    • Epic system (tools, reports, technology fixes);

    • Providers – Capacity (Mondays & Fridays; weekends for select services; services at right location);

    • Demand (wait times, rate of incoming calls/requests to set up appointments);

    • Insurance coverage.

  • Cancer Moonshot Research Dollars Must Go to NCI—Not NIH—Groups Say

    Nearly 50 cancer-related organizations urged Congressional leaders to ensure that funds slated for research in the National Cancer Moonshot Initiative go directly to NCI—as opposed to NIH or any other federal entity.

    The letter, dated Nov. 3, was authored by One Voice Against Cancer, a broad coalition that convenes on national funding and policy issues in oncology.

    “It is … imperative that funding provided for Cancer Moonshot research be specifically directed to NCI,” the letter states.

  • San Antonio’s CTRC Joins MD Anderson Network

    The UT Health Science Center at San Antonio and MD Anderson Cancer Center announced an affiliation to create a cancer care program in San Antonio.

    Under the agreement announced earlier this week, MD Anderson will join forces with the Cancer Therapy & Research Center of the UT Health Science Center.

  • Guest Editorial

    A Countdown: Top 10 Problems With NCI-Designated Cancer Centers

    For nearly a half century, much of the “war on cancer” has been fought at NCI-designated cancer centers, the 69 major medical schools and free-standing research institutes have this designation.

    All the big names are there: UCLA, Stanford, Memorial Sloan Kettering, Dana-Farber, MD Anderson, etc.  The NCI “designates” centers for containing organizational structures that create synergies among cancer researchers.  Designated centers promote multi-disciplinary collaborations, provide scientific tools too expensive for individual laboratories (core resources), incentivize translation of scientific ideas into therapies, etc.

  • In Brief

    • Inova and UVA partnership to establish NCI-designated comprehensive cancer center
    • Eckhardt named director of LIVESTRONG Cancer Institute
    • Kachinc elected president of American Board of Radiology
    • O’Connell receives ACCC Research Award; Presant receives David King Award
    • ASCO and Innovative Oncology Business Solutions collaborate on medical home program
    • UPMC collaborates on radiation therapy center in Ireland
    • Schulman IRB launches central oncology review
    • Engleka joins Burson-Marsteller
    • Cincinnati practice joins US Oncology Network
    • Merck and ACS publish report on Global burden of cancer in women
  • Drugs and Targets

    • Roche receives FDA approval for Tecentriq complementary diagnostic in NSCLC
    • BMS receives Health Canada conditional approval for Opdivo-Yervoy combination
    • Hoffmann-LaRoche’s Alecensaro receives Health Canada approval NSCLC
    • Novogen and Genentech enter in commercialization agreement got glioblastoma multiforme drug candidate
    • NICE recommends Eribulin for locally advanced metastatic breast cancer
Issue 40 - Oct. 28, 2016
  • ACA Premiums Up by 25%—Why?

    How Will Oncology Be Affected?

    HHS officials earlier this week announced that health insurance premiums under the Affordable Care Act plans will, on the average, increase by 25 percent next year.

    Experts say that this could be happening at least in part because patients who signed up for the ACA exchanges turned out to be sicker and older than underwriters originally anticipated.

  • Public Health Groups Sue to Force FDA to Mandate Graphic Warnings on Cigarettes

    Eight public health and medical groups filed suit in federal court to force FDA to issue a final rule requiring graphic health warnings on cigarette packs and advertising.

    The lawsuit was filed in Boston by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative, and several individual pediatricians.

  • COA Reports More Attrition of Cancer Clinics

    Since 2008, 1,581 community oncology practices have closed, been acquired, merged, or are struggling to stay open, according to the 2016 Community Oncology Practice Impact Report.

    “An average of 3.6 practices have closed per month since COA began tracking this data,” said Bruce Gould, president and medical director of Northwest Georgia Oncology Centers, and president of the Community Oncology Alliance, in a statement.

  • Drugs and Targets

    • Keytruda Is First Checkpoint Inhibitor To Get Approval for Front Line NSCLC
    • Xtandi Receives FDA Approval for Supplemental New Drug Application
    • YS-ON-001 granted orphan drug designation by FDA
  • In Brief

    • Achilefu Gets DOD Distinguished Investigator Award in Breast Cancer
    • Gov. Andrew Cuomo announced NY-Cuba Partnership for U.S. Clinical Trial of a Cuban Immunotherapy
    • Vanderbilt University Medical Center, Meharry Medical College, and Tennessee State University receive continued federal funding from U54 Partners in Eliminating Cancer Disparities Grants 
    • Grace Lu-Yao joins the Sidney Kimmel Cancer Center at Jefferson
    • Sharon Byers named chief development and marketing officer of the American Cancer Society
    • Emory St. Joseph’s Hospital expands the Winship Cancer Institute
    • Ellen and Gary Davis give $2 million to Weill Cornell Medicine 
    • Varian Medical Systems and McKesson Specialty Health announce a strategic agreement
Issue 39 - Oct. 21, 2016
  • Biden Delivers Task Force Report—

    Five Moonshot Goals in Cancer

    Vice President Joe Biden and the National Cancer Moonshot Task Force published their final reports Oct. 17, summarizing the moonshot’s achievements, and outlining five strategic goals and action plans for the years to come.

    The two reports conclude the 2016 National Cancer Moonshot Initiative, and the Obama administration’s efforts to develop a national conversation on cancer research.

  • Obama: The Moonshot, “Architecture and a Framework” for Cancer Research

    President Barack Obama accepted Vice President Joe Biden and the National Cancer Moonshot Task Force’s reports—blueprints for how the federal government should focus on cancer research, oncology bioinformatics, and patient access and care over the next few years.

    “This all comes down to, ‘How does it impact patients?’ And so Joe, I think, has done a great job in engaging people who are going through battling cancer right now, and finding ways that we’re not just coming up with cures, but we’re also making sure that these systems are set up so that they’re easier for people to access,’ Obama said at a press conference Oct. 17.

  • LLS Starts Beat AML Master Trial

    After four decades of few improvements in the treatment for acute myeloid leukemia, the Leukemia and Lymphoma Society has launched a precision medicine trial to identify targeted treatments for patients with AML.

    The society’s trial—called Beat AML Master Trial—was announced by Vice President Joe Biden Oct. 17 at a White House event rolling out Moonshot-related initiatives.

  • Califf, Bach, Jasin, Offit, Venter Among New Members of NAM

    The National Academy of Medicine announced today the election of 70 regular members and nine international members during its annual meeting. 

    The NAM Articles of Organization stipulate that at least one-quarter of the membership is selected from fields outside the health professions.

  • In Brief

    • Fuchs Named Director at Yale
    • Cox Wins Statistics Top Prize
    • David Cella received National Academy of Medicine Gustav O. Lienhard Award
    • Marcio Fagundes and Michael Chuong joined the Miami Cancer Institute at Baptist Health South Florida’s integrated Radiation Oncology Department
    • The Robert H. Lurie Comprehensive Cancer Center announced a partnership that will make Tempus as a preferred partner
    • Leidos Biomedical Research, Inc. awarded ATCC
    • Carol Burke elected president of the American College of Gastroenterology
    • The Pan Mass Challenge raised $47 million
    • The Scripps Research Institute and the California Institute for Biomedical Research announced the signing of a strategic affiliation
  • Drugs and Targets

    • Lartruvo gets accelerated approval for sarcoma
    • Tecentriq approved for a type of NSCLC
    • Venclyxto granted a positive opinion from the European Committee for Medicinal Products for Human Use
    • Onivyde in combination with 5-fluorouracil and leucovorin received marketing authorization from The European Commission
    • CDC recommended 11-to-12-year-olds receive two doses of HPV vaccine
    • IBM Watson Health and Quest Diagnostics launched IBM Watson Genomics from Quest Diagnostics
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
CCL Oct 2016 - Oct. 20, 2016
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Issue 38 - Oct. 14, 2016
  • Davidson Moves to Seattle Cancer Consortium

    Nancy Davidson was named executive director of the Fred Hutchinson/University of Washington Cancer Consortium effective Dec. 1. For nearly eight years, Davidson has served as director of the University of Pittsburgh Cancer Institute.

    In the new role, Davidson, will coordinate cancer treatment, clinical and translational research programs of consortium members Fred Hutch, UW School of Medicine, Seattle Children’s and Seattle Cancer Care Alliance, the cancer treatment arm of Fred Hutch, UW Medicine and Seattle Children’s.

  • Where is the FY18 Bypass Budget? 

    Cancer Groups Want to Know

    The NCI Bypass Budget was expected to be made public on Oct. 6.

    Alas, this didn’t happen; why didn’t it?

    America’s top cancer groups would like to know, and theirs is not idle curiosity. The NCI Bypass Budget is an important, unique authority established by the National Cancer Act of 1971. 

  • Guest Editorial

    Goodman: Too Many PD-1 Trials for Adults, Too Few for Children

    Kudos to The Cancer Letter’s report on the 803 PD-1 or PD-L1 trials. As Rick Pazdur noted, that is just too many resources chasing the same idea for adult cancer studies.  

    Alas, as of Friday, Oct. 7, clinicaltrials.gov shows only two open trials for a PD-1 or PD-L1 trial for patients 0 to 17 years of age, and both are monotherapies. There are no listed combination trials that are open and accept kids. There are no PD-L2 trials listed that accept kids.

  • In Brief

    • Adrian Lee named director of the Institute for Precision Medicine
    • Kwok-Kin Wong named chief of hematology and medical oncology at the Perlmutter Cancer Center at NYU Langone Medical Center
    • Yanis Boumber joins the Department of Thoracic Medical Oncology and the Molecular Therapeutics Program at Fox Chase Cancer Center
    • Stanley Marks honored through the establishment of the Stanley M. Marks–OHA Endowed Chair in Hematology/Oncology Leadership
    • Robert Figlin appointed deputy director of the Integrated Oncology Service Line at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute
    • Suresh Ramalingam selected to hold the Roberto C. Goizueta Distinguished Chair for Cancer Research
    • Jacqueline Corrigan-Curay selected as permanent director of FDA Office of Medical Policy at the Center for Drug Evaluation and Research
    • Ann Richmond wins the 2016 William S. Middleton Award
    • Marc Benioff and wife Lynne give $20 million toward construction of the Lawrence J. Ellison Institute for Transformative Medicine of University of Southern California
    • Boris Lushniak named dean of the University of Maryland School of Public Health
    • Southern Research Institute awarded five-year IDIQ contract from NCI
    • Dr. Susan Love Research Foundation receives $3 million NCI grant 
    • NIH expands a five-year funding award to The Scripps Research Institute from $120 million to $207 million
    • Mount Sinai receives a $10 million grant from NCI
    • The University of Michigan Comprehensive Cancer Center and Tempus partner to bring MI-ONCOSEQ to patients and healthcare providers
    • Merck KGaA announces the recipients of the 2016 Grant for Oncology Innovation
    • Research!America announces 2017 Advocacy Award winners
  • Drugs and Targets

    • Genentech receives second Breakthrough Therapy Designation from FDA for Alecensa

    • Gamida Cell says FDA has granted Breakthrough Therapy Designation to NiCord
    • Foundation Medicine, Inc. announces new clinical markers added to FoundationOne and FoundationOne Heme products
    • Abbvie said Health Canada issued a Notice of Compliance with Conditions for Venclexta
    • The US Oncology Network selects Myriad Genetics as its preferred provider laboratory for hereditary cancer testing
  • Funding Opportunities

    Pershing Square Sohn Cancer Research Alliance is accepting applications for its Prize for Young Investigators in Cancer Research.

    The prize of $200,000 per year for up to three years is awarded annually to at least five New York City-based scientists, enabling them to continue to pursue explorative and high-risk/high-reward research at a stage when traditional funding is lacking.

Issue 37 - Oct. 7, 2016
Issue 36 - Sep. 30, 2016
  • Two Gigantic Health Systems Integrate Cancer Data to Bring Precision Medicine to Community Care

    By Matthew Bin Han Ong

    Two of the nation’s biggest nonprofit health systems—Dignity Health and Catholic Health Initiatives—launched a precision medicine program that has the potential to create the largest collection of clinical cancer data ever compiled by a single organization.

    Together, Dignity and CHI, based in San Francisco and Englewood, Colo., respectively, operate nearly 150 hospitals and care centers across the U.S. Both rank in the top five largest nonprofit hospital systems.

  • NCI Suspends Frederick Lab Re-Competition Citing Moonshot, Zika and Ebola Research

    NCI has suspended re-competition of the the $400 million-a-year operations and technical support contract for the Frederick National Laboratory for Cancer Research.

    A brief notice of suspension was posted on the Federal Business Opportunities website at 4:06 p.m. Friday, Sept. 30, in the final business hours of the final day of the fiscal year.

  • Conversation with The Cancer Letter

    NCI’s Care Delivery Research Program Seeks to Involve Scientists from Other Fields

    Paul Jacobsen was named associate director of the NCI Division of Cancer Control and Population Science Healthcare Delivery Research Program. Jacobsen says he hopes his joining the institute signals to the scientific community the strength of the institute’s commitment to healthcare delivery research.

    “The use of ‘healthcare delivery research’ in the name of the program was intended to signal an interest in adding to the richness of traditional health services research by involving scientists from other fields whose work would be applicable to cancer care delivery settings,” said Jacobsen, who was most recently the associate center director for population science at the Moffitt Cancer Center.

  • Continuing Resolution Funds Zika, But Not Cancer or Biden’s Moonshot

    A continuing resolution passed Congress passed Sept. 28 will avoid a government shutdown and fund federal agencies through Dec. 9.

    This legislation comes two days before the government’s current funding was due to expire, at midnight Sept. 30. This would have closed all nonessential parts of the government, including NIH.

  • In Brief

    • University of Michigan Cancer Center appoints research leadership team
    • Richard Goldberg retires from Ohio State Cancer Center
    • Peter Schultz receives international Heinrich Wieland Prize
    • Lisa Kennedy Sheldon named chief clinical officer of Oncology Nursing Society
    • Christopher Heery named chief medical officer of Bavarian Nordic A/S
    • Timothy Kuzel named division chief at Rush University Medical Center
    • Morphotek Inc. enters sponsored research agreement with Fox Chase Cancer Center
    • Tempus partners with Northwestern’s Lurie Cancer Center on precision medicine partnership
  • Drugs and Targets

    • Multiple Myeloma Research Foundation contributes data to NCI Genomic Data Commons
    • Janssen submits supplemental FDA New Drug Application for ibrutinib
    • Boehringer Ingelheim and ViraTherapeutics to collaborate on oncolytic virus therapy platform
    • Genomics England Partners with GenomOncology on 100,000 Genomes Project
    • Pronai Therapeutics obtains exclusive license to develop and commercialize PNT737
    • Prix Galien Foundation announces “Discovery of the Decade” nominees
Issue 35 - Sep. 23, 2016
  • No Moonshot Funds In House & Senate FY17 Appropriations Bills

    The National Cancer Moonshot Initiative is not slated to receive funding in fiscal 2017—neither the House nor Senate appropriations bill includes the $680 million the White House proposed for Vice President Joe Biden’s project.

    Despite great bipartisan breast-beating in support of boosting the NCI and NIH budgets, Congress has not set aside funding for the moonshot, a broad scientific and public health effort focused on improving clinical trials, data sharing, and streamlining regulatory processes for oncology products at FDA.

  • Obituary

    Sargent, Mayo Biostatistician and Clinical Trialist, Dies Unexpectedly at 46

    Dan Sargent, one of the world’s foremost experts in oncology clinical trials, died unexpectedly on Sept. 2. Sargent died from an acute illness, Mayo officials said. He was 46.

    “This is a tremendous loss to Mayo Clinic as well as the national and international cancer research community. Dan has given so much to so many,” said Robert Diasio, director of the Mayo Clinic Cancer Center. “We are deeply saddened by his passing. Our thoughts and prayers are with his wife and family.”

  • Conversation with The Cancer Letter

    OHSU Seeks to Raise another $1 Billion; Keith Todd Describes the Strategy

    After raising $1 billion for Knight Cancer Institute, the Oregon Health and Science University fundraising team set out to raise another $1 billion over five years—before 2020.

    Some of the money—at least $200 million—would go to cancer, but the rest is slated to support research and patient care in other areas of medicine, including neuroscience, HIV, heart disease, blindness, and child health.

  • In Brief

    • American Association for Cancer Research releases 2016 Cancer Progress Report
    • 90 cancer groups and centers urge CMS to rescind proposed lung cancer screening reimbursement cuts
    • Rep. Michael Burgess (R-TX) receives ASCO Congressional Leadership Award
    • Spectrum Pharmaceuticals Inc. under investigation for potential securities fraud
    • Columbia University and New York-Presbyterian rename shared medical campus for donors Herbert and Florence Irving
    • Shirley Johnson named senior vice president of Nursing & Patient Care Services of Roswell Park Cancer Institute
    • Falk Medical Research Trust awards $485,000 for uveal melanoma research
    • American Brain Tumor Association awards 16 brain tumor research grants
  • Drugs and Targets

    • Dignity Health and Catholic Health Initiatives launch Precision Medicine Alliance
    • EMA recommends conditional marketing authorization for olaratumab
    • Golden Meditech and MD Anderson announce creation of Cellenkos Inc.
    • St. Jude Children’s Research Hospital and Wellcome Trust Sanger Institute agree to exchange cancer mutation data
    • ORIEN and HudsonAlpha announce new research collaboration
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

CCL 39-08 - Sep. 22, 2016
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