The Cancer Letter Publications

Issue 12 - Mar. 22, 2019

TCL45-12 (63 downloads)

Texas cancer researchers vying to renew CPRIT beyond its 2023 sunset date
The institute is spending more than NCI in the state
The Cancer Prevention and Research Institute of Texas—the second largest publicly-funded granting organization for cancer after NIH—may receive $3 billion more to stay open past its current sunset date in 2023.
Conversation with The Cancer Letter
James Willson: CPRIT is money well spent
Advocates of renewing the Cancer Prevention and Research Institute of Texas argue that the agency is a good investment for the state.
In Brief
- Françoise Mornex becomes first female recipient of Heine H. Hansen Award
- Gift to UPMC Children’s Hospital of Pittsburgh establishes treatment suite for rare early childhood cancer
Funding Opportunities
DoD Prostate Cancer Research Program announces funding opportunities
The FY19 Defense Appropriation provides $100 million to the Department of Defense Prostate Cancer Research Program to support innovative, high-impact prostate cancer research.
Trials & Tribulations
SWOG’s 1501 study takes aim at the silo wall between cardiology and oncology
Many have written and spoken about the goal of eliminating the effect of developing and delivering medical care in “silos.”
Clinical Roundup
- Breast ultrasound and cancer detection rates increased under new laws
- Duke study says genomic testing associated with lower health care costs in high-risk breast cancer patients
- Braftovi with Mektovi + Erbitux or panitumumab recommended in advanced BRAF-mutant colorectal
- Data from GARNET study indicates robust activity of dostarlimab in endometrial cancer
Drugs & Targets
- Tecentriq + chemo gets FDA approval in extensive-stage SCLC
- Strata Oncology launches expanded StrataNGS
- Oncoceutics and NCI collaborate to develop ONC206
- FDA issues warning letters to breast implant manufacturers to deliver on post-approval requirements

Issue 11 - Mar. 15, 2019

TCL45-11 (269 downloads)

News Analysis
The Gottlieb-Sharpless-Lowy rearrangement
No prizes should be handed out to anyone who predicted that:
1. Scott Gottlieb would leave his job as FDA commissioner,
2. Gottlieb would suggest NCI Director Ned Sharpless as his replacement, and
3. NCI Deputy Director Doug Lowy would step in as NCI acting director.
Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent
President Donald Trump has proposed to cut $4.7 billion from the NIH budget, with almost $900 million coming out of NCI during the fiscal year 2020.
AACR News
DuBois to receive Magaret Foti award; Freireich–Lifetime Achievement award; Hudson and Robison–Team Science award
The American Association for Cancer Researc will honor the following cancer researchers, clinicians, and physician-scientists at the AACR Annual Meeting 2019, to be held March 29-April 3 in Atlanta.
ASCO News
Hortobagyi to deliver Karnofsky lecture; Brugge–Science of Oncology lecture; Wolmark–Gianni Bonadonna lecture
The American Society of Clinical Oncology and ASCO’s Conquer Cancer Foundation announced the winners of Special Awards, the society’s highest honors, and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards.
In Brief
- Fred Hirsch to join Mount Sinai Tisch Cancer Institute
- Reps. Higgins, Guthrie, Matsui and Bilirakis announce the Cancer Drug Parity Act
- Ong named a finalist in the 25th Annual NIHCM Research and Journalism Awards
Conversation with The Cancer Letter
TMIST PI Pisano: “Are we further reducing breast cancer mortality the more intensively we screen?”
The Tomosynthesis Mammographic Imaging Screening Trial, a massive randomized trial of early detection, is asking an important question:
Is digital breast tomosynthesis better than digital mammography in reducing development of advanced breast cancer?
Clinical Roundup
- UAMS study shows potential to alter neck dissection surgery in head and neck cancer
Drugs & Targets
- European Commission approves Keytruda + chemotherapy for NSCLC
- Tecentriq + Abraxane regimen gets accelerated approval for breast cancer
- Trazimera, Herceptin biosimilar, gets FDA approval
- myPath melanoma test receives Medicare coverage

Issue 10 - Mar. 8, 2019

TCL45-10 (326 downloads)

Trump’s proposal for pediatric cancer has NCI envisioning the first data federation of its kind
In anticipation of an infusion of funds from Congress, NCI is developing a blueprint for a comprehensive cancer data federation—starting with pediatric cancer.
Conversation with The Cancer Letter
Sharpless: With $500 million, NCI can create data federation that would change research in childhood cancer
If this effort is highly successful for childhood cancer, then we’ll broaden the efforts to other cancers next. This is an important first step in learning how useful radical data sharing and aggregation can be.
Conversation with The Cancer Letter
CHOP’s Resnick: Big data will transition from research to the standard of care in the clinic
It’s extremely exciting to hear and see both the NCI and the administration and other community partners and patient groups really coming together and reconsidering, ‘What are the unmet needs that can inform in new ways through new approaches of integration?
Conversation with The Cancer Letter
St. Jude’s Roberts: “No single institution can maximize cures and minimize toxicities alone”
Historically, cancer research drug development has largely been focused upon adult cancers with drugs trickling down to pediatric trials over time. But we now know that 55 percent of the driver mutations are unique to childhood cancers. So, relying upon that old model is not going to serve children well.
Guest Editorial
Needed: A fully funded data federation for pediatric cancer with deep genomic sequencing and clinical records
It was a thrilling moment for me when, sitting on my living room couch, listening to the State of the Union address, I heard the president say:
“Many childhood cancers have not seen new therapies in decades. My budget will ask the Congress for $500 million over the next 10 years to fund this critical life-saving research.”
Gottlieb resigns at FDA, recommends Sharpless as successor
Scott Gottlieb has submitted a letter of resignation from his job as FDA commissioner, reportedly recommending that NCI Director Ned Sharpless be appointed as his successor at the agency.
In Brief
- Raymond DuBois receives AACR Margaret Foti Award
- Charles Sawyers to present AACR Princess Takamatsu memorial lecture
- Alberto Mantovani receives Pezcoller Foundation-AACR Award
- Jeffrey Bluestone to receive AACR-Irving Weinstein Foundation lectureship award
- Manuel Hidalgo named chief of hematology and medical oncology at Weill Cornell
- Greg Delgoffe to receive Sy Holzer Endowed Immunotherapy Research Fund
Funding Opportunities
FDA Oncology Center of Excellence publishes research contract opportunities
The FDA Oncology Center of Excellence seeks white papers to award contracts for oncology regulatory science research through a Broad Agency Announcement, FDABAA-19-00123.
Clinical Roundup
- Genentech submits sNDA for Venclexta plus Gazyva for previously untreated CLL
- Study: AI may perform as well as radiologists
Drugs & Targets
- Paige.AI receives FDA Breakthrough Device designation
- Lynparza receives positive EU CHMP opinion in breast cancer
- Breast Cancer Index receives expanded Medicare coverage
NCI Trials
NCI Trials for March
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 9 - Mar. 1, 2019

TCL45-09 (225 downloads)

ODAC gives thumbs down to single-arm trial of two-drug combination for multiple myeloma
Committee focuses on meaning of equipoise, accelerated approval, confirmatory trials
It’s not just the absence of a randomized trial that prompted the FDA Oncologic Drugs Advisory Committee to recommend against an accelerated approval of the Karyopharm Therapeutics Inc. drug selinexor for late-stage multiple myeloma.
FDA tightens regulation of robotic devices in minimally invasive surgery for cancer
Device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may now be required to study long-term oncologic endpoints in surgical trials, according to a safety communication published by FDA on Feb. 28.
In Brief
- NCORP networks to take part in NCI’s Moonshot Tissue Procurement Protocol
Conversation with The Cancer Letter
CDC: HPV vaccine dramatically reduced HPV-related cervical precancers over 6 years
The number of cases of HPV+ cervical precancers has dropped by 21 percent from 2008 to 2014, according to a survey by the Centers for Disease Control and Prevention.
Clinical Roundup
- BRACAnalysis CDx test identified patients with pancreatic cancer who benefitted from Olaparib
- PET scans show biomarkers could spare some breast cancer patients from chemotherapy
- Medicaid expansion in Kentucky led to more screening and higher CRC survival
- Study shows annual non-invasive stool test effective for colon cancer screening
- Lab-grown mini tumors could help identify personalized treatments for people with rare cancers
- Inherited mutations may play a role in development of pancreatic cancer
Drugs & Targets
- FDA approves new formulation of Herceptin
- FDA approves Lonsurf with GEJ adenocarcinoma

Issue 8 - Feb. 22, 2019

TCL45-08 (223 downloads)

NCI invites scientists to step up competition for $173 million set-aside for commercialization
NCI would like you to know that it has a pot of money for commercialization projects—please apply.
Together, the institute’s Small Business Innovation Research and Small Business Technology Transfer programs are giving out $173 million in fiscal 2019. At NIH, these programs gave out $1.145 billion.
Conversation with The Cancer Letter
Caryn Lerman on leading USC Norris: Team science is where breakthroughs emerge
Caryn Lerman was named director of USC Norris Comprehensive Cancer Center.
When she reports to work at USC on March 15, Lerman will be the only behavioral scientist to lead an NCI-designated cancer center. She also will hold the position of professor of psychiatry and the behavioral sciences at the Keck School of Medicine of USC.
In Brief
- NCI’s Rosenberg to receive Szent-Györgyi prize
- Vale named executive director of HHMI Janelia Research Campus
- Baylor consolidates cancer center clinics on new McNair Campus
- Merck to acquire Immune Design
- Doubrava joins Fox Chase
Funding Opportunities
ASCO invites applications for research based on data from CancerLinQ Discovery
The American Society of Clinical Oncology is inviting applications for research grants for projects that use data from CancerLinQ Discovery, an offering of ASCO’s CancerLinQ initiative, as a source.
Clinical Roundup
- Guidelines recommend genetic testing for all people with breast cancer
- Keytruda + Inlyta reduced risk of death by nearly half compared to sunitinib in RCC
- OS and PFS for Keytruda in hepatocellular carcinoma did not meet statistical significance
- Merck expands immuno-oncology program with three phase III trials in prostate cancer
- Opdivo + Yervoy shows response in pre-treated patients with prostate cancer
- Janssen announces preliminary results from phase II GALAHAD in prostate cancer
- Roswell Park researchers identify protein that contributes to racial disparities in prostate cancer
- AVEO Oncology announces TIVO-3 trial topline results
- SCLC may respond to combination of immunotherapy and DNA damage repair inhibitors
- Study finds melanoma brain metastases immunosuppressive with treatment-resistant metabolism
- Dasatinib enhances response to checkpoint inhibitors, study finds
- Integrating heart disease and cancer care could reduce overall health care costs
- CASSINI Trial publishes data on preventing blood clots in cancer patients
Drugs & Targets
- FDA approves Keytruda for adjuvant treatment of melanoma
- FDA accepts IND for TR1801-ADC, an ADC targeting cMet positive solid tumors
- FDA grants priority review to Merck’s sBLA for Keytruda monotherapy in SCLC
- FDA publishes revised draft guidance for investigational tobacco products

Issue 7 - Feb. 15, 2019

TCL45-07 (530 downloads)

Guest Editorial
Making the case to double NIH
The decision to double the budget of the National Institutes of Health should be easy, because it will save lives and save our economy simultaneously. The case for NIH is overwhelming, and there is broad bipartisan congressional support. So why is it so challenging?
NCI Director’s Report
Sharpless: Please stay in oncology, don’t stop sending good research ideas to NCI
The mathematical concepts underlying the challenge NCI is facing today aren’t difficult to grasp. In fact, a 14-year-old in an algebra class should be able to get it, NCI Director Ned Sharpless said to the National Cancer Advisory Board Feb. 12.
In Brief
- Caryn Lerman named director at USC Norris Comprehensive Cancer Center
- St. Baldrick’s and ACS form partnership focused on pediatric cancers
- Report calls on US to accelerate the elimination of cervical cancer worldwide
Clinical Roundup
- Keytruda + Inlyta improves OS, PFS and ORR vs. Sunitinib in RCC
- Immunotherapy appears better than chemotherapy for skin cancer
- Group of lymph nodes to determine prognosis for mesothelioma
- Phase III ARCHES trial shows Xtandi improved PFS in prostate cancer
- Opdivo + Yervoy shows continued survival benefit in RCC
- Immunotherapy effective in recurrent glioblastoma
- Black-white cancer mortality gap nearly eliminated in some age groups
- Report calls on US to accelerate the elimination of cervical cancer worldwide
Drugs & Targets
- European Commission approves Sprycel + chemo for pediatric
- FDA grants Priority Review for Keytruda in head and neck squamous cell carcinoma
- FDA accepts sBLA and grants Priority Review for Bavencio + Inlyta in RCC

Issue 6 - Feb. 8, 2019

TCL45-06 (536 downloads)

Guest Editorial
Two singular men shared an uncommon greatness: Waun Ki Hong and John Mendelsohn
Waun Ki Hong and John Mendelsohn were singular forces who combined to change the world of oncology and, in the process, the lives of countless trainees, faculty, patients, and families.
Conversation with The Cancer Letter
NYU receives NCI Comprehensive Cancer Center designation
The Laura and Isaac Perlmutter Cancer Center at NYU Langone Health received the Comprehensive Cancer Center designation from NCI.
Trump to dedicate $500M over 10 years to childhood cancer
In his State of the Union address Feb. 5, President Donald Trump said he plans to ask Congress for $500 million over 10 years to fund pediatric cancer research—an amount Speaker of the House Nancy Pelosi (D-CA) said is insufficient.
In Brief
- Foundation Medicine gets genomic profiling contract from Veterans Affairs
- Higgins, King, Kilmer, Fitzpatrick to serve as co-chairs of House Cancer Caucus
- NETRF announces $2.5 million research grants to treat tumors
- Chien-Chi Lin wins $1.5M grant in pancreatic cancer
- ADEPT System Cancer Imager wins Illinois Tech’s $1 million Nayar Prize Competition
- Christiana’s Boman receives $900K grant for stem cell research
Clinical Roundup
- Study finds HIV+ cancer patients benefit from immunotherapy
- High-dose radiation therapy improves long-term survival in stage IV cancers
- Combination of Veyonda/radiotherapy delivers clinical benefits
- Prolonged time sitting shown to increase risk of colorectal cancer
Drugs & Targets
- FDA approves therapy for adult patients with blood clotting disorder
- Pfizer given positive CHMP opinion for Vizimpro in NSCLC
- Genentech submits sBLA for Kadcyla for breast cancer
- Merck KGaA and GSK to co-develop immunotherapy M7824
- FDA pursues order to bar some retailers from selling tobacco in efforts to target tobacco use by minors
NCI Trials
NCI Trials for February
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 5 - Feb. 1, 2019

TCL45-05 (655 downloads)

20-year follow-up data are in: Prostate cancer prevention works; concerns about high-grade disease dismissed
Prostate cancer is the most common solid tumor in men. It has been estimated that 60-75 percent of men will have histologic evidence of prostate cancer during their lifetime and that 2-4 percent of men will die of the disease. African American men are at a greater risk of diagnosis and death.
Guest Editorial
The Prostate Cancer Prevention Trial and nine lessons in prostate cancer medicine
The publication by Ian M. Thompson and colleagues in last week’s New England Journal of Medicine regarding long term follow-up of patients in the NCI-sponsored Prostate Cancer Prevention Trial (PCPT) marks a good opportunity to review and reflect on the history of the trial and the past 30 years of prostate cancer medicine.
Real-World Evidence
Gottlieb: FDA to expand real-world data infrastructure to enhance AI capabilities
FDA is enhancing its ability to handle real-world evidence by training reviewers in data science via a curriculum on machine learning and artificial intelligence, said FDA Commissioner Scott Gottlieb.
Industry a no-show as Sens. Grassley and Wyden hold hearing on drug pricing
Earlier this week, the Senate Committee on Finance convened what is likely to be the first in a series of hearings focused on the rising costs of prescription drugs, oncology drugs among them.
In Brief
- Califano named physician-in-chief of Moores Cancer Center
- NYU receives anonymous $75M gift to establish center for blood cancers
- Ross Mitchell named artificial intelligence officer at Moffitt
- Sagar Lonial awarded Gray Family Chair in Cancer at Winship
- Silvia Formenti and Heather McArthur awarded SU2C Laura Ziskin Prize
- Helen Heslop named by SU2C to lead ‘Dream Team’
- Robert Prins receives grant to research brain tumor treatments
- Johns Hopkins Greenberg Bladder Cancer Institute Awards focused on bladder cancer in women
- ASCO names advance of the year: progress in treating rare cancers
Trials & Tribulations
Glioblastoma patient is first to receive treatment under Right to Try. Our question is Why?
A University of California, Irvine patient with glioblastoma recently received an experimental cancer vaccine from the U.S. subsidiary of Brussels-based Epitopoietic Research Corp. (ERC-USA). While most cases of patients receiving experimental medical treatment are not particularly newsworthy, this one was.
Clinical Roundup
- Study incorporates patient feedback into better cancer treatments
- Patients getting placebo allowed to cross to Erleada as TITAN results unblinded
- Antioxidants may enhance chemotherapy treatment for brain tumor
Drugs & Targets
- Lung-MAP precision medicine trial expands
- Alimta + Keytruda and platinum chemo for NSCLC gets FDA label expansion
- Trovagene and PoC Capital agree to fund clinical development of onvansertib in metastatic colorectal cancer

Issue 4 - Jan. 25, 2019

TCL45-04 (763 downloads)

Conversation with The Cancer Letter
Why austerity measures amid Congressional generosity? Sharpless explains the counterintuitive
In recent years, NCI spending on extramural research has been following the same trajectory as Congressional appropriations for the institute: up, up, up.
FDA approves 19 new cancer drugs and biologics in 2018—and don’t forget two new endpoints and “real-time” review
Last year, FDA approved 19 applications for new cancer drug and biologics as well as 38 supplemental indications and four biosimilars, agency officials said.
Conversation with The Cancer Letter
Brawley aims to create a “huge collaboration” in research on disparities
Otis W. Brawley was named the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University.
In Brief
- Rosanna Morris named chief operating officer at MD Anderson
- Health groups call for speedy end of shutdown
- Kyn Therapeutics partners with Celgene to develop immuno-oncology therapies
Funding Opportunities
Colorectal Cancer Alliance announces funding recipients for colon and rectal cancer research needs
Colorectal Cancer Alliance is providing a total of $625,000 in grants to four researchers, including one advancing personalized treatment options for rectal cancer patients and three seeking to understand the root cause of rising colorectal cancer rates in patients under age 50.
Clinical Roundup
- Finasteride found to be safe, effective prevention for prostate cancer
- Remote participation enables patients with ALK-positive lung cancer to enroll in study of treatment resistance
- Servier & Taiho present Lonsurf data at ASCO 2019 GI Symposium
- New test for esophageal cancer could save millions of lives
- AbbVie’s Imbruvica fails late-stage pancreatic cancer study
Drugs & Targets
- European Commission authorizes Rubraca tablets in ovarian cancer
- Bristol-Myers Squibb withdraws U.S. application for Opdivo + Yervoy in first-line lung cancer
- FDA finalizes policy on labeling for accelerated approval drugs
- FDA grants Illumina’s TruSight Assay Breakthrough Device designation
- Amgen’s Blincyto approved in Europe for leukemia
- Genmab initiates of FDA submission for expansion of daratumumab in multiple myeloma

Issue 3 - Jan. 18, 2019

TCL45-03 (305 downloads)

Thomas Jefferson University vying to acquire venerable but troubled Fox Chase Cancer Center
Thomas Jefferson University is vying to acquire Fox Chase Cancer Center from its current owner, Temple University, the two institutions announced Jan. 10.
New MSK rules prohibit service on boards of for-profit entities in healthcare
An internal task force formed to investigate conflicts of interest at Memorial Sloan Kettering Cancer Center has produced three initial recommendations that codify the moratoria that were put in place after multiple ethics transgressions at the cancer center were revealed by The New York Times and ProPublica last fall.
Guest Editorial
Waun Ki Hong– A Career of Vision
On Jan. 2, my friend and long-time mentor Waun Ki Hong passed away. In thinking about what Ki did for me personally and the impact he had on the lives and professional careers of so many people, I pulled out a speech I gave at his retirement celebration at MD Anderson on Aug. 15, 2014. I was struck that even in his passing so many of my thoughts ring true today. Perhaps this will give readers of The Cancer Letter a sense of the man.
In Brief
- Wasif Saif, Louis Potters, Matthew Weiss named deputy physicians in chief at Northwell Health Cancer
- Duke partners with Teen Cancer America, First Citizens Bank to enhance teen and young adult oncology program
- Adi Gazdar researcher at UT Southwestern, NCI dies at 81
Funding Opportunities
LUNGevity Foundation issues an RFA for 2019 Career Development Awards for Translational Research in Lung Cancer
LUNGevity has issued a Request for Applications for translational research for Career Development Awards that will be granted in 2019. The RFA is available on the LUNGevity website and is also posted on the proposalCENTRAL website.
Trials and Tribulations
Giving every patient an opportunity to participate in and benefit from cancer progress
Last week, the American Cancer Society released its annual Facts and Figures report, showing that we continue to make exceptional progress against cancer, most notably with a 27 percent decline in the death rate across all cancer types over the last 25 years.
Clinical Roundup
- Keytruda reduced risk of death vs. chemo in esophageal carcinoma
- Array Biopharma announces 15.3 months median overall OS from phase III BEACON CRC trial in colorectal cancer
Drugs & Targets
- FDA approves Cabometyx for previously treated hepatocellular carcinoma
- European Commission approves Opdivo + low-dose Yervoy in RCC
- QIAGEN receives approval for EGFR test in lung cancer as companion diagnostic in Japan
- FDA accepts sBLA for Tecentriq + Abraxane and carboplatin for lung cancer