The Cancer Letter

Issue 45 - Dec. 6, 2019

TCL45-45 (79 downloads)

LOWY: Paylines are dropping because NCI is drawing more applicants who would’ve previously gone elsewhere
After an examination of the causes of an avalanche of grant applications directed at NCI, institute officials found that new applications largely come from principal investigators who are switching their research focus to cancer. No other NIH institute or center faces such pressure.
NCI Director’s Report
Sharpless reflects on his time at FDA: “The engine producing new cancer therapies and diagnostics is doing very well”
The progress in cancer exceeds that of any other therapeutic area right now—at least as far as FDA is concerned, NCI Director Ned Sharpless said at a Dec. 3 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board.
Senate committee votes 18-5 in support of Hahn, but questions his commitment to aggressive e-cigarette policy
A Senate committee Dec. 3 cleared the path for Stephen M. Hahn to become the next FDA commissioner, though some Democratic and Republican senators voiced concerns that he wouldn’t take aggressive action to ban flavored e-cigarettes in this role.
AACR, Research!America urge Congress to pass spending bill with funding boost for health agencies
The American Association for Cancer Research and Research!America are urging Congress to pass the FY20 appropriations bill by Dec. 20.
In Brief
- Williams, Ingram, Mitchell to join President’s Cancer Panel
- Belani named IASLC chief science officer
- ACCC project focuses on multidisciplinary cutaneous squamous cell carcinoma care
- Nimer receives Oscar de la Renta Endowed Chair in Cancer Research
- Barker named chief strategy officer at USC Lawrence J. Ellison Institute for Transformative Medicine
- Car named Agios chief scientific officer
- Peterson receives $1.4M grant for innovative approach to attacking metastatic TNBC
- Mt. Sinai receives $1M grant for prostate cancer research
Funding Opportunities
ACS and Flatiron Health launch real-world data impact award
The American Cancer Society and Flatiron Health launched a joint grant-making program that supports both organizations’ goals of accelerating cancer research and improving treatment and care options for patients.
Clinical Roundup
- Study finds wide county-level variation in rates of surgery for early-stage lung cancer
- Tecentriq + Avastin combination demonstrates improvement in OS, PFS in HCC
- Alunbrig demonstrates reduced risk of death, disease progression in ALK+ NSCLC
- Experimental targeted therapy may be better for repeat kidney cancer patients than FDA-approved counterpart, study finds
- Duke researchers develop technique to visually depict how cancer cells grow and spread in colon tissue
Drugs & Targets
- FDA approves Tecentriq + chemo as initial treatment metastatic non-squamous NSCLC indication
- FDA approves FoundationOne CDx as a Companion Diagnostic for Piqray in new indication
- FDA grants Priority Review to Merck’s Supplemental Biologics License Application for Keytruda in NMIBC indication
- FDA accepts NDA for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements
- China approves Keytruda for first-line treatment in metastatic squamous NSCLC+chemo indication
- Lynparza approved in China as a first-line maintenance therapy in BRCA-mutated advanced ovarian cancer indication
NCI Trials
NCI Trials for December 2019
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 44 - Nov. 22, 2019

TCL45-44 (256 downloads)

Real-World Evidence
Real-world evidence at a glance:
How a collaboration of “frenemies” produced common definitions for real-world endpoints
Ten health care research organizations, with help from FDA and NCI, have developed a set of common definitions for real-world endpoints, including overall survival, progression-free survival, and other non-traditional endpoints.
Conversation with The Cancer Letter
Friends’ Allen: Real-world endpoints can be used to fill evidence gaps about performance of medical products
If real-world endpoints are indeed accurate proxies for clinical trial endpoints, real-world endpoints should start to look increasingly similar to the clinical trial endpoints as more stringent criteria are applied, said Jeff Allen, president and CEO of Friends of Cancer Research.
Conversation with The Cancer Letter
Learning to harmonize:
Ten health care research organizations tell us how they formulated common definitions for real-world endpoints
We asked the leadership of 10 companies to share their visions of the future of data sharing, describe their portfolios in real-world evidence, and opine on what it would take to convince FDA accept real-world endpoints in regulatory decision-making in oncology.
Hahn pledges to be guided by “science and data” in considering vape flavor ban if confirmed at FDA
Questions on flavored vaping products dominated the Nov. 20 Senate confirmation hearing for Stephen M. Hahn, the administration’s pick for the job of FDA Commissioner.
Robotic mastectomy surgeon sues Monmouth, alleging defamation, antitrust violations
Stephen A. Chagares, a New Jersey general surgeon who recently set off a national debate by using a robotic surgical device to perform mastectomies, has filed a lawsuit claiming defamation and violation of federal and state antitrust laws on the part of Monmouth Medical Center.
In Brief
- Ethan Basch receives ACCC Clinical Research award
- Harmar Brereton, Dana Dornsife receive NCCS Ellen Stovall Award
- Timothy Mullett named chair-elect of the American College of Surgeons Commission on Cancer
- Roswell Park receives nearly $22M in government funding
- BMS completes acquisition of Celgene
Clinical Roundup
- Care in a multidisciplinary prostate cancer clinic increases discussion of treatment options, adherence to guidelines
- UCSD researchers focus on persistent opioid use, abuse and toxicity among cancer survivors
- In Opdivo + Yervoy vs. Opdivo alone in resected high-risk melanoma and PD-L1 <1% does not meet primary endpoints
Drugs & Targets
- FDA takes second action under international collaboration, approving treatment option for CLL or SLL
- FDA grants Q BioMed approval to manufacture non-opioid cancer palliation drug
- FDA approves crizanlizumab-tmca for sickle cell disease
- FDA approves givosiran for acute hepatic porphyria
- European Commission approves two regimens of Keytruda for front-line metastatic, unresectable HNSCC
- European Commission grants marketing authorization for Darzalex + lenalidomide and dexamethasone in frontline MM
- Japan grants approval of Myriad Genetics’ BRACAnalysis Diagnostic System for breast cancer patients

Issue 43 - Nov. 15, 2019

TCL45-43 (245 downloads)

Conversation with The Cancer Letter
U.S. Nobel laureates tell us what they think about cancer research, moonshots, the dark side, funding, meritocracy, herd mentality, Trump, and joy
William Kaelin and Gregg Semenza have a message for young scientists: do science for its own sake—and enjoy it.
Conversation with The Cancer Letter
Teitell: How immunotherapy became the fourth pillar of cancer care at UCLA
As one of the cancer hospitals serving Los Angeles County, the UCLA Jonsson Comprehensive Center has to face the challenge of providing the most sophisticated—and most expensive—care to a largely underserved population.
White papers by Friends address external controls, progression on immunotherapy, companion diagnostics
Friends of Cancer Research has published three white papers that focus on the development of external controls, the assessment of combination immuno-oncology therapies for patients with disease progression, and the generation of data for companion diagnostics.
In Brief
- Ashwani Rajput named director of The Johns Hopkins Kimmel Cancer Center
- VUMC’s Rathmell to Receive 2019 Eugene P. Schonfeld Award
- St. Baldrick’s Foundation awards nearly $1.5M in grants to expand children’s clinical trials
- Moffitt collaborates with VA hospitals to expand clinical cancer research
Trials & Tribulations
Noorchashm: “Biopsy your tumors”—with failed fibroid guidelines, gynecologists might as well be reading tea leaves
I write, again, compelled by emerging scientific facts regarding a serious systemic error of negligence on the part of the main American gynecological societies, AAGL and ACOG, and their member practitioners—though the problem I highlight here also affects overseas gynecological counterparts, specifically the RCOG in the United Kingdom.
Drugs & Targets
- FDA grants Breakthrough Device Designation for Exact Sciences blood-based test for detection of HCC
- FDA accepts BMS application for Opdivo + Yervoy for liver cancer
- Janssen seeks FDA approval for Imbruvica + rituximab for previously untreated patients with CLL
- Canada approves Imbruvica combination for CLL indication
- UroGen receives rights to Zalifrelimab for intravesical treatment of urinary tract cancers

LOWY: Paylines are dropping because NCI is drawing more applicants who would’ve previously gone elsewhere

NCI Director’s Report

Sharpless reflects on his time at FDA: “The engine producing new cancer therapies and diagnostics is doing very well”

Senate committee votes 18-5 in support of Hahn, but questions his commitment to aggressive e-cigarette policy

AACR, Research!America urge Congress to pass spending bill with funding boost for health agencies

In Brief

Funding Opportunities

ACS and Flatiron Health launch real-world data impact award

Clinical Roundup

Drugs & Targets

NCI Trials

NCI Trials for December 2019

Real-World Evidence

Real-world evidence at a glance:

How a collaboration of “frenemies” produced common definitions for real-world endpoints

Conversation with The Cancer Letter

Friends’ Allen: Real-world endpoints can be used to fill evidence gaps about performance of medical products

Conversation with The Cancer Letter

Learning to harmonize:

Ten health care research organizations tell us how they formulated common definitions for real-world endpoints

Hahn pledges to be guided by “science and data” in considering vape flavor ban if confirmed at FDA

Robotic mastectomy surgeon sues Monmouth, alleging defamation, antitrust violations

In Brief

Clinical Roundup

Drugs & Targets

Conversation with The Cancer Letter

U.S. Nobel laureates tell us what they think about cancer research, moonshots, the dark side, funding, meritocracy, herd mentality, Trump, and joy

Conversation with The Cancer Letter

Teitell: How immunotherapy became the fourth pillar of cancer care at UCLA

White papers by Friends address external controls, progression on immunotherapy, companion diagnostics

In Brief

Trials & Tribulations

Noorchashm: “Biopsy your tumors”—with failed fibroid guidelines, gynecologists might as well be reading tea leaves

Drugs & Targets