The Cancer Letter

Issue 44 - Nov. 22, 2019

TCL45-44 (253 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 (244 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

Issue 42 - Nov. 8, 2019

TCL45-42 (225 downloads)

Lomustine’s path from unavailable but cheap to plentiful but expensive
Needed: a better manufacturing method
Lomustine, a.k.a. CCNU, is an old cancer drug.
A couple of years ago, it was hard to obtain but cheap. It has since turned a corner, becoming plentiful but wildly expensive.
Conversation with The Cancer Letter
Purdue’s Thompson: Lomustine establishes proof of principle for resolving cancer drug shortages
David H. Thompson, a professor at the Department of Chemistry at Purdue University and a member of the Purdue Center for Cancer Research, is working on a better and faster way to produce drugs and eliminate shortages.
Texas votes to keep CPRIT open with another $3 billion in state funding
Texans have approved an additional $3 billion in state funds for the Cancer Prevention and Research Institute of Texas, extending the institute’s operations well past its sunset date in 2023.
Sharpless returns to NCI; Hahn to be nominated FDA commissioner; Giroir assumes acting role
Norman E. Sharpless has returned to his previous role of NCI director earlier this week after serving as acting FDA commissioner since April 5.
FDA Office of Hematology and Oncology Products is now Office of Oncologic Diseases
The Office of Hematology and Oncology Products at FDA has been renamed the Office of Oncologic Diseases—a move that includes an internal reorganization of divisions, as part of modernization plans approved in September 2019.
In Brief
- Carolyn Hayes named nursing leader at Rutgers Cancer Institute and RWJBarnabas Health
- Elaine Fuchs receives Ohio State’s Block Memorial Lectureship Award
- ACCC recognizes seven cancers programs with Innovator Awards at 36th National Oncology Conference
- Brawley receives University of Chicago Professional Achievement Award
- ASCO, IASLC work to improve lung cancer care in Brazil
- NIH REACH awards five new Hubs $4M each
Trials & Tribulations
Major gaps persist in Americans’ knowledge of and actions on cancer prevention
Each year, the American Society of Clinical Oncology conducts its National Cancer Opinion Survey to better understand Americans’ views on a wide range of cancer-related issues and uncover areas that need to be addressed.
Clinical Roundup
- Phase III trial of Ninlaro as first-line maintenance therapy meets PFS in multiple myeloma
- Inovio demonstrates 80% 6-month PFS in phase II glioblastoma multiforme study with INO-5401 + Libtayo
- AppliedVR and NCI evaluate virtual reality to address cancer-related anxiety
- Thermo Fisher Scientific introduces NGS platform that delivers faster results
NCI Trials
NCI Trials for November 2019
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

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

Lomustine’s path from unavailable but cheap to plentiful but expensive

Needed: a better manufacturing method

Conversation with The Cancer Letter

Purdue’s Thompson: Lomustine establishes proof of principle for resolving cancer drug shortages

Texas votes to keep CPRIT open with another $3 billion in state funding

Sharpless returns to NCI; Hahn to be nominated FDA commissioner; Giroir assumes acting role

FDA Office of Hematology and Oncology Products is now Office of Oncologic Diseases

In Brief

Trials & Tribulations

Major gaps persist in Americans’ knowledge of and actions on cancer prevention

Clinical Roundup

NCI Trials

NCI Trials for November 2019