36 Kidney Cancer Journal
Newsworthy, late-breaking information from Web-based
sources, professional societies, and government agencies
KCA accepting applications for investigator awards
HOUSTON—The Kidney Cancer Associations is accepting
applications for their Young Investigator Awards (YIAs)
through August 5, 2020. Four $75,000 YIAs are available.
Recipients will be announced in fall 2020.
YIAs encourage promising researchers in urology and
clinical oncology who are planning to pursue an investigative
career in kidney cancer.
The priority research areas that emerged as a result of
the KCA’s Think Tank: Coalition for a Cure, held last fall in
conjunction with the 18th International Kidney Cancer
Symposium, included cure or durable therapeutic response,
improved screening and surveillance, neoadjuvant
and adjuvant treatment strategies, and non-clear cell renal
cell carcinoma. All grant proposals will be evaluated by an
independent panel of reviewers, who are recognized experts
in the field. They will conduct a blinded, scored review
of all applications received.
Complete details about the grant application process
are available here:
https://kidneycancer.submittable.com/submit All questions
regarding the grant application process should be
submitted to grants@kidneycancer.org.
FDA approves additional pembrolizumab
dosing strategy, 400 mg per 6 weeks
The FDA has approved an additional recommended
dosage of 400 mg every six weeks (Q6W) for pembrolizumab
(Keytruda), the anti-PD-1 therapy, across all
adult indications, including monotherapy and combination
therapy. This indication is approved under accelerated
approval based on pharmacokinetic data, the relationship
of exposure to efficacy and the relationship of exposure to
safety. Continued approval for this dosing may be contingent
upon verification and description of clinical benefit in
the confirmatory trials. This new dosage option will be
available in addition to the current dose of 200 mg every
three weeks (Q3W).
“The important social distancing measures for COVID-
19 have created a number of challenges for people with
cancer, including keeping to planned treatment schedules,”
said Dr. Roy Baynes, senior vice president and head of
global clinical development, chief medical officer, Merck
Research Laboratories. “Today’s approval of an every sixweek
dosing schedule for Keytruda gives doctors an option
to reduce how often patients are at the clinic for their
treatment.”
Regenerative Medicine Advanced Therapy Designation
awarded to ilixadencel in kidney cancer
STOCKHOLM—Immunicum has received Regenerative
Medicine Advanced Therapy (RMAT) designation from the
FDA for the company’s lead candidate, ilixadencel, a cellbased,
off-the-shelf immune primer for the treatment of
metastatic renal cell carcinoma (mRCC). The FDA’s decision
was made based on the previously communicated results
from the Phase 2 MERECA clinical trial that evaluated the
safety and efficacy of ilixadencel in combination with Sutent
® (sunitinib) in patients with newly diagnosed mRCC.
Advantages of the RMAT designation include all the benefits
of the Fast Track and Breakthrough Therapy Designation
programs, including guidance and early interactions
with the FDA to discuss potential surrogate or intermediate
endpoints to support accelerated approval as well as
potential ways to satisfy post-approval requirements.
Established in 2017 under the 21st Century Cures Act in
the US, RMAT designation is an expedited program designed
to facilitate the development and review of regenerative
medicine therapies intended to address an unmet
medical need in patients with serious conditions. An investigational
regenerative medicine therapy (e.g. cell or gene
therapy) is eligible for RMAT designation if it is intended to
treat, modify, reverse or cure a serious condition and preliminary
clinical evidence indicates that the drug or therapy
has the potential to address unmet medical needs for
such a disease or condition. As a cell therapy medicinal
product, ilixadencel falls within the definition of a regenerative
medicine therapy.
The latest results of the Phase 2 MERECA trial were presented
in February at the ASCO-SITC Clinical Immuno-Oncology
Symposium 2020 in Orlando, Florida. As of
December 2019, the patient follow up data indicated a
separation in Kaplan-Meier survival curves in favor of the
ilixadencel treatment group in line with the projected separation
based on the data from July 2019. The median OS
value could not be calculated yet in either group as the
data are not mature. The confirmed ORR for the ilixadencel
treatment group was 42.2% (19/45) versus 24.0% (6/25) for
the sunitinib control group.
KCA initiative brings personalized nutrition
support to patients and caregivers
HOUSTON – The Kidney Cancer Association (KCA) is partnering
with Savor Health® to bring Ina®, The Intelligent Nutrition
Assistant to the kidney cancer community. Ina®
provides personalized, evidence-based nutrition support
“on demand” to help people living with cancer stay wellnourished
and manage symptoms.
Developed by oncology-credentialed medical experts,
Ina® is available 24/7 via SMS text. Patients and caregivers
can text their questions on nutrition and symptom management
from their cell phone and Ina® will respond with
personalized nutrition tips, recipes, and answers – no
phone calls or appointments necessary. All knowledge and
advice is based on scientific evidence and the training of
oncology-credentialed registered dietitians, nurses, and
physicians who are experts in the needs of cancer patients.
(continued on page 62)
MEDICAL INTELLIGENCE
/submit
link