SCOTTSDALE, Ariz., Feb. 13, 2018 /PRNewswire-USNewswire/
-- Analysis of the phase II CONDOR trial indicates that the
immune checkpoint inhibitor durvalumab is tolerable among heavily
pre-treated patients with recurrent or metastatic head and neck
cancer and has the potential to slow growth in tumors with low or
negative expression of the PD-L1 protein. The previously reported
phase II HAWK trial demonstrated the safety and efficacy of
durvalumab monotherapy in head and neck tumors that express high
levels of PD-L1, and CONDOR (NCT02319044) is the first trial to
show similar findings for durvalumab monotherapy in patients with
low or negative PD-L1. The study will be presented today in an
online news briefing and at the 2018 Multidisciplinary Head and
Neck Cancers Symposium in Scottsdale,
Arizona.
Cancerous cells produce proteins to stop the body's natural
immune response to recognize and respond to the disease. Immune
checkpoint inhibitors such as durvalumab are designed to block
these so-called "checkpoint" proteins—thus allowing the immune
system to remain active and attack tumors more successfully.
Potential limitations with this type of immunotherapy, however,
include the possibility that patients will not respond to treatment
and/or that they may experience treatment-related side effects if
the immune system also mistakenly targets healthy cells.
"Two immunotherapies have already been approved for use in
platinum-refractory recurrent or metastatic head and neck cancer,
but not all patients respond to these therapies. For immunotherapy
to increase its clinical utility, it's important that we can better
identify the patients who will most likely respond to treatment,"
said Lillian Siu, MD, lead author of
the study, as well as a senior medical oncologist at Princess
Margaret Cancer Centre and a professor of medicine at the
University of Toronto.
"In the phase II CONDOR trial, durvalumab, an investigational
PD-L1 inhibitor, showed an overall response rate consistent with
other single-agent PD-1/PD-L1 inhibitors in second-line settings
for head and neck cancer. Our results add to the body of evidence
that this immune checkpoint inhibitor is tolerable and has
demonstrated encouraging clinical activity across a range of
tumors, including in heavily pre-treated recurrent or metastatic
head and neck cancer."
Findings are based on 267 patients with metastatic (64% of
patients) or recurrent (36%) cancer of the oral cavity, oropharynx,
hypopharynx or larynx who had not responded to prior platinum-based
chemotherapy, and who had low or negative expression of the PD-L1
protein. Patients were stratified by HPV and smoking status and
randomized to one of three treatment arms: durvalumab alone (10
mg/kg, IV Q2W) (67 patients); tremelimumab alone (10 mg/kg IV Q4W
×7 then Q12W ×2) (67 patients); or durvalumab plus tremelimumab
([20 mg/kg D Q4W + 1 mg/kg T Q4W] ×4 then 10 mg/kg D Q2W) (133
patients). Median follow-up was 5.8 months. Responses were measured
using Response Evaluation Criteria In Solid Tumors (RECIST) version
1.1.
Safety profiles of durvalumab alone and in combination with
tremelimumab were consistent with those for similar
immunotherapeutic agents. Treatment-related adverse events of any
grade were highest for durvalumab alone (63.1% of patients),
followed by durvalumab+tremelimumab (57.9%) and tremelimumab alone
(55.4%); rates for grade 3 or 4 events, conversely, were highest
for tremelimumab (16.9%), followed by durvalumab+tremelimumab
(15.8%) and durvalumab (12.3%). Twelve of the 267 patients
discontinued therapy due to a treatment-related adverse event,
including seven patients in the combination arm and five in the
tremelimumab monotherapy arm. One death in the combination therapy
group was associated with treatment.
Durvalumab showed encouraging anti-tumor activity both alone and
in combination with tremelimumab. Seventeen patients experienced
partial responses to treatment, for overall response rates (ORR) of
9.2 percent for durvalumab alone, 7.8 percent for
durvalumab+tremelimumab and 1.6 percent for tremelimumab alone. Ten
of the 17 partial responses were ongoing as of March 31, 2017. The ORR rate for durvalumab
monotherapy was consistent with other single-agent PD-1/PD-L1
inhibitors in this setting.
Median overall survival was 7.6 months for
durvalumab+tremelimumab, 6.0 months for durvalumab and 5.5 months
for tremelimumab. There was no observed difference in clinical
activity between durvalumab alone and durvalumab in combination
with tremelimumab.
The abstract, "A Randomized, Open-Label, Multicenter, Global
Phase 2 Study of Durvalumab (D), Tremelimumab (T), or D Plus T in
Patients with PD-L1 Low/Negative Recurrent or Metastatic (R/M) Head
and Neck Squamous Cell Carcinoma (HNSCC): CONDOR," will be
presented in detail during the Plenary Session at the 2018
Multidisciplinary Head and Neck Cancers Symposium in Scottsdale, Arizona. To schedule an interview
with Dr. Siu and/or outside experts in head and neck cancer,
contact ASTRO's media relations team at press@astro.org.
ATTRIBUTION TO THE 2018 MULTIDISCIPLINARY HEAD AND NECK
CANCERS SYMPOSIUM REQUESTED IN ALL COVERAGE.
This study was funded by AstraZeneca.
Original abstract available; email press@astro.org
for a copy.
Patient Resources on Head and Neck Cancer and Radiation
Therapy
- Digital brochure: Radiation Therapy for Head and Neck
Cancer
- Videos: Radiation Therapy for Head and Neck Cancer (Spanish
version), An Introduction to Radiation Therapy (Spanish
version)
- Additional brochures, videos and information on radiation
therapy from ASTRO's patient site, RTAnswers.org
ABOUT THE SYMPOSIUM
The 2018
Multidisciplinary Head and Neck Cancer Symposium is
sponsored by the American Society for Radiation Oncology (ASTRO),
the American Society of Clinical Oncology (ASCO) and the American
Head & Neck Society (AHNS). The two-and-a-half day meeting
includes interactive educational sessions focused on topics such as
novel multidisciplinary therapies, directed therapy, treatment
guidelines, prevention, surveillance and supportive care, as well
as oral abstract presentations of the current science of relevance
to the head and neck cancer community.
ABOUT ASTRO
The American Society for Radiation
Oncology (ASTRO) is the world's largest radiation oncology society,
with more than 10,000 members who are physicians, nurses,
biologists, physicists, radiation therapists, dosimetrists and
other health care professionals who specialize in treating patients
with radiation therapies. The Society is dedicated to improving
patient care through professional education and training, support
for clinical practice and health policy standards,
advancement of science and research, and advocacy. ASTRO
publishes three medical journals, International Journal of
Radiation Oncology • Biology • Physics
(www.redjournal.org), Practical Radiation Oncology
(www.practicalradonc.org) and Advances in
Radiation Oncology (www.advancesradonc.org);
developed and maintains an extensive patient website, RT Answers
(www.rtanswers.org); and created the Radiation
Oncology Institute (www.roinstitute.org), a nonprofit
foundation to support research and education efforts around the
world that enhance and confirm the critical role of radiation
therapy in improving cancer treatment. To learn more about ASTRO,
visit www.astro.org and follow us on our
blog, Facebook and
Twitter.
ABOUT ASCO
Founded in 1964, the American Society of
Clinical Oncology, Inc. (ASCO®) is committed to making a
world of difference in cancer care. As the world's leading
organization of its kind, ASCO represents more than 40,000 oncology
professionals who care for people living with cancer. Through
research, education, and promotion of the highest-quality patient
care, ASCO works to conquer cancer and create a world where cancer
is prevented or cured, and every survivor is healthy. ASCO is
supported by its affiliate organization, the Conquer Cancer
Foundation. Learn more at www.ASCO.org, explore
patient education resources at www.Cancer.Net, and
follow us on Facebook, Twitter, LinkedIn, and YouTube.
ABOUT AHNS
The American Head & Neck Society
(AHNS) is the single largest organization in North America for the advancement of research
and education in head and neck oncology. The mission of the
American Head and Neck Society is: to promote and advance
the knowledge of prevention, diagnosis, treatment, and
rehabilitation of neoplasms and other diseases of the head and
neck; to promote and advance research in diseases of the head and
neck, and; to promote and advance the highest professional and
ethical standards. For more information, visit
www.ahns.info.
Contact: Liz Gardner
703-286-1600
liz.gardner@astro.org
Jeff
White
703-839-7392
jeff.white@astro.org
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SOURCE American Society for Radiation Oncology