FDA approved new immunotherapy regimen for patients with melanoma

Date:
March 23, 2022
Source:
Johns Hopkins Medicine
Summary:
The U.S. Food and Drug Administration has approved a novel therapy
for patients with metastatic or inoperable melanoma, an aggressive
type of skin cancer.



FULL STORY ==========================================================================
The U.S. Food and Drug Administration has approved a novel therapy for
patients with metastatic or inoperable melanoma, an aggressive type
of skin cancer. The treatment, developed based on original research
conducted at the Johns Hopkins Kimmel Cancer Center, is comprised of two immunotherapy agents, relatlimab (anti-LAG-3) and nivolumab (anti-PD-1),
which delayed time to cancer progression significantly more than nivolumab alone in a global, multi-center clinical trial. Results from the study,
called RELATIVITY-047, were published in The New England Journal of
Medicine on Jan. 6, 2022. Evan J. Lipson, M.D., an associate professor of oncology at the Johns Hopkins Kimmel Cancer Center and Bloomberg~Kimmel Institute for Cancer Immunotherapy, is a co-author of the study and
presented initial findings at the 2021 American Society of Clinical
Oncology (ASCO) annual meeting.


==========================================================================
"The FDA's approval of this novel combination therapy is an
exciting development for all of us in the melanoma community," says
Dr. Lipson. "Our collaborative research with scientists and physicians worldwide has demonstrated that targeting LAG-3 effectively activates
the immune system against cancer and has established the LAG-3 pathway
as the third immune checkpoint pathway in history, after CTLA-4 and
PD-1, for which blockade has a clinical benefit." Checkpoint inhibitor immunotherapy works by blocking specific proteins on the surfaces of
cells that help cancer evade the body's immune system. Blocking these checkpoints helps the immune system fight and eliminate cancer.

In the RELATIVITY-047 trial, 714 patients with advanced, previously
untreated melanoma were randomized to receive either relatlimab plus
nivolumab, or nivolumab alone. Median progression-free survival --
the length of time that cancer does not worsen -- was 10.2 months among patients who received the combination treatment, significantly longer
than the 4.6 months seen among those who received nivolumab alone. At
one year, progression-free survival was 48% for patients receiving
combination therapy and 37% for those receiving nivolumab alone.

Nivolumab acts on a protein called PD-1 and is FDA-approved for treating melanoma and several other cancer types. Relatlimab blocks signaling of
an inhibitory protein called LAG-3 displayed on immune system T cells, reinvigorating their anti-tumor activity.

The anti-tumor effects of LAG-3 blockade were originally co-discovered
by scientists at the Bloomberg~Kimmel Institute. Preclinical studies of
the combination therapy in mice started at Johns Hopkins in 2010, with a
grant from the Melanoma Research Alliance to Johns Hopkins investigators Suzanne L.

Topalian, M.D., professor of surgery and oncology at Johns Hopkins,
and Drew M.

Pardoll, M.D., Ph.D., director of the Bloomberg~Kimmel Institute for
Cancer Immunotherapy and co-director of the Cancer Immunology Program
at the Johns Hopkins Kimmel Cancer Center.

The RELATIVITY-047 trial was sponsored by Bristol-Myers Squibb
Co. Dr. Lipson is a paid consultant and advisory board member. Dr. Pardoll receives research grant support. Dr. Topalian is a paid consultant and
receives research grant support. Dr. Pardoll is an inventor on a patent
on the blockade of LAG-3 for the treatment of cancer. Under a license
agreement between BMS and the Johns Hopkins University, Dr. Pardoll,
and the University are entitled to royalty distributions related to the technology cited in the study and discussed in this publication. These arrangements have been reviewed and approved by the Johns Hopkins
University in accordance with its conflict-of-interest policies.


========================================================================== Story Source: Materials provided by Johns_Hopkins_Medicine. Note:
Content may be edited for style and length.


========================================================================== Journal Reference:
1. Hussein A. Tawbi, Dirk Schadendorf, Evan J. Lipson, Paolo
A. Ascierto,
Luis Matamala, Erika Castillo Gutie'rrez, Piotr Rutkowski, Helen J.

Gogas, Christopher D. Lao, Juliana Janoski De Menezes,
Ste'phane Dalle, Ana Arance, Jean-Jacques Grob, Shivani
Srivastava, Mena Abaskharoun, Melissa Hamilton, Sarah Keidel,
Katy L. Simonsen, Anne Marie Sobiesk, Bin Li, F. Stephen Hodi,
Georgina V. Long. Relatlimab and Nivolumab versus Nivolumab in
Untreated Advanced Melanoma. New England Journal of Medicine,
2022; 386 (1): 24 DOI: 10.1056/NEJMoa2109970 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/03/220323130313.htm

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