MRA Hails FDA Approval of First Combination Immunotherapy for Melanoma

WASHINGTON–(BUSINESS WIRE)–The Melanoma
Research Alliance
(MRA) welcomes the U.S. Food and Drug
Administration (FDA) decision to approve the use of Bristol-Myers
Squibb’s (BMS) nivolumab (Opdivo®) and ipilimumab (Yervoy®) in
combination as a treatment for patients with unresectable or metastatic
melanoma without a BRAF mutation, known as BRAF wild-type melanoma.
Approximately half of patients’ melanomas harbor BRAF mutations and the
other half are BRAF wild-type.

The FDA’s accelerated approval of the two-drug regimen marks the first
approval of combination immunotherapy treatments for advanced melanoma
and comes less than one year after the first approval of nivolumab by
the FDA.

Ipilimumab
and nivolumab
are two types of immunotherapy that help the body’s own immune system
attack cancer cells. Ipilimumab is an anti-CTLA-4 inhibitor, while
nivolumab is an anti-PD-1 drug; each was previously FDA-approved as
monotherapy for the treatment of advanced melanoma.

The decision by FDA was based on the results of the CheckMate-069 trial,
which looked at the combination of ipilimumab and nivolumab as compared
to ipilimumab alone in previously untreated, BRAF wild-type patients.
Recently reported studies
showed the use of these two therapies in combination yielded better
results than ipilimumab on its own in previously untreated melanoma
patients – the so-called first-line setting.

“Based on the findings reported in scientific meetings and prestigious
medical publications, the combination of ipilimumab and nivolumab are
clearly active against melanoma. We’re pleased that both BMS and the FDA
acted quickly so that patients will have access to the latest advances
in melanoma treatment,” said Louise M. Perkins, Ph.D., MRA’s
Chief Science Officer. “The pace of change in melanoma treatment is
unprecedented and a testament to the amazing advances in both
immunotherapy and targeted therapy research.”

Of the $68 million the eight-year old MRA has thus far provided for
melanoma research, more than $26 million has gone to immunotherapy, such
as immune checkpoint blockade approaches, including anti-PD-1 and
anti-CTLA-4. Approved first for melanoma, nivolumab is also approved for
squamous non-small cell lung cancer, and immune checkpoint drugs
targeting CTLA-4 and PD-1 are being tested in more than 10 different
types of cancer.

“The FDA’s latest approval signifies the rapidly changing treatment
landscape for patients with melanoma,” said Debra Black, MRA
Co-Founder and Chair of the Board. “We have more work to do to improve
the survival rates for patients with advanced melanoma, particularly as
rates of melanoma continue to rise, but this is an important decision
that has the potential to benefit many patients.”

With this recent news, since MRA launched in 2007, nine therapies have
been approved to treat melanoma including two approved drug
combinations, drastically changing the outlook for patients with
melanoma and other cancers.

About The Melanoma Research Alliance (MRA)

MRA is a public charity formed in 2007 under the auspices of the Milken
Institute, with the generous founding support of Debra and Leon Black.
MRA is the largest private funder of melanoma research and has provided
nearly $68 million to research seeking to better prevent, diagnose, and
treat melanoma, the deadliest type of skin cancer. Due to the ongoing
support of its founders, 100 percent of every dollar MRA raises goes to
support its melanoma research program. MRA’s ability to fund
wide-ranging research in melanoma is amplified by unique collaborations
and partnerships with individuals, private foundations, and
corporations. Visit www.CureMelanoma.org
for more information, or follow us on Twitter
or Facebook.

Contacts

Emily Dammeyer, 202.336.8922
edammeyer@curemelanoma.org
or
Anreder
& Company
212.532.3232
Steven S. Anreder
steven.anreder@anreder.com
or
Michael
Wichman
michael.wichman@anreder.com