Moderna, Merck vaccine combo cut melanoma recurrence by 44% - study
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[December 13, 2022]
By Julie Steenhuysen and Michael Erman
CHICAGO (Reuters) - An experimental personalized melanoma vaccine
developed by Moderna Inc given with Merck & Co's blockbuster
immunotherapy Keytruda cut the risk of the skin cancer's recurrence or
death by 44% compared with Keytruda alone in a midstage trial.
The study is the first randomized trial to show that combining mRNA
vaccine technology - which has been behind the development of successful
COVID-19 vaccines - with a drug that revs up the immune response would
offer a better result for patients with the most deadly type of skin
cancer.
The companies hailed the results as spectacular.
"It's a tremendous step forward in immunotherapy," Eliav Barr, Merck's
head of global clinical development and chief medical officer, said in
an interview.
Paul Burton, Moderna's chief medical officer, said in a separate
interview the combination "has the capacity to be a new paradigm in the
treatment of cancer."
The ongoing study involved 157 patients with stage III/IV melanoma whose
tumors were surgically removed before being treated with the
drug/vaccine combo or Keytruda alone with the aim of delaying disease
recurrence.
The combination was generally safe and showed a statistically
significant benefit compared with Keytruda alone after a year of
treatment. Serious drug-related side effects occurred in 14.4% of
patients who received the drug-vaccine combination compared with 10%
with Keytruda alone.
A PROMISING FIELD
In October, Merck exercised an option to jointly develop and
commercialize the treatment, known as mRNA-4157/V940, sharing costs and
any profits equally. Merck and Moderna plan to discuss the results with
regulatory authorities and start a phase 3 study in melanoma patients in
2023.
The Merck/Moderna collaboration is one of several combining powerful
drugs that unleash the immune system to target cancers with mRNA vaccine
technology. These so-called neoadjuvant vaccines are designed to target
highly mutated tumors.
The personalized vaccine works in concert with Merck's Keytruda, a
so-called checkpoint inhibitor designed to disable a protein called
programmed death 1, or PD-1, that helps tumors to evade the immune
system.
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A sign marks the headquarters of
the coronavirus disease (COVID-19) vaccine maker Moderna in
Cambridge, Massachusetts, U.S., April 28, 2022. REUTERS/Brian Snyder
To build the vaccine, researchers
took samples of patients' tumors and healthy tissue. After analyzing
the samples to decode their genetic sequence and isolate mutant
proteins associated only with the cancer, that information was used
to design a tailor-made cancer vaccine.
When injected into a patient, the patient's cells act as a
manufacturing plant, producing perfect copies of the mutations for
the immune system to recognize and destroy.
Moderna's personalized vaccine can be made in about eight weeks, a
timeframe the company eventually hopes to cut in half, Burton said.
Assuming the combination is eventually approved, he said Moderna
would need to do a "massive scale-up" of its manufacturing
capabilities and that company is "all in".
Barr said the companies intend to study the approach in other types
of highly mutated cancers, such as lung cancer. Other highly mutated
cancers include bladder cancers and some triple negative breast
cancers.
Moderna mRNA competitor BioNTech SE likewise has several cancer
vaccine trials in the works including one with Memorial Sloan
Kettering Cancer Center in New York, which is testing a personalized
BioNTech vaccine in combination with Roche's Tecentriq in patients
with pancreatic cancer.
Gritstone Bio Inc is testing a personalized, self-amplifying mRNA
vaccine in combination with Bristol Myers Squibb's immunotherapies
Opdivo and Yervoy in a midstage trial in patients with advanced
solid tumors.
Experts said the personalized vaccines were among several promising
cancer vaccine ideas in the works after many failures in the field.
“In general, I think cancer vaccines are kind of at a tipping point,
and there are going to probably be a lot of vaccines coming down the
pipeline in the next five years,” said Dr. Mary Lenora Disis,
director of the UW Medicine Cancer Vaccine Institute in Seattle.
Although the COVID-19 pandemic demonstrated the speed, ease and
safety of mRNA vaccines, they came out of years of cancer vaccine
research, she said. "When COVID came, they were able to easily
pivot."
(Reporting by Julie Steenhuysen and Michael Erman; Editing by
Caroline Humer, Bill Berkrot and Edwina Gibbs)
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