Moderna, Merck cancer vaccine combo cuts melanoma recurrence by 44% (updated)

Gritstone bio

13/12/2022 13:41

(Adds share movement)
    By Julie Steenhuysen and Michael Erman
       CHICAGO, Dec 13 (Reuters) - A combination of Moderna
Inc's  MRNA.O  experimental melanoma vaccine and Merck & Co's
 MRK.N  blockbuster immunotherapy Keytruda cut the risk of skin
cancer's recurrence or death by 44% compared with Keytruda alone
in a mid-stage trial.
    Moderna's shares rose over 8% in premarket trading on
Tuesday after the data, which the companies hailed as
spectacular. Merck's shares were up nearly 2% at $111.12. 
    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.
    "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 III
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.
    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 halve, Burton
said.
    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  22UAy.DE  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  ROG.S  Tecentriq in patients with pancreatic cancer.
    Gritstone Bio Inc  GRTS.O  is testing a personalized,
self-amplifying mRNA vaccine in combination with Bristol Myers
Squibb's  BMY.N  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.
 (Reporting by Julie Steenhuysen in Chicago, Michael Erman in
New Jersey and Aditya Samal in Bengaluru; Editing by Caroline
Humer, Edwina Gibbs and Mark Potter)
 ((julie.steenhuysen@thomsonreuters.com; 312-408-8131; Reuters
Messaging: Julie.steenhuysen.reuters.com@reuters.net))