Moderna, Merck’s cancer vaccine with Keytruda improved survival in trial

modern And Merck on Monday announced more positive three years of data on its experimental vaccine, given to patients with the deadliest form of skin cancer in combination with Keytruda therapy.

The vaccine along with Merck’s Keytruda improved survival and showed long-term effectiveness in a midterm study in patients with a deadly form of skin cancer. Moderna and Merck are presenting data at American Society of Clinical Oncology annual meeting in Chicago.

The shot is a key part of Moderna’s plan, helping to shore up investor sentiment towards the biotech company after a difficult period last year, when demand for its Covid vaccine fell strong, Now Its only commercial product.

The data includes preliminary results the two companies announced in December.

Among the new data, nearly 75% of patients taking this combination were still alive without any signs or symptoms of the cancer returning after 2 1/2 years. That compares with 55.6% of patients taking Keytruda alone.

That benefit was observed in different groups of patients, regardless of whether they had tumors with large numbers of mutations or whether they had enough of a protein — called PD-L1 — that helps control the body’s immune response. or not.

Dr. Kyle Holen, Moderna’s head of development, therapeutics and oncology, said the data reflect the shot’s potential to help treat a “broad range” of melanoma patients.

The overall survival rate for patients who received the vaccine combined with Keytruda was 96% at 2½ years. That compares with 90.2% of those taking Keytruda alone.

As the companies have previously announced, patients with serious forms of cancer, known as melanoma, who received the combination treatment had a 49% lower risk of death or cancer recurrence compared with people only took Keytruda after about three years. This combination also reduces the risk of melanoma spreading to other parts of the body or death by 62%.

According to the data, the most common side effects associated with the vaccine are fatigue, pain at the injection site and chills. Most of those side effects are mild. Patients taking this combination had slightly higher immune-related side effects.

The vaccine uses mRNA technology similar to Moderna’s Covid vaccine, which is custom-made based on analysis of the patient’s tumor after surgical removal. The injection is designed to train the immune system to recognize and attack specific mutations in cancer cells.

Moderna is excited about reducing the time between initial tumor analysis and the patient receiving the drug, CEO Stephane Bancel said in an interview with CNBC.

Meanwhile, Merck’s Keytruda, approved to treat melanoma and other cancers, belongs to a widely used class of immunotherapies designed to neutralize a certain protein that helps cancer. Mail evades the immune system.

The US Food and Drug Administration in February issued it Breakthrough therapy designation Cancer vaccines to treat melanoma. That designation is intended to accelerate the development and review of treatments for serious and life-threatening diseases.

But Moderna also plans to apply for accelerated approval to the FDA, Bancel noted. This process allows for accelerated approval of drugs to treat serious conditions that fill an unmet medical need.

According to the American Cancer Society, melanoma is responsible for the majority of skin cancer deaths. According to the organization, melanoma rates have increased rapidly over the past few decades.

According to the American Cancer Society, about 100,000 people will be diagnosed with melanoma in the US this year, and nearly 8,000 are expected to die from the disease.

Two drugmakers are studying this combination to treat late-stage melanoma in one phase three trial, starting in July. Bancel said the progress of that trial so far is “exceeding our plans.”

Moderna is also conducting another phase three vaccine trial in patients with a type of lung cancer.

This year, Merck and Moderna began two-part mid- to late-stage trials of the vaccine and Keytruda in patients with advanced stages of common skin cancer. The companies are also conducting a phase two trial in some patients with a type of kidney cancer and another study in people with a type of bladder cancer.