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FDA Approves Immunotherapy for Mismatch Repair-deficient Colon Cancer

The Food and Drug Administration (FDA) has approved the immunotherapy drug Tecentriq (atezolizumab) plus chemotherapy for people with stage III mismatch repair-deficient colon cancer after surgery. The agency approved both intravenous and under-the-skin formulations of Tecentriq, MedPage Today reported. The FDA based its decision on results from a phase III clinical trial that involved 712 people with stage III mismatch repair-deficient colon cancer who had no evidence of disease following surgery. Participants received either Tecentriq and chemotherapy or chemotherapy alone. At three years, 86.3% of the Tecentriq group was alive without recurrence, compared with 76.2% of people who received chemotherapy alone. “By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death,” Frank Sinicrope, a trial investigator and medical oncologist at Mayo Clinic in Rochester, Minnesota, said in a press release. Sinicrope also noted that the approval allows care to be tailored to the mismatch repair status of a patient’s cancer. Mismatch repair proteins normally correct mistakes that occur when cells copy their DNA. When this repair system does not work properly, genetic errors can accumulate and contribute to cancer development. An estimated 15% of colorectal cancers are mismatch repair deficient.

Age-based Genetic Testing Could Miss 72% of People With Inherited Cancer-risk Mutations

Genetic testing for inherited cancer-risk mutations is often recommended based, in part, on a person’s age at diagnosis, but guidance that restricts testing to people younger than 50 would have missed nearly three-quarters of people who have these mutations, according to a study published in Cancer Discovery. In the study, 39,184 people with one of 32 solid tumor cancers underwent genetic testing to find inherited gene mutations that increase cancer risk. Researchers divided participants into three groups based on their age at diagnosis relative to the average age at diagnosis for their specific cancer type: early-, average- and late-onset cancer. They found that 18.4% of people with early-onset cancer, 15.6% of people with average-onset cancer and 12.3% of people with late-onset cancer had inherited cancer-risk mutations. If testing had been limited to people younger than 50, then 4,601 people with mutations, or 72% of those who tested positive for mutations, would have been missed, the study found. Researchers said the findings support offering genetic testing to all people with cancer. “We’re not advocating for genetic testing for the entire population,” study author Zsofia Stadler, a medical oncologist and clinical geneticist at Memorial Sloan Kettering Cancer Center in New York City, told Inside Precision Medicine. “We’re advocating for genetic testing for all cancer patients. I do think that’s where the field needs to go.” Genetic testing can determine whether people with cancer have an increased risk for additional cancers and can help oncologists select appropriate treatment. If a patient tests positive for an inherited mutation that increases cancer risk, their family members can also undergo testing to see whether they have the mutation and could benefit from more or earlier screening. “You’re not just potentially preventing cancers or future cancers in these cancer patients,” Stadler said. “You’re preventing cancers potentially in entire families.”

NIH to Launch Program to Ramp Up Cancer Vaccine Research

The National Institutes of Health (NIH) has announced plans for an initiative intended to accelerate research on cancer vaccines. Modeled after the framework that supported the quick development of the COVID-19 vaccine, this program will involve the NIH, the Foundation for the NIH, researchers, pharmaceutical and biotech companies, advocacy groups, nonprofits, and patients, the New York Times reported. Expected to begin in December, the initiative will start with small-scale studies on general vaccine technology that will take about three years to complete. Those will be followed by larger clinical trials that will test vaccines in people with colorectal, liver, pancreatic and certain pediatric cancers. Stacey Adam, chief clinical officer of the Foundation for the NIH, told the Times that the goal of the program is to deliver cancer vaccines to patients in the next seven to 10 years, which is faster than the eight to 15 years typical for the Food and Drug Administration approval process. While COVID-19 and flu vaccines work by priming the body’s immune system to help prevent illness, cancer vaccines are given to people who already have the disease with the goal of preventing recurrence. Personalized for each patient, these vaccines train the immune system to recognize and target cancer cells. In early-phase clinical trials, vaccines have been tested to see whether they can prevent recurrence in people with melanoma, glioblastoma and kidney and pancreatic cancers, but outside of melanoma, the studies have not been large enough to show definitive benefit. “The science is there; the technologies are there,” Adam told the Times. “Everything is coming to a head. Now is the time to jump start.”