Level 1 - Absolute Beginner
Lung cancer is a hard illness. Some cases come from a change in a gene called KRAS.
A company named Roche made a new medicine. It is called divarasib.
Doctors tested it on 338 people. They compared it with two older medicines.
People who took the new medicine lived longer. The results came out on October 25.
- cancer
- A serious illness where bad cells grow.
- lung
- A body part you use to breathe.
- gene
- A tiny part of a cell that gives the body instructions.
- medicine
- Something you take to get better.
- test
- To check if something works.
- compare
- To look at two things to see how they differ.
- result
- What you learn at the end of a test.
- longer
- For more time.
Level 2 - Elementary
A new cancer medicine has beaten two approved drugs in a large trial. The medicine, divarasib, is made by Roche and it targets lung cancers that carry a change in the KRAS gene, called G12C.
The trial, named Krascendo 1, included 338 patients in 26 countries. All of them had already been treated before. They were given either divarasib or one of two older drugs, sotorasib or adagrasib.
Patients on divarasib lived a median of 17.7 months. Patients on the older drugs lived 12.0 months. The cancer also took longer to grow, 9.8 months compared with 5.7 months.
The findings were shown at a big cancer meeting in Europe and printed in the New England Journal of Medicine. Liver problems were less common with divarasib, but stomach side effects were more common.
- trial
- A test of a medicine on people.
- target
- To aim at something.
- mutation
- A change in a gene.
- approved
- Officially allowed for use.
- median
- The middle value in a list of numbers.
- patient
- A person who gets medical care.
- side effect
- An unwanted effect of a medicine.
- journal
- A magazine where scientists publish their work.
Level 3 - Intermediate
A next generation KRAS inhibitor, divarasib, has outperformed two approved drugs in a phase 3 trial of lung cancer patients, according to results presented at the European Society for Medical Oncology congress and published in the New England Journal of Medicine on October 25. The drug, developed by Roche, targets tumors with the KRAS G12C mutation.
The open label trial, Krascendo 1, randomized 338 previously treated patients at 151 centers in 26 countries to receive divarasib or either sotorasib or adagrasib. Median overall survival was 17.7 months with divarasib against 12.0 months, a 44 percent lower risk of death, and median progression free survival was 9.8 months against 5.7 months.
The safety picture was mixed. Liver toxicity occurred in 26.9 percent of patients on divarasib versus 39.2 percent on the comparison drugs, though gastrointestinal side effects were more frequent. Because most numbers so far come from company and institutional releases, doctors will study the full paper, including confidence intervals, before deciding how much the result should change practice.
- inhibitor
- A drug that blocks the action of a molecule.
- outperform
- To do better than.
- mutation
- A permanent change in a gene.
- randomized
- Assigned by chance to a group.
- open label
- A trial in which patients and doctors know the treatment given.
- progression free survival
- The time before a cancer starts to grow again.
- toxicity
- The degree to which a drug is harmful.
- confidence interval
- A range showing how certain a result is.
Level 4 - Advanced
Roche's divarasib, a next generation KRAS G12C inhibitor, has bested two approved agents in a phase 3 study of previously treated non-small cell lung cancer, data unveiled at the European Society for Medical Oncology congress and published simultaneously in the New England Journal of Medicine on October 25. The result may recalibrate expectations for a class of drugs that, since their approval, have delivered benefits that were real but modest.
In the open label Krascendo 1 trial, 338 patients across 151 centers in 26 countries were randomized to divarasib or to sotorasib or adagrasib. Median overall survival reached 17.7 months versus 12.0, a hazard ratio of 0.56 that corresponds to a 44 percent reduction in the risk of death, and median progression free survival stretched to 9.8 months from 5.7.
The tolerability profile cuts both ways: hepatotoxicity affected 26.9 percent of divarasib recipients against 39.2 percent on the comparators, but gastrointestinal adverse events were more common. Since the numbers circulating derive largely from sponsor and institutional announcements, the oncology community will scrutinize the complete publication, its confidence intervals and the open label design before concluding that the drug has displaced its predecessors.
- bested
- Defeated or outdid.
- recalibrate
- To readjust in light of new information.
- modest
- Small or limited in size or amount.
- hazard ratio
- A measure comparing the rate of events between two groups.
- tolerability
- The degree to which side effects can be endured.
- hepatotoxicity
- Damage to the liver caused by a substance.
- comparator
- A treatment used as a standard of comparison.
- displace
- To take the place of.