A clinical trial for lung cancer was stopped after researchers found out that their candidate drug had statistically significant results. The researchers said that the drug was so effective in shrinking lung cancer tumors that they want it to be made available to the patient the soonest possible time.
The drug is known as Kevtruda which is the same drug taken by Former United States President Jimmy Carter. The drug is effective in killing advanced melanoma cells that has spread to his brain.
Last August 20, 2015, Former President Jimmy Carter announced to the media about his cancer diagnosis and treatment plans held in the Carter Center in Atlanta.
Kevtruda has been tested for 305 lung cancer sufferers who have not yet received any medications or any other treatment modalities. The researchers specifically choose these study participants to test how the drug works against the standard chemotherapy drugs.
Merck, the company that develops Kevtruda, said that the drug works better than the standard chemotherapeutic drugs, so they decided to stop the clinical trial. So they can give more lung cancer patients a chance to take the drug.
Merck noted that Kevtruda help patients live longer without any of the tumors growing and spreading to other distant organs.
Dr. Roger Perlmutter, President of Merck Research Laboratories said that the details of the clinical study are not yet available. But they will be sharing the data with the regulatory authorities and medical community around the world.
There were already independent committees who evaluated the details of the clinical trial. They assessed how the patients are improving. One of the independent committees has recommended stopping the trial based from the positive results. But they also haven’t shared any details with any company or regulators yet.
Dr. Pasi Janne, a Lung cancer specialist at Dana-Farber Cancer Institute and Harvard Medical School said in an interview with NBC News that the findings were already significant enough that the study can be a practice-changing finding.
Janne added that cancer research usually goes into slow procedure. In testing new drugs, patients may get the best therapy available or the experimental drug. Sometimes they get both. Cancer drugs are tested first on patients who tried every treatment options available and yet the cancer tumor cells are still recurring.
Dr. Janne noted that it will be beneficial for a company if their drug is the first one to be given to a patient because they could easily assess if it works better than the standard of care.
Merck has submitted an approval request to the Food and Drug Administration to use Kevtruda as first-line treatment for lung cancer patients.
FDA has already given accelerated approval for several drugs that belong to the checkpoint inhibitors category which Kevtruda also belongs.
This checkpoint inhibitors drugs work by stopping the tumor cells from growing and replacing the normal and healthy immune cells. These inhibitors works by targeting the genetic mutations that causes the spread of cancer. Unlike other drugs, it does not target where the cancer starts but it works on stopping the further growth of the cancer cells.
Kevtruda or Pembrolizumab targets two genes called PD-1 or anti-programmed-death-receptor-1 and PD-L1. When these two genes interact, the tumors cells can escape the identification and destruction of the immune system cells.
PD-1 works by stopping immune cells from mistakenly killing normal healthy cells. Tumor cells activate PD-L1 to turn on PD-1 when an immune cells approach.
The clinical trial included patients whose tumor cells produce a lot of PD-L1.
Mercks rival drug is Opdivo by Bristol-Myers works similarly with Kevtruda and has a separate approval application for FDA.
Competition Heats Up for Cancer Drugs
The competition heats for Merck and Bristol-Myers, as both companies works on the same idea of how Kevtruda works. Being a first-line treatment is advantageous for any pharmaceutical company because their flagship drug will be the gold standard of the rest of the drugs in a similar category.
If Mercks will be able to prove the efficacy profile of Kevtruda, this drug will be welcomed by lung cancer patients, their families and the medical community. It will also help improve the survival rate of one of the deadliest and fastest spreading cancer in the world.