FDA approves drug for persistently deadly form of lung cancer
The Food and Drug Administration last week approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer and have a life expectancy of four to five months.
The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Some 40% of those who got the drug responded.
After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
“I feel it’s a light after a long time,” he added.
Dr. Timothy Burns, a lung cancer specialist at the University of Pittsburgh, said that the drug “will be practice-changing.”
(Burns was not an investigator in the study but has served on an Amgen advisory committee for a different drug.)
The drug, though, has a side effect that can be serious — cytokine release syndrome. It’s an overreaction of the immune system that can result in symptoms like a rash, a rapid heartbeat and low blood pressure.
Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected.
The standard treatment is old-fashioned chemotherapy — unchanged for decades — combined with immunotherapies that add about two months to patients’ life span. But, almost inevitably, the cancer resists the treatment.
“Ninety-five percent of the time, it will come back, often in a matter of months,” Burns said. And when it comes back, he added, patients find it harder to tolerate the chemotherapy, and the chemotherapy is even less effective.
Most patients live just eight to 13 months after their diagnosis, despite having chemotherapy and immunotherapy. The group of patients in the clinical trial had already had two or even three rounds of chemotherapy, which is why their life expectancy without the drug was so short.
There were several reasons that patients with small cell lung cancer had been left behind.
One is the type of gene mutation the cancer relies on to grow.
Dr. Jay Bradner, Amgen’s chief scientific officer, explained that other cancers are caused by aberrant genes that are turned on. Treatment involves drugs to turn those genes off.
But small cell lung cancer is propelled by genes that are turned off, which makes them difficult to target, Bradner explained. Another reason is the cancer’s ability to block immune system cells that try to destroy it.
Tarlatamab is an antibody built to overcome those obstacles.
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