Amgen Inc’s Lumakras pill reduced the risk of disease progression in patients with advanced lung cancer by 34 percent compared with chemotherapy in a clinical trial, the company said on Sunday.
There was no significant difference in overall survival between the two treatments in the confirmatory study required by US regulators as a condition of accelerated approval for Lumakras. But Amgen said the trial was not designed to detect a survival difference.
For the latest headlines, follow our Google News channel online or via the app.
The company is also testing whether the drug could be effective against lung cancer earlier in the disease, and said last month a small study of Lumakras combined with immunotherapy found high rates of liver toxicity and that further study was needed.
More detailed results from the 345-patient study, including median progression-free survival -- the length of time until the cancer begins to worsen -- will be presented on Monday at the annual meeting of the European Society for Medical Oncology (ESMO) in Paris.
Wall Street analysts, such as Michael Yee at Jefferies, have said investors expect a modest benefit of around two months for the Amgen drug over chemotherapy.
Amgen said 33 percent of Lumakras trial patients experienced serious side effects such as diarrhea and elevated liver enzymes, compared with 40 percent of chemotherapy patients.
The medication is designed to target a mutated form of a gene known as KRAS that occurs in about 13 percent of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.
“We are offering the choice of a pill ... versus chemotherapy that means going to the hospital,” Amgen oncology head Jean-Charles Soria told Reuters.
Lumakras was approved by the US Food and Drug Administration last year under an accelerated pathway for advanced lung cancer patients with KRAS mutations whose disease has worsened after treatment with chemotherapy or other medicines.
The agency also asked Amgen to study a lower dose of Lumakras, known chemically as sotorasib. The company said those results are expected in the fourth quarter of this year.
The FDA is slated to make an approval decision on a potential rival KRAS-targeting drug, Mirati Therapeutics Inc’s adagrasib, by mid-December.
Mirati in May said adagrasib shrank tumors in 44 percent of advanced lung cancer patients in clinical trials, but also caused serious side effects in 43 percent of them.
At the ESMO meeting this week, Amgen is also presenting early data from a trial of Lumakras in combination with other cancer drugs for patients with colorectal cancer.
Genetic mutations could be why some smokers never get lung cancer: StudySmoking cigarettes is widely known to be one of the biggest contributors to lung cancer, but some scientists have reported a new explanation as to why ... Healthy Living
I have lung cancer, I’ve never smoked: US comedian GriffinOutspoken US comedian Kathy Griffin, whose decades-long stand-up career was briefly derailed in 2017 after a grisly stunt with a prop depicting Donald ... World News
UAE approves lung cancer drug Lumakras following US FDA approvalThe United Arab Emirates’ Ministry of Health and Prevention approved the registration and use of lung cancer drug Lumakras, following its approval by ... Gulf
Tagrisso shown to slow lung cancer spreading to brain, says AstraZenecaAstraZeneca’s top-selling drug Tagrisso has been shown to slow the spread of a certain type of lung cancer to the brain when diagnosed at an early ... Healthy Living
Immunotherapy boosts survival outlook for lung cancer patientsAn immunotherapy treatment helped significantly boost survival rates among patients suffering from advanced lung cancer, according to the results of a ... Healthy Living
Veteran television host Larry King reveals lung cancer diagnosisLarry King has revealed that he was diagnosed with stage 1 lung cancer and had successful surgery this summer.“I didn’t have any pain, but ... Television & Radio
Cigarette filters may increase lung cancer riskCigarette filters, introduced decades ago to reduce the amount of tar smokers inhale, also alter other properties of smoke and smoking in a way that ... Healthy Living
Conservative radio host Rush Limbaugh announces lung cancer diagnosis on airConservative radio talk show host Rush Limbaugh announced on Monday that he has been diagnosed with “advanced lung cancer” but plans to ... Television & Radio