© Reuters. Amgen Inc.’s cancer drug, Lumakras, is displayed in its packaging at Thousand Oaks, in California, USA on September 10, 2022. Amgen / Handout via REUTERS
By Deena Beasley
(Reuters) – Amgen Inc The company said on Sunday it said Lumakras’ (NASDAQ:) oral tablet reduced the risk of disease progression in patients with end-stage lung cancer by 34% compared with chemotherapy in a clinical trial. ready.
There was no significant difference in overall survival between the two treatments in the validation study required by US regulators as a condition for expedited approval for Lumakras. But Amgen said the test was not designed to detect differences in survival.
The company is also testing whether the drug could be effective against lung cancer in its early stages, and said last month a small study of Lumakras combined with the Immunoassays have shown a high rate of hepatotoxicity and require further study.
More detailed results from the 345-patient study, including median progression-free survival – the length of time until the cancer starts to get worse – will be presented Monday at the meeting. annual European Society of Medical Oncology (ESMO) in Paris.
Wall Street analysts, such as Michael Yee at Jefferies, say investors expect modest gains of about two months on Amgen versus 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 drug is designed to target a mutated form of a gene called KRAS that occurs in about 13% of non-small cell lung cancer cases, the most common form of the disease and less frequent in some tumors other snakes.
Amgen’s chief of oncology, Jean-Charles Soria, told Reuters: “We’re making a choice…
Lumakras was approved by the US Food and Drug Administration last year under an accelerated pathway for patients with end-stage lung cancer with the KRAS mutation whose disease has worsened after treatment. with chemotherapy or other drugs.
The agency also asked Amgen to study a lower dose of Lumakras, chemically known as sotorasib. Those results are expected in the fourth quarter of this year, the company said.
The FDA is expected to issue an approval decision on a potential KRAS-targeting drug, Mirati Therapeutics (NASDAQ: Inc’s adagrasib, in mid-December.
Mirati in May said adagrasib shrunk tumors in 44% of terminal lung cancer patients in clinical trials, but also caused serious side effects in 43% of them.
At this week’s ESMO meeting, Amgen also presented initial data from the trial of Lumakras in combination with other cancer drugs for patients with colorectal cancer.