Mirati - oncology?

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The class is shutting the bed.


STAT:Amgen declares success, and little else, in Phase 3 cancer trial

Amgen’s cancer treatment Lumakras met its primary endpoint in a pivotal lung cancer study, the company said yesterday in a statement that divulged almost no other information on the closely watched therapy.

The study, designed to confirm an earlier trial that won Lumakras FDA approval, enrolled 345 patients with a specific form of non-small cell lung cancer who had already been treated with chemotherapy and a checkpoint inhibitor like Keytruda. Amgen’s drug met its goal of beating the standard of care on the measure of progression-free survival, the company said. Details — including the size of Lumakras’ benefit — will have to wait for a later medical meeting, Amgensaid.

Lumakras, approved last year as the first treatment for patients with lung cancer caused by a specific genetic mutation to the KRAS protein, has been a commercial disappointment thus far. Earlier this month, a study combining Lumakras with checkpoint inhibitors ran into serious liver side effects, forcing lung cancer patients to abandon treatment and leading to substantially lower tumor response rates.
 
































“The Lumakras story is not over by any means, but these results are going to disappoint the field, there’s no doubt about that.”


Amgen’s pathbreaking cancer treatment disappoints


Amgen’s Lumakras made history in 2021 as the first medicine granted conditional approval for difficult-to-treat cancers with mutations to a gene called KRAS. But more recent data suggest the drug isn’t as powerful as it once seemed, with the latest disappointment coming from a study designed to confirm that pioneering approval.

As STAT’s Adam Feuerstein reports, Lumakras met its primary endpoint in the lung cancer trial by delaying tumor growth by a little more than one month compared to the standard chemotherapy, docetaxel, a lower-than-expected improvement that will likely lead to full FDA approval. However, a secondary analysis of overall survival trended in the wrong direction: Patients given docetaxel lived longer by three weeks compared to patients treated with Lumakras.

To oncologists, the results were a surprising setback, even though Amgen’s drug met its primary goal. “If you had asked any lung cancer specialist what was going to happen when you compare Lumakras to docetaxel, none would have told you that there’d be no survival benefit,” said Benjamin Levy, a lung cancer physician and clinical director of medical oncology at Johns Hopkins Sidney Kimmel Cancer Center. “The Lumakras story is not over by any means, but these results are going to disappoint the field, there’s no doubt about that.”

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anonymous said:
“The Lumakras story is not over by any means, but these results are going to disappoint the field, there’s no doubt about that.”


Amgen’s pathbreaking cancer treatment disappoints


Amgen’s Lumakras made history in 2021 as the first medicine granted conditional approval for difficult-to-treat cancers with mutations to a gene called KRAS. But more recent data suggest the drug isn’t as powerful as it once seemed, with the latest disappointment coming from a study designed to confirm that pioneering approval.

As STAT’s Adam Feuerstein reports, Lumakras met its primary endpoint in the lung cancer trial by delaying tumor growth by a little more than one month compared to the standard chemotherapy, docetaxel, a lower-than-expected improvement that will likely lead to full FDA approval. However, a secondary analysis of overall survival trended in the wrong direction: Patients given docetaxel lived longer by three weeks compared to patients treated with Lumakras.

To oncologists, the results were a surprising setback, even though Amgen’s drug met its primary goal. “If you had asked any lung cancer specialist what was going to happen when you compare Lumakras to docetaxel, none would have told you that there’d be no survival benefit,” said Benjamin Levy, a lung cancer physician and clinical director of medical oncology at Johns Hopkins Sidney Kimmel Cancer Center. “The Lumakras story is not over by any means, but these results are going to disappoint the field, there’s no doubt about that.”

Read more.
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The Meek kiss of death takes out another company.
 
























The good news is no more scissoring innuendos thrown in our faces 24/7. We have no good visionary leaders at the VP levels and their ignorance is showing. All smoke and mirror smiles.
 








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