Clinical Amgen's Lumakras Shows Promise in Late-Stage Colon Cancer Trial

Amgen’s Lumakras Shows Promise in Late-Stage Colon Cancer Trial


Amgen has announced successful results from a late-stage clinical trial for its KRAS-blocking drug, Lumakras. The trial, known as CodeBreak 300, focused on patients with a certain type of colon cancer and measured progression-free survival. Both tested doses of Lumakras met the trial’s main goal, with positive outcomes observed when Lumakras was combined with the drug Vectibix.

The Food and Drug Administration (FDA) previously approved Lumakras for the treatment of lung cancer, targeting tumors driven by the mutated KRAS gene. While initial studies showed limited effectiveness of Lumakras as a standalone treatment for colon cancer, Amgen proceeded to explore its potential when combined with Vectibix, an antibody-drug also sold by the company. Encouraging results from the fall of 2021 led to the commencement of the Phase 3 trial, which has now produced favorable outcomes.

Although Lumakras’ approval was considered a significant achievement in research, its sales have not met analysts’ early expectations. Despite generating $77 million in sales between April and June, this figure remains similar to the same period the previous year. Amgen attributes the slower growth in Lumakras prescription volume to both lower net selling prices and inventory stocking, which have offset its potential expansion.

Apart from Lumakras’ success in colon cancer, Amgen has made public its choice to suspend enrollment in a study that explored the combination of Lumakras with a common type of immunotherapy for lung cancer. This decision was prompted by previous data that raised concerns about potential lung toxicity arising from such combinations. Amgen’s primary focus is now on prioritizing patient safety above all else.

Amgen is now focused on converting Lumakras’ accelerated approval for lung cancer into full approval, with the FDA set to make a decision by December 24 based on Phase 3 study findings comparing Lumakras with chemotherapy in individuals with non-small cell lung cancer.

Furthermore, Amgen shared encouraging results from a Phase 2 study of tarlatamab, another cancer drug developed by the company. The study focused on individuals with the less common small cell form of lung cancer, showing promising potential for this novel bispecific antibody.

Amgen’s Lumakras has shown promising results in a late-stage colon cancer trial, and the company is continuing to explore its potential in lung cancer while prioritizing patient safety in combination therapies. The biotechnology firm also demonstrated positive developments with its bispecific antibody tarlatamab in the context of small cell lung cancer. Specific data from the Lumakras trial will be presented at an upcoming medical meeting, and the company is eager to discuss its findings with regulators as it aims for further advancements in cancer treatment.

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