Amgen’s Immunotherapy for Lung Cancer Reduces Disease Progression by 34%

Results from the Phase III CodeBreaK 200 clinical trial found that Amgen’s targeted therapy Lumakras successfully extended progression-free survival (PFS) by about two months and was 15% more effective at extending PFS to one year when compared to docetaxel chemotherapy. During the trial, patients taking Lumakras suffered fewer treatment-related adverse events (TRAE) versus docetaxel, including 7% fewer minor TRAEs and 12% fewer severe TRAEs. 

CodeBreaK was the first phase III clinical trial for a KRAS immunotherapy to show significant all-around improvement over chemotherapy. Despite the PFS improvements, the trial did not demonstrate an improved survival rate in patients using Lumakras compared to those using docetaxel. 

Amgen received accelerated FDA approval for its novel KRAS G12C inhibitor last year, and it remains the only immunotherapy available to treat this kind of cancer mutation.  

The approval of Lumakras has relieved patients who previously lacked a targeted therapy for their specific type of cancer. NSCLC diagnoses currently comprise 85% of all lung cancer cases in the United States, and KRAS G12C mutations drive about 13% of those diagnoses or roughly 23,000 cases each year. 

"The totality of evidence from this study supports LUMAKRAS as an important targeted treatment option for patients with non-small cell lung cancer who harbor the KRAS G12C mutation and reinforces the critical need for comprehensive biomarker testing for all patients with advanced disease," said David M. Reese, MD, executive vice president of Research and Development at Amgen. 

According to their press release, Amgen is continuing to study the effectiveness of Lumakras against early lung cancer, although a small initial study has discovered high rates of liver toxicity.  

Besides Lumakras, the oncology division at Amgen is investigating 18 different agents for their use in treating 11 types of cancer. And to build upon its internal assets, Amgen recently acquired the immuno-oncology firm Five Prime Therapeutics and its pipeline of drugs in a $1.9 billion deal.  

Amgen is now finding success with its portfolio of monoclonal antibodies. Last year, the company received FDA approval for its cholesterol treatment, Repatha, a targeted therapy that treats hypercholesterolemia in children. Tezspire, Amgen’s monoclonal antibody for severe asthma, was granted FDA approval around the same time.  

Through a development partnership, pharmaceutical companies Eli Lilly and Amgen leveraged their pharmaceutical manufacturing and unique investigative agents early in the pandemic to create monoclonal antibodies that treated COVID-19. Amgen is now pursuing additional protein therapeutics in partnership with Generate Biomedicine’s machine learning technology platform.