Amgen Lumakras seeks full approval, KRAS inhibitor competitor trial data to be "invalidated"

At the 2022 European Society of Medical Oncology (ESMO) congress held recently, Amgen released the detailed results of its Lumakras (sotorasib) global Phase 3 CodeBreaK 200 trial, in which previously treated KRAS G12C mutant non-small cell lung cancer patients, Lumakras reduced the risk of disease progression or death by 34%

Lumakras is currently the only KRAS inhibitor product

The proportion of patients in the Lumakras group who survived for one year was 24.

For patients without the exact time of disease progression, Lumakras' performance appeared relatively weak

Based on historical data, industry watchers largely expect a two-month difference

Lumakras also appears to have a lower tumor response rate in the new trial than in earlier studies

Jean-Charles Soria, MD, senior vice president of global development of oncology at Amgen, noted in an interview ahead of the data release that the patients in the two studies were slightly different

The trial investigators said it was not surprising

Regarding whether Lumakras improved the life expectancy of patients, there was no significant difference

As the first randomized study of KRAS inhibitors, CodeBreaK 200 also has the potential to block the accelerated approval path

Meanwhile, Amgen and Mirati are also battling for colorectal cancer in a new field, and so far, Amgen has fallen behind

At ESMO 2022, updated data from the Phase 1b CodeBreaK 101 trial showed that Lumakras' combination with Amgen's EGFR inhibitor Vectoribix (panitumumab) narrowed tumors

In contrast, according to new data from the Krystal-1 trial presented at the ESMO conference, Mirati's adagrasib, in combination with Eli Lilly's EGFR inhibitor Erbitux, reported a 46 percent colorectal cancer response rate

However, Mirati's data involved 28 patients, and Amgen's data involved

References: New Drug Frontier WeChat public account, Amgen official website, fiercepharma.
com