BMS is evaluating monoclonal antibody BMS-986012 in the Phase II study until 2025. Credit: Katherine Welles/Shutterstock.

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s (BMS) Krazati (adagrasib) as a second-line treatment for KRAS-mutated locally advanced or metastatic colorectal cancer.

The drug’s approved use will be in combination with Eli Lilly’s epidermal growth factor receptor (EGFR) antagonist Erbitux (cetuximab). Krazati gained US FDA accelerated approval as a second-line treatment of KRAS-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in 2022.

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Krazati’s conditional approval in colorectal cancer was based on data from the open-label Phase I/II KRYSTAL-1 trial (NCT03785249). The study evaluated the Krazati and Erbitux combination therapy in 94 patients with KRAS-mutated colorectal cancer. The study met its primary endpoint with an overall response rate of 34%, all of which were partial responses. The median duration of response was 5.8 months.

Serious adverse reactions occurred in 30% of the trial participants. The most common adverse events included non-specific side effects like rash, nausea, diarrhoea, vomiting and fatigue along with liver toxicity, anaemia and peripheral neuropathy.

Krazati targets an altered protein produced by a KRAS-G12C mutation, thereby making it inactive. BMS added the therapy to its portfolio as part of the $5.8bn acquisition of Mirati Therapeutics. Krazati pulled in $21m in sales in the first quarter of this year, per BMS financials. It is expected to generate $1.3bn in global sales in 2029, as per GlobalData’s analysis.

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In comparison, Krazati’s main competitor, Amgen’s KRAS inhibitor Lumakras (sotorasib), is forecasted to generate $1bn in global sales in the same period. In October 2023, a US FDA Drug Advisory Committee voted against the drug’s full approval in NSCLC, stating that the supporting data for the treatment was unreliable to support full approval for Lumakras.

Amgen is seeking approval for Lumakras in colorectal cancer indication as well. In October 2023, the company presented positive data from the Phase III CodeBreak 300 trial (NCT05198934) evaluating Lumakras in combination with the company’s EGFR antagonist Vectibix (panitumumab) in patients with KRAS-mutated locally advanced or metastatic colorectal cancer.

At a median follow-up of 7.8 months, the participants in the Lumakaras/Vectibix combination therapy group had a median progression-free survival (PFS) of 5.6 months, compared with a 2.2-month PFS in the other arm for the investigator’s choice of therapy. Amgen plans to apply for US FDA approval for the Lumakras and Vectibix combination therapy in the first half of this year.