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Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated metastatic colorectal cancer (mCRC).
The regulatory body approved Lumakras plus Vectibix for treating KRAS G12C-mutated mCRC in adult patients who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Lumakras is presently approved for treating advanced or metastatic non-small cell lung cancer (NSCLC). The drug was approved in the United States in May 2021 and in the EU (marketed as Lumykras) in January 2022.
In the past year, shares of Amgen have dropped 12.2% compared with the industry’s decline of 14.1%.
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Latest Nod Based on AMGN's CodeBreaK 300 Study
Lumakras’ approval for the mCRC indication was based on data from the phase III CodeBreaK 300 study, which evaluated Lumakras plus Vectibix versus the investigator's choice of therapy in KRAS G12C–mutated mCRC.
Data from the CodeBreaK 300 study showed that treatment with Lumakras plus Vectibix led to superior progression-free survival (PFS) versus the investigated standard-of-care (SOC) in KRAS G12C-mutated mCRC – the study’s primary endpoint.
The study evaluated two different doses of Lumakras (960 mg daily or 240 mg daily) in combination with Vectibix versus the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC.
Per management, the combo of Lumakras plus Vectibix is now the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to demonstrate superior PFS versus the investigated SOC.
Data from the CodeBreaK 300 study also showed that treatment with Lumakras plus Vectibix demonstrated favorable overall survival and overall response rate in treating KRAS G12C-mutated mCRC – the study's key secondary endpoints.
More Updates on AMGN's Lumakras
In the first nine months of 2024, Lumakras recorded sales worth $265 million, reflecting an increase of 30.5% on a year-over-year basis.
Label expansion studies on Lumakras in earlier lines of therapy, which have the potential to significantly expand the currently addressable patient population, are ongoing.
Amgen is also evaluating Lumakras in phase I and phase II studies for treating NSCLC as monotherapy and in combination with other therapies. Approval for expanded indications can potentially boost the drug’s sales in future quarters.
AMGN's Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold).