At Present Only 2 Drugs Are Approved In Market With More Than 90 Drugs In Clinical Trials
KRAS-targeted therapies have emerges as a groundbreaking opportunity in oncology drug development, addressing a long-standing challenge in cancer treatment. after decades of being considered “undruggable”, the KRAS protein has finally succumbed to therapeutic intervention, opening a substantial commercial opportunity for pharmaceutical companies. The market for these therapies has shown a remarkable growth since the first approval in 2021, exceeding US$ 300 million in 2023, driven by high unmet medical needs and the prevalence of KRAS mutations in various cancers.
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As of July 2024, two KRAS targeted therapies have received approval. The first, Lumakras (sotorasib) from Amgen, was approved in May 2021 for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations. The second, Krazati (adagrasib) from Mirati Therapeutics, received approval in December 2022, also for NSCLC patients with KRAS G12C mutations. Furthermore, in June 2024, it received an accelerated approval for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in combination with Erbitux (cetuximab). These approvals have validated the KRAS-targeting approach and paved the way for further development in this space.
Currently undergoing late-stage clinical trials and possibly the next in line for regulatory clearance are D-1553 (Garsorasib) from Chia Tai Tianqing Pharmaceutical, Glecirasib (JAB-21822) from Jacobio Pharma, and MK-1084 from Merck, among others. This shows the robust involvement of pharmaceutical companies around the world working to improve treatment outcomes for patients with KRAS-mutated cancers. In addition, certain regional drug regulatory agencies have accepted the New Drug Application (NDA) for Glecirasib and Garsorasib, as well as a few others. These drugs are anticipated to be approved and launched within the next year.
The commercial opportunity for KRAS-targeted therapies is significant, underpinned by several key factors. KRAS mutations occur in approximately 25% of all cancers, with particularly high frequencies in pancreatic cancer, colorectal cancer and lung cancer. This translates into a substantial patient population, providing a large addressable market. While current approved therapies majorly focus on the G12C mutations, such as G12V and G12D. Success in these areas would significantly expand the market potential.
Combination therapies represent another avenue for growth. KRAS inhibitors are being studies in combination with targeted therapies, immunotherapies, and standard-of-care treatments. For instance, Sidney Kimmel Comprehensive Cancer Center is conducting a Phase 1 clinical trial assessing the combination of a KRAS-targeted vaccine with Nivolumab (anti-PD-1) and Ipilimumab (anti-CTLA-4) for patients with NSCLC. Successful combinations could lead to improved efficacy, expanded indications, and increased market share. Additionally, the global potential is considerable. Initial approvals have focused on the US market, but global expansion presents significant opportunities, particularly in Europe and Asia.
As precision medicines addressing a critical unmet need, KRAS-targeted therapies command premium pricing. For example, Lumakras is priced at approximately US$ 22,245 per month in the US. This pricing strategy, combined with the potential for label expansion to other KRAS-mutated cancers, further enhances the commercial prospects of these therapies.
The rapid market growth and intense research activity in this field suggests that KRAS-targeted therapies will continue to be a major focus of for pharmaceutical companies and investors. As more data emerges from ongoing clinical trials and potentially new approvals are granted, the market is expected to expand significantly in the coming years, possibly reaching billions of dollars annually within the next decade.
