Release Date: 24-May-2023
Lumakras was the first KRAS inhibitor to be granted approval by the FDA in 2021 post which it has been showing a continuous growth in its sales. From earning US$ 90 Million in 2021, Amgen earned US$ 285 Million in 2022, which is a substantial growth for a novel drug. The drug was approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing the KRAS G12C mutation. Recently, data from a phase I/II clinical trial with patients suffering from heavily pretreated, metastatic pancreatic cancer harboring G12C mutation showed that Lumakras demonstrated promising anti-cancer activity, proving that targeting the KRAS mutations is a feasible approach for treating advanced pancreatic cancer as well.
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Coming second to Lumakras is Krazati, developed and manufactured by Mirati Therapeutics. Krazati was only recently approved by the FDA in December 2022, and the drug is yet to be launched in the market. Its EMA approval is also awaited after which it is anticipated to enter the US and EU markets, generating huge revenues for Mirati. Both Lumakras and Krazati have been approved for the same indication but Mirati claims that Krazati has better overall response rate and longer median duration of responses which makes it the better of the two. Krazati can also readily penetrate the central nervous readily, making it a choice to consider when making a treatment plan for patients whose cancers have metastasized to the brain.
Apart from these two, JDQ443, mRNA-5671, RMC-6291 and siG12D LODER are some other candidates present in different phases of clinical trials. A number of prominent pharmaceutical companies have been developing drugs and therapies targeting different KRAS mutations and it is anticipated the next 5-6 years will see in the approval of more KRAS inhibitors. Some companies having KRAS targeting drugs in their pipeline include Novartis, Jacobio Pharmaceuticals, Boehringer Ingelheim, Gilead Sciences, Mirati and Eli Lilly, while Antengene, Shanghai Henlius and Genhouse Bio have assets in preclinical stages. Moreover, D3S-001, an asset of D3 Bio was recently granted the FDA fast track designation for the treatment of colorectal cancer bearing the KRAS G12C mutation which makes it eligible for FDA’s expedited programs if relevant criteria are met.
Similar to other immunotherapies, treatment with KRAS inhibitors is also faced with resistance from cancer cells. To overcome this, many combination therapies are being assessed in clinical trials, mostly in combination with an inhibitor targeting the PD-1 immune checkpoint protein. Synergic blockade of KRAS and PD-1 have shown exceptional results in clinical trials, which has fueled the evaluation of more KRAS inhibitors with PD-1 inhibitors. Mirati is conducting clinical trials assessing the synergic effects of Krazati with inhibitors of PD -1/PD-L1 and additionally, nectin-4.
Cancer has emerged as one of biggest causes of deaths among the morbid population and the numbers do not seem to decline. Therefore, it has become essential to come up with appropriate treatment strategies to obstruct the different mechanisms adopted by cancer cells to grow and metastasize. The KRAS protein is now known to play an important role in many steps of cancer and has emerged as a significant target in cancer therapeutics. A number of favorable factors are fueling the development of KRAS targeting drugs as a result of which, numerous candidates have entered the clinical and developmental pipelines. It is anticipated that some more candidates will get regulatory and market approval in the coming few years, which will generate more interest in the KRAS protein. It is also expected that as a result of future research, drugs targeting other KRAS mutations will be developed because different cancers overexpress different mutations, which can change the strategies employed for treatment.