Sotorasib is under clinical development by Amgen and currently in Phase III for Metastatic Colorectal Cancer. According to GlobalData, Phase III drugs for Metastatic Colorectal Cancer have a 51% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Sotorasib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Sotorasib overview

Sotorasib (Lumakras / Lumykras) is a acrylamide derivative, acts as antineoplastic agent. It is formulated as film-coated tablets for oral route of administration. It is indicated for the treatment of adult patients with KRAS-G12C mutated locally advanced or metastatic non-small cell lung cancer and it is also indicated for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.

Sotorasib (AMG-510) is under development for the treatment of solid tumors including non-squamous non-small cell lung cancer with a specific KRAS mutation, appendiceal cancer and colorectal cancer. The drug candidate is administered through oral route in the form of tablet. The drug candidate is a small molecule targeting KRAS (G12C).

it was also under development for unresectable or metastatic pancreatic cancer.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

For a complete picture of Sotorasib’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.