Olafertinib is under clinical development by Checkpoint Therapeutics and currently in Phase II for Non-Small Cell Lung Cancer. According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 39% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Olafertinib’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.

Olafertinib overview

Olafertinib is under development for the treatment of non-small cell lung cancer in patients with EGFR T790M mutation as second-line therapy. It is administered orally. The drug candidates target the epidermal growth factor receptor (EGFR). It is developed based on structure-based drug design platform.

Checkpoint Therapeutics overview

Checkpoint Therapeutics, a subsidiary of Fortress Biotech Inc, is a clinical-stage biopharmaceutical company that acquires, develops, and commercializes novel treatments for solid tumor cancers. Its lead product candidate, CK-101 molecule is in Phase I clinical trials for the treatment of patients with positive epidermal growth factor receptor (EGFR). The company’s other lead product candidate CK-301, is an anti-PD L1 antibody intended for the treatment of patients with non-small cell lung cancer (NSCLC) and other solid tumors. Its other pipeline products include a portfolio of human immuno-oncology agents and targeted anti-cancer agents intended for the treatment of multiple types of cancer including renal cell carcinoma, EGFR mutation-positive NSCLC and multiple forms of cancer. The company also works in partnership with other pharmaceutical companies to co-develop its antibodies. Checkpoint Therapeutics is headquartered in New York, the US.

For a complete picture of Olafertinib’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.