Sotorasib, which is claimed to be the first KRAS G12C inhibitor to enter the clinic, is being assessed in the wide clinical programme examining 10 combinations with global sites spreading across four continents.
Amgen stated that the sotorasib clinical programme has also built the clinical data set with over 600 patients studied across 13 tumour types.
The designation and real-time oncology review (RTOR) of sotorasib is based on positive phase 2 results in patients with advanced NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy.
CodeBreaK 100 is the first phase 1 and 2, first-in-human and open-label multicentre study that recruited patients with KRAS G12C-mutant solid tumours.
According to the company, the primary endpoint for the phase 2 study was centrally assessed objective response rate.
Amgen recruited 126 NSCLC patients, of which 123 had centrally evaluable lesions by RECIST at baseline. With topline results are expected in 2021, the phase 2 trial in colorectal cancer (CRC) is fully recruited.
The company is also currently recruiting subjects in the phase 3 randomised active-controlled study to compare sotorasib with docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200).
Amgen research and development executive vice president Dr David Reese said: “Breakthrough therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers.
“We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it.”
Earlier this month, Amgen, along with two other drugmakers Takeda and UCB, has enrolled the first patient in a global platform trial of hospitalised patients with Covid-19.